NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedType 2 diabetes mellitus
Date of first enrollment2007/02/01
Target sample size210
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeHbA1c change at the completion of treatment from baseline
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe 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

Contact

public contact
Name
Address Japan
Telephone
E-mail
Affiliation Takeda Pharmaceutical Company Limited Contact for Clinical Trial Infomation
scientific contact
Name Kohei Kaku
Address 577,Matsushima,kurashiki-Shi,Okayama,Japan Japan
Telephone
E-mail
Affiliation Department of Medicine, Kawasaki Medical School Diabetes and Endocrine Division