- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00568074
Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes
February 17, 2017 updated by: Novo Nordisk A/S
Efficacy and Safety of Repaglinide, Glurenorm® and Glucobay® in Chinese Subjects With Type 2 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
131
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China, 100029
- Novo Nordisk Investigational Site
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Shanghai
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Shanghai, Shanghai, China, 200025
- Novo Nordisk Investigational Site
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Shanghai, Shanghai, China, 200433
- Novo Nordisk Investigational Site
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Sichuan
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Chengdu, Sichuan, China, 610041
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: after 3 months of treatment
|
after 3 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
---|
adverse events
|
fasting blood glucose
|
hypoglycaemia episodes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 16, 2003
Primary Completion (Actual)
September 2, 2004
Study Completion (Actual)
September 2, 2004
Study Registration Dates
First Submitted
December 4, 2007
First Submitted That Met QC Criteria
December 4, 2007
First Posted (Estimate)
December 5, 2007
Study Record Updates
Last Update Posted (Actual)
February 20, 2017
Last Update Submitted That Met QC Criteria
February 17, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGEE-1555
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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