Evaluate safety as mono or combination therapies with anti-diabetes mellitus drugs in Japanese subjects with type 2 diabetes mellitus
Study identifier:D1692C00012
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A long term open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or combination therapies with anti-diabetic drugs in Japanese subjects with type 2 diabetes who have inadequate glycemic control
Medical condition
Type2 Diabetes
Phase
Phase 3
Healthy volunteers
No
Study drug
Dapagliflozin
Sex
All
Actual Enrollment
728
Study type
Interventional
Age
20 Years +
Date
Study Start Date: 01 Feb 2011
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Sept 2012
Study design
Allocation: N/A
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol Myers Squibb
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Open label treatment | Drug: Dapagliflozin Oral Dose 5 or 10 mg |
Contacts
Investigators
Principal Investigator
Dr Jisin Yang
AstraZeneca KK
