Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes
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 diabetics...
Brief Summary
Official Title: “Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese 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 diabetics.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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 Investigator Information
Lead Investigator: Novo Nordisk Industry
Overall Clinical Trial Officials and Contacts
Han Lijun Study Director Novo Nordisk
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00568074
