Search Results
within category "Diabetes & Hormones"
Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Efficacy and Safety of Efpeglenatide Versus Placebo in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Alone or in Combination With Oral Antidiabetic Drug(s) (AMPLITUDE-L)
Primary Objective:
To demonstrate the superiority of once weekly injection of efpeglenatide in comparison to
placebo in glycated hemoglobin (HbA1c) change in participants with type 2 diabetes mellitus
(T2DM) inadequately controlled with basal insulin alone or in combination with oral
antidiabetic drugs (OADs).
Secondary Objectives:
- To demonstrate the superiority of once weekly injection of efpeglenatide in comparison
to placebo on glycemic control.
- To demonstrate the superiority of once weekly injection of efpeglenatide in comparison
to placebo on body weight.
- To evaluate the safety of once weekly injection of efpeglenatide.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03713684
STU-2019-1783
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Inclusion criteria:
• Participant must be ≥18 years of age at the time of signing the informed consent.
• Participants with type 2 diabetes mellitus (T2DM).
• Diabetes diagnosed at least 1 year before screening.
• Participants on basal insulin regimen alone or in combination with oral antidiabetic
drugs (OADs) for at least 6 months prior to screening.
• Glycated hemoglobin (HbA1c) between 7.0% and 10.0% (inclusive) measured by the central
laboratory at screening.
Exclusion criteria:
• History of severe hypoglycemia requiring emergency room admission or hospitalization
within 3 months prior to screening.
• Retinopathy or maculopathy with one of the following treatments, either recent (within
3 months prior to screening) or planned: intravitreal injections or laser or
vitrectomy surgery.
• Clinically relevant history of gastrointestinal disease associated with prolonged
nausea and vomiting, including (but not limited to) gastroparesis, unstable and not
controlled gastroesophageal reflux disease requiring medical treatment within 6 months
prior to screening.
• History of pancreatitis (unless pancreatitis was related to gallstones and
cholecystectomy has been performed), pancreatitis during previous treatment with
incretin therapies, chronic pancreatitis, pancreatectomy.
• Personal or family history of medullary thyroid cancer (MTC) or genetic conditions
that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
• Body weight change of ≥5 kg within the last 3 months prior to screening.
• Systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg at
randomization.
• End-stage renal disease as defined by estimated glomerular filtration rate (eGFR, by
Modification of Diet in Renal Disease [MDRD]) of <15 mL/min/1.73 m2.
• Laboratory findings at the screening Visit:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper
limit of normal (ULN) or total bilirubin >1.5 x ULN (except in case of documented
Gilbert's syndrome);
• Amylase and/or lipase: >3 x ULN;
• Calcitonin ≥5.9 pmol/L (20 pg/mL).
• Gastric surgery or other gastric procedures intended for weight loss within 2 years
prior to screening, or planned during study period.
• Pregnant (confirmed by serum pregnancy test at screening) or breast-feeding women.
• Women of childbearing potential (WOCBP) not willing to use highly effective method(s)
of birth control or who are unwilling to be tested for pregnancy during the study
period and for at least 5 weeks after the last dose of study intervention.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes (FOCUS)
This study will look at the long-term effects of semaglutide (active medicine) on diabetic
eye disease when compared to placebo (dummy medicine). The study will be performed in people
with type 2 diabetes. Participants will either get semaglutide or placebo in addition to
their diabetes medicines - which treatment the participant gets is decided by chance.
Participants will inject the study medicine using a pen-injector. The medicine must be
injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last
for 5 years.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03811561
STU-2019-0479
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Inclusion Criteria:
• Male or female, age greater than or equal to 18 years at the time of signing informed
consent
• Diagnosed with type 2 diabetes mellitus greater than or equal to 10 years prior to the
day of screening
• HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
• Eye inclusion criteria (both eyes must meet all criteria):
• Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive)
evaluated by fundus photography and confirmed by central reading centre
• No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema
twelve months prior to the day of screening
• No anticipated need for ocular or intraocular treatment for diabetic retinopathy or
diabetic macular oedema within six months after randomisation
• Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS
visual acuity protocol
• No previous treatment with pan-retinal laser photocoagulation
• No substantial non-diabetic ocular condition that, in the opinion of the
ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema
progression during the trial
• No substantial media opacities that would preclude successful imaging
Exclusion Criteria:
• Any of the following: myocardial infarction, stroke, hospitalization for unstable
angina pectoris or transient ischaemic attack within the past 60 days prior to the day
of screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
• Subjects presently classified as being in New York Heart Association (NYHA) Class IV
• Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR
less than 30 ml/min/1.73 m^2
• Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or
medullary thyroid carcinoma
• Presence or history of malignant neoplasms within the past 5 years prior to the day of
screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
• Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using highly effective contraceptive methods
• Current or previous (within 30 days before screening) treatment with any glucagon like
peptide-1 (GLP-1) receptor agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor
• Receipt of any investigational medicinal product within 30 days before screening
• Previous participation in this trial. Participation is defined as randomisation
• Known or suspected hypersensitivity to trial products or related products
• Any disorder, which in the investigator's opinion might jeopardise subject's safety or
compliance with the protocol
A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome (GRACE)
This is a Phase 3, double-blind, placebo-controlled, randomized-withdrawal study to assess
the efficacy, safety and pharmacokinetics (PK) of relacorilant in patients with endogenous
Cushing syndrome and concurrent type 2 diabetes mellitus/impaired glucose tolerance and/or
uncontrolled hypertension
Call 214-648-5005 studyfinder@utsouthwestern.edu
Oksana Hamidi
179331
All
18 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03697109
STU-2019-0789
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Inclusion Criteria:
• Has a confirmed diagnosis of endogenous Cushing syndrome
• Meets at least one of the following criteria:
• Has Type 2 diabetes mellitus
• Has impaired glucose tolerance
• Has hypertension
Exclusion Criteria:
• Has non-endogenous source of hypercortisolemia
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
• Has poorly controlled hypertension
• Has poorly controlled diabetes mellitus
• Has severe renal insufficiency
Improving Chronic Disease Management With Pieces (ICD-Pieces)
ICD-Pieces (Parkland Intelligent e-Coordination and Evaluation System) trial is a National
Institutes of Health (NIH) Healthcare Systems(HCS) Collaboratory demonstration project to
improve management of patients with a triad of Chronic Kidney Disease, hypertension and
diabetes with Pieces in four HCS including Parkland, Texas Health Resources (THR), ProHealth
Physicians Incorporation and North Texas VA. Pieces is a decision support technology platform
created by Parkland Center for Clinical Innovation(PCCI).
The primary objective is to test the hypothesis that a collaborative model of primary care
and subspecialty care intervention enhanced by Pieces and practice facilitators compared to
standard clinical practice will reduce all-cause hospitalizations in patients with coexisting
chronic kidney disease, diabetes and hypertension.
Secondary objectives are: a)Test if implementation of the collaborative model will reduce
30-day readmissions, emergency room visits, cardiovascular events or deaths and
disease-specific hospitalizations; b) Develop and validate risk predictive models for
disease-specific hospitalizations, all-cause hospitalizations, 30-day readmissions, emergency
room visits, cardiovascular events and deaths for patients with chronic kidney disease,
diabetes and hypertension. c) Collect demographic and clinical data to assist phenotyping
patients with chronic kidney disease, diabetes and hypertension. d) Obtain safety data
including Acute Kidney Injury, progression of chronic kidney disease, electrolyte
disturbances and medication errors, and drug toxicity; e) Collect resource utilization
information including hospitalizations, emergency room visits, outpatient visits, and
diagnostic or therapeutic procedures completed.
