JRCT ID: jRCT2080221168
Registered date:23/07/2010
Basic Information
Recruitment status | |
---|---|
Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus patients whose blood glucose levels are not adequately controlled by pioglitazone in addition to diet and exercise therapies |
Date of first enrollment | 23/07/2010 |
Target sample size | 120 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : SMP-508 (repaglinide) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material : Oral |
Outcome(s)
Primary Outcome | Efficacy: HbA1C etc |
---|---|
Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
---|---|
Age maximum | Not applicable |
Gender | Both |
Include criteria | Patients with type 2 diabetes mellitus who meet the following requirements -Patients who have been on a fixed regimen of diet and exercise therapies -Patients who have been taking pioglitazone continuously at a fixed dose -Patients whose HbA1C level is 6.5% <= HbA1C <= 9.0% and is stable over 4 weeks -Patients aged 20 or older -Outpatients etc. |
Exclude criteria | -Patients with hepatic dysfunction -Patients with renal dysfunction -Patients with cardiac diseases -Patients with severe hypertension etc. |
Related Information
Primary Sponsor | Dainippon Sumitomo Pharma Co., Ltd. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101204 |
Contact
Public contact | |
Name | |
Address | http://www.ds-pharma.com/inquiry/index.html |
Telephone | |
Affiliation | Dainippon Sumitomo Pharma Co., Ltd. |
Scientific contact | |
Name | |
Address | http://www.ds-pharma.com/inquiry/index.html |
Telephone | |
Affiliation | Dainippon Sumitomo Pharma Co., Ltd. |