52 Week Trial of Liraglutide in Type 1 Diabetes

Sponsor
CHU de Quebec-Universite Laval
Study ID
NCT01787916
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide will be compared to placebo for 24 weeks in a cross-over design
  • Placebos — DRUG
    placebo will be compared to liraglutide for 24 weeks in a cross-over design

Study Details

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.

Key Dates

Start date
Apr 30, 2013
Status verified
Mar 2014
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
    Liraglutide, s.c., 1.8 mg, die, 24 weeks
  • Placebo Comparator: Placebo
    Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks

Primary Outcome Measure

Assessment of Changes in Glycemic Control by HbA1c. [ Time Frame: Measure changes in HbA1c at 24 and 52 weeks from baseline ]

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