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

Laval University

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Drug: Placebos; Drug: Liraglutide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01787916

2013LIDO

Details and patient eligibility

About

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.

Full description

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Liraglutide

Experimental group

Description:

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

Treatment:

Drug: Liraglutide

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos