Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD 1)

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); rosiglitazone (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 globally (the United States of America excepted).

This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

Official title: Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

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

Glycemic control parameters (fasting plasma glucose, -glucose profiles)

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. 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 to 45. 0 kg/m2.

Exclusion Criteria:

- Treatment with insulin within the last three months

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

- Any serious medical condition

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

breastfeeding

Mar del Plata (7600), Argentina

VIC 3162, Australia

São Paulo SP, Brazil

Sofia, Bulgaria

Split, Croatia

Pilsen, Czech Republic

Oulu, Finland

Paris, France

Athens, Greece

Hong Kong, Hong Kong

Chandigarh, India

Haifa, Israel

Perugia, Italy

Kelantan, Malaysia

Quezon City, Philippines

Zabrze, Poland

Timisoara, Romania

Durban, South Africa

Palma de Mallorca, Spain

St. Gallen, Switzerland

Taipei, Taiwan

Bangkok, Thailand

Izmiir, Turkey

Clinical Trials at Novo Nordisk

Starting date: May 2006
Last updated: September 10, 2007