ADJUnct Semaglutide Treatment in Type 1 Diabetes

NCT ID: NCT05537233

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2024-08-06

Brief 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.

Detailed Description

After being informed about the study and potential risks, all patients given written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner using computer generated randomization scheme to receive either semaglutide or placebo (1:1 ratio) for 26 weeks.

Conditions

Type 1 Diabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Semaglutide

Participants in this group will receive semaglutide once weekly injection in addition to their standard closed-loop therapy

Group Type: EXPERIMENTAL

Semaglutide

Intervention Type: DRUG

Semaglutide up to 1 mg per week in addition to standard closed-loop therapy

Control

Participants in this group will receive placebo once weekly injection in addition to their standard closed-loop therapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Injection placebo up to 1 mg per week in addition to standard closed-loop therapy

Interventions

Semaglutide

Semaglutide up to 1 mg per week in addition to standard closed-loop therapy

Intervention Type: DRUG

Placebo

Injection placebo up to 1 mg per week in addition to standard closed-loop therapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 and ≤ 65 years

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

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

4. Willing to use once weekly semaglutide

5. Willing to share devices (HCL system) data uploads

6. HbA1c >7.0% and <10.0%

7. Body mass index ≥30 kg/m2

8. Has current glucagon product to treat severe hypoglycemia

9. Has current ketone meters to check ketones

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

Exclusion Criteria

1. Age <18 years and >65 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. Not willing to share the devices (HCL system) data uploads

6. Non compatible devices (e.g. pump, CGM or smart phones) for data transfer

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

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

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

10. Women of childbearing age wanting to become pregnant

11. Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period

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

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

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

15. Serum triglycerides >500 mg/dL

16. Planning for bariatric surgery during the study period

17. eGFR below 45 ml/min/1.73 m^2 using CKD-EPI formula

18. History of severe hypoglycemia in the previous 3 months

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

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

21. History of any form of pancreatitis

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

23. History of congestive heart failure class III or IV

24. History of acute or chronic liver disease

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

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

27. Have a pacemaker, metal implants, or aneurysm clips or weigh >330 lbs (exclusion only if doing MRI)

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

29. Participation to other intervention trials during the study period

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Viral N. Shah

OTHER

Sponsor Role: lead

Responsible Party

Viral N. Shah

Professor of Medicine, Division of Endocrinology & Metabolism

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Viral N Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

Iowa Diabetes Research Center

West Des Moines, Iowa, United States

Henry Ford Hospital

Detroit, Michigan, United States

Harold Schnitzer Diabetes Health Center

Portland, Oregon, United States

Countries

United States

References

Shah VN, Akturk HK, Kruger D, Ahmann A, Bhargava A, Bakoyannis G, Pyle L, Snell-Bergeon JK. Semaglutide in Adults with Type 1 Diabetes and Obesity. NEJM Evid. 2025 Aug;4(8):EVIDoa2500173. doi: 10.1056/EVIDoa2500173. Epub 2025 Jun 23.

Reference Type: DERIVED

PMID: 40550013 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22388

Identifier Type: -

Identifier Source: org_study_id