Official Title: “Liraglutide Effect and Action in Diabetes (LEAD-3): Effect on Glycemic Control of Liraglutide Versus Glimepiride in Type 2 Diabetes”

Double blind trial with an open label extension conducted in the United States of America (USA) and Mexico. A second open label extension is registered, for internal administrative purposes only, as NN2211-3529.

Trial dates:

Original trial: Start February 2006, finish November 2007 First extension: Start March 2007, finish November 2008 The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: liraglutide
  • 1.2 mg for s.c. injection
• Drug: glimepiride
  • 8 mg capsule
• Drug: liraglutide
  • 1.8 mg for s.c. injection
• Drug: glimepiride
  • 8 mg capsule
• Drug: placebo
  • Glimepiride placebo, 8mg capsule
• Drug: placebo
  • Liraglutide placebo, 200 microL
• Drug: placebo
  • Liraglutide placebo, 300 microL

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Active Comparator: C1
• Active Comparator: C2

Primary Measures

• Change in HbA1c
  • Time Frame: after 52 weeks and after 104 weeks
    Safety Issue?: No

Secondary Measures

• Body weight
  • Time Frame: after 52 weeks and after 104 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: after 52 weeks and after 104 weeks
    Safety Issue?: Yes
• Glycemic Control
  • Time Frame: after 52 weeks and after 104 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Type 2 diabetes
• Treatment with diet/exercise or with oral anti-diabetic drugs alone for at least 2 months
• Diet/exercise treated subjects with HbA1c between 7.0% and 11%
• OAD treated subjects with HbA1c between 7.0% and 10%
• Body Mass Index (BMI) less than or equal to 45 kg/m2

Exclusion Criteria:

• Treatment with insulin for the last 3 months
• Treatment with any drug that could interfere with the glucose level (besides use of a single anti-diabetic compound)
• Any serious medical condition

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Paula Hale, MD Study Director Novo Nordisk  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00294723

Study ID Number: NN2211-1573

ClinicalTrials.gov Identifier: NCT00294723

Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Clinical Trials at Novo Nordisk