Candidate patients in selected clinics will be enrolled over a period of 2 years and followed
for 12 months. Pieces will ascertain both primary and secondary outcomes from the Electronic
Health Record supported with data from the Dallas Fort Worth Hospital Council (DFWHC),
Accountable Care Organization (ACO) reports and VA database, and deaths from Social Security
Index (SSI) data.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Miguel Vazquez
17567
All
18 Years to 85 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02587936
STU 062015-016
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Inclusion Criteria
• CKD Inclusion Criteria (present at least ≥ 3 months apart)
1. There will be two or more Estimated Glomerular Filtration Rate (eGFRs)
calculations less than 60ml/minute (corrected for BSA) or
2. Two or more positive tests for albuminuria and/or proteinuria
Albuminuria/proteinuria can be defined by quantitative criteria with
albumin/creatinine ratio greater than 30mg/g, urine protein creatinine ratio
greater than 200mg/g or positive dipstick with protein detection (adjusted for
urinary concentration/specific gravity).
• Diabetes Inclusion Criteria Only patients with type 2 diabetes will be enrolled in
this study.
1. Random blood glucose greater than 200mg/dL
2. Hemoglobin A1C greater than 6.5%
3. Use of hypoglycemic agents or
4. Type 2 diabetes included in problem list
• Hypertension Inclusion Criteria
1. Systolic blood pressure greater than 140 mmHg on two different occasions at least
one week apart
2. Diastolic blood pressure greater than 90 on two occasions at least more than one
week apart
3. Use of antihypertensive agents except thiazide diuretics or
4. Hypertension included in problem list
Exclusion Criteria:
• Exclusion criteria will be minimal in this pragmatic trial. The collaborative model of
care will not be implemented in patients younger than 18 years or older than 85 years
of age or patients who have CKD stage 5/End Stage Renal Disease(ESRD.
• Primary care practitioners have the option of not implementing the intervention on any
of their patients if they believe benefit to be minimal or risk too high due to
patient comorbidities
Other: Collaborative Model of Primary care and Subspecialty care
Type 2 Diabetes, Hypertension, Chronic Kidney Disease, Diabetes, High BP
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of
paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT
associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The
24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing
Period 2).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Raymond Quigley
15874
All
up to 9 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04064827
STU-2019-1512
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Inclusion Criteria:
• Participant is currently diagnosed with and/or being treated for secondary
hyperparathyroidism (SHPT).
• Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving
peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial
Screening.
• For entry into the Washout Period (for vitamin D receptor activator [VDRA] non-naive
participants), the participant must meet the appropriate laboratory criteria based
upon the participant's age as described in the protocol.
• For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive
participants who have completed the Washout Period), the participant must meet the
appropriate laboratory criteria based upon the participant's age as described in the
protocol.
Exclusion Criteria:
• Participant is expected or scheduled to receive a kidney transplant within 6 months of
Screening or is a kidney transplant recipient.
• Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD)
within 6 months of the initial Screening visit.
• Participant has had a parathyroidectomy within 12 weeks prior to Screening.
• Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a
dose equivalent to more than > 0.16 mg/kg/day or 5 mg prednisone/day, whichever is
lower), 4 weeks prior to Dosing.
• Participant is receiving calcimimetics at the time of Screening or is expected to
initiate calcimimetics at any time throughout the study.
• Participant is unable to take oral medications.
This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints
using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual
Care (UC) during a 13-week study period. Participants may be enrolled initially into a
screening protocol and then transfer into the RCT protocol, or they may enter directly into
the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care
(UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas System for 3
months. At the completion of use of the BP system (end of RCT for BP Group and end of
Extension Phase for UC Group), participants will enter a 2-4 day Transition Phase and be
randomly assigned to either transition back to their usual mode of therapy (MDI or pump
therapy) based on therapeutic guidance from the iLet BP System or transition back to their
usual mode of therapy based on what their own insulin regimens were prior to enrolling in the
RCT.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Philip Raskin
15956
All
6 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04200313
STU-2019-1241
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Inclusion Criteria:
• 1. Clinical diagnosis of T1D for at least one year and using insulin for at least 1
year 2. Diabetes managed using the same regimen (either pump or MDI, with or without
CGM) for ≥ 3 months
3. Age ≥ 6 years old
• Exception: the initial 5-participant test run will be limited to >18 years old
4. Current use of a CGM, or if not a CGM user, at least 3 blood glucose meter
tests daily on average over the last 4 weeks (according to judgment of
investigator if meter is not available).
5. Willingness not to start any new non-insulin glucose-lowering agent during the
course of the trial
6. For participants <18 years old, living with one or more parent/legal guardian
knowledgeable about emergency procedures for severe hypoglycemia.
7. Investigator believes that the participant can safely use the iLet and will
follow the protocol
• The investigator will take into account the participant's HbA1c level, compliance
with current diabetes management, and prior acute diabetic complications. For
this reason, there is no upper limit on HbA1c specified for eligibility.
8. If a GLP-1 agonist or pramlintide is being used, participant must be willing
to discontinue use while the iLet BP system is being used, including the
randomized trial and extension study.
Exclusion Criteria:
• Eligibility may be assessed initially in a separate screening protocol or at a
screening visit in the RCT protocol. To be eligible for all phases of the study, a
participant must meet all of the following inclusion criteria and none of the
exclusion criteria:
Inclusion
1. Clinical diagnosis of T1D for at least one year and using insulin for at least 1 year
2. Diabetes managed using the same regimen (either pump or MDI, with or without CGM) for
≥ 3 months
3. Age ≥ 6 years old
• Exception: the initial 5-participant test run will be limited to >18 years old
4. Current use of a CGM, or if not a CGM user, at least 3 blood glucose meter tests daily
on average over the last 4 weeks (according to judgment of investigator if meter is
not available).
5. Willingness not to start any new non-insulin glucose-lowering agent during the course
of the trial
6. For participants <18 years old, living with one or more parent/legal guardian
knowledgeable about emergency procedures for severe hypoglycemia.
7. Investigator believes that the participant can safely use the iLet and will follow the
protocol
• The investigator will take into account the participant's HbA1c level, compliance
with current diabetes management, and prior acute diabetic complications. For this
reason, there is no upper limit on HbA1c specified for eligibility.
8. If a GLP-1 agonist or pramlintide is being used, participant must be willing to
discontinue use while the iLet BP system is being used, including the randomized trial
and extension study.
Exclusion
1. Unable to provide informed consent (e.g. impaired cognition or judgment)
2. Unable to safely comply with study procedures and reporting requirements (e.g.
impairment of vision or dexterity that prevents safe operation of the bionic pancreas,
impaired memory)
3. Unable to speak and read English
• For pediatric participants, both caregivers and participants must be able to speak
and read English
4. Plan to change usual diabetes regimen in the next 3 months
• This would include changing from MDI to pump. pump to MDI, change in insulin
automation delivery system, starting a CGM if not previously used, changes in
drug therapy specifically for glucose control except for changes in one insulin
analog to another.
• Changes in insulin dose, carb ratio, sensitivity factor and basal rate profile
are allowed.
5. Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery
system
6. Use of Apidra as the pre-study rapid-acting insulin analog and unwilling to switch to
lispro or aspart for the duration of the study
7. Known hemoglobinopathy (sickle cell trait is not an exclusion)
8. Current participation in another diabetes-related clinical trial
9. History of cystic fibrosis, pancreatitis, or other pancreatic disease, including
pancreatic tumor or insulinoma, or history of complete pancreatectomy
10. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be
susceptible to RF interference
11. Established history of allergy or severe reaction to adhesive or tape that must be
used in the study
12. Current use of SGLT2 inhibitors or a sulfonylurea drug (use more than 3 months prior
to enrollment is acceptable)
• If using GLP1 agonist, pramlintide, or metformin drugs must be on a stable dose for
3 months prior to enrollment (and as per inclusion criterion #8, must be willing to
discontinue use of GLP-1 agonist or pramlintide while using the iLet BP system during
the RCT and the extension phase).
13. Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 3
months, or sexually active without use of contraception
14. Renal failure on dialysis or with an eGFR <30mL/min
• If eGFR is not available within the last 12 months, it must be obtained as part of
usual care in order to confirm eligibility.
15. Presence of a medical condition or use of a medication that, in the judgment of the
investigator, clinical protocol chair, or medical monitor, could compromise the
results of the study or the safety of the participant. Conditions to be considered by
the investigator may include the following:
• Alcohol or drug abuse
• Use of prescription drugs that may dull the sensorium, reduce sensitivity to
symptoms of hypoglycemia, or hinder decision making during the period of
participation in the study
• Coronary artery disease that is not stable with medical management, including
unstable angina, angina that prevents moderate exercise (e.g. climbing a flight
of stairs) despite medical management, or within the last 12 months before
screening a history of myocardial infarction, percutaneous coronary intervention,
enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass
grafting
• Congestive heart failure with New York Heart Association (NYHA) Functional
Classification III or IV
• History of TIA or stroke in the last 12 months
• Untreated or inadequately treated mental illness
• History of eating disorder within the last 2 years, such as anorexia, bulimia, or
diabulemia or omission of insulin to manipulate weight
• History of intentional, inappropriate administration of insulin leading to severe
hypoglycemia requiring treatment
16. Employed by, or having immediate family members employed by Beta Bionics, or being
directly involved in conducting the clinical trial, or having a direct supervisor at
place of employment who is also directly involved in conducting the clinical trial (as
a study investigator, coordinator, etc.); or having a first-degree relative who is
directly involved in conducting the clinical trial
Device: Bionic Pancreas
Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 1, Other Endocrine System, Pancreas
Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency
Determine the Safety, Tolerability and Pharmacokinetics of single doses of ARCT-810 in
Clinically Stable Patients (stable on standard of care treatment, e.g., diet ± ammonia
scavengers) with Ornithine Transcarbamylase Deficiency.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Markey McNutt
59152
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04442347
STU-2020-0554
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Inclusion Criteria:
• Males and females ≥18 years of age with documented diagnosis of late onset OTC
deficiency confirmed with genetic testing.
• Subject's Ornithine Transcarbamylase deficiency (OTCD) is stable as evidenced by a) no
clinical symptoms of hyperammonemia and b) an ammonia level <100 µmol/L (170 µg/dL) at
the Screening evaluation. Subjects must remain free from symptoms of hyperammonemia
throughout the screening period.
• If using nitrogen ammonia scavenger therapy, must be on a stable regimen for ≥ 28 days
prior to signing informed consent and must remain on the same regimen throughout the
screening period
• Must have maintained a stable protein restricted diet +/- amino acid supplementation
for at least 28 days prior to signing informed consent and continue to maintain a
stable diet for the duration of the study
• No clinically significant abnormal findings on medical history, clinical laboratory
test results (other than ammonia) vital sign measurements, 12-lead ECG results, or
physical examination
• Males must be surgically sterile or willing to use adequate contraception; females
must be post-menopausal, surgically sterile or willing to use adequate contraception
Exclusion Criteria:
• History of clinically significant disease(s) (other than OTCD)
• Abnormal hepatic enzymes, significant renal impairment, clinically significant anemia
or uncontrolled diabetes
• Blood Pressure greater than 160/100 mm Hg
• Malignancy within 5 years prior to study
• Treatment with another investigational drug, biological agent, or device within one
month of screening, or 5 half-lives of investigational drug, whichever is longer
• Gene therapy within 1 year prior to screening
• Prior organ transplant
• Positive viral serology test results for HIV type 1 or 2 antibodies, hepatitis B
surface antigen (HBsAg) or hepatitis C virus (HCV) antibody
A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 1)
This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an
insulin taken once daily which is already available on the market) in people with type 2
diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to
insulin glargine taken daily. Participants will either get insulin icodec that participants
will have to inject once a week on the same day of the week or insulin glargine that
participants will have to inject once a day at the same time every day. Which treatment
participants get is decided by chance.
The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The
study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone
calls with the study doctor. At 11 clinic visits participant will have blood samples taken.
At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the
visit.
Participants will be asked to wear a sensor that measures the blood sugar all the time in 5
periods of about one month during the study (about 5 months in total). Women cannot take part
if pregnant, breast-feeding or plan to become pregnant during the study period.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04460885
STU-2020-1108
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Inclusion Criteria:
• Male or female aged above or equal to 18 years at the time of signing informed
consent.
• Diagnosed with type 2 diabetes mellitus (T2D) 180 days or more prior to the day of
screening.
• HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by
central laboratory analysis.
• Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to
the day of screening is allowed, as is prior insulin treatment for gestational
diabetes.
• Stable daily dose(s) 90 days or more prior to the day of screening of any of the
following anti-diabetic drug(s) or combination regimen(s): a. Any metformin
formulations at least or greater than 1500 mg or maximum tolerated or effective dose.
b. Any metformin combination formulations equal to or above 1500 mg or maximum
tolerated or effective dose. c. Any of the following oral anti-diabetic drug classes
including combinations ((equal to or above half of the maximum approved dose according
to local label or maximum tolerated or effective dose): Sulfonylureas, Meglitinides
(glinides), dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2
(SGLT2) inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, Oral combination
products (for the allowed individual oral anti-diabetic drugs), Oral or injectable
glucagon-like peptide 1 (GLP-1) receptor agonists
• Body mass index (BMI) equal to or below 40.0 kg/m^2.
Exclusion Criteria:
• Any episodes (as declared by the subject or in the medical records) of diabetic
ketoacidosis within 90 days prior to the day of screening.
• Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or
transient ischaemic attack within 180 days prior to the day of screening.
• Chronic heart failure classified as being in New York Heart Association Class IV at
screening.
• Anticipated initiation or change in concomitant medications (for more than 14
consecutive days) known to affect weight or glucose metabolism (e.g. treatment with
orlistat, thyroid hormones, or corticosteroids).
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a fundus examination performed within the past 90 days prior to screening or in the
period between screening and randomisation. Pharmacological pupil-dilation is a
requirement unless using a digital fundus photography camera specified for non-dilated
examination
Drug: Insulin icodec, Drug: Insulin glargine
Diabetes Mellitus, Type 2, Other Endocrine System, Pancreas
Diet Treatment Glucose Transporter Type 1 Deficiency (G1D)
Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be
enrolled. To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in
addition to IQ, language, working memory, processing speed, emotional and behavioral
functioning, ataxia, and other neuropsychological and neurological performance indices in
children and adults genetically diagnosed with G1D receiving a regular diet at enrollment.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Juan Pascual
85158
All
24 Months to 35 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03181399
STU 122016-013
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Inclusion Criteria:
• Diagnosis of glucose transporter type I deficiency (G1D), confirmed by clinical
genotyping at a CLIA-certified laboratory or by PET scan.
• Stable diet on either a modified atkins diet or on no dietary therapy (i.e., no
dietary therapy for 1 month).
• Males and females 24 months to 35 years old, inclusive.
Exclusion Criteria:
• Subjects with evidence of independent, unrelated metabolic and/or genetic disease.
• Subjects with a chronic gastrointestinal disorder, such as irritable bowel syndrome,
Crohn's disease, or colitis that could increase the subject's risk of developing
diarrhea or stomach pain.
• Subjects with a BMI (body mass index) greater than or equal to 30.
• Subjects currently on dietary therapy (i.e., ketogenic diet, medium chain triglyceride
supplemented diets, Atkins diet, low glycemic index diet).
• Subjects with no evidence of abnormal EEG (spike wave discharges) in the last 12
months.
• Women who are pregnant or breast-feeding may not participate. Women who plan to become
pregnant during the course of the study, or who are unwilling to use birth control to
prevent pregnancy (including abstinence) may not participate. Females age 10 and over
will be asked to provide a urine sample for a pregnancy test via dipstick. Subjects
will be asked to agree to abstinence or another form of birth control for the duration
of the study.
