JRCT ID: jRCT2080220179
Registered date:25/11/2005
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 diet and exercise therapies |
Date of first enrollment | 25/11/2005 |
Target sample size | |
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: postprandial blood glucose, HbA1c etc |
---|---|
Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
---|---|
Age maximum | Not applicable |
Gender | Both |
Include criteria | <Inclusion criteria> Patients with type 2 diabetes mellitus who satisfy the following inclusion criteria -Patients who are undergoing only diet and exercise therapies -Patients whose HbA1c levels are 6.5% <= HbA1c <= 9.0%, and are stable over 4 weeks -Patients aged 20 or older -Outpatients etc. <Exclusion criteria> -Patients with hepatic dysfunction -Patients with renal dysfunction -Patients with cardiac diseases or severe hypertension etc. |
Exclude criteria |
Related Information
Primary Sponsor | Dainippon Sumitomo Pharma Co., Ltd. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-050182 |
Contact
Public contact | |
Name | |
Address | http://www.ds-pharma.com/inquiry/index.html |
Telephone | |
Affiliation | Dainippon Sumitomo Pharma Co., Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |