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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Person who has given written consent

• Patient over 18 years of age

• Patient with type 1 diabetes confirmed by a C-peptide below laboratory standards

• Age at diagnosis \< 35 years

• Treated with optimized insulin therapy (multi-injections or pump) for at least 1 year, having received specific therapeutic education on insulin dose adaptation.

• BMI (weight/height2) ≥ 27 Kg/m².

• At least one of the following criteria:

‣ Family history of type 2 diabetes (parents, grandparents, uncles, aunts, brothers and sisters)

⁃ Family history of obesity (BMI\>30 Kg/m2) (parents, grandparents, uncles, aunts, siblings)

⁃ Triglycerides \> 1.50g/l (1.7mmol/l)

⁃ HDL\< 0.5 g/l (1.29 mmol/l) in women, HDL\<0.4 g/l (1.03 mmol/l) in men

• HbA1c ≥ 7.5% and \< 12% in the 3 months preceding inclusion

• Having continuous glucose monitoring by a CGM (Holter Glucose Monitoring) system: Guardian, Dexcom or Free Style Libre

• For women of childbearing age: using an effective method of contraception until 2 months after the end of treatment. Effective contraception includes: hormonal contraception, intrauterine device, bilateral tubal occlusion, vasectomy and sexual abstinence

Locations
Other Locations
France
Chu Dijon Bourgogne
RECRUITING
Dijon
Contact Information
Primary
Benjamin BOUILLET
benjamin.bouillet@chu-dijon.fr
03.80.29.34.53
Time Frame
Start Date: 2022-07-12
Estimated Completion Date: 2026-08
Participants
Target number of participants: 76
Treatments
Experimental: Semaglutide
Active_comparator: Control
Sponsors
Leads: Centre Hospitalier Universitaire Dijon

This content was sourced from clinicaltrials.gov