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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
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE February 4, 2013
First Posted Date  ICMJE February 11, 2013
Results First Submitted Date  ICMJE January 27, 2016
Results First Posted Date  ICMJE January 5, 2018
Last Update Posted Date January 5, 2018
Study Start Date  ICMJE April 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01787916 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2013)
Assessment of changes in various metabolic measures (composite) [ 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 glycemic variation, risk of hypoglycemia, glucagon in blood, weight, body mass index (BMI), waist circumference, central adipose tissue area, satiety sensations, the presence of the metabolic syndrome and insulin sensitivity assessed by euglycemia-hyperinsulinemic clamp and estimated glucose disposal rate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 52 Week Trial of Liraglutide in Type 1 Diabetes
Official Title  ICMJE Cross-over, Double-blind, Unicentric, 52 Week Trial of Liraglutide in Type 1 Diabetes.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • Drug: Liraglutide
    Liraglutide will be compared to placebo for 24 weeks in a cross-over design
    Other Name: Victoza
  • Drug: Placebos
    placebo will be compared to liraglutide for 24 weeks in a cross-over design
Study Arms  ICMJE
  • Experimental: Liraglutide
    Liraglutide, s.c., 1.8 mg, die, 24 weeks
    Intervention: Drug: Liraglutide
  • Placebo Comparator: Placebo
    Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
    Intervention: Drug: Placebos
Publications * Dubé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01787916
Other Study ID Numbers  ICMJE 2013LIDO
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: individual data will not be available to other researchers
Responsible Party CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Stanley John Weisnagel, MD CHU de Québec
Principal Investigator: Martin D'Amours, MD CHU de Québec
PRS Account CHU de Quebec-Universite Laval
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP