To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together

NCT00318461 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of adding liraglutide to metformin versus metformin alone or metformin with glimepiride in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 1,091 people

Who can join Ages 18–80 · all sexes

Timeline Started 2006-05 · est. completion 2008-11

Where 190 sites · Argentina, Australia, Belgium, Bulgaria, Croatia, Denmark, Germany, Hungary, India, Ireland, Italy, Netherlands, Norway, Romania, Russia, Slovakia, South Africa, Spain, Sweden, United Kingdom

What this study is testing ClinicalTrials.gov NCT00318461 ↗

Description as written by the study sponsor.

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

Treatments tested

liraglutide Drug

0.6 mg for s.c. (under the skin) injection.
metformin Drug

1.5-2.0 g tablets
glimepiride Drug

4 mg tablets
placebo Drug

Glimepiride placebo 1 mg and 2 mg tablets
placebo Drug

Liraglutide placebo 1-3 mL for s.c. (under the skin) injection
liraglutide Drug

1.2 mg for s.c. (under the skin) injection
liraglutide Drug

1.8 mg for s.c. (under the skin) injection

Main thing measured	Change in Glycosylated A1c (HbA1c) at Week 26
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00318461 ↗