52 Week Trial of Liraglutide in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— LIDO  

Official title:

Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787916
• Other study ID #: 2013LIDO
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2013
• Last updated: December 5, 2017
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2014
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
Canada	CHU de Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measure changes in HbA1c at 24 and 52 weeks from baseline
Secondary	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	Measure changes in the composite at 24 and 52 weeks from baseline