Status:
COMPLETED
Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917
Lead Sponsor:
Daiichi Sankyo
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00290940
Start Date
January 1 2006
End Date
April 1 2007
Last Update
September 11 2007
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Birmingham, Alabama, United States, 35205
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