Liraglutide in Type 1 Diabetes

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Collaborators: University Hospital, Gentofte, Copenhagen; University of Copenhagen
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Type 1 diabetes according to WHO criteria ≥ 1 year

• Age ≥ 18 years

• BMI > 25 kg/m2

• HbA1c > 8.0 % at visit 0

Exclusion Criteria:

• Insulin pump treatment

• Hypoglycaemia unawareness (unability to register low blood glucose)

• Diabetic gastroparesis

• Compromised kidney function (eGFR < 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0

• Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)

• Acute or chronic pancreatitis

• Inflammatory bowel disease

• Cancer unless in complete remission for > 5 years

• History of thyroid adenoma or carcinoma

• Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation

• Alcohol/drug abuse

• Fertile women not using contraceptives

• Pregnant or nursing women

• Known or suspected hypersensitivity to trial product or related products

• Receipt of an investigational drug within 30 days prior to visit 0

• Simultaneous participation in any other clinical intervention trial