NCT01787916

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

January 5, 2018

Completed
Last Updated

January 5, 2018

Status Verified

March 1, 2014

Enrollment Period

2 years

First QC Date

February 4, 2013

Results QC Date

January 27, 2016

Last Update Submit

December 5, 2017

Conditions

Type 1 Diabetes

Keywords

type 1 diabetesoverweightinsulinliraglutide

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measure changes in HbA1c at 24 and 52 weeks from baseline

Secondary Outcomes (1)

  • Assessment of Changes on Adipose Tissue

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

Study Arms (2)

Liraglutide

EXPERIMENTAL

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

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

LiraglutideDRUG

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

Also known as: Victoza
Liraglutide
PlacebosDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • type 1 diabetes non smoker BMI superior or equal to 25 diabetes duration superior or equal to 5 years

You may not qualify if:

  • diabetic complication HbA1c superior or equal to 8.5% cancer acute or chronic pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Québec

Québec, G1V 4G2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28722271DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1OverweightInsulin Resistance

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinism

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Weisnagel
Organization
CHU de Quebec
john.weisnagel@crchul.ulaval.ca
4185254444

Study Officials

  • Stanley John Weisnagel, MD

    CHU de Québec

    PRINCIPAL INVESTIGATOR

  • Martin D'Amours, MD

    CHU de Québec

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 11, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 5, 2018

Results First Posted

January 5, 2018

Record last verified: 2014-03

Data Sharing

IPD Sharing
Will not share

individual data will not be available to other researchers

Locations

CA(1)