Trial · Interventional

CompletedPhase 4Results postedRegistry data

52 Week Trial of Liraglutide in Type 1 Diabetes

Short name LIDO

NCTNCT01787916Other id2013LIDO

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 15 participants (actual)
Sponsor: CHU de Quebec-Universite Laval · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Canada
Start: Apr 2013
Primary completion: Apr 2015
Completion: Apr 2015
First posted: 11 Feb 2013 (estimated)
Last update posted: 5 Jan 2018
Conditions: Type 1 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2013201420152016

Ph 4
LIDO
NCT01787916
Apr 2013 to Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LiraglutideDrug
PlacebosDrug

Arms2

Experimental
Liraglutide
Liraglutide, s.c., 1.8 mg, die, 24 weeks
Placebo comparator
Placebo
Liraglutide placebo (visually identical to study drug) will be given s.c. 1.8 mg for 24 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

Assessment of Changes in Glycemic Control by HbA1c.
Time frame · Measure changes in HbA1c at 24 and 52 weeks from baseline
Registry 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.

Secondary outcomes(1)

Assessment of Changes on Adipose Tissue
Time frame · Measure changes in the composite at 24 and 52 weeks from baseline
Registry description
To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Measure changes in HbA1c at 24 and 52 weeks from baseline

Assessment of Changes in Glycemic Control by HbA1c.

Group	Value (percentage of HbA1c)	Spread
Liraglutide	0.3	0.1
Placebo	0.2	0.1

Secondary and other outcome results(1)

Secondary outcome· Measure changes in the composite at 24 and 52 weeks from baseline

Assessment of Changes on Adipose Tissue

Group	Value

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LiraglutideLiraglutide, s.c., 1.8 mg, die, 24 weeks Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design	–	0 / 15	13 / 15
PlaceboPlacebo visually identical to study drug will be given Liraglutide: Liraglutide will be compared to placebo for 24 weeks in a cross-over design	–	0 / 15	0 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

12 results

Beyond glycaemic control: A cross-over, double-blinded, 24-week intervention with liraglutide in type 1 diabetes.

Dubé et al. 2018Diabetes, obesity & metabolismcited by 35

PMID 28722271DOI 10.1111/dom.13063PUB-28722271

Full text at the publisher12 results

Publisher page See results (12)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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