Status:
COMPLETED
Trial to Evaluate the Efficacy and Safety of Dapagliflozin in Japanese Type 2 Diabetes Mellitus Patients
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to obtain information on efficacy and safety of dapagliflozin in Japanese patients with Type 2 Diabetes. This will be done by comparing the effect of dapagliflozin to plac...
Eligibility Criteria
Inclusion
- Japanese Subjects with type 2 diabetes mellitus.
- Strictly/relatively treatment naïve Subjects with HbA1c ≥ 7.0% and ≤ 10%, or Subjects treated with single or two (less than half of the approved maximal dose for each) oral anti-hyperglycaemic agent with HbA1c ≤ 8%.
- Provision of informed consent.
Exclusion
- Having clinically relevant medical history or concurrent disease such as cardiovascular disease, renal disease, retinopathy, hepatic disease and haematological disease.
- The investigator(s) judged that the Subject should not participate in the study according to screening test or medical history.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT00972244
Start Date
August 1 2009
End Date
May 1 2010
Last Update
October 14 2013
Active Locations (20)
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1
Research Site
Anjyo, Japan
2
Research Site
Bunkyō City, Japan
3
Research Site
Chūōku, Japan
4
Research Site
Daitō, Japan