SEMAGLUTIDE for Type 1 diabetes | Double diabetes

Inclusion criteria

• {"criterion_text":"- Person who has provided written consent\n- 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.\n- Patient over 18 years of age\n- Type 1 diabetic patient confirmed by a C-peptide below laboratory standards\n- Age at diagnosis < 35 years\n- Treated with optimized insulin therapy (multi-injections or pump) for at least 1 year, having received specific therapeutic education on insulin dose adaptation.\n- BMI (weight/height²) ≥ 27 kg/m²\n- 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\n- HbA1c ≥ 7.5% and < 12% in the 3 months prior to inclusion\n- With continuous glucose monitoring by a CGM (Holter Glucose Monitoring) system: Guardian, Dexcom or Free Style Libre"}

Exclusion criteria

• {"criterion_text":"- Person not affiliated to a national health insurance\n- History of bariatric surgery\n- History of pancreatitis\n- Allergy to the active substance or to one of the excipients of OZEMPIC®\n- Patients treated with GLP1 agonists or oral antidiabetics in the month prior to inclusion\n- Pregnant, parturient or nursing woman\n- HbA1c ≥ 12% in the 3 months prior to inclusion\n- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy, confirmed by fundus examination performed within 6 months prior to selection\n- Person subject to a measure of legal protection (guardianship, tutorship)\n- Person subject to a measure of court protection\n- Renal impairment (GFR < 30 ml/mn)\n- Hepatic impairment (INR > 1.5)\n- BMI > 40 kg/m²"}

Primary endpoints

• {"endpoint_text":"- Percentage of time spent in glycemic target range (0.70-1.80 g/l) between D0 and D180.","definition_or_measurement_approach":"Change in percentage of time spent within the glycemic target (0.70-1.80 g/l) between D0 and D180; measured from continuous glucose monitoring data (devices allowed: Guardian, Dexcom or Free Style Libre) as indicated in the protocol and inclusion criteria."}

Secondary endpoints

• {"endpoint_text":"- HbA1c","definition_or_measurement_approach":""}
• {"endpoint_text":"- Weight, waist circumference","definition_or_measurement_approach":""}
• {"endpoint_text":"- Daily dose of insulin administered","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Assessed on CGM data (Free Style Libre, Guardian or Dexcom) using Standard Deviation (SD) and Mean Amplitude of Glycemic Excursions (MAGE); comparisons made between groups for D0–D180, D0–D90 and D90–D180."}
• {"endpoint_text":"- interstitial glucose time < 0.7 g/l and <0.54 g/l (Free Style Libre data)","definition_or_measurement_approach":"Measured using Free Style Libre interstitial glucose data as percentage of time below the specified thresholds (<0.7 g/l and <0.54 g/l)."}
• {"endpoint_text":"- Percentage of adverse events in the 2 groups","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

01-07-2024

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

526

Number Of Sites

5

Number Of Participants

76

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France