Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-5)

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); insulin glargine (Drug); metformin (Drug); glimepiride (Drug)

Phase: Phase 3

Status: Completed

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 Africa, Asia, Europe and South America.

This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

Official title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-Month Randomised, Double-Blind, Parallel-Group, Multi-Centre, Multi-National Trial With an Open-Label Treat-to-Target Insulin Glargine Control Arm.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c

Secondary outcome:

body weight

Safety and tolerability

Beta-cell function

Glycaemic control

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

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Treatment with oral anti-diabetic drugs for at least 3 months

- HbA1c: 7. 5-10. 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 to 45 kg/m2

Exclusion Criteria:

- Treatment with insulin within the last 3 months

- Treatment with any drug that could interfere with the glucose level

- Any serious medical condition

- Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Mendoza, Argentina

Vienna, Austria

Rio de Janeiro, Brazil

Aarhus, Denmark

Kuopio, Finland

Nevers, France

Hyderabad, India

Siena, Italy

Den Haag, Netherlands

Rud, Norway

Quezon City, Philippines

Zabrze, Poland

Moscow, Russian Federation

Lubochna, Slovakia

Pretoria, South Africa

Barcelona, Spain

Guildford, United Kingdom

Clinical Trials at Novo Nordisk

Starting date: May 2006
Last updated: August 31, 2007