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

Daiichi Sankyo

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: pioglitazone

Drug: CS-917

Drug: metformin hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

CS0917-A-U205

Details and patient eligibility

About

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

Enrollment

400 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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