Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05305794

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-12-18

76

Participants Needed

1

Research Sites

316 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written consent
  • Age 18 years or older
  • Confirmed type 1 diabetes with low C-peptide levels
  • Diagnosed with diabetes before age 35
  • Receiving optimized insulin therapy (multiple injections or pump) for at least 1 year with education on dose adjustment
  • Body mass index (BMI) of 27 kg/m² or more
  • At least one of the following: family history of type 2 diabetes, family history of obesity (BMI >30 kg/m²), triglycerides over 1.50 g/l, or low HDL cholesterol (below 0.5 g/l in women or 0.4 g/l in men)
  • HbA1c between 7.5% and 12% in the last 3 months before inclusion
  • Using a continuous glucose monitoring system (Guardian, Dexcom, or Free Style Libre)
  • For women of childbearing age: using effective contraception during the study and for 2 months after
Not Eligible

You will not qualify if you...

  • Not covered by national health insurance
  • Pregnant, giving birth, or breastfeeding
  • HbA1c 12% or higher in the last 3 months
  • Uncontrolled or unstable diabetic eye disease confirmed within 6 months
  • Under legal protection (such as curatorship or guardianship)
  • Severe kidney failure (GFR below 30 ml/min)
  • Liver failure (INR greater than 1.5)
  • BMI over 40 kg/m²
  • History of weight loss surgery
  • History of pancreatitis
  • Allergy to semaglutide or any of its components
  • Use of GLP1 agonists or oral antidiabetic drugs within one month before inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chu Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

B

Benjamin BOUILLET

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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