Status:
RECRUITING
Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Double Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- person not affiliated to national health insurance
- Pregnant, parturient or breastfeeding woman
- HbA1c ≥12% in the 3 months preceding inclusion.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, confirmed by a fundus examination performed in the 6 months preceding the selection
- Person under a measure of legal protection (curatorship, guardianship)
- Renal insufficiency (GFR\<30 ml/mn)
- Hepatic insufficiency (INR\> 1.5)
- BMI \>40 kg/m².
- History of bariatric surgery
- History of pancreatitis
- Allergy to the active substance or to one of the excipients of OZEMPIC®.
- Patients treated with GLP1 agonists or oral antidiabetics in the month preceding month prior to inclusion
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05305794
Start Date
July 12 2022
End Date
August 1 2028
Last Update
December 18 2025
Active Locations (1)
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1
Chu Dijon Bourgogne
Dijon, France, 21000