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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: liraglutide

Drug: glimepiride

Drug: rosiglitazone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00318422

NN2211-1436

2005-003414-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

1,041 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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