Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Overview[ - collapse ][ - ]
Purpose | The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise |
---|---|
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Saxagliptin Drug: Saxagliptin Drug: Saxagliptin Drug: Placebo matching Saxagliptin Drug: Metformin Drug: Placebo matching Metformin Drug: Saxagliptin Drug: Metformin |
Phase | Phase 3 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00121641 |
First Received | July 15, 2005 |
Last Updated | August 5, 2011 |
Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | July 15, 2005 |
---|---|
Last Updated Date | August 5, 2011 |
Start Date | July 2005 |
Estimated Primary Completion Date | February 2010 |
Current Primary Outcome Measures |
|
Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
Brief Title | Saxagliptin Treatment in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise |
---|---|
Official Title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise |
Brief Summary | The purpose of this clinical research study is to learn whether saxagliptin (BMS-477118) is more effective than placebo as a treatment for type 2 diabetic subjects who are not sufficiently controlled with diet and exercise |
Detailed Description | All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin added onto their blinded study medication. Subjects with screening hemoglobin A1c (A1C) > 10.0% and ≤ 12.0%, who otherwise meet all inclusion/exclusion criteria, were eligible to enroll directly into Open-Label Treatment Cohort (Direct Enrollees) and receive open-label saxagliptin 10 mg. Those who completed the short-term period were eligible to enter into the long-term treatment extension period.Saxagliptin dose titration was not permitted. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Saxagliptin Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]) Other Names: BMS-477118Drug: Saxagliptin Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT) Other Names: BMS-477118Drug: Saxagliptin Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Other Names: BMS-477118Drug: Placebo matching Saxagliptin Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT) Drug: Metformin Tablets, Oral, 500 mg, daily (42 months LT) Drug: Placebo matching Metformin Tablets, Oral, 0 mg, daily (42 months LT) Drug: Saxagliptin Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT) Open Label Other Names: BMS-477118Drug: Metformin Tablets, Oral, 500-2000 mg (as needed for rescue) |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 1035 |
Estimated Completion Date | February 2010 |
Estimated Primary Completion Date | August 2006 |
Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes mellitus - Drug naive - Hemoglobin (Hb) A1c >= 7.0% and <= 10.0% (>10% and <= 12% for open label arm) - Fasting C-peptide >= 1 ng/mL - Body mass index <= 40 kg/m2 Exclusion Criteria: - Symptomatic poorly controlled diabetes - Recent cardiac or cerebrovascular event - Serum creatinine >= 1.5 mg/dL for males and >= 1.4 mg/dL for Women of Child Bearing Potential |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Australia, Canada, Mexico, Puerto Rico, Taiwan |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00121641 |
---|---|
Other Study ID Numbers | CV181-011 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | August 2011 |
Locations[ + expand ][ + ]
Local Institution | Anniston, Alabama, United States |
---|---|
Local Institution | Birmingham, Alabama, United States |
Local Institution | Calera, Alabama, United States |
Local Institution | Jonesboro, Arizona, United States |
Local Institution | Mesa, Arizona, United States |
Local Institution | Pheonix, Arizona, United States |
Local Institution | Little Rock, Arkansas, United States |
Local Institution | Anaheim, California, United States |
Local Institution | Fountain Valley, California, United States |
Local Institution | Fresno, California, United States |
Local Institution | Long Beach, California, United States |
Local Institution | Los Angeles, California, United States |
Local Institution | Northridge, California, United States |
Local Institution | Rolling Hills Estates, California, United States |
Local Institution | Sacramento, California, United States |
Local Institution | Santa Ana, California, United States |
Local Institution | Spring Valley, California, United States |
Local Institution | Tustin, California, United States |
Local Institution | Castle Rock, Colorado, United States |
Local Institution | Denver, Colorado, United States |
Local Institution | Loveland, Colorado, United States |
Local Institution | Altamonte Springs, Florida, United States |
Local Institution | Chipley, Florida, United States |
Local Institution | Cocoa Beach, Florida, United States |
Local Institution | Coral Gables, Florida, United States |
Local Institution | Fort Lauderdale, Florida, United States |
Local Institution | Jupiter, Florida, United States |
Local Institution | Kissimmee, Florida, United States |
Local Institution | Marianna, Florida, United States |
Local Institution | New Port Richey, Florida, United States |
Local Institution | Ocala, Florida, United States |
Local Institution | West Palm Beach, Florida, United States |
Local Institution | Vernon Hills, Illinois, United States |
Local Institution | Dubuque, Iowa, United States |
Local Institution | Iowa City, Iowa, United States |
Local Institution | Waterloo, Iowa, United States |
