Phase 3 study on combinational therapy of SMP-508 with metformin in patients with type 2 diabetes mellitus
Phase 3
- Conditions
- Type 2 diabetes mellitus whose blood glucose levels are not adequately controlled by metformin in addition to diet and exercise therapies
- Registration Number
- JPRN-jRCT2080221166
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 120
Inclusion 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 metformin 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.
Exclusion Criteria
-Patients with history of lactic acidosis
-Patients with hepatic dysfunction
-Patients with renal dysfunction
-Patients with cardiac diseases
-Patients with severe hypertension
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: HbA1C etc
- Secondary Outcome Measures
Name Time Method