52 Week Trial of Liraglutide in Type 1 Diabetes (LIDO)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Liraglutide
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, overweight, insulin, liraglutide
Eligibility Criteria
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
Sites / Locations
- CHU de Québec
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Liraglutide
Placebo
Arm Description
Liraglutide, s.c., 1.8 mg, die, 24 weeks
Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01787916
First Posted
February 4, 2013
Last Updated
December 5, 2017
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Novo Nordisk A/S
1. Study Identification
Unique Protocol Identification Number
NCT01787916
Brief Title
52 Week Trial of Liraglutide in Type 1 Diabetes
Acronym
LIDO
Official Title
Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, overweight, insulin, liraglutide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide
Arm Type
Experimental
Arm Description
Liraglutide, s.c., 1.8 mg, die, 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
placebo will be compared to liraglutide for 24 weeks in a cross-over design
Primary Outcome Measure Information:
Title
Assessment of Changes in Glycemic Control by HbA1c.
Description
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.
Time Frame
Measure changes in HbA1c at 24 and 52 weeks from baseline
Secondary Outcome Measure Information:
Title
Assessment of Changes on Adipose Tissue
Description
To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue
Time Frame
Measure changes in the composite at 24 and 52 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley John Weisnagel, MD
Organizational Affiliation
CHU de Québec
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin D'Amours, MD
Organizational Affiliation
CHU de Québec
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Québec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
individual data will not be available to other researchers
Citations:
PubMed Identifier
28722271
Citation
Dube MC, D'Amours M, Weisnagel SJ. Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes. Diabetes Obes Metab. 2018 Jan;20(1):178-184. doi: 10.1111/dom.13063. Epub 2017 Sep 6.
Results Reference
derived
Learn more about this trial
52 Week Trial of Liraglutide in Type 1 Diabetes
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