Clinical trial NCT00290940: Evaluation of Glucose Lowering Effect, Safety and Tolerability of CS-917
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of CS-917 as Monotherapy for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes mellitus, Type 2
High blood sugar
Hyperglycemia
Antihyperglycemic agents
CS-917
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Mean change from baseline in HbA1C after 12 weeks compared to placebo
Secondary outcomes:
measure: Onset of efficacy of CS-917
measure: Safety and tolerability of CS-917
measure: Changes in other relevant glycemic and metabolic measures
measure: Proportion of subjects achieving therapeutic response
measure: Proportion of subjects discontinuing or requiring rescue for continued or worsening hyperglycemia
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Cudahy
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Studio City
country: United States
state: California
city: Vista
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: West Hills
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Brooksville
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Sebastian
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Rome
country: United States
state: Georgia
city: Warner Robins
country: United States
state: Georgia
city: Shawnee Mission
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Oxon Hill
country: United States
state: Maryland
city: Cadillac
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Interlochen
country: United States
state: Michigan
city: Livonia
country: United States
state: Michigan
city: Port Gibson
country: United States
state: Mississippi
city: Rolling Fork
country: United States
state: Mississippi
city: Excelsior Springs
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Elizabeth
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Charlotte
country: United States
state: North Carolina
city: Lenoir
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Delaware
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Beaver
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Charleston
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Lake Jackson
country: United States
state: Texas
city: North Richland Hills
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
References: