NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080220708

Registered date:10/04/2009

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedType2 Diabetes Mellitus
Date of first enrollment10/04/2009
Target sample size
Countries of recruitment
Study typeInterventional
Intervention(s)investigational material(s) Generic name etc : KRP-104 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : twice a day,12weeks control material(s) Generic name etc : KRP-104,Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : twice a day,12weeks

Outcome(s)

Primary OutcomeHbA1c change from baseline on HbA1c at 12 weeks
Secondary OutcomeFPG,glycoalbumin,insulin etc. change from baseline on FPG at 12 weeks change from baseline on glycoalbumin at 12 weeks change from baseline on insulin at 12 weeks etc.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 74age old
GenderBoth
Include criteriaInclusion Criteria; -Diagnosis of type 2 diabetes -Outpatients etc.
Exclude criteriaExclusion criteria; -Diagnosis of type 1 diabetes -Patients with malignant tumor -Patients with severe hepatic dysfunction -Patients with severe renal dysfunction -Patients with severe blood dyscraaia -Patients with severe cardiovascular or pulmonary dysfunction etc.

Related Information

Contact

Public contact
Name
Address develop1@mb.kyorin-pharm.co.jp
Telephone
E-mail
Affiliation Kyorin Pharmaceutical Co.,LTD
Scientific contact
Name
Address develop1@mb.kyorin-pharm.co.jp
Telephone
E-mail
Affiliation Kyorin Pharmaceutical Co.,LTD