Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT05305794
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05305794
Study Brief:
Protocol Section:
NCT05305794