52 Week Trial of Liraglutide in Type 1 Diabetes
This trial is active, not recruiting.
|Condition||type 1 diabetes|
|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|
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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Assessment of changes in glycemic control by HbA1c.
time frame: Measure changes in HbA1c at 24 and 52 weeks from baseline
Assessment of changes in various metabolic measures (composite)
time frame: Measure changes in the composite at 24 and 52 weeks from baseline
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
|Official title||Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.|
|Principal investigator||Stanley John Weisnagel, MD|
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