52 Week Trial of Liraglutide in Type 1 Diabetes
- Registration Number
- NCT01787916
- Lead Sponsor
- CHU de Quebec-Universite Laval
- Brief Summary
To our knowledge, no trial has specifically studied the effect of liraglutide combined with a basal/bolus insulin regimen in type 1 diabetes in a cross-over, double-blind, unicentric model. Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.
Hypothesis Overweight participants with type 1 diabetes on liraglutide/insulin treatment will present improved glucose control with decreased HbA1c, decreased fasting and mean weekly glucose concentrations and glycemic excursions as well as increased insulin sensitivity compared to participants on placebo/insulin treatment. Participants with liraglutide/insulin treatment will also present improved endothelial function, lower body weight, central adipose tissue assessed by CT scan and higher satiety sensations assessed by visual analogue scales.
- Detailed Description
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years
- diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebos Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks Liraglutide Liraglutide Liraglutide, s.c., 1.8 mg, die, 24 weeks
- Primary Outcome Measures
Name Time Method Assessment of Changes in Glycemic Control by HbA1c. Measure changes in HbA1c at 24 and 52 weeks from baseline To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.
- Secondary Outcome Measures
Name Time Method Assessment of Changes on Adipose Tissue Measure changes in the composite at 24 and 52 weeks from baseline To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue
Trial Locations
- Locations (1)
CHU de Québec
🇨🇦Quebec, Canada