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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); metformin (Drug); glimepiride (Drug); placebo (Drug); placebo (Drug); liraglutide (Drug); liraglutide (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Milan Zdravkovic, MD, Ph.D, Study Director, Affiliation: Novo Nordisk A/S

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.

The 26 weeks double-blind period will be followed by an 18 months open label extension.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c

Secondary outcome:

Body weight

Glycaemic control parameters (fasting plasma glucose, 7-point glucose profiles)

Beta-cell function

Safety and tolerability

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects diagnosed with type 2 diabetes and treated with OAD(s) for at least 3 months

- HbA1c: 7. 0-11. 0 % (both incl.) in subjects on OAD monotherapy. 7. 0-10. 0 % (both incl.)

in subjects on OAD combination therapy

- Body Mass Index (BMI) less than or equal 40 kg/m2

Exclusion Criteria:

- Subjects treated with insulin within the last three months

- Subjects with any serious medical condition

- Females of child bearing potential who are pregnant, breast-feeding or have the

intention of becoming pregnant or not using adequate contraceptive methods

- Subjects using any drug (except for OADs), which in the Investigator's opinion could

interfere with the glucose level (e. g. systemic corticosteroids)

Ciudad Autonoma de Bs As, Argentina

Box Hill, Australia

Leuven, Belgium

Sofia, Bulgaria

Zagreb, Croatia

Aarhus, Denmark

Bad Lauterberg, Germany

Pecs, Hungary

Gopalapuram, Chennai, India

Dublin, Ireland

Milano, Italy

Rotterdam, Netherlands

Trondheim, Norway

St. Cluj-Napoca, Romania

Moscow, Russian Federation

Bratislava, Slovakia

Durban, South Africa

Granada, Spain

Lund, Sweden

Oxford, United Kingdom

Clinical Trials at Novo Nordisk

Starting date: May 2006
Ending date: November 2008
Last updated: February 15, 2008