Clinical trial NCT00246987: A Trial to Evaluate BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Official title: A Phase 3, Randomized, Double-blind, Placebo Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of BMS-298585 as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes, Type 2
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-11-01
Enrollment: 341
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: To determine the effect on glycemic control and lipid parameters of the 2.5 and 5 mg. doses of BMS-298585 in drug naive subjects with Type 2 diabetes as an adjunct to diet and exercise.


Eligibility criteria: Inclusion Criteria:

* Subjects with Type 2 diabetes
* Drug Naive
* HbA1c \>= 7.0% and \<= 10.0%
* Body Mass Index \<= 41 kg/m2
* Serum TG \<= 600 mg/dL

Exclusion Criteria:

* Symptomatic Type 2 diabetes
* History of bladder cancer
* History of Myocardial Infarction (MI), coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, Transient Ischemic Attach (TIA), or Cerebrovascular Accident (CVA) within 6 months, congestive heart failure (NYHA Class II and IV), uncontrolled hypertension, history of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

Primary outcomes:
measure: Change in HbA1c from baseline to Week 24
Secondary outcomes:
measure: Changes achieved from baseline in FPG after 24 weeks. Changes achieved from baseline in 3 hour post-prandial AUC for glucose and insulin levels after 24 weeks vs. placebo.
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Local Institution
state: Alabama
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Haleyville
country: United States
facility: Local Institution
state: Alabama
city: Hoover
country: United States
facility: Local Institution
state: Alabama
city: Fayetteville
country: United States
facility: Local Institution
state: Arizona
city: Hot Springs
country: United States
facility: Local Institution
state: Arizona
city: Mesa
country: United States
facility: Local Institution
state: Arizona
city: Phoenix
country: United States
facility: Local Institution
state: Arizona
city: Tucson
country: United States
facility: Local Institution
state: Arizona
city: Tulsa
country: United States
facility: Local Institution
state: Arizona
city: Concord
country: United States
facility: Local Institution
state: California
city: Fountain Valley
country: United States
facility: Local Institution
state: California
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Los Gatos
country: United States
facility: Local Institution
state: California
city: Raleigh
country: United States
facility: Local Institution
state: California
city: Roseville
country: United States
facility: Local Institution
state: California
city: San Diego
country: United States
facility: Local Institution
state: California
city: Spring Valley
country: United States
facility: Local Institution
state: California
city: Tustin
country: United States
facility: Local Institution
state: California
city: Colorado Springs
country: United States
facility: Local Institution
state: Colorado
city: Golden
country: United States
facility: Local Institution
state: Colorado
city: Littleton
country: United States
facility: Local Institution
state: Colorado
city: New Britain
country: United States
facility: Local Institution
state: Connecticut
city: Altamonte Springs
country: United States
facility: Local Institution
state: Florida
city: Brandon
country: United States
facility: Local Institution
state: Florida
city: Chipley
country: United States
facility: Local Institution
state: Florida
city: Coral Gables
country: United States
facility: Local Institution
state: Florida
city: Kissimmee
country: United States
facility: Local Institution
state: Florida
city: Longwood
country: United States
facility: Local Institution
state: Florida
city: Melbourne
country: United States
facility: Local Institution
state: Florida
city: New Port Richie
country: United States
facility: Local Institution
state: Florida
city: Ocala
country: United States
facility: Local Institution
state: Florida
city: Pinellas Park
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Overland Park
country: United States
facility: Local Institution
state: Kansas
city: Shawnee Mission
country: United States
facility: Local Institution
state: Kansas
city: Lexington
country: United States
facility: Local Institution
state: Kentucky
city: Madisonville
country: United States
facility: Local Institution
state: Kentucky
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Gulfport
country: United States
facility: Local Institution
state: Mississippi
city: St. Peters
country: United States
facility: Local Institution
state: Mississippi
city: Chesterfield
country: United States
facility: Local Institution
state: Missouri
city: Kansas City
country: United States
facility: Local Institution
state: Missouri
city: Springfield
country: United States
facility: Local Institution
state: Missouri
city: Elizabeth
country: United States
facility: Local Institution
state: New Jersey
city: Toms River
country: United States
