Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone
Overview[ - collapse ][ - ]
| Purpose | The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone |
|---|---|
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: Saxagliptin + Metformin Drug: Saxagliptin + Metformin Drug: Saxagliptin + Metformin Drug: Placebo + Metformin Drug: Pioglitazone |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT00121667 |
| First Received | July 18, 2005 |
| Last Updated | August 5, 2011 |
| Last verified | August 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 18, 2005 |
|---|---|
| Last Updated Date | August 5, 2011 |
| Start Date | August 2005 |
| Estimated Primary Completion Date | February 2010 |
| Current Primary Outcome Measures | Baseline and Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [Time Frame: Baseline, Week 24] [Designated as safety issue: No]Mean change from baseline is adjusted for baseline value. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone |
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| Official Title | "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial to Evaluate the Efficacy and Safety of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone" |
| Brief Summary | The purpose of this clinical research study is to learn whether Saxagliptin added to Metformin therapy is more effective than Metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with Metformin alone |
| 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 pioglitizone added onto their blinded study medication |
| 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 + Metformin Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Names: BMS-477118Drug: Saxagliptin + Metformin Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Names: BMS-477118Drug: Saxagliptin + Metformin Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT) Other Names: BMS-477118Drug: Placebo + Metformin Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT) Drug: Pioglitazone Tablets, Oral, 15 - 45 mg (as needed for rescue) |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 1462 |
| Estimated Completion Date | February 2010 |
| Estimated Primary Completion Date | October 2006 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of Metformin therapy for at least 8 weeks prior to screening. - HbA1c >= 7.0% and <= 10.0 % - Body mass index <= 40 kg/m2 - Fasting C-peptide >= 1 ng/dL 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 females |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Australia, Brazil, Canada, Chile, Mexico, Puerto Rico, Taiwan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00121667 |
|---|---|
| Other Study ID Numbers | CV181-014 |
| 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 | Haleyville, Alabama, United States |
| Local Institution | Mesa, Arizona, United States |
| Local Institution | Phoenix, Arizona, United States |
| Local Institution | Jonesboro, Arkansas, United States |
| Local Institution | Little Rock, Arkansas, United States |
| Local Institution | Sherwood, Arkansas, United States |
| Local Institution | Encino, California, United States |
| Local Institution | Fountain Valley, California, United States |
| Local Institution | Fresno, California, United States |
| Local Institution | Los Angeles, California, United States |
| Local Institution | Mission Viejo, California, United States |
| Local Institution | Northridge, California, United States |
| Local Institution | Orange, California, United States |
| Local Institution | Roseville, California, United States |
| Local Institution | Sacramento, 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 | Colorado Springs, Colorado, United States |
| Local Institution | Denver, Colorado, United States |
| Local Institution | Golden, 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 | Jacksonville, Florida, United States |
| Local Institution | Kissimmee, Florida, United States |
| Local Institution | Marianna, Florida, United States |
| Local Institution | Miami, Florida, United States |
| Local Institution | New Port Richey, Florida, United States |
| Local Institution | Ocala, Florida, United States |
| Local Institution | Tallahassee, Florida, United States |
| Local Institution | Tampa, Florida, United States |
| Local Institution | Decatur, Georgia, United States |
| Local Institution | Chicago, Illinois, United States |
| Local Institution | Vernon Hills, Illinois, United States |
| Local Institution | Elkhart, Indiana, United States |
| Local Institution | Lafayette, Indiana, United States |
| Local Institution | Iowa City, Iowa, United States |
| Local Institution | Waterloo, Iowa, United States |
| Local Institution | Topeka, 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 | Boston, Massachusetts, United States |
