52 Week Trial of Liraglutide in Type 1 Diabetes (LIDO)

December 5, 2017 updated by: CHU de Quebec-Universite Laval

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

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G2
        • CHU de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Liraglutide
Liraglutide will be compared to placebo for 24 weeks in a cross-over design
Other Names:
  • Victoza
Placebo Comparator: Placebo
Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks
Drug: Placebos
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

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

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Stanley John Weisnagel, MD, CHU de Québec
  • Principal Investigator: Martin D'Amours, MD, CHU de Québec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

December 5, 2017

Last Verified

March 1, 2014

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)?

NO

IPD Plan Description

individual data will not be available to other researchers

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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