52 Week Trial of Liraglutide in Type 1 Diabetes

CHU de Quebec-Universite Laval15 enrolled

Overview

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.

Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

LiraglutideDRUG

Liraglutide will be compared to placebo for 24 weeks in a cross-over design

PlacebosDRUG

placebo will be compared to liraglutide for 24 weeks in a cross-over design

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Québec

Québec, Canada

Outcomes

Primary Outcomes

Assessment of Changes in Glycemic Control by HbA1c.

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.

Time frame: Measure changes in HbA1c at 24 and 52 weeks from baseline

Secondary Outcomes

Assessment of Changes on Adipose Tissue

To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue

Time frame: Measure changes in the composite at 24 and 52 weeks from baseline

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.