| Local Institution | Kansas City, 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 | Toms River, New Jersey, United States |
| Local Institution | Albuquerque, New Mexico, United States |
| Local Institution | Charlotte, North Carolina, United States |
| Local Institution | Greensboro, North Carolina, United States |
| Local Institution | Morehead City, North Carolina, United States |
| Local Institution | Salisbury, North Carolina, United States |
| Local Institution | Sparta, North Carolina, United States |
| Local Institution | Wilmington, North Carolina, United States |
| Local Institution | Winston Salem, North Carolina, United States |
| Local Institution | Athens, Ohio, United States |
| Local Institution | Columbus, Ohio, United States |
| Local Institution | Lyndhurst, Ohio, United States |
| Local Institution | Oklahoma City, Oklahoma, United States |
| Local Institution | Tulsa, Oklahoma, United States |
| Local Institution | Eugene, Oregon, United States |
| Local Institution | Portland, Oregon, United States |
| Local Institution | Carlisle, Pennsylvania, United States |
| Local Institution | Langhorne, Pennsylvania, United States |
| Local Institution | Levittown, Pennsylvania, United States |
| Local Institution | Philadelphia, Pennsylvania, United States |
| Local Institution | Pittsburgh, Pennsylvania, United States |
| Local Institution | Charleston, South Carolina, United States |
| Local Institution | Duncan, South Carolina, United States |
| Local Institution | Bristol, Tennessee, United States |
| Local Institution | Austin, Texas, United States |
| Local Institution | Bryan, Texas, United States |
| Local Institution | Carrollton, Texas, United States |
| Local Institution | Dallas, Texas, United States |
| Local Institution | Houston, Texas, United States |
| Local Institution | San Antonio, Texas, United States |
| Local Institution | Temple, Texas, United States |
| Local Institution | Salt Lake City, Utah, United States |
| Local Institution | Hampton, Virginia, United States |
| Local Institution | Virginia Beach, Virginia, United States |
| Local Institution | Olympia, Washington, United States |
| Local Institution | Spokane, Washington, United States |
| Local Institution | Mar Del Plata, Buenos Aires, Argentina |
| Local Institution | Rosario, Santa Fe, Argentina |
| Local Institution | Buenos Aires, Argentina |
| Local Institution | Cordoba, Argentina |
| 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 | Fortaleza, Ceara, Brazil |
| Local Institution | Belem, Para, Brazil |
| Local Institution | Porto alegre, Rio Grande Do Sul, Brazil |
| Local Institution | Campinas, Sao Paulo, Brazil |
| Local Institution | Marilia, Sao Paulo, Brazil |
| Local Institution | Sao Paulo, Brazil |
| Local Institution | Calgary, Alberta, Canada |
| Local Institution | Coquitlam, British Columbia, Canada |
| Local Institution | Kelowna, British Columbia, Canada |
| Local Institution | Surrey, British Columbia, Canada |
| Local Institution | Brandon, Manitoba, Canada |
| Local Institution | Portage La Prairie, Manitoba, Canada |
| Local Institution | Winnipeg, Manitoba, Canada |
| Local Institution | Bathurst, New Brunswick, Canada |
| Local Institution | Mount Pearl, Newfoundland and Labrador, Canada |
| Local Institution | St. John's, Newfoundland and Labrador, Canada |
| Local Institution | St. Johns, Newfoundland and Labrador, Canada |
| Local Institution | Aylmer, Ontario, Canada |
| Local Institution | London, Ontario, Canada |
| Local Institution | Oakville, Ontario, Canada |
| Local Institution | Sarnia, Ontario, Canada |
| Local Institution | Thornhill, Ontario, Canada |
| Local Institution | Toronto, Ontario, Canada |
| Local Institution | Woodstock, Ontario, Canada |
| Local Institution | Charlottetown, Prince Edward Island, Canada |
| Local Institution | Drummondville, Quebec, Canada |
| Local Institution | Fleurimont, Quebec, Canada |
| Local Institution | Longueuil, Quebec, Canada |
| Local Institution | St. Leonard, Quebec, Canada |
| Local Institution | Saskatoon, Saskatchewan, Canada |
| Local Institution | Santiago, Metropolitana, Chile |
| Local Institution | Santiago De Chile, Metropolitana, Chile |
| Local Institution | Celaya, Guanajuato, Mexico |
| Local Institution | Guadalajara, Jalisco, Mexico |
| Local Institution | Morelia, Michioacan, Mexico |
| Local Institution | Monterrey, Nuevo Leon, Mexico |
| Local Institution | Hermosillo, Sonora, Mexico |
| Local Institution | Merida, Yucatan, Mexico |
| Local Institution | Distrito Federal, Mexico |
| Local Institution | Durango, Mexico |
| Local Institution | Carolina, Puerto Rico |
| Local Institution | Ponce, Puerto Rico |
| Local Institution | Rio Pieoras, Puerto Rico |
| Local Institution | San Juan, Puerto Rico |
| Local Institution | Hualien, Taiwan |
| Local Institution | Taichung, Taiwan |
| Local Institution | Taipei, Taiwan |