NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT1080222299

Registered date:21/11/2013

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType 2 diabetes
Date of first enrollment21/11/2013
Target sample size
Countries of recruitment
Study typeInterventional
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 Outcomesafety and efficacy
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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 criteria1) Subjects with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.

Related Information

Contact

Public contact
Name
Address clinical.info@kyowa-kirin.co.jp
Telephone
E-mail
Affiliation Kyowa Hakko Kirin Co., Ltd.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation