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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 (Responsible Party):
Novo Nordisk A/S Identifier:
First received: December 4, 2007
Last updated: February 17, 2017
Last verified: February 2017
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
Intervention Model: Parallel Assignment
Masking: No masking
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 ]

Secondary Outcome Measures:
  • fasting blood glucose
  • hypoglycaemia episodes
  • adverse events

Enrollment: 131
Study Start Date: December 16, 2003
Study Completion Date: September 2, 2004
Primary Completion Date: September 2, 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200025
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200433
China, Sichuan
Novo Nordisk Investigational Site
Chengdu, Sichuan, China, 610041
Novo Nordisk Investigational Site
Beijing, China, 100029
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00568074     History of Changes
Other Study ID Numbers: AGEE-1555
Study First Received: December 4, 2007
Last Updated: February 17, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017