JRCT ID: jRCT2080221167
Registered date:23/07/2010
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus whose blood glucose levels are not adequately controlled by metformin 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 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | Not applicable |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Patients with type 2 diabetes mellitus who participated in the previous study "Phase 3 study on combinational therapy of SMP-508 with metformin in patients with type 2 diabetes mellitus", and meet all of the following requirements. -Patients who underwent the surveys, observations, and tests, etc. scheduled to be conducted in week 16 of the previous study. -Patients who, prior to admission to the study, voluntarily agree to participate in the study after receiving an explanation of the study objectives, methods, and potential risks, -Patients who provide written informed consent. |
Exclude criteria | -Women who are pregnant or have a potential of pregnancy during the study, women who are at risk of pregnancy due to lack of appropriate contraceptive measures, or lactating mothers -Patients who will require surgery. -Patients whom the investigator or subinvestigator considers to be unsuitable for administration to the study for any other reason. |
Related Information
Primary Sponsor | Dainippon Sumitomo Pharma Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-101203 |
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. |