A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
Overview[ - collapse ][ - ]
Purpose | The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Dapagliflozin Drug: Dapagliflozin Drug: Dapagliflozin Drug: Dapagliflozin Drug: Dapagliflozin Drug: Dapagliflozin Drug: Dapagliflozin matching Placebo Drug: Metformin Drug: Metformin (as needed for rescue based on protocol specific criteria) |
Phase | Phase 3 |
Sponsor | Bristol-Myers Squibb |
Responsible Party | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier | NCT00528372 |
First Received | September 11, 2007 |
Last Updated | December 15, 2010 |
Last verified | December 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | September 11, 2007 |
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Last Updated Date | December 15, 2010 |
Start Date | September 2007 |
Estimated Primary Completion Date | July 2010 |
Current Primary Outcome Measures | Change from baseline in hemoglobin A1C [Time Frame: at Week 24] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise |
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Official Title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin 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 if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied. |
Detailed Description | All eligible subjects will receive single-blind placebo medication during the 2 week lead-in period. All arms may include the addition of open label metformin 500-2000 mg (as needed for rescue based on protocol specific criteria) |
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 | Type 2 Diabetes |
Intervention | Drug: Dapagliflozin Tablets, Oral, 2.5 mg, QAM, once daily, up to 102 weeks Other Names: BMS-512148Drug: Dapagliflozin Tablets, Oral, 2.5 mg, QPM, once daily, up to 102 weeks Other Names: BMS-512148Drug: Dapagliflozin Tablets, Oral, 5 mg, QAM, once daily, up to 102 weeks Other Names: BMS-512148Drug: Dapagliflozin Tablets, Oral, 5 mg, QPM, once daily, up to 102 weeks Other Names: BMS-512148Drug: Dapagliflozin Tablets, Oral, 10 mg, QAM, once daily, up to 102 weeks Other Names: BMS-512148Drug: Dapagliflozin Tablets, Oral, 10 mg, QPM, once daily, up to 102 weeks Other Names: BMS-512148Drug: Dapagliflozin matching Placebo Tablets, Oral, 0 mg, QAM & QPM, once daily, up to 102 weeks Drug: Metformin Tablets, Oral, 500 mg, QAM, starting at week 24 up to 102 weeks Drug: Metformin (as needed for rescue based on protocol specific criteria) Open Label Tablets, Oral, 500-2000 mg |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 560 |
Estimated Completion Date | July 2010 |
Estimated Primary Completion Date | February 2009 |
Eligibility Criteria | Inclusion Criteria: - Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control - Drug naive or treated with anti-diabetic medication for < 24 weeks - C-peptide ≥ 1.0 ng/mL - Body Mass Index ≤ 45.0 kg/m2\ - Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women Exclusion Criteria: - AST and /or ALT > 3.0 times the upper limit of normal - Serum total bilirubin > 1.5 times ULN - Creatinine kinase ≥ 3 times the upper limit of normal - Symptoms of severely uncontrolled diabetes - Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States, Canada, Mexico, Russian Federation |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00528372 |
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Other Study ID Numbers | MB102-013 |
Has Data Monitoring Committee | No |
Information Provided By | Bristol-Myers Squibb |
Study Sponsor | Bristol-Myers Squibb |
Collaborators | AstraZeneca |
Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
Verification Date | December 2010 |
Locations[ + expand ][ + ]
43rd Medical Associates, P.C. | Phoenix, Arizona, United States, 85051 |
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Clinical Research Advantage, Inc | Tempe, Arizona, United States, 85282 |
Clin Res Advantage, Inc/East Valley Family Physicians, Plc | Tempe, Arizona, United States, 85282 |
Valley Research | Fresno, California, United States, 93720 |
Cherlin, Richard | Los Gatos, California, United States, 95032 |
Ritchken & First M.D.'S | San Diego, California, United States, 92117 |
Torrance Clinical Research | Torrance, California, United States, 90717 |
Aurora Family Medicine Center, P.C. | Aurora, Colorado, United States, 80012 |
Expresscare Clinical Research | Colorado Springs, Colorado, United States, 80909 |
Denver Internal Medicine Group | Denver, Colorado, United States, 80209 |
Center For Internal Medicine | Denver, Colorado, United States, 80209 |
Central Florida Clinical Trials | Altamonte Springs, Florida, United States, 32701 |
Family Care Associates | Chipley, Florida, United States, 32428 |
Westside Center For Clinical Research | Jacksonville, Florida, United States, 32205 |
Panhandle Family Care Associates | Marianna, Florida, United States, 32446 |
Louisiana Heart Center | Slidell, Louisiana, United States, 70458 |
Jackson, Danny W. | Rolling Fork, Mississippi, United States, 39159 |
Woodlake Research | Chesterfield, Missouri, United States, 63017 |
Nevada Alliance Against Diabetes | Las Vegas, Nevada, United States, 89101 |
Slocum-Dickson Medical Group, Pllc | New Hartford, New York, United States, 13413 |
Internist Associates Of Central New York, P. C. | Syracuse, New York, United States, 13210 |
Southgate Medical Group | West Seneca, New York, United States, 14224 |
Providence Health Partners | Dayton, Ohio, United States, 45439 |
Newark Physician Associates | Newark, Ohio, United States, 43055 |
Physician Research, Inc. | Zanesville, Ohio, United States, 43701 |
Gilbert Medical Research, Llc | Bethany, Oklahoma, United States, 73008 |
Integris Family Care Yukon | Yukon, Oklahoma, United States, 73109 |
Banksville Medical, Pc | Pittsburgh, Pennsylvania, United States, 15216 |
Southeastern Research Associates, Inc. | Taylors, South Carolina, United States, 29687 |
Holston Medical Group | Kingsport, Tennessee, United States, 37660 |
Village Family Practice | Houston, Texas, United States, 77024 |
Sam Clinical