Weekly GLP1 Agonist Treatment for Double Diabetes

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study

This study is testing if a weekly injection of a new diabetes medication can help people with both type 1 diabetes and insulin resistance manage their blood sugar better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Locations: 1 site (Dijon)
• Trial ID: NCT05305794 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with confirmed type 1 diabetes, a BMI of 27 or higher, and evidence of insulin resistance.

Not a fit: Patients without a history of insulin resistance or those not meeting the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve glycemic control and overall health for patients with double diabetes.

How similar studies have performed: Other studies have shown promising results with GLP1 agonists in managing insulin resistance, suggesting potential success for this approach in double diabetes.

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

Where this trial is running

Dijon

• Chu Dijon Bourgogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Benjamin BOUILLET

Conditions Double Diabetes