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NCT00568074 Clinical Trial

Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00568074
Other study ID # AGEE-1555
Secondary ID
Status Completed
Phase Phase 4
First received December 4, 2007
Last updated February 17, 2017
Start date December 16, 2003
Est. completion date September 2, 2004

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date September 2, 2004
Est. primary completion date September 2, 2004
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• repaglinide

• Glurenorm®

• Glucobay®

Locations
Country Name City State
China Novo Nordisk Investigational Site Beijing
China Novo Nordisk Investigational Site Chengdu Sichuan
China Novo Nordisk Investigational Site Shanghai Shanghai
China Novo Nordisk Investigational Site Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 3 months of treatment
Secondary fasting blood glucose
Secondary hypoglycaemia episodes
Secondary adverse events
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