52 Week Trial of Liraglutide in Type 1 Diabetes (LIDO)
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|ClinicalTrials.gov Identifier: NCT01787916|
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Liraglutide Drug: Placebos||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Liraglutide, s.c., 1.8 mg, die, 24 weeks
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Other Name: Victoza
Placebo Comparator: Placebo
Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
placebo will be compared to liraglutide for 24 weeks in a cross-over design
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787916
|CHU de Québec|
|Quebec, Canada, G1V 4G2|
|Principal Investigator:||Stanley John Weisnagel, MD||CHU de Québec|
|Principal Investigator:||Martin D'Amours, MD||CHU de Québec|