JRCT ID: jRCT2080221436
Registered date:18/04/2011
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 Diabetes Mellitus |
Date of first enrollment | 18/04/2011 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : Dapagliflozin INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : 5mg or 10mg, Oral Dose |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | - Provision of informed consent prior to any study specific procedures - Men or women age 20 years old or more (Either gender needs to be 40% or higher of total number of treated subjects) - diagnosed with type2 DM |
Exclude criteria | - Type 1 diabetes mellitus - FPG more than 240 mg/dL before treatment started - Subjects who have history of unstable or rapidly progressing renal disease - Subjects who have severe hepatic insufficiency and/or significant abnormal liver function - Significant cardiovascular history |
Related Information
Primary Sponsor | AstraZeneca |
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Secondary Sponsor | Bristol-Myers Squibb |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-111475 |
Contact
Public contact | |
Name | |
Address | RD-clinical-information-Japan@astrazeneca.com |
Telephone | |
Affiliation | AstraZeneca KK |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |