Effect of Weekly GLP1 Agonist Treatment in "double Diabetes"

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Mar 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called semaglutide, a GLP1 agonist, on patients with "double diabetes." Double diabetes occurs when someone has type 1 diabetes—where the body doesn’t produce insulin—and also shows signs of insulin resistance, which is more common in type 2 diabetes. The researchers believe that semaglutide, which has been effective in treating type 2 diabetes, might help improve blood sugar control and reduce insulin resistance in these patients.

To be eligible for this trial, participants must be over 18 years old, diagnosed with type 1 diabetes at age 35 or younger, and have been using insulin therapy for at least a year. They should also have a body mass index (BMI) of 27 or higher, and have certain family health histories or blood test results that indicate insulin resistance. Participants can expect to receive weekly injections of semaglutide and will be monitored closely throughout the study. It's important to note that women who can become pregnant will need to use effective birth control during the trial. This study is currently recruiting participants, and it aims to find out if semaglutide can provide better health outcomes for those with double diabetes.

Gender

ALL

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