Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD-4)

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); rosiglitazone (Drug); metformin (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Paula Hale, MD, Study Director, Affiliation: Novo Nordisk

This trial is conducted in the United States of America (USA) and Canada.

This trial is designed to show the effect of treatment with liraglutide when added to existing rosiglitazone and metformin combination therapy and to compare it with the effects of therapy with rosiglitazone and metformin alone.

Official title: Effect on Glycemic Control of Liraglutide in Combination With Rosiglitazone Plus Metformin Versus Rosiglitazone Plus Metformin in Subjects With Type 2 Diabetes.

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

Primary outcome: HbA1c after 26 weeks of treatment

Secondary outcome:

body weight

Safety and tolerability

Glycaemic control

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

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Treated with oral anti-diabetic (OAD) drugs for at least 3 months

- Treated with one or more OAD and in moderate to poor glycemic control

- Body Mass Index (BMI) less than or equal to 45. 0 kg/m2

Exclusion Criteria:

- Treatment with insulin within the last three months prior to the trial except due to intercurrent illness, at the discretion of the Investigator

- Any serious medical condition

- Treatment with any drug that could interfere with glucose level

Novo Nordisk Clinical Trial Call Center, Las Vegas, Nevada 89103, United States

Starting date: May 2006
Last updated: April 24, 2007