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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: rosiglitazone

Drug: metformin

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00333151

NN2211-1574

Details and patient eligibility

About

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.

Enrollment

576 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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