Overview

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The extension will consist of two 26-week periods: 1. Week 27-52 after randomisation - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen. 2. Week 53-78 after randomisation - Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals. - Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Liraglutide
Metformin
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- Type 2 diabetes

- Treatment with metformin alone for at least three months

- HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)

- Body Mass Index (BMI) less than or equal to 45.0

Exclusion Criteria:

- Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or
dipeptidyl peptidase-4 (DPP-4) inhibitors

- Treatment with anti-diabetic drugs other than metformin within the last three months

- Any serious medical condition

- Females who are pregnant, have the intention of becoming pregnant or are breastfeeding