Official Title: “Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes”

This trial is conducted in Japan.

The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1C after 24 and 52 weeks 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: May 2008

Intervention(s) in this Clinical Trial

• Drug: liraglutide
  • 0.9 mg/day. Injected s.c. once daily.
• Drug: glibenclamide
  • 1.25-2.5 mg tablet. Given orally once or twice daily.
• Drug: placebo
  • liraglutide placebo. Injected s.c. once daily.
• Drug: placebo
  • glibenclamide placebo. Given orally once or twice daily.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• HbA1C
  • Time Frame: after 24 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Body weight
  • Time Frame: after 24 and 52 weeks of treatment
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: For the duration of the trial
    Safety Issue?: Yes
• Glycaemic control parameters
  • Time Frame: after 24 and 52 weeks of treatment
    Safety Issue?: No
• HbA1C
  • Time Frame: after 52 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes
• Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks
• HbA1C greater than or equal to 7.0% and less than 10.0%
• BMI less than 35 kg/m2

Exclusion Criteria:

• Treatment with insulin within the last 12 weeks
• Treatment with any drug that could interfere with the glucose level
• Any serious medical condition
• Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novo Nordisk

Overall Clinical Trial Officials and Contacts

Yasuyuki Katayama, MD Study Director Novo Nordisk Pharma Ltd.  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00393718

Study ID Number: NN2211-1700

ClinicalTrials.gov Identifier: NCT00393718

Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Clinical Trials at Novo Nordisk