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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: December 4, 2007
Last updated: September 23, 2009
Last verified: September 2009
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: repaglinide
Drug: Glurenorm®
Drug: Glucobay®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 3 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting blood glucose [ Designated as safety issue: No ]
  • hypoglycaemia episodes [ Designated as safety issue: No ]
  • adverse events [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: December 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00568074

China, Shanghai
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Han Lijun Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00568074     History of Changes
Other Study ID Numbers: AGEE-1555 
Study First Received: December 4, 2007
Last Updated: September 23, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on December 02, 2016