Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917
NCT ID: NCT00290940
Last Updated: 2007-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
400 participants
INTERVENTIONAL
2006-01-31
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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CS-917
metformin hydrochloride
pioglitazone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Locations
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Birmingham, Alabama, United States
Northport, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Hot Springs, Arkansas, United States
Cudahy, California, United States
Long Beach, California, United States
Roseville, California, United States
Sacramento, California, United States
Spring Valley, California, United States
Studio City, California, United States
Vista, California, United States
Walnut Creek, California, United States
West Hills, California, United States
Wilmington, Delaware, United States
Brooksville, Florida, United States
Fort Lauderdale, Florida, United States
Kissimmee, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Sebastian, Florida, United States
St. Petersburg, Florida, United States
Tallahassee, Florida, United States
West Palm Beach, Florida, United States
Rome, Georgia, United States
Warner Robins, Georgia, United States
Shawnee Mission, Kansas, United States
Topeka, Kansas, United States
Topeka, Kansas, United States
Oxon Hill, Maryland, United States
Cadillac, Michigan, United States
Detroit, Michigan, United States
Interlochen, Michigan, United States
Livonia, Michigan, United States
Port Gibson, Mississippi, United States
Rolling Fork, Mississippi, United States
Excelsior Springs, Missouri, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Elizabeth, New Jersey, United States
Toms River, New Jersey, United States
Charlotte, North Carolina, United States
Lenoir, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Delaware, Ohio, United States
Marion, Ohio, United States
Oklahoma City, Oklahoma, United States
Beaver, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
Nashville, Tennessee, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
North Richland Hills, Texas, United States
San Antonio, Texas, United States
Burke, Virginia, United States
Olympia, Washington, United States
Madison, Wisconsin, United States
Countries
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Other Identifiers
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CS0917-A-U205
Identifier Type: -
Identifier Source: org_study_id