Effect of Weekly GLP1 Agonist Treatment in "Double Diabetes"
ConditionDouble Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Dijon
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Insulin + semaglutide treatment
DrugUsual 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
DrugUsual insulin treatment
Biological check-up
Biological/Vaccineat D0, D90 and D180
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: SemaglutideExperimental treatment 2 interventions
Group B: ControlActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of time spent within glycemic target range (0.70-1.80 g/l)
Time frame
Change from baseline at Day 180Sponsors and contacts
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Source ClinicalTrials.gov