facility: Local Institution
state: New Jersey
city: Endwell
country: United States
facility: Local Institution
state: New York
city: West Seneca
country: United States
facility: Local Institution
state: New York
city: Charlotte
country: United States
facility: Local Institution
state: North Carolina
city: High Point
country: United States
facility: Local Institution
state: North Carolina
city: Morehead City
country: United States
facility: Local Institution
state: North Carolina
city: Salisbury
country: United States
facility: Local Institution
state: North Carolina
city: Winston Salem
country: United States
facility: Local Institution
state: North Carolina
city: Franklin
country: United States
facility: Local Institution
state: Ohio
city: Newark
country: United States
facility: Local Institution
state: Ohio
city: Zanesville
country: United States
facility: Local Institution
state: Ohio
city: Eugene
country: United States
facility: Local Institution
state: Oregon
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Reading
country: United States
facility: Local Institution
state: Pennsylvania
city: Warminster
country: United States
facility: Local Institution
state: Pennsylvania
city: East Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Johnston
country: United States
facility: Local Institution
state: Rhode Island
city: Providence
country: United States
facility: Local Institution
state: Rhode Island
city: Anderson
country: United States
facility: Local Institution
state: South Carolina
city: Greer
country: United States
facility: Local Institution
state: South Carolina
city: Mount Pleasant
country: United States
facility: Local Institution
state: South Carolina
city: Knoxville
country: United States
facility: Local Institution
state: Tennessee
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Fort Worth
country: United States
facility: Local Institution
state: Texas
city: Lubbock
country: United States
facility: Local Institution
state: Texas
city: San Angelo
country: United States
facility: Local Institution
state: Texas
city: San Antonio
country: United States
facility: Local Institution
state: Texas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
city: Richmond
country: United States
facility: Local Institution
state: Virginia
city: Virginia Beach
country: United States
facility: Local Institution
state: Virginia
city: Edmonds
country: United States
facility: Local Institution
state: Washington
city: Federal Way
country: United States
facility: Local Institution
state: Washington
city: Olympia
country: United States
facility: Local Institution
state: Washington
city: Spokane
country: United States
facility: Local Institution
state: Washington
city: Vancouver
country: United States
facility: Local Institution
state: Washington
city: Milwaukee
country: United States
facility: Local Institution
state: Wisconsin
city: Canberra
country: Australia
facility: Local Institution
state: New South Wales
city: Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Wollongong
country: Australia
facility: Local Institution
state: New South Wales
city: Kippa Ring
country: Australia
facility: Local Institution
state: Queensland
city: Meadowbrook
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Launceston
country: Australia
facility: Local Institution
state: Tasmania
city: Melbourne
country: Australia
facility: Tasmania
state: Victoria
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Coquitlam
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Manuels
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Markham
country: Canada
facility: Local Institution
state: Ontario
city: Oakville
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Thornhill
country: Canada
facility: Local Institution
state: Ontario
city: Thunder Bay
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Charlottetown
country: Canada
facility: Local Institution
state: Prince Edward Island
city: Chicoutimi
country: Canada
facility: Local Institution
state: Quebec
city: Drummondville
country: Canada
facility: Local Institution
state: Quebec
city: Granby
country: Canada
facility: Local Institution
state: Quebec
city: Laval
country: Canada
facility: Local Institution
state: Quebec
city: Longueuil
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Pointe-Claire
country: Canada
facility: Local Institution
state: Quebec
city: St-Lambert
country: Canada
facility: Local Institution
state: Quebec
city: Ste-Foy
country: Canada
facility: Local Institution
state: Quebec
city: Regina
country: Canada
facility: Local Institution
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Durango
country: Mexico
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Mrokow
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Zabrze
country: Poland
facility: Local Institution
city: Anasco
country: Puerto Rico
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Rio Pieoras
country: Puerto Rico
facility: Local Institution
city: Changhua
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
Study officials:
References: