Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917
Phase 2
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00290940
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
- Drug naive or newly diagnosed type 2 diabetic subjects:
- Never received oral antihyperglycemic or insulin therapy or
- No oral antihyperglycemic or insulin therapy for more than 6 months since original diagnosis and
- No insulin therapy within one year of screening, with the exception of use during hospitalization or for use in gestational diabetes and
- No antihyperglycemic therapy for more than three consecutive days, or a total of of seven non-consecutive days, during the 8 weeks prior to screening.
- HbA1C>6.7% and < or = to 10% at screening
Exclusion Criteria
- Current insulin therapy
- Symptoms of poorly controlled diabetes
- History of diabetic ketoacidosis or hyperosmolar, nonketonic coma within one year of screening
- Serum bicarbonate < or = to 19 meq/L
- Serum creatinine (Scr) > 1.4 mg/dL (females) or 1.5 mg/dL (males)
- Contraindication to metformin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean change from baseline in HbA1C after 12 weeks compared to placebo
- Secondary Outcome Measures
Name Time Method Onset of efficacy of CS-917 Safety and tolerability of CS-917 Changes in other relevant glycemic and metabolic measures Proportion of subjects achieving therapeutic response Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia