A randomised, double-blind, placebo controlled study of the effect of liraglutide as an
additional treatment to insulin on HbA1c, body weight and hypoglycaemia in poorly regulated
type 1 diabetes patients.
Background: Treatment with glucagon-like peptid 1 (GLP-1) agonists liraglutide and exanatide
leads to weight loss and decrease in haemoglobin A1c in oral anti diabetic treated type 2
diabetes patients.
It is estimated that 40-50 % of type 1 diabetes patients in the US suffers from overweight or
poor glycaemic control (HbA1c > 8 %).
Small studies, not placebo controlled, reports effects of adding liraglutide to a group of
well regulated (HbA1c < 7.5 %) normal to overweight insulin treated type 1 diabetes patients
for 24 weeks. A decrease in HbA1c, weight, insulin doses and glycaemic excursions measured by
continuous glucose monitoring was seen.
Primary objective:To investigate the effect of liraglutide 1.8 mg once daily compared to
placebo for 24 weeks on change in HbA1c in patients with type 1 diabetes as an add-on therapy
to insulin. Secondary objectives:To investigate the effect of liraglutide as an add-on
therapy to insulin compared to placebo on change in:Weight, insulin dose,hypoglycaemic
events, CGM, BMI, body composition, quality of life, treatment satisfaction,food preferences,
meal test, CIMT, PWV and 24 hour blood pressure.
Phase:
Phase 4
Details
Lead Sponsor:
Steno Diabetes Center Steno Diabetes Center Copenhagen
Collaborators:
University Hospital, Gentofte, Copenhagen University of Copenhagen