2024-514906-30-00招募中3 期
TOLEDDO: Effect of weekly GLP1 agonist treatment in "double diabetes": a randomized, open-label study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Percentage of time spent in glycemic target range (0.70-1.80 g/l) between D0 and D180.
研究概览
简要总结
To study, in patients with type 1 diabetes with "double diabetes", the effect of 6 months of additional treatment with semaglutide on the change in the percentage of time spent within the glycemic target (0.70-1.80 g/l) between 0 and 6 months compared with standard treatment.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of time spent in glycemic target range (0.70-1.80 g/l) between D0 and D180.
Percentage of time spent in glycemic target range (0.70-1.80 g/l) between D0 and D180.
次要结局
- HbA1c
- Weight, waist circumference
- Daily dose of insulin administered
- Glycemic variability, assessed on data from continuous glucose recording using a continuous glucose meter (Free Style Libre, Guardian or Dexcom) by Standard Deviation (SD) and Mean Amplitude of Glycemic Excursions (MAGE). We will look at the variation in each criterion between the 2 groups between t0 and t6 months, between t0 and 3 months and between t3 months and t6 months.
- interstitial glucose time < 0.7 g/l and <0.54 g/l (Free Style Libre data)
- Percentage of adverse events in the 2 groups
研究者
Chef de projets recherche
Scientific
Centre Hospitalier Universitaire De Dijon
研究点 (5)
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