ADJUnct Semaglutide Treatment in Type 1 Diabetes

Last updated: March 28, 2025
Sponsor: Viral N. Shah
Overall Status: Completed

Phase

2

Condition

Obesity

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 1

Treatment

Semaglutide

Placebo

Clinical Study ID

NCT05537233
22388
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  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

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-IQsystem

  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 thetime 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) duringthe trial period

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

  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 5years

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

  27. Have a pacemaker, metal implants, or aneurysm clips or weigh >330 lbs (exclusiononly 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 thatmake a person unfit for the study at the discretion of the investigators

Study Design

Total Participants: 115
Treatment Group(s): 2
Primary Treatment: Semaglutide
Phase: 2
Study Start date:
April 11, 2023
Estimated Completion Date:
August 06, 2024

Study 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.

Connect with a study center

  • Barbara Davis Center for Diabetes

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Iowa Diabetes Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Harold Schnitzer Diabetes Health Center

    Portland, Oregon 97239
    United States

    Site Not Available

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