JRCT ID: jRCT2080220708
Registered date:10/04/2009
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type2 Diabetes Mellitus |
Date of first enrollment | 10/04/2009 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | HbA1c change from baseline on HbA1c at 12 weeks |
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Secondary Outcome | FPG,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 |
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Age maximum | <= 74age old |
Gender | Both |
Include criteria | Inclusion Criteria; -Diagnosis of type 2 diabetes -Outpatients etc. |
Exclude criteria | Exclusion 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
Primary Sponsor | Kyorin Pharmaceutical Co.,LTD |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-090735 |
Contact
Public contact | |
Name | |
Address | develop1@mb.kyorin-pharm.co.jp |
Telephone | |
Affiliation | Kyorin Pharmaceutical Co.,LTD |
Scientific contact | |
Name | |
Address | develop1@mb.kyorin-pharm.co.jp |
Telephone | |
Affiliation | Kyorin Pharmaceutical Co.,LTD |