• Allergy/sensitivity to C7.
• Previous use of triheptanoin in the past 1 month. Subjects who participate in Protocol
1 of this study are thus eligible.
• Subjects exhibiting signs of dementia, or diagnosed with any degenerative brain
disorder (such as Alzheimer's disease) that would confound assessment of cognitive
changes, in the opinion of the investigator.
• Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements.
• Inability or unwillingness of subject or legal guardian/representative to give written
informed consent, or assent for children age 10-17.
• Addition of a new antiseizure drug in the previous 3 months.
Drug: Triheptanoin
Glucose Transporter Type 1 Deficiency Syndrome, Epilepsy, GLUT1DS1, Glut1 Deficiency Syndrome 1, Autosomal Recessive, Glucose Metabolism Disorders, Glucose Transport Defect, Glucose Transporter Protein Type 1 Deficiency Syndrome
A Neurosteroid Intervention for Menopausal and Perimenopausal Depression
HYPOTHESIS:
Pregnenolone administration will be associated with greater reduction in depressive symptom
severity than placebo in women with current mMDD.
STUDY AIMS:
Primary Aim: Determine if pregnenolone is associated with greater reduction in depressive
symptom severity than placebo in women with mMDD, as measured by MADRS.
Secondary Aims:
1. Determine if pregnenolone is associated with greater reduction in anxiety symptom
severity than placebo in women with mMDD.
2. Determine if pregnenolone is associated with greater improvement in cognition than
placebo in women with mMDD.
3. Determine if pregnenolone is associated with greater improvement in quality of life than
placebo in women with mMDD.
4. Determine if pregnenolone is associated with greater improvement in vasomotor symptoms
of menopause than placebo.
Mechanistic Aims:
1. Determine whether changes in neurosteroid levels with pregnenolone mediate clinical
response.
2. Determine if baseline neurosteroid levels predict pregnenolone response.
3. Determine whether depressive symptoms, anxiety, sleep or vasomotor symptoms improve
first. A crossed-lagged panel model will explore serial correlations between changes in
outcome measures.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Edson Brown
10878
Female
40 Years to 67 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03505905
STU 102017-068
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Inclusion Criteria:
The participants must meet the following criteria:
• Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years
of the last menstrual period if not surgically postmenopausal), including:
• Women who have experienced changes in menstrual cycle frequency or duration, and/or
physical symptoms indicative of menopausal transition, as determined by clinician
• Women who are using hormonal IUDs (i.e. brands Mirena and Skyla), with FSH level > 20
mIU/m (as menstrual periods are irregular with IUDs that utilize hormones, making
irregular/absent periods difficult to assess as related to the menopausal transition).
• Women with significant menopause-related physical symptoms, indicated by any of the
following criteria:
• Greene Climacteric Scale total scores > 20
• Greene Climacteric Scale sub-score for vasomotor symptoms >3
• 5 or more bothersome hot flashes per week (self-reported)
• Women meeting DSM-5 criteria for current major depressive disorder (assessed by the
SCID)
• Baseline HRSD score of ≥ 18
• Subject agrees to abstain from disallowed medications for the duration of the trial
Exclusion Criteria:
The participants must not meet any of the following criteria:
• Vulnerable populations (e.g. pregnant/nursing, severe cognitive or intellectual
impairment, incarcerated)
• Pregnancy (determined by urine pregnancy test), intending pregnancy or breast feeding
• Psychiatric disorder other than MDD that is acute and the primary focus of symptom
burden or treatment.
• History of bipolar disorder or psychotic disorder
• Current substance use disorder
• Positive baseline urine drug screen of an illicit substance (in this study: opioids
and cocaine,) with the exception of a medication used with a prescription (use of a
detected substance that is used with a prescription, such as an opioid pain
medication, is not necessarily exclusionary and will be based upon judgment of the PI,
particularly in the cases of chronic opioid use). Participants who screen positive for
marijuana will be offered a rescreen for eligibility at a later date.
• Current eating disorder
• Treatment resistant depression (failure of 2 adequate antidepressant trials or
electroconvulsive therapy (ECT) during current episode; adequate antidepressant trials
are defined as within the US FDA approved dosage for the medication and used for at
least 6 weeks, with failure described by the patient as <50% improvement based on her
subjective experience).
• High risk for suicidal acts including active suicidal ideation with plan and intent or
> 2 suicide attempts in lifetime or any attempt in the past 6 months
• Use of selective estrogen-receptor modulators (SERMs), hormone replacement therapy,
hormonal contraceptives (hormonal IUDs allowed), episodic sleep medications (chronic,
regular, stable-dose benzodiazepines and hypnotics such as zolpidem, Sonata
(Zaleplon), and Lunesta (Eszopiclone) OR sleep-seating antihistamines such as Unisom
(Doxylamine succinate) or diphenhydramine allowed) within 2 weeks of the baseline
visit and randomization. Antidepressants will be allowed for those participants who
have been taking the antidepressant for 6 weeks with a stable dose for at least 4
weeks.
• Use of natural menopause and depression supplements, phytoestrogens, soy-based
medications, steroids within 2 weeks of baseline visit and randomization.
• Use of any disallowed medications (specified in the Excluded Concomitant Medication
section below).
• Women who have received a gonadal hormonal intervention within 1 month prior to study
entry (stable thyroid medications are allowed).
• Not using a medically approved method of birth control, if sexually active and not 12
or more months since last menstrual period IUDs, condoms, abstinence are acceptable
forms of contraception in this study; due to the possible interactions with the study
medication, oral contraceptive pills will be prohibited.
• Uncontrolled hypertension (>160/95mmHg)
• Active coronary artery disease, atrial fibrillation, stroke, deep vein thrombosis,
pulmonary embolism or blood clotting disorder
• Any severe, life threatening or unstable medical condition that, based on
clinician-judgment, would make participation in the study unsafe or inappropriate
• Personal or first degree family history of known hormone sensitive tumors
• History of allergic reaction or side effects with prior pregnenolone use
• Clinically significant laboratory or physical examination findings
• Concurrent enrollment in another clinical trial
Exclusion of Concomitant Medications:
• Selective estrogen-receptor modulators (SERMs)
• Hormone replacement therapy
• Hormonal contraceptives, excluding Mirena IUD or other IUD with localized progesterone
• Natural menopause or antidepressant supplements
• Episodic sleep medications (chronic, regular, stable-dose benzodiazepines and
hypnotics such as zolpidem, Sonata (Zaleplon), and Lunesta (Eszopiclone) OR
sleep-sedating antihistamines such as Unisom (Doxylamine succinate) or diphenhydramine
allowed)
• Sub-therapeutic dosages of antidepressants used for other indications will be
permissible with the exclusion of SSRIs, SNRIs, and Wellbutrin.
• Phytoestrogens
• Soy-based medications or supplements
Drug: Pregnenolone, Drug: Placebo
Major Depressive Disorder, Menopause, Perimenopause
Study of Etelcalceide in Pediatric Subjects With Secondary Hyperparathyroidism and CKD on Hemodialysis
Study of Etelcalcetide in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic
Kidney Disease on Hemodialysis
Call 214-648-5005 studyfinder@utsouthwestern.edu
Mouin Seikaly
16504
All
up to 18 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03633708
STU-2019-0502
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Inclusion criteria
• Dry weight ≥ 7 kg during screening.
• Diagnosed with CKD and SHPT undergoing hemodialysis at the time of screening.
• Diagnosis of SHPT with the mean of the 2 consecutive central laboratory iPTH values ≥
400 pg/mL (42 pmol/L) during screening, on separate days and within 2 weeks of
enrolment.
• Serum cCa value ≥ 9.0 mg/dL (2.25 mmol/L) for subjects ≥ 2 years of age and older and
serum cCa value ≥ 9.6 mg/dL (2.4 mmol/L) for subjects 28 days to < 2 years of age
obtained from the central laboratory during screening.
• Dialysate Ca level ≥ 2.5 mEq/L during screening.
• SHPT not due to vitamin D deficiency, per investigator assessment.
Exclusion
• Anticipated or scheduled parathyroidectomy or kidney transplant during the study
period.
• Subject has received a parathyroidectomy within 6 months prior to randomization.
• Receipt of cinacalcet therapy within 30 days prior to screening assessments and
through randomization.
• Receipt of etelcalcetide within 6 months prior to screening assessments and through
randomization.
RATIONALE
The accrual of data from the laboratory and from epidemiologic and prevention trials has
improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus
(T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and
characterization of the early metabolic abnormalities in T1DM is steadily increasing.
However, information regarding the natural history of T1DM remains incomplete. The TrialNet
Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been
designed to clarify this picture, and in so doing, will contribute to the development and
implementation of studies aimed at prevention of and early treatment in T1DM.
Purpose:
TrialNet is an international network dedicated to the study, prevention, and early treatment
of type 1 diabetes. TrialNet sites are located throughout the United States, Canada,
Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is
dedicated to testing new approaches to the prevention of and early intervention for type 1
diabetes.
The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to
enhance our understanding of the demographic, immunologic, and metabolic characteristics of
individuals at risk for developing type 1 diabetes.
The Natural History Study will screen relatives of people with type 1 diabetes to identify
those at risk for developing the disease. Relatives of people with type 1 diabetes have
about a 5% percent chance of being positive for the antibodies associated with diabetes.
TrialNet will identify adults and children at risk for developing diabetes by testing for
the presence of these antibodies in the blood. A positive antibody test is an early
indication that damage to insulin-secreting cells may have begun. If this test is positive,
additional testing will be offered to determine the likelihood that a person may develop
diabetes. Individuals with antibodies will be offered the opportunity for further testing to
determine their risk of developing diabetes over the next 5 years and to receive close
monitoring for the development of diabetes.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Perrin White
17917
All
1 Year to 45 Years old
N/A
This study is also accepting healthy volunteers
NCT00097292
STU 042011-074
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Inclusion Criteria:
• Individuals 1 to 45 years old who have an immediate family member with type 1
diabetes (such as a child, parent, or sibling)
• Individuals 1-20 years old who have an extended family member with type 1 diabetes
(such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
Exclusion Criteria:
To be eligible a person must not:
• Have diabetes already
• Have a previous history of being treated with insulin or oral diabetes medications.
• Currently be using systemic immunosuppressive agents (topical and inhaled agents are
acceptable)
• Have any known serious diseases
Diabetes Mellitus, Type 1, Pancreas
"at risk" for developing type 1 diabetes, T1DM, T1D, juvenile diabetes, Type 1 Diabetes TrialNet, TrialNet
A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes (SUSTAIN FORTE)
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with
type 2 diabetes (T2D). People taking part in the study will take the medicine together with
their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a
dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance.
Participants will inject semaglutide under the skin once a week. The study will last for
about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study
doctor. At the visits participants will have blood taken and eye tests done. Women cannot
take part if pregnant, breast-feeding or planning to become pregnant during the study period.
Female participants who can get pregnant will be checked 11 times for pregnancy via urine
tests.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03989232
STU-2019-0771
Show full eligibility criteria
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Inclusion Criteria:
• Male or female, age equal to or above18 years at the time of signing informed consent
• Diagnosed with T2D at least 180 days prior to the day of screening
• HbA1c of 8-10% (64−86 mmol/mol) (both inclusive)
• Stable daily dose(s) for 90 days prior to the day of screening of:
• Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective
dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the
maximum approved dose according to local label or maximum tolerated or effective dose)
Exclusion Criteria:
• Treatment with any medication for the indication of diabetes or obesity other than
stated in the inclusion criteria within the past 90 days prior to the day of
screening. However, short term insulin treatment for a maximum of 14 days prior to the
day of screening is allowed, as is prior insulin treatment for gestational diabetes
• Renal impairment measured as estimated glomerular filtration rate (eGFR) value of <30
mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology Collaboration
(CKDEPI) creatinine equation as defined by KDIGO 2012 classification
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a fundus examination performed within the past 90 days prior to screening or in the
period between screening and randomisation. Pharmacological pupil-dilation is a
requirement unless using a digital fundus photography camera specified for non-dilated
examination
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease (FLOW)
The researchers are doing this study to see if semaglutide can slow down the growth and
worsening of chronic kidney disease in people with type 2 diabetes. Participants will get
semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants'
study medicine - which treatment participants get is decided by chance. Semaglutide is a
medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes.
Participants will get the study medicine in a pen. Participants will use the pen to inject
the medicine in a skin fold once a week. The study will close when there is enough
information collected to show clear result of the study. The total time participants will be
in this study is about 3 to 5 years, but it could be longer.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03819153
STU-2019-0651
Show full eligibility criteria
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Inclusion Criteria:
• Male or female, age above or equal to 18 years at the time of signing informed
consent. Japan: Male or female, age above or equal to 20 years at the time of signing
informed consent
• Diagnosed with type 2 diabetes mellitus
• HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol)
• Renal impairment defined either by:
1. serum creatinine-based eGFR greater than or equal to 50 and less than or equal to
75 mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
2. serum creatinine-based eGFR greater than or equal to 25 and less than 50
mL/min/1.73 m^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g
• Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone
system (RAAS) blocking agent including an angiotensin converting enzyme (ACE)
inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is
contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks
prior to the date of the laboratory assessments used for determination of the
inclusion criteria for renal impairment and kept stable until screening
Exclusion Criteria:
• Congenital or hereditary kidney diseases including polycystic kidney disease,
autoimmune kidney diseases including glomerulonephritis or congenital urinary tract
malformations
• Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to
screening
• Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or
transient ischaemic attack within 60 days prior to the day of screening
• Presently classified as being in New York Heart Association (NYHA) Class IV heart
failure
• Planned coronary, carotid or peripheral artery revascularisation
• Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal
dialysis
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a fundus examination performed within the past 90 days prior to screening or in the
period between screening and randomisation. Pharmacological pupil-dilation is a
requirement unless using a digital fundus photography camera specified for non-dilated
examination
A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL)
The researchers are doing this study to look whether the type 2 diabetes medicine,
semaglutide, has a positive effect on heart disease. Participants will either get semaglutide
tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance.
Participants must take one tablet with water every morning on an empty stomach and not eat or
drink anything for at least 30 minutes. The study will last for about 3.5-5 years.
Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women
cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during
the study period.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
50 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03914326
STU-2019-0647
Show full eligibility criteria
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Inclusion Criteria:
• Male or female, age equal to or above 50 years at the time of signing informed consent
• Diagnosed with type 2 diabetes mellitus
• HbA1c 6.5% •10.0% (47 •86 mmol/mol) (both inclusive) (latest available and no more
than 30 days old local laboratory assessment based on medical records or point of care
measurement)
• At least one of the below conditions (a-d):
a) Coronary heart disease defined as at least one of the following: i. Prior
myocardial infarction ii. Prior coronary revascularisation procedure iii. 50% or above
stenosis in coronary artery documented by cardiac catheterisation, computerized
tomography coronary angiography iv. Coronary heart disease with ischaemia documented
by stress test with any imaging modality b) Cerebrovascular disease defined as at
least one of the following: i. Prior stroke ii. Prior carotid artery revascularisation
procedure iii.50% or above stenosis in carotid artery documented by X-ray angiography,
magnetic resonance angiography, computerized tomography angiography or Doppler
ultrasound c) Symptomatic peripheral artery disease (PAD) defined as at least one of
the following: i. Intermittent claudication with an Ankle-brachial index (ABI) below
0.85 at rest ii. Intermittent claudication with a 50% or above stenosis in peripheral
artery (excluding carotid) documented by X-ray angiography, magnetic resonance
angiography, computerized tomography angiography or Doppler ultrasound iii. Prior
peripheral artery (excluding carotid) revascularization procedure iv. Lower extremity
amputation at or above ankle due to atherosclerotic disease (excluding e.g. trauma or
osteomyelitis) d) Chronic kidney disease defined as: i. eGFR below 60 mL/min/1.73 m^2
(based on medical records using latest available and no more than 6 months old
assessment)
Exclusion Criteria:
• Any of the following: myocardial infarction, stroke, hospitalisation for unstable
angina pectoris or transient ischaemic attack within the past 60 days prior to the day
of screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
• Heart failure presently classified as being in New York Heart Association Class IV
• Treatment with any glucagon-like peptide-1 receptor agonist within 30 days before
screening
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes (PIONEER PLUS)
This study compares three doses of once daily semaglutide tablets in people with type 2
diabetes who were previously treated with other oral anti-diabetic medicines. Participants
will be initiated on the lowest starting dose of 3 mg and gradually increased until they
reach the final trial dose of 14 mg, 25 mg or 50 mg once daily semaglutide tablets. The final
three doses will be randomized (i.e., decided by chance). Participants will be administered
one tablet per day for 68 weeks. Women cannot take part if they are pregnant, breast-feeding
or planning to become pregnant during the study period. Women who can get pregnant will be
checked for pregnancy via urine tests. Once daily semaglutide tablets (3 mg, 7 mg and 14 mg)
are approved for the treatment of type 2 diabetes in the US, in the EU and in some other
countries, under the brand name Rybelsus®.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04707469
STU-2020-1301
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
• Male or female, age above or equal to 18 years at the time of signing informed
consent.
• Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of
screening.
• HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
• BMI equal to or above 25 kg/m^2
• Stable daily dose(s) for 90 days prior to the day of screening of any of the following
treatment regimens:
• No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a
*:
• Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
• Sulfonylureas (SU) (equal to or above half of the maximum approved dose according
to local label or maximum tolerated or effective dose).
• Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
• Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local
label).
• Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be
willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
Exclusion Criteria:
• Treatment with any medication indicated for the treatment of diabetes or obesity other
than stated in the inclusion criteria within the past 90 days prior to the day of
screening. However, short term insulin treatment for a maximum of 14 days prior to the
day of screening is allowed.
• Renal impairment measured as estimated glomerular filtration rate (eGFR) value of
below 30 mL/min/1.73 m^2 according to Chronic Kidney Disease Epidemiology
Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving
global outcomes (KDIGO 2012) classification.
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a fundus examination performed within the past 90 days prior to screening or in the
period between screening and randomisation. Pharmacological pupil-dilation is a
requirement unless using a digital fundus photography camera specified for non-dilated
examination.
Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
Funding Source - FDA OOPD
This study is being done to find out whether an investigational (not approved by FDA ) drug
called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in
combination can treat the high blood fat (elevated triglycerides)levels found in the
condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone,
the current standard medical care.
It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in
lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The
researchers are interested in learning whether any one of these drugs when given alone or in
combination is more effective and safe in treating T1HLP.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Abhimanyu Garg
12461
All
12 Years to 100 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT01675154
STU 012013-042
Show full eligibility criteria
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Inclusion Criteria:
• Type I hyperlipoproteinemia.
• Fasting serum triglyceride levels of greater than 1000 mg/dL.
• Age > 12 years
Exclusion Criteria:
• Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism,
alcoholism and drug therapy such as estrogens and estrogen analogues, steroids,
HIV-protease inhibitors, retinoic acid derivatives and interferons.
• Pregnant or lactating women
• Significant liver disease (elevated transaminases > 2 times upper limit of normal)
• Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks for men or 168 g
per week for men)
• Drug use (cocaine, marijuana, LSD, etc.)
• Major surgery in the past three months
• Congestive heart failure
• Serum creatinine greater than 2.5 mg/dL
• Cancer within the past five years
• Gastrointestinal surgery in the past
• Current therapy with anti-coagulants, digoxin and anti-arrhythmics
• Chronic malabsorption syndromes
• Cholestasis
• Acute illnesses such as acute pancreatitis in the last 8 weeks
This is a prospective, non-randomized, non-blinded observational study. The overarching goal
is to discover new disease-associated genes in children, while establishing a specific focus
on disorders where molecular characterization is most likely to lead to novel therapies. This
study will merge detailed phenotypic characterization of patients presenting to the Pediatric
Genetics and Metabolism Division in the Department of Pediatrics/Children's Medical Center at
Dallas and collaborating clinics with Next-Generation sequencing techniques to identify
disease-producing mutations. The primary objective of the study is to identify novel
pathogenic mutations in children with rare Mendelian disorders. A secondary objective of the
study is to establish normative ranges of a large number of metabolites from healthy newborns
and older children.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ralph DeBerardinis
99018
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT02650622
STU 112014-001
Show full eligibility criteria
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Inclusion criteria of Cohort 1- Newborn:
• Subjects aged 1-2 days
• Subjects with gestational age 37-42 weeks
• Subjects with stable clinical status (admitted to normal newborn nursery)
Inclusion criteria of Cohort 2 •Older children:
• Subjects aged 0-18 years
Inclusion criteria of Cohort 3 •Diseased children:
Subjects (no age limit) with ANY phenotype as below:
• Confirmed metabolic or genetic diseases
• Suspected metabolic or genetic diseases
• Episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia, metabolic
acidosis)
• Developmental regression
• Major congenital malformation
• Other unexplained symptoms of potential genetic origin
Exclusion criteria of Cohort 1 •Newborn:
• Subjects with gestational age <37 weeks or >42 weeks
• Subjects with overt signs of metabolic dysfunction, distress or genetic diseases
including hypoglycemia, hyperglycemia, sepsis/shock, hypoxemia, or major congenital
malformation
• Subjects with mothers whose pregnancies were complicated by gestational diabetes,
gestational hyperglycemia, gestational hypertension, preeclampsia, or any other major
disorders.
Exclusion criteria of Cohort 2 •Older children:
• Subjects with confirmed metabolic or genetic diseases
• Subjects with suspected metabolic or genetic diseases
• Subjects with episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia,
metabolic acidosis)
• Subjects with developmental regression
• Subjects with major congenital malformation
Exclusion criteria of Cohort 3 •Diseased children No.
Gan & Lee Insulin Glargine Target Type (1) Evaluating Research (GLITTER 1)
Primary Objective:
- To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms
of immunogenicity
Secondary Objective:
- Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin
antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26
Call 214-648-5005 studyfinder@utsouthwestern.edu
Philip Raskin
15956
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03371082
STU 092017-071
Show full eligibility criteria
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Inclusion Criteria:
• Type 1 Diabetes
Biological: Gan & Lee Insulin Glargine Injection, Biological: Lantus®
Diabetes Mellitus, Type 1
Diabetes, Diabetes Type 1, Type 1, Basal, Insulin, Glargine, T1DM, Diabetes Mellitus, Insulin Dependent Diabetes
A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
This study compares insulin 287 (a possible new medicine) to insulin glargine (a medicine
doctors can already prescribe) in people with type 2 diabetes. Different ways of switching
from the insulin which the participants are already on to insulin 287 are also compared. This
is done to find the best way to switch to insulin 287. The participants will either get
insulin 287 that they will have to inject once a week or insulin glargine that they will have
to inject once a day. Which treatment any participant gets is decided by chance. The study
will last for about 5 months (23 weeks). The participants will have 14 clinic visits and 6
phone calls with the study doctor. At 3 of the clinic visits participants will be asked not
to eat or drink anything (except for water) in the last 8 hours before the visit. During the
study, the doctor will ask the participants to: 1) measure their blood sugar every day with a
blood sugar meter using a finger prick; 2) write down different information in a diary daily
and return this to their study doctor. 3) wear a medical device (sensor) that measures the
participants blood sugar all the time for 18 weeks (about 4 months) during the study.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03922750
STU-2019-0746
Show full eligibility criteria
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Inclusion criteria:
• Male or female, aged 18-75 years (both inclusive) at the time of signing informed
consent.
• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the
day of screening.
• Glycosylated haemoglobin (HbA1c) of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as
assessed by central laboratory.
• Treated with once daily or twice daily basal insulin analogue (insulin degludec,
insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both
inclusive) greater than or equal to 90 days prior to the day of screening.
• Stable daily dose(s) for 90 days prior to the day of screening of any of the following
antidiabetic drug(s) or combination regime(s):
1. Any metformin formulations greater than or equal to 1500 mg or maximum tolerated
or effective dose (as documented in subject's medical records).
2. Free or fixed combination therapy: Metformin as outlined above with or without
dipeptidyl peptidase 4 inhibitors (DPP4i) with or without sodium-glucose
cotransporter 2 inhibitors (SGLT2i) is allowed: 1) DPP4i (greater than or equal
to half of the maximum approved dose according to local label or maximum
tolerated or effective dose); 2) SGLT2i (greater than or equal to half of the
maximum approved dose according to local label or maximum tolerated or effective
dose.
• Body mass index (BMI) less than or equal to 40.0 kg/m^2.
Exclusion criteria:
• Known or suspected hypersensitivity to trial product(s) or related products.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using an adequate contraceptive method.
• Participation in any clinical trial of an approved or non-approved investigational
medicinal product within 90 days before screening.
• Any disorder, except for conditions associated with type 2 diabetes mellitus, which in
the investigator's opinion might jeopardise subject's safety or compliance with the
protocol.
• Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of
screening and between screening and randomisation.
• Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's
questionnaire question 8.
• Recurrent severe hypoglycaemic episodes within the last year as judged by the
Investigator.
• Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or
transient ischaemic attack within 180 days prior to the day of screening and between
screening and randomisation.
Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab (PROTECT)
The purpose of this study is to determine whether teplizumab slows the loss of β cells and
preserves β cell function in children and adolescent 8-17 years old who have been diagnosed
with T1D in the previous 6 weeks..
Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Perrin White
17917
All
8 Years to 17 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03875729
STU-2019-1046
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Inclusion Criteria:
1. Is 8 to 17 years of age, inclusive, at the time of randomization/initiation of study
drug administration.
2. Has received a diagnosis of T1D according to the criteria from the American Diabetes
Association.
3. Is able to be randomized and initiate study drug within 6 weeks (42 days) of the
formal T1D diagnosis.
4. Has a peak stimulated C-peptide of ≥0.2 pmol/mL from a mixed meal tolerance test
(MMTT) at screening.
5. Has a positive result on testing for T1D-related autoantibodies.
Exclusion Criteria:
1. Has any autoimmune disease other than T1D with the exception of stable thyroid or
celiac disease.
2. Has an active infection and/or fever.
3. Has a history of or serologic evidence at screening of current or past infection with
human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus
(HCV).
4. An individual who has a medical, psychological or social condition that, in the
opinion of the Principal Investigator, would interfere with safe and proper completion
of the trial.
Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20)
The study is a 2 arm, multi-center, randomized, open-labeled clinical trial designed to
assess the effects of varying doses and schedules of oral insulin on immunological and
metabolic markers in relatives at risk for type 1 diabetes (T1D).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Philip Raskin
15956
All
3 Years to 45 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02580877
STU 102015-077
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Inclusion Criteria:
• Participants in TrialNet Natural History/Pathway to Prevention Study (TN01); is
relative of proband with type 1 diabetes
• Between ages 3-45 with normal Oral Glucose Tolerance Test (OGTT) or between ages 3-7
with an abnormal OGTT
• Confirmed positive for insulin autoantibodies within previous six months
• Confirmed positive for one or more other autoantibodies on two separate occasions
within the past six months
Exclusion Criteria:
• Diagnosed with type 1 diabetes
• History of treatment with insulin or oral hypoglycemic agent
• History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids
within the past two years for a period of more than three months
• Ongoing use of medications known to influence glucose tolerance
• Pregnant or intending to become pregnant while on study or lactating
Drug: 67.5 mg oral insulin crystals daily, Drug: 500mg oral insulin crystals every other week
The primary purpose of this study is to evaluate the efficacy of alogliptin 25 milligram (mg)
once daily compared to placebo when administered as monotherapy, or when added onto a
background of metformin alone, insulin alone, or a combination of metformin and insulin, as
measured by the glycosylated hemoglobin (HbA1c) change from Baseline at Week 26 in pediatric
participants with type 2 diabetes mellitus (T2DM).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Olga Gupta
136963
All
10 Years to 17 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02856113
STU 012018-092
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Inclusion Criteria:
1. Has a confirmed diagnosis of T2DM using American Diabetes Association (ADA) and World
Health Organization (WHO) criteria (laboratory determinations of fasting plasma
glucose [FPG] greater than or equal to [>=] 126 mg/dL, random glucose >=200 mg/dL
[>=11.10 mmol/L], HbA1c >=6.5 percent (%), or 2-hour oral glucose tolerance test
[OGTT] glucose >=200 mg/dL), documented in the participants' medical record.
2. The participant and/or his/her legal representative (that is, parents or legal
guardians) are able and willing to monitor their own blood glucose concentrations with
a home glucose monitor and complete participant diaries.
Exclusion Criteria:
1. Has a history of hypersensitivity or allergy to alogliptin, other dipeptidyl
peptidase-4 (DPP-4) inhibitors, metformin, insulin or related compounds.
2. Has a confirmed diagnosis of type 1 diabetes mellitus or maturity-onset diabetes of
the young (MODY).
3. Has a hemoglobin level <11.0 gram per deciliter (g/dL) (<110 gram per liter [g/L]) for
males and <10.0 g/dL (<100 g/L) for females.
4. Has a history of any hemoglobinopathy that may affect determination of HbA1c levels.
5. Has a history of bariatric surgery.
6. Has a history of proliferative diabetic retinopathy within the 6 months prior to
Screening.
7. Has had more than 1 episode of diabetic ketoacidosis (DKA) at any time after diagnosis
of T2DM.
8. Has a history of more than 1 episode of pancreatitis.
9. Has serum creatinine >=1.5 mg/dL for male participants or >=1.4 mg/dL for female
participants, or creatinine clearance <60 milliliter per minute (mL/min) based on
calculation by central lab using the Schwartz formula for estimated glomerular
filtration rate (eGFR) at screening Visit.
10. Has a documented history of infection with human immunodeficiency virus or chronic
active viral hepatitis.
11. The participant and/or his/her legal representative (that is, parents or legal
guardians) is unable to understand verbal or written English, or any other language
for which a certified translation of the approved informed consent/assent is
available.
Additional Criteria That Must be Met Prior to Randomization:
For participants who have had the diagnosis of T2DM for less than 1 year and/or who are
taking insulin at Screening, additional criteria will need to be met prior to
randomization:
1. Must have an HbA1c level of >=6.5% to <11.0% if the participant is treatment naïve or
on metformin alone or >=7.0% to <11.0% if the participant is on insulin alone or in
combination with metformin.
2. The participant must not have received any investigational compound within 30 days or
5 half-lives, whichever is longer, prior to randomization.
3. Must not have received an antidiabetic agent other than metformin or insulin within
the 12 weeks prior to randomization.
4. Must not have received oral or parenteral steroids for more than 3 weeks
(cumulatively) within the 6 months prior to randomization or have received a course of
oral or parenteral steroids within the 2 months prior to randomization.