Local Institution | Wichita, Kansas, United States |
Local Institution | Lexington, Kentucky, United States |
Local Institution | Munfordville, Kentucky, United States |
Local Institution | New Orleans, Louisiana, United States |
Local Institution | West Monroe, Louisiana, United States |
Local Institution | Baltimore, Maryland, United States |
Local Institution | Chester, Maryland, United States |
Local Institution | Prince Frederick, Maryland, United States |
Local Institution | Ayer, Massachusetts, United States |
Local Institution | Boston, Massachusetts, United States |
Local Institution | Rolling Fork, Mississippi, United States |
Local Institution | Kansas City, Missouri, United States |
Local Institution | Springfield, Missouri, United States |
Local Institution | St. Louis, Missouri, United States |
Local Institution | Kalispell, Montana, United States |
Local Institution | Omaha, Nebraska, United States |
Local Institution | Las Vegas, Nevada, United States |
Local Institution | Middletown, New Jersey, United States |
Local Institution | Toms River, New Jersey, United States |
Local Institution | Cooperstown, New York, United States |
Local Institution | Greensboro, North Carolina, United States |
Local Institution | Huntersville, North Carolina, United States |
Local Institution | Sparta, North Carolina, United States |
Local Institution | Statesville, North Carolina, United States |
Local Institution | Winston Salem, North Carolina, United States |
Local Institution | Athens, Ohio, United States |
Local Institution | Franklin, Ohio, United States |
Local Institution | Oklahoma City, Oklahoma, United States |
Local Institution | Tulsa, Oklahoma, United States |
Local Institution | Portland, Oregon, United States |
Local Institution | Fleetwood, Pennsylvania, United States |
Local Institution | Philadelphia, Pennsylvania, United States |
Local Institution | Pittsburgh, Pennsylvania, United States |
Local Institution | Charleston, South Carolina, United States |
Local Institution | Bristol, Tennessee, United States |
Local Institution | Morristown, Tennessee, United States |
Local Institution | Bryan, Texas, United States |
Local Institution | Dallas, Texas, United States |
Local Institution | Fort Worth, Texas, United States |
Local Institution | Houston, Texas, United States |
Local Institution | San Antonio, Texas, United States |
Local Institution | Temple, Texas, United States |
Local Institution | Texarkana, Texas, United States |
Local Institution | The Colony, Texas, United States |
Local Institution | Salt Lake City, Utah, United States |
Local Institution | Virginia Beach, Virginia, United States |
Local Institution | Olympia, Washington, United States |
Local Institution | Sydney, New South Wales, Australia |
Local Institution | Woollongong, New South Wales, Australia |
Local Institution | Brisbane, Queensland, Australia |
Local Institution | Kippa Ring, Queensland, Australia |
Local Institution | Meadowbrook, Queensland, Australia |
Local Institution | Adelaide, South Australia, Australia |
Local Institution | Woodville South, South Australia, Australia |
Local Institution | Perth, Western Australia, Australia |
Local Institution | Calgary, Alberta, Canada |
Local Institution | Edmonton, Alberta, Canada |
Local Institution | Kelowna, British Columbia, Canada |
Local Institution | Quesnel, British Columbia, Canada |
Local Institution | Vancouver, British Columbia, Canada |
Local Institution | Portage La Prairie, Manitoba, Canada |
Local Institution | Winnipeg, Manitoba, Canada |
Local Institution | Bathurst, New Brunswick, Canada |
Local Institution | Moncton, New Brunswick, Canada |
Local Institution | Manuels, Newfoundland and Labrador, Canada |
Local Institution | Mount Pearl, Newfoundland and Labrador, Canada |
Local Institution | St. John's, Newfoundland and Labrador, Canada |
Local Institution | Newmarket, Ontario, Canada |
Local Institution | Oakville, Ontario, Canada |
Local Institution | Peterborough, Ontario, Canada |
Local Institution | Sarnia, Ontario, Canada |
Local Institution | Strathroy, Ontario, Canada |
Local Institution | Thornhill, Ontario, Canada |
Local Institution | Toronto, Ontario, Canada |
Local Institution | Charlottetown, Prince Edward Island, Canada |
Local Institution | Drummondville, Quebec, Canada |
Local Institution | Fleurimont, Quebec, Canada |
Local Institution | Gatineau, Quebec, Canada |
Local Institution | Granby, Quebec, Canada |
Local Institution | Longueuil, Quebec, Canada |
Local Institution | Montreal, Quebec, Canada |
Local Institution | St. Leonard, Quebec, Canada |
Local Institution | Ste-Foy, Quebec, Canada |
Local Institution | Saskatoon, Saskatchewan, Canada |
Local Institution | Mexico City, Distrito Federal, Mexico |
Local Institution | Mexico D.F., Distrito Federal, Mexico |
Local Institution | Guadalajara, Jalisco, Mexico |
Local Institution | Monterrey, Nuevo Leon, Mexico |
Local Institution | Hermosillo, Sonora, Mexico |
Local Institution | Aguascalientes, Mexico |
Local Institution | Durango, Mexico |
Local Institution | Carolina, Puerto Rico |
Local Institution | Guaynabo, Puerto Rico |
Local Institution | Ponce, Puerto Rico |
Local Institution | Rio Piedras, Puerto Rico |
Local Institution | San Juan, Puerto Rico |
Local Institution | Hualien, Taiwan |
Local Institution | Taichung, Taiwan |
Local Institution | Taipei, Taiwan |