UMIN ID: UMIN000001381
Registered date:01/10/2008
A Phase 2/3 Study of SYR-322 as an Add-on to an Alpha-Glucosidase Inhibitor
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus |
Date of first enrollment | 2007/02/01 |
Target sample size | 210 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Each subject will orally receive SYR-322 12.5mg once daily before breakfast for 12 weeks. Voglibose 0.2mg will also be administered orally three times daily before each meal for 20 weeks(8 weeks screening plus 12 weeks treatment). Each subject will orally receive SYR-322 25mg once daily before breakfast for 12 weeks. Voglibose 0.2mg will also be administered orally three times daily before each meal for 20 weeks(8 weeks screening plus 12 weeks treatment). Each subject will orally receive Placebo once daily before breakfast for 12 weeks. Voglibose 0.2mg will also be administered orally three times daily before each meal for 20 weeks(8 weeks screening plus 12 weeks treatment). |
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 | 20years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | The subject has taken any antidiabetic medications except Alpha-glucosidase inhibitors within the last 4 weeks prior to the initiation of screening period(week -8) and during screening period. |
Related Information
Primary Sponsor | Takeda Pharmaceutical Company Limited |
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Secondary Sponsor | |
Source(s) of Monetary Support | Takeda Pharmaceutical Company Limited |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | |
Affiliation | Takeda Pharmaceutical Company Limited Contact for Clinical Trial Infomation |
scientific contact | |
Name | Kohei Kaku |
Address | 577,Matsushima,kurashiki-Shi,Okayama,Japan Japan |
Telephone | |
Affiliation | Department of Medicine, Kawasaki Medical School Diabetes and Endocrine Division |