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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2

• Registration Number: NCT00568074
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-16
• Primary Completion: 2004-09-02
• Study Completion: 2004-09-02
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	after 3 months of treatment

Secondary Outcome Measures

Name	Time	Method
hypoglycaemia episodes
adverse events
fasting blood glucose

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇨🇳 Beijing, China