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Completed

NCT Number: NCT01787916

52 Week Trial of Liraglutide in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Body Weight Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Immune System Diseases Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Québec

Québec, G1V 4G2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Other names: Victoza

Placebos

Drug

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

Primary outcomes

  1. Assessment of Changes in Glycemic Control by HbA1c.

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

    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.

Secondary outcomes

  1. Assessment of Changes on Adipose Tissue

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

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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: LIDO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 11, 2013
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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