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

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 2

In brief

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

Key facts

Study ID

NCT00290940

Run by

Daiichi Sankyo

People needed

400

Starts

2006-01-01

Expected to finish

2007-04-01

Last updated by the study team

2007-09-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Northport, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Cudahy, California, United States
• Study site — Long Beach, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — Spring Valley, California, United States
• Study site — Studio City, California, United States
• Study site — Vista, California, United States
• Study site — Walnut Creek, California, United States
• Study site — West Hills, California, United States
• Study site — Wilmington, Delaware, United States
• Study site — Brooksville, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Sebastian, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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