JRCT ID: jRCT2080220568
Registered date:10/06/2008
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus. |
Date of first enrollment | 10/06/2008 |
Target sample size | 240 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : SYR-322 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral |
Outcome(s)
Primary Outcome | HbA1c change at the completion of treatment from baseline |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Key Criteria for inclusion: - The subject has been taking a stable dosage regimen of pioglitazone for at least 16 weeks prior to the initiation of the treatment period (Week 0) - The subject has an HbA1c value of 6.5% or more and below 10.0% at 14 weeks after the initiation of the screening period (Week -2) Key Criteria for exclusion: - The subject has taken any antidiabetic medications except pioglitazone within the last 16 weeks prior to the initiation of the treatment period (Week 0) - The subject with a history or symptoms of heart failure |
Exclude criteria |
Related Information
Primary Sponsor | Takeda Pharmaceutical Company Limited |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-080590 |
Contact
Public contact | |
Name | |
Address | https://www.takeda.co.jp/contact/form/en/form/index.html |
Telephone | |
Affiliation | Takeda Phamaceutical Company Limited |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |