Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment liraglutide
Phase phase 4
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator Novo Nordisk A/S
Start date April 2013
End date December 2014
Trial size 15 participants
Trial identifier NCT01787916, 2013LIDO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Liraglutide, s.c., 1.8 mg, die, 24 weeks
liraglutide Liraglutide
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
(Placebo Comparator)
Placebo visually identical to study drug will be given
liraglutide Liraglutide
Liraglutide will be compared to placebo for 24 weeks in a cross-over design

Primary Outcomes

Measure
Assessment of changes in glycemic control by HbA1c.
time frame: Measure changes in HbA1c at 24 and 52 weeks from baseline

Secondary Outcomes

Measure
Assessment of changes in various metabolic measures (composite)
time frame: Measure changes in the composite at 24 and 52 weeks from baseline

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years Exclusion Criteria: - diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis

Additional Information

Official title Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
Principal investigator Stanley John Weisnagel, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.