NCT05305794

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Between 16% and 22% of type 1 diabetic patients present a clinical and biological profile of insulin resistance favored by a family history of type 2 diabetes or metabolic syndrome. They constitute a group of patients with "double diabetes" since they have both true type 1 diabetes and inherited insulin resistance, typical of type 2 diabetes. For several years, GLP1 agonists have been successfully used in the treatment of type 2 diabetes, leading to very significant improvements in glycemic control and weight loss. Because of the insulin-sensitizing power of GLP1 agonists, the investigators hypothesize that they could reduce insulin resistance in patients with "double diabetes" and thus improve their glycemic control. The investigators propose to use in this study semaglutide, the most recent and most potent GLP1 agonist (superiority demonstrated compared to exenatide LP and dulaglutide) and administered as a weekly subcutaneous injection (in contrast to liraglutide administered daily).

Conditions

• Double Diabetes

Interventions

Type	Name	Description
DRUG	Insulin + semaglutide treatment	Usual insulin treatment + semaglutide (0.25 mg/week for 4 weeks, then 0.50 mg/week for 4 weeks, then 1 mg/week for 18 weeks, i.e. a total duration of 26 weeks). Upon introduction of semaglutide (ozempic) treatment, insulin doses will be reduced by 10% (basal insulin, basal rate and bolus)
DRUG	Usual insulin treatment	Usual insulin treatment
BIOLOGICAL	Biological check-up	at D0, D90 and D180

Timeline

• Start date: 2022-07-12
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2022-03-31
• Last updated: 2025-12-18

Locations

1 site across 1 country: France