CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,091 enrolled
Drug / intervention
liraglutide +6 moredrug
Likely dose
liraglutide 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00318461
NCT00318461Phase 3Completed
CompareCT.gov

Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes

Novo Nordisk A/S·interventional·Posted Apr 26, 2006·Updated Mar 7, 2017

In Brief

A Phase 3 clinical trial evaluating liraglutide, metformin, and 2 other interventions for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 1,091 participants across 190 sites in 20 countries.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesArgentina, Australia, Belgium, Bulgaria, Croatia, Denmark, Germany, Hungary, India, Ireland, Italy, Netherlands, Norway, Romania, Russia, Slovakia, South Africa, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 26, 2006
Enrollment StartMay 1, 2006
Primary CompletionMay 1, 2007
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.2 years ago

Interventions

liraglutidedrug

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

metformindrug

1.5-2.0 g tablets

glimepiridedrug

4 mg tablets

placebodrug

Glimepiride placebo 1 mg and 2 mg tablets

placebodrug

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

liraglutidedrug

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

liraglutidedrug

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