Effect of Liraglutide or Exenatide Added to an Ongoing Treatment on Blood Glucose Control in Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the effect on glycaemic control of liraglutide or exenatide when added to subject's ongoing OAD (oral anti-diabetic drug) treatment of either metformin, sulphonylurea or a combination of both in subjects with type 2 diabetes. Two trial periods: A 26 week randomised, followed by a 52 week extension (14 + 38 weeks) where all subjects received liraglutide + OAD after previous randomisation to either liraglutide or exenatide, both combined with OAD treatment.

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

Details

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

Criteria

Inclusion Criteria:

• Type 2 diabetes

• Stable treatment with Oral Anti-Diabetic Drugs (metformin, sulphonylurea or a combination of both) for at least 3 months at the discretion of the Investigator

• HbA1C equal to or greater than 7.0% and equal to or lower than 11.0%

• Body Mass Index (BMI) equal to or lower than 45.0 kg/m2

Exclusion Criteria:

• Previous treatment with insulin

• Treatment with any anti-diabetic drug other than metformin and sulphonylurea

• Any previous exposure to exenatide or liraglutide

• Impaired liver or/and renal function

• History of any significant cardiac events

• Known retinopathy or maculopathy requiring acute treatment

• Recurrent major hypoglycaemia or hypoglycaemic unawareness