52 Week Trial of Liraglutide in Type 1 Diabetes

NCT ID: NCT01787916

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Liraglutide

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

Group Type: EXPERIMENTAL

Liraglutide

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

Liraglutide

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

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Other Intervention Names

Victoza

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stanley John Weisnagel, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec

Martin D'Amours, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec

Locations

CHU de Québec

Québec, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28722271 (View on PubMed)

Other Identifiers

2013LIDO

Identifier Type: -

Identifier Source: org_study_id