Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
78 participants
INTERVENTIONAL
2019-05-01
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control
Standard of care insulin will be used as an active comparator arm for 1/3 of patients (38 patients) for the entire duration of the study.
Insulin
Standard of care insulin for pump or injection and serves as a control
Dual Therapy
Once a week injection of Semaglutide (a GLP-1 receptor agonist) in addition to standard of care insulin for the first six months in 2/3 of patients (76 patients). Semaglutide is a clear, colorless solution that contains 2 mg of semaglutide in a 1.5 mL (1.34 mg/mL) pre-filled, disposable, single-patient-use pen injector. Semaglutide will be started at the 0.25 mg dose for the first two weeks, then increased to 0.5 mg at week 2, and then yet again increased to 1.0 mg at week 4.
Insulin
Standard of care insulin for pump or injection and serves as a control
Semaglutide
Injectable weekly GLP-1RA given as open label experimental drug
Triple therapy
Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of Dapagliflozin (an SGLT-2 inhibitor) added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)). Dapagliflozin will be started at 5 mg for one week, and then increased to 10 mg for the remainder of the study
Insulin
Standard of care insulin for pump or injection and serves as a control
Semaglutide
Injectable weekly GLP-1RA given as open label experimental drug
Dapagliflozin
Oral daily SGLT2 Inhibitor given as experimental drug
Triple therapy control
Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of the Placebo form of Dapagliflozin added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)).
Insulin
Standard of care insulin for pump or injection and serves as a control
Semaglutide
Injectable weekly GLP-1RA given as open label experimental drug
Placebo to Dapagliflozin
Placebo to Dapagliflozin given as a control to the experimental drug
Interventions
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Insulin
Standard of care insulin for pump or injection and serves as a control
Semaglutide
Injectable weekly GLP-1RA given as open label experimental drug
Dapagliflozin
Oral daily SGLT2 Inhibitor given as experimental drug
Placebo to Dapagliflozin
Placebo to Dapagliflozin given as a control to the experimental drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. C-peptide \<0.23 nM
3. Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII
4. Regularly measuring blood sugars four or more times daily.
5. HbA1c of \>7.5%.
6. Well versed in CHO counting\*
7. Age 18-70 years.
8. BMI ≥25 kg/m2.
Exclusion Criteria
2. Previous use of any agent other than insulin for treatment of diabetes in the last 3 months.
3. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to the screening visit
4. Frequent episodes of severe hypoglycemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), and/or glucagon therapy administered by a third-party individual within 1 month prior to the screening visit
5. Symptoms of poorly controlled diabetes that would preclude participation in this trial
6. Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program
7. History of bariatric surgery or lap-band procedure within 12 months prior to screening
8. History of Addison's disease or chronic adrenal insufficiency
9. History of diabetes insipidus
10. Hepatic disease or cirrhosis with Aspartate Aminotransferase (AST) \> 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) \> 3X ULN
11. Serum Total Bilirubin \> 2X ULN unless exclusively caused by Gilbert's Syndrome
12. Hemoglobin \< 11.0 g/dL (110 g/L) for men; hemoglobin \< 10.0 g/dL (100 g/L) for women.
13. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months or patients with congestive heart failure.
14. ESRD on hemodialysis; and or e-GFR \< 60 ml/min/1.73m2
15. HIV or Hepatitis B/C positive status
16. Any other life-threatening, noncardiac disease
17. History of pancreatitis
18. Women who are pregnant or women of childbearing potential who are not using adequate contraception or who are breast feeding
19. Inability to give informed consent
20. History of gastroparesis
21. History of medullary thyroid carcinoma or MEN 2 syndrome
22. History of serious hypersensitivity reaction to these agents
23. Painful gallstones
24. Alcoholism
25. Hypertriglyceridemia (\>500 mg/dl)
26. Recurrent genital mycotic infection.
27. Hypovolemic patients or with chronic renal insufficiency.
28. Patients with any malignancy except treated in situ malignancy and basal cell carcinoma of the skin
29. Unexplained hematuria
30. Patients with a history of diabetic retinopathy
31. Use of an investigational agent or therapeutic regimen within 30 days of study
32. Participation in any other concurrent interventional clinical trial
18 Years
75 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
Juvenile Diabetes Research Foundation
OTHER
State University of New York at Buffalo
OTHER
Responsible Party
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paresh Dandona
SUNY Distinguished Professor, Head of Endocrinology, Diabetes, and Metabolism, State University of New York
Principal Investigators
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Husam Ghanim, PhD
Role: STUDY_DIRECTOR
State University of NY at Buffalo
Locations
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Diabetes and Endocrinology Research Center of WNY
Williamsville, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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1987
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00002775
Identifier Type: -
Identifier Source: org_study_id
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