To Evaluate the Effect of Liraglutide Versus Glimepiride (Amaryl®) on Haemoglobin A1c

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in North America (the United States of America (USA) and Mexico).

The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Glimepiride; Liraglutide

Criteria

Inclusion Criteria:

• Type 2 diabetes

• TTreatment with diet/exercise or with not more than half maximal dose of oral anti-diabetic drugs alone for at least 2 months

• Diet/exercise treated subjects with HbA1c between 7.0% and 11%, inclusive

• OAD (oral anti-diabetic drug) treated subjects with HbA1c between 7.0% and 10%, inclusive

• Body Mass Index (BMI) less than or equal to 45 kg/m^2

Exclusion Criteria:

• Treatment with insulin for the last 3 months, except short-term treatment for intercurrent illness

• Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)

• Any serious medical condition