Official Title: “Effect of Liraglutide or Glimepiride Added to Metformin on Glycaemic Control in Subjects With Type 2 Diabetes”

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin 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: January 2009

Intervention(s) in this Clinical Trial

• Drug: liraglutide
  • 0.6 mg/day, s.c. injection
• Drug: placebo
  • Glimepiride placebo, capsules
• Drug: liraglutide
  • 1.2 mg/day, s.c. injection
• Drug: liraglutide
  • 1.8 mg/day, s.c. injection
• Drug: glimepiride
  • Capsules, 4.0 mg/day
• Drug: metformin
  • Tablets
• Drug: placebo
  • Liraglutide placebo, s.c. injection

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Experimental: B
• Experimental: C
• Experimental: D

Primary Measures

• Change in HbA1c
  • Time Frame: After 16 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Body weight
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Fasting blood glucose
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• 7-point plasma glucose profiles (self-measured)
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Beta-cell function and lipid profile
  • Time Frame: For the duration of the trial
    Safety Issue?: No
• Hyperglycaemic episodes and adverse events
  • Time Frame: For the duration of the trial
    Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes
• Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months
• HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone
• HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy
• BMI less than 45.0 kg/m2

Exclusion Criteria:

• Treatment with insulin within the last 3 months prior to the trial
• Impaired liver or/and renal function
• Significant cardiovascular disease over the last 6 months
• Known retinopathy or maculopathy
• Recurrent major hypoglycaemia or hypoglycaemic unawareness

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

Marcin Zychma, MD, PhD Study Director Novo Nordisk A/S  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00614120

Study ID Number: NN2211-1796

ClinicalTrials.gov Identifier: NCT00614120

Health Authority: China: State Food and Drug Administration

Clinical Trials at Novo Nordisk