Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"

Sponsor
Centre Hospitalier Universitaire Dijon
Study ID
NCT05305794
Phase
PHASE3
Status
Recruiting
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Conditions

  • Double Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Insulin + semaglutide treatment — DRUG
    Usual insulin treatment + semaglutide (0.25 mg/week for 4 weeks, then 0.50 mg/week for 4 weeks, then 1 mg/week for 18 weeks, i.e. a total duration of 26 weeks). Upon introduction of semaglutide (ozempic) treatment, insulin doses will be reduced by 10% (basal insulin, basal rate and bolus)
  • Usual insulin treatment — DRUG
    Usual insulin treatment
  • Biological check-up — BIOLOGICAL
    at D0, D90 and D180

Study Details

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).

Key Dates

Start date
Jul 12, 2022
Status verified
Dec 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
  • Active Comparator: Control

Primary Outcome Measure

Percentage of time spent within glycemic target range (0.70-1.80 g/l) [ Time Frame: Change from baseline at Day 180 ]

Central Contacts