ate phase II study on dose response of SMP-508 therapy in patients with type 2 diabetes mellitus who are concomitantly taking alpha-glucosidase inhibitor
Phase 2
- Conditions
- Type 2 diabetes mellitus patients whose blood glucose levels are not adequately controlled by alpha-glucosidase inhibitor in addition to diet and exercise therapies
- Registration Number
- JPRN-jRCT2080220292
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with type 2 diabetes mellitus who satisfy the following inclusion criteria
-Patients who are taking alpha-glucosidase inhibitor in addition to 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.
-Patients with hepatic dysfunction
-Patients with renal dysfunction
-Patients with cardiac diseases or severe hypertension
etc.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: postprandial blood glucose, HbA1c etc
- Secondary Outcome Measures
Name Time Method