TOLEDDO: Effect of weekly GLP1 agonist treatment in double diabetes: a randomized, open-label study - TOLEDDO

Centre Hospitalier Universitaire De Dijon0 个研究点目标入组 76 人开始时间: 2024年6月24日最近更新: 2024年7月22日

试验速览

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•Person who has provided written consent, For women of childbearing age with effective contraception for up to 2 months after the end of treatment. Effective contraception includes: hormonal contraception, intrauterine device, bilateral tubal occlusion, vasectomy and sexual abstinence., Patient over 18 years of age, Type 1 diabetic patient 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 : o Family history of type 2 diabetes (parents, grandparents, uncles, aunts, siblings), o Family history of obesity (BMI > 30 Kg/m²) (parents, grandparents, uncles, aunts, brothers and sisters), o Triglycerides > 1.50g/l (1.7mmol/l), o 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 prior to inclusion, With continuous glucose monitoring by a CGM (Holter Glucose Monitoring) system: Guardian, Dexcom or Free Style Libre

•Person not affiliated to a national health insurance, 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 prior to inclusion, Pregnant, parturient or nursing woman, HbA1c = 12% in the 3 months prior to inclusion, Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, confirmed by fundus examination performed within 6 months prior to selection, Person subject to a measure of legal protection (guardianship, tutorship), Person subject to a measure of court protection, Renal impairment (GFR < 30 ml/mn), Hepatic impairment (INR > 1.5), BMI > 40 kg/m²

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