Official Title: “Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chineese Subjects With Type 2 Diabetes Mellitus”

This trial is conducted in Asia.

The aim of this trial is to compare the efficacy and safety of repaglinide and Glurenorm® and Glucobay® given as the mono-therapy in Chinese subjects being treatment-naive type 2 diabetes.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: repaglinide
• Drug: Glurenorm®
• Drug: Glucobay®

Primary Measures

• HbA1c
  • Time Frame: after 3 months of treatment
    Safety Issue?: No

Secondary Measures

• fasting blood glucose
  • Safety Issue?: No
• hypoglycaemia episodes
  • Safety Issue?: No
• adverse events
  • Safety Issue?: No

Inclusion Criteria:

• Type 2 diabetes
• No previous treatment for diabetes
• HbA1c: 7.0-12.0%

Exclusion Criteria:

• Type 1 diabetes
• Uncontrolled treated/untreated hypertension
• Any condition that the Investigator and/or Sponsor feels would interfere with trial participation or evaluation of results
• Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures (adequate contraceptive measures are: sterilisation, intra-uterine device (IUD), oral contraceptives or barrier methods)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 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

Han Lijun Study Director Novo Nordisk  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00568074

Study ID Number: AGEE-1555

ClinicalTrials.gov Identifier: NCT00568074

Health Authority: China: State Food and Drug Administration

Clinical Trials at Novo Nordisk