ong-term study on combinational therapy of SMP-508 with pioglitazone in patients with type 2 diabetes mellitus
- Conditions
- Type 2 diabetes mellitus whose blood glucose levels are not adequately controlled by pioglitazone in addition to diet and exercise therapies
- Registration Number
- JPRN-jRCT2080221169
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 120
Patients with type 2 diabetes mellitus who participated in the previous study Phase 3 study on combinational therapy of SMP-508 with pioglitazone 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.
-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, and 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: HbA1C etc
- Secondary Outcome Measures
Name Time Method