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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT00294723

Run by

Novo Nordisk A/S

People needed

746

Starts

2006-02-01

Expected to finish

2008-11-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Escondido, California, United States
• Novo Nordisk Investigational Site — Fullerton, California, United States
• Novo Nordisk Investigational Site — Inglewood, California, United States
• Novo Nordisk Investigational Site — Mission Viejo, California, United States
• Novo Nordisk Investigational Site — Orange, California, United States
• Novo Nordisk Investigational Site — Santa Barbara, California, United States
• Novo Nordisk Investigational Site — Spring Valley, California, United States
• Novo Nordisk Investigational Site — Vista, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Daytona Beach, Florida, United States
• Novo Nordisk Investigational Site — Delray Beach, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Longwood, Florida, United States
• Novo Nordisk Investigational Site — Ocala, Florida, United States
• Novo Nordisk Investigational Site — Saint Cloud, Florida, United States
• Novo Nordisk Investigational Site — Athens, Georgia, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Blue Ridge, Georgia, United States
• Novo Nordisk Investigational Site — Columbus, Georgia, United States
• Novo Nordisk Investigational Site — Marietta, Georgia, United States
• Novo Nordisk Investigational Site — Concord, California, United States

Full record on ClinicalTrials.gov

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