Clinical Trial

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

Study acronym: TOLEDDO
Recruiting Phase 3
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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).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2022-03-30; most recent amendment 2025-12-11.
Status change: Active, Not Recruiting → Recruiting 2024-10-25
Status change: Recruiting → Active, Not Recruiting 2024-05-02
Status change: Not Yet Recruiting → Recruiting 2022-07-18
Trial Details
NCT Number NCT05305794
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Double Diabetes
Enrollment 76 participants
Start Date 2022-07-12
Primary Completion 2028-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-18