ADJUnct Semaglutide Treatment in Type 1 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes, Obesity

In brief

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.

Key facts

Study ID

NCT05537233

Run by

Viral N. Shah

People needed

115

Starts

2023-04-11

Expected to finish

2024-08-06

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For an eligible subject, all inclusion criteria must be answered "yes"
• 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
• Planning for bariatric surgery during the study period
• eGFR below 45 ml/min/1.73 m\^2 using CKD-EPI formula
• History of severe hypoglycemia in the previous 3 months
• History of diabetic ketoacidosis requiring hospitalization in the past 3 months
• History of allergy to any form of insulin, GLP-1RA or its excipients
• History of any form of pancreatitis
• History of stroke, myocardial infarction in the past 3 months
• History of congestive heart failure class III or IV
• History of acute or chronic liver disease
• History of malignancy requiring chemotherapy, surgery or radiation in previous 5 years

Where it is running

• 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

Full record on ClinicalTrials.gov

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