Official Title: “Liraglutide Effect and Action in Diabetes (LEAD 2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes”

This trial is conducted in Europe, Oceania, Africa, Asia and South America.

This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride.

The 26 weeks double-blind period will be followed by an 18 months open label extension.

Study Type: Interventional

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

Study Primary Completion Date: May 2007

Intervention(s) in this Clinical Trial

• Drug: liraglutide
  • 0.6 mg for s.c. injection
• Drug: metformin
  • 1.5-2.0 g tablets
• Drug: glimepiride
  • 4 mg tablets
• Drug: placebo
  • Glimepiride placebo 1 mg and 2 mg tablets
• Drug: placebo
  • Liraglutide placebo 1-3 mL for s.c. injection
• Drug: liraglutide
  • 1.2 mg for s.c. injection
• Drug: liraglutide
  • 1.8 mg for s.c. injection

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B
• Active Comparator: C
• Active Comparator: D
• Active Comparator: E

Primary Measures

• HbA1c
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Body weight
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Glycaemic control parameters (fasting plasma glucose, 7-point glucose profiles)
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Beta-cell function
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: after 26 weeks of treatment
    Safety Issue?: Yes

Inclusion Criteria:

• Subjects diagnosed with type 2 diabetes and treated with OAD(s) 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 40 kg/m2

Exclusion Criteria:

• Subjects treated with insulin within the last three months
• Subjects with any serious medical condition
• Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
• Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

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

Milan Zdravkovic, MD, Ph.D Study Director Novo Nordisk A/S  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00318461

Study ID Number: NN2211-1572

ClinicalTrials.gov Identifier: NCT00318461

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Clinical Trials at Novo Nordisk