5. Has a systolic blood pressure <160 millimeter of mercury (mmHg) and a diastolic
pressure <100 mm Hg. (Antihypertensive medications will be allowed during the study).
6. Has an alanine aminotransferase (ALT) level <3*upper limit of normal (ULN) or an ALT
level <5 *ULN with a confirmed diagnosis of nonalcoholic fatty liver disease
(NAFLD).7. Does not plan to leave the geographic area within 1 calendar year following
randomization.
For participants who have had the diagnosis of T2DM for less than 1 year and/or who are
taking insulin prior to randomization, the following criteria must also be met:
8. Must have a fasting C-peptide concentration>=0.6 nanogram per milliliter (ng/mL) (>=0.20
nanomole per liter [nmol/L]) (drawn at least 1 week after treatment for ketosis or
acidosis, if applicable).
9. No presence of autoantibodies as documented by glutamic acid decarboxylase [GAD] 65 and
islet antigen [IA]-2 antibodies below the upper limit of the normal reference ranges at
randomization.
10. Have a body mass index (BMI) greater than (>) 85th percentile, documented at
randomization.
Averting Complications of Proton Pump Inhibitor Therapy by Effervescent Calcium Magnesium Citrate
Proton pump inhibitors (PPIs) are widely used for the control of gastric ulcer-gastritis,
erosive esophagitis (gastroesophageal reflux disease), peptic ulcer disease (duodenal ulcer),
and heartburn. Despite their efficacy, their use has been implicated in possibly causing
fragility fractures (osteoporosis), hypomagnesemia (magnesium deficiency) and increased risk
of chronic kidney disease (CKD). The current trial represents the investigators' ongoing
effort to discern whether these complications could be averted by effervescent calcium
magnesium citrate (EffCaMgCit).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Khashayar Sakhaee
16334
All
21 Years to 99 Years old
Phase 3
This study is also accepting healthy volunteers
NCT03812380
STU 042018-078
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Inclusion Criteria:
• Must have taken PPI (omeprazole or equivalent ≥ 20 mg/day, ≥ three times per week, for
at least 2 months)
• Expected to continue at a similar dosage
• Stage 1 hypertension (with systolic blood pressure <140 and diastolic <90)
• controlled diabetes mellitus Type II with HbA1C less than 7%
Exclusion Criteria:
• end-stage renal failure on dialysis
• hypercalcemia
• hypophosphatemia (serum P < 2.5 mg/dL)
• hypertension stage 2 or higher
• diabetes Type II with HbA1C ≥ 7%
• treatment with adrenocorticosteroids, diuretics, non-steroidal anti-inflammatory
agents
• regular dose of magnesium supplements, bisphosphonate, teriparatide, denosumab or
selective estrogen receptor modulators.
Inclusion/exclusion of other drugs or conditions will be considered on an individual basis.
Red Blood Cell Exchange Transfusion as a Novel Treatment for GLUT1 Deficiency Syndrome
This proposal is an investigator-initiated, single-site proof of concept trial. Five patients
will undergo isovolemic hemodilution-red cell exchange (IHD- RBCx) with up to 10 units of red
cell antigens (Rh group, Kell, Duffy, Kidd blood group antigens) matched normal donor red
cells to replace a target of 70% of the patient's red cells with donor red cells. The
procedure will be performed as an outpatient according to protocols established for sickle
cell anemia patients. One of the investigators is an expert on RBCx and will oversee the
transfusion. Subjects will be assessed before and after transfusion, and at two months post
transfusion. Outcome measures include neurological exam, electroencephalography (EEG),
neuropsychological testing, and biochemical assays.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Juan Pascual
85158
All
16 Years to 64 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04137692
STU 122014-010
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Inclusion Criteria:
• Male or Female
• Age 16 years to 64 years old.
• Diagnosed with genetically-confirmed glucose transporter type 1 disorder
• Patients not currently receiving dietary therapy, including ketogenic diet or other
dietary therapy, due to failure of these diets to achieve seizure remission or due to
patient preference, including compliance or tolerance issues. Patients currently on
Modified Atkins Diet (MAD) and / or taking Medium Chain Triglyceride (MCT) oil are
allowed.
Exclusion Criteria:
• Currently on the ketogenic diet or taking triheptanoin (C7) oil
• No genetic confirmation of G1D diagnosis
• Unable to return for follow up visits
• Weak peripheral veins, such that IV placement is contraindicated (required for
transfusion)
• Serious chronic medical conditions, such as congestive heart failure, renal failure,
liver failure, or any other medical conditions that preclude large volume
transfusions.
• Patients currently pregnant or breast-feeding are excluded from participating in this
research. Patients who plan on getting pregnant during this research or who are
unwilling to use birth control, including abstinence, during the course of this
research are also excluded due to safety concerns for the fetus.
Other: Red Blood Cell Transfusion
Glucose Transporter Type 1 Deficiency Syndrome, GLUT1DS1, Brain and Nervous System, Other Hematopoietic
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
This is an open-label extension study to evaluate the long-term safety of relacorilant in
patients with endogenous Cushing syndrome who successfully completed participation in a
Corcept-sponsored study of relacorilant and may benefit from continuing treatment.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Oksana Hamidi
179331
All
Not specified
Phase 2
This study is NOT accepting healthy volunteers
NCT03604198
STU-2020-0455
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Inclusion Criteria:
• Major
Inclusion Criteria:
• Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing
syndrome with at least 80% compliance with the dosing schedule.
• According to the Investigator's opinion will benefit from continuing treatment
with relacorilant
Exclusion Criteria:
• Major
Exclusion Criteria:
• Premature discontinuation from a relacorilant parent study.
• Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
• Has poorly controlled hypertension
• Has Stage ≥ 4 renal failure
Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (GLITTER 2)
Primary Objective:
• To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of
immunogenicity
Secondary Objective:
• Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin
antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26
Call 214-648-5005 studyfinder@utsouthwestern.edu
Philip Raskin
15956
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03371108
STU 102017-066
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Inclusion Criteria:
• Type 2 Diabetes
Biological: Gan & Lee Insulin Glargine Injection, Biological: Lantus®
Diabetes Mellitus, Type 2
Diabetes, Diabetes Type 2, Type 2, Basal, Insulin, Glargine, T2DM, Diabetes Mellitus
Characterization of AmnioExcel Plus in Two Treatment Paradigms
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot
wounds (n=20) that receive optimal treatment including serial wound debridement and
off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be
applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum
every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended
for AE+ application, the wound will be treated as SOC). In addition, the Investigators will
collect data on other potential confounding factors that could affect healing such as
antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes
control, infection, perfusion, and activity. Wound healing, including wound size and adverse
events will be evaluated.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Lawrence Lavery
116716
All
21 Years to 90 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04233580
STU-2019-1527
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Criteria for Inclusion of Subjects:
• 21-90 years of age
• Able to provide informed consent
• Chronic foot ulceration below the ankle •persistent for >30 days but <6 months
Criteria for Exclusion of Subjects:
• <21 or >90 years of age
• Unable to provide informed consent
• History of poor compliance in the opinion of the investigator
• Gangrene
• Untreated osteomyelitis
• Widespread malignancy
• Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines that in
the opinion of the investigator will impact the subject's participation in the study
• Pregnancy
Device: Amnio Excel + weekly, Device: Amnio Excel + max every 2 weeks
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing
intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who
request long-term, reversible contraception for up to 10 years.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Denisse Holcomb
81275
Female
16 Years to 45 Years old
Phase 3
This study is also accepting healthy volunteers
NCT00995150
STU 062010-087
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Inclusion Criteria:
• Healthy women requesting contraception
• 16-35 years old
• Cohort 36-45 years old
• Sexually active
Exclusion Criteria:
• Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy
within 24 months of study entry
• Currently breastfeeding
• Current persistent, abnormal vaginal bleeding