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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Liraglutide
Drug: Placebos
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liraglutide First, Then Placebo Placebo First, the Liraglutide
Hide Arm/Group Description

Liraglutide, s.c., 1.8 mg, die, 24 weeks

First Intervention (24 weeks)", "Washout (4 weeks)", and "Second Intervention (24 weeks

subjects were submitted to placebo and liraglutide in a randomly manner
Period Title: First Intervention (24 Weeks)
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Washout (4 Weeks)
Started 8 7
Completed 8 7
Not Completed 0 0
Period Title: Second Intervention (24 Weeks)
Started 8 7
Completed 8 7
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description Patients beginning with liraglutide will be switched to Placebo and vice versa
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female 8
Male 7
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 15 participants
15
1.Primary Outcome
Title Assessment of Changes in Glycemic Control by HbA1c.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:

Liraglutide, s.c., 1.8 mg, die, 24 weeks

Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design

Placebo visually identical to study drug will be given

Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of HbA1c
0.3  (0.1) 0.2  (0.1)
2.Secondary Outcome
Title Assessment of Changes on Adipose Tissue
Hide 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
Outcome Measure Data Not Reported
Time Frame 1 yr
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description

Liraglutide, s.c., 1.8 mg, die, 24 weeks

Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design

Placebo visually identical to study drug will be given

Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design

All-Cause Mortality
Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/15 (86.67%)      0/15 (0.00%)    
Gastrointestinal disorders     
nausea *  13/15 (86.67%)  13 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Weisnagel
Organization: CHU de Quebec
Phone: 4185254444 ext 47035
Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01787916     History of Changes
Other Study ID Numbers: 2013LIDO
First Submitted: February 4, 2013
First Posted: February 11, 2013
Results First Submitted: January 27, 2016
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018