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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00568074
First received: December 4, 2007
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568074

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

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov 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
Acarbose
Gliquidone
Repaglinide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014