JRCT ID: jRCT1080222299
Registered date:21/11/2013
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 diabetes |
Date of first enrollment | 21/11/2013 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : Onglyza tablet INN of investigational material : saxagliptin Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : oral, once daily control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : oral, once daily |
Outcome(s)
Primary Outcome | safety and efficacy |
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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 | 1) Subjects with a diagnosis of type 2 diabetes mellitus. 2) Subjects who have been undergoing dietary and exercise therapy and have not taken any oral antihyperglycemic medications for more than 12 weeks prior to initiation of study treatment. |
Exclude criteria | 1) Subjects with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus. |
Related Information
Primary Sponsor | Kyowa Hakko Kirin Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-132348 |
Contact
Public contact | |
Name | |
Address | clinical.info@kyowa-kirin.co.jp |
Telephone | |
Affiliation | Kyowa Hakko Kirin Co., Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |