Semaglutide in Adults With Type 1 Diabetes

• Status: Not yet recruiting
• Trial end date: 2025-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the use of once weekly semaglutide injection in inadequately controlled obese adults with type 1 diabetes (T1D) using FDA-approved hybrid closed-loop therapies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Juvenile Diabetes Research Foundation

Criteria

Inclusion Criteria:

For an eligible subject, all inclusion criteria must be answered "yes"

1. Age >18 years at screening

2. Patients with clinical diagnosis of T1D diagnosed for at least 12 months

3. Patient is on FDA- approved hybrid closed-loop system (HCL) for ≥ 3 months

4. Willing to use once weekly semaglutide

5. Point-of-care HbA1c >7.0% and <10.0%

6. Body mass index ≥30 kg/m2

7. Ability to provide informed consent before any trial-related activities

Exclusion Criteria:

1. Age ≤18 years and ≤60 years

2. HbA1c ≤7.0 % or ≥ 10.0% at screening

3. Less than 12 months of insulin treatment

4. Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system

5. Unavailability of compatible smart phone for device data transfer

6. Current use of multiple daily injection or inhaled insulin (Afrezza)

7. Patients with T1D using any glucose lowering medications other than insulin at the time of screening

8. Pregnancy, breast feeding, and positive pregnancy test during screening

9. Women of childbearing age wanting to become pregnant or not using adequate contraceptive measures

10. Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (>4 weeks continuously), during the study period

11. Use of GLP-1RA or weight loss medications in the past 3 month

12. Clinical diagnosis/history of gastroparesis or gastric motility disorders

13. Fasting serum triglycerides >500 mg/dL

14. Planning for bariatric surgery during the study period

15. eGFR below 45 ml/min/1.73 m^2 using MDRD formula

16. History of severe hypoglycemia in the previous 3 months

17. History of diabetic ketoacidosis requiring hospitalization in the past 3 months

18. History of allergy to any form of insulin, GLP-1RA or its excipients

19. History of any form of pancreatitis

20. History of stroke, myocardial infarction in the past 3 months

21. History of congestive heart failure class III or IV

22. History of acute or chronic liver disease

23. History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years

24. Personal or family history of multiple endocrine neoplasia type 2 (MEN-2) or familial thyroid carcinoma or non-familial medullary thyroid carcinoma

25. Use of investigational drugs within 5 half-lives prior to screening

26. Participation to other intervention trials during the study period

27. Any comorbidities or medical conditions such as severe psychiatric disorder that make a person unfit for the study at the discretion of the investigators