52 Week Trial of Liraglutide in Type 1 Diabetes

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br>Liraglutide, s.c., 1.8 mg, die, 24 weeks | Drug: Liraglutide<br>* Liraglutide will be compared to placebo for 24 weeks in a cross-over design<br>* Other names: Victoza;|
| Placebo Comparator: Placebo<br>Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks | Drug: Placebos<br>* placebo will be compared to liraglutide for 24 weeks in a cross-over design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, overweight, insulin, liraglutide