- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01787916
52 Week Trial of Liraglutide in Type 1 Diabetes (LIDO)
Cross-over, Double-blind, Unicentric, 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Quebec, Canada, G1V 4G2
- CHU de Québec
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liraglutide
Liraglutide, s.c., 1.8 mg, die, 24 weeks
|
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Other Names:
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Placebo Comparator: Placebo
Liraglutide placebo (visually identical to study drug) will be given s.c.
1.8 mg for 24 weeks
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placebo will be compared to liraglutide for 24 weeks in a cross-over design
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measure changes in HbA1c at 24 and 52 weeks from baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Measure changes in the composite at 24 and 52 weeks from baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stanley John Weisnagel, MD, CHU de Québec
- Principal Investigator: Martin D'Amours, MD, CHU de Québec
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013LIDO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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