A Dose-Finding Study of R7201/CSG452 in Patients With Type 2 Diabetes Mellitus
Phase 2
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- JPRN-jRCT2080220828
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd. , Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
type 2 diabetes, diagnosed for >=3 months;
- either treated with diet, exercise and stable metformin, or with diet and exercise alone.
Exclusion Criteria
- type 1 diabetes mellitus
- currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin
- currently or within 6 months prior to screening treated with any PPARgamma agonist
- uncontrolled hypertension
- significant pre-diagnosed diabetic complications requiring treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute change in HbA1c<br>Time Frame: From baseline to end of treatment period
- Secondary Outcome Measures
Name Time Method 1. Absolute change in parameters of glycemic control<br>2. Absolute change in body weight, waist-to-hip ratio, waist circumference<br>3. Adverse events, laboratory parameters, vital signs<br><br>1. Time Frame: From baseline to end of treatment period<br>2. Time Frame: From baseline to end of treatment period <br>3. Time Frame: Throughout study