Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare glucose lowering with CS-917 compared to placebo after 3 months of treatment

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Metformin; Pioglitazone

Criteria

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