Conditions: Type 1 Diabetes
Keywords: type 1 diabetes overweight insulin liraglutide
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 15
Healthy volunteers: no

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.

Arms:
arm 1: Liraglutide, s.c., 1.8 mg, die, 24 weeks arm 2: Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks

Interventions: intervention 1: Liraglutide intervention 2: Placebos
Intervention descriptions: intervention 1: Liraglutide will be compared to placebo for 24 weeks in a cross-over design intervention 2: placebo will be compared to liraglutide for 24 weeks in a cross-over design

Protocol document: