Weekly GLP1 Agonist Treatment for Double Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of semaglutide, a GLP1 agonist, on patients with double diabetes, a condition characterized by the presence of both type 1 diabetes and insulin resistance. The study aims to determine if weekly subcutaneous injections of semaglutide can improve glycemic control and reduce insulin resistance in these patients. Participants will receive either the semaglutide treatment alongside their usual insulin therapy or continue with standard insulin treatment. The trial will assess the efficacy of this approach in managing the unique challenges faced by individuals with double diabetes.

Why it matters

Who can join: the full rules

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 who have received GLP-1 agonist therapy or who received such therapy within the year prior to enrollment
* Patients who have received oral antidiabetic therapy within the month prior to enrollment

Where it's running

• Chu Dijon Bourgogne
  Dijon, France Recruiting

Study contacts

• Study coordinator: Benjamin BOUILLET
• Email: benjamin.bouillet@chu-dijon.fr
• Phone: 03.80.29.34.53

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.