ADJUnct Semaglutide Treatment in Type 1 Diabetes

NCT05537233 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 22388
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 4

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.

Conditions

Type 1 Diabetes; Obesity

Keywords

Type 1 diabetes; Obesity; HbA1c; Time-in-range; Weight loss; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group

  Primary outcome will be analyzed per statistical analysis plan using intention to treat basis.

  26 weeks

Secondary Outcomes (10)

• Change in HbA1c

  26 weeks

• Change in Mean Glucose

  26 weeks

• Percent Time Spent in CGM-measured Glucose Range of 70-140 mg/dL (Time in Tight Target Range; TTIR)

  26 weeks

• Percent Time Spent in CGM-measured Glucose >180 mg/dL

  26 weeks

• Percent Time Spent in CGM-measured Glucose >250mg/dL

  26 weeks

Other Outcomes (44)

• Change in Patient Reported Quality of Life

  26 weeks

• Proportion of Participants With HbA1c <7%

  26 weeks

• Proportion of Participants With HbA1c <7.5%

  26 weeks

Study Arms (2)

Semaglutide

EXPERIMENTAL

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

Drug: Semaglutide

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Semaglutide DRUG

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

Semaglutide

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 and ≤ 65 years
• Patients with clinical diagnosis of T1D diagnosed for at least 12 months
• Patient is on FDA- approved hybrid closed-loop system for ≥ 3 months
• Willing to use once weekly semaglutide
• Willing to share devices (HCL system) data uploads
• HbA1c \>7.0% and \<10.0%
• Body mass index ≥30 kg/m2
• Has current glucagon product to treat severe hypoglycemia
• Has current ketone meters to check ketones
• Ability to provide informed consent before any trial-related activities

You may not qualify if:

• Age \<18 years and \>65 years
• HbA1c ≤7.0 % or ≥ 10.0% at screening
• Less than 12 months of insulin treatment
• Use of unapproved insulin for HCL system. E.g. use of Fiasp in the Tandem Control-IQ system
• Not willing to share the devices (HCL system) data uploads
• Non compatible devices (e.g. pump, CGM or smart phones) for data transfer
• Current use of multiple daily injection or inhaled insulin (Afrezza)
• Patients with T1D using any glucose lowering medications other than insulin at the time of screening
• Pregnancy, breast feeding, and positive pregnancy test during screening
• Women of childbearing age wanting to become pregnant
• Unwilling to use acceptable contraceptive methods (for both men and women) during the trial period
• Current use (≥ 2 weeks of continuous use) of any steroidal medication, or anticipated long-term steroidal treatment (\>4 weeks continuously), during the study period
• Use of GLP-1RA or weight loss medications in the past 3 month
• Clinical diagnosis/history of gastroparesis or gastric motility disorders
• Serum triglycerides \>500 mg/dL

Sponsors & Collaborators

• Viral N. Shah: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (4)

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

Iowa Diabetes Research Center

West Des Moines, Iowa, 50265, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Harold Schnitzer Diabetes Health Center

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 40550013 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Obesity; Weight Loss

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Viral N Shah, MD
• Organization: Indiana University School of Medicine

shahvi@iu.edu

317-278-6017

Study Officials

• Viral N Shah, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Division of Endocrinology & Metabolism

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 13, 2022
• Study Start: April 11, 2023
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: September 3, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)