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

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ClinicalTrials.gov Identifier: NCT00568074
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide Drug: Glurenorm® Drug: Glucobay® Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus
Study Start Date : December 16, 2003
Actual Primary Completion Date : September 2, 2004
Actual Study Completion Date : September 2, 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Repaglinide
U.S. FDA Resources




Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 3 months of treatment ]

Secondary Outcome Measures :
  1. fasting blood glucose
  2. hypoglycaemia episodes
  3. adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568074


Locations
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
China
Novo Nordisk Investigational Site
Beijing, China, 100029
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00568074     History of Changes
Other Study ID Numbers: AGEE-1555
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Repaglinide
Gliquidone
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action