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...
Date First Received: December 4, 2007
Last Updated: April 30, 2009
Verified by: Novo Nordisk, January 2009
Clinical Trial Phase: Phase 4 | Start Date: December 2003
Overall Status: Completed
Estimated Enrollment: 131
Brief Summary
Official Title: “Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chineese Subjects With Type 2 Diabetes Mellitus”
Condition Keyword(s):
Intervention(s):
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
Study Primary Completion Date: September 2004
Intervention(s) in this Clinical Trial
- Drug: repaglinide
- Drug: Glurenorm®
- Drug: Glucobay®
Outcome Measures for this Clinical Trial
Primary Measures
- HbA1c
- Time Frame: after 3 months of treatment
Safety Issue?: No
- Time Frame: after 3 months of treatment
Secondary Measures
- fasting blood glucose
- Safety Issue?: No
- hypoglycaemia episodes
- Safety Issue?: No
- adverse events
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
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
Clinical Trial Sponsor Information
Lead Sponsor: Novo Nordisk
Overall Clinical Trial Officials and Contacts
Han Lijun Study Director Novo Nordisk
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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 Authorship and Review
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