Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"
Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes": a Randomized Open-label Study
- Double Diabetes
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Centre Hospitalier Universitaire Dijon
- Enrolment target
- 76
- Started
- 12 July 2022
- Main results due
- August 2028
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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 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
What this study is about
In the sponsor’s own words, from the registry.
Between 16% and 22% of type 1 diabetic patients present a clinical and biological profile of insulin resistance favored by a family history of type 2 diabetes or metabolic syndrome. They constitute a group of patients with "double diabetes" since they have both true type 1 diabetes and inherited insulin resistance, typical of type 2 diabetes.
For several years, GLP1 agonists have been successfully used in the treatment of type 2 diabetes, leading to very significant improvements in glycemic control and weight loss.
Because of the insulin-sensitizing power of GLP1 agonists, the investigators hypothesize that they could reduce insulin resistance in patients with "double diabetes" and thus improve their glycemic control.
The investigators propose to use in this study semaglutide, the most recent and most potent GLP1 agonist (superiority demonstrated compared to exenatide LP and dulaglutide) and administered as a weekly subcutaneous injection (in contrast to liraglutide administered daily).
Study sites(1)
Chu Dijon Bourgogne
Dijon, France
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05305794. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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