Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes (LEAD 1)
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: liraglutide (Drug); rosiglitazone (Drug); glimepiride (Drug)
Phase: Phase 3
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
Safety and tolerability
Glycemic control parameters (fasting plasma glucose, -glucose profiles)
Minimum age: 18 Years.
Maximum age: 80 Years.
- 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.
- 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
Locations and Contacts
Mar del Plata (7600), Argentina
VIC 3162, Australia
São Paulo SP, Brazil
Pilsen, Czech Republic
Hong Kong, Hong Kong
Quezon City, Philippines
Durban, South Africa
Palma de Mallorca, Spain
St. Gallen, Switzerland
Clinical Trials at Novo Nordisk
Starting date: May 2006
Last updated: September 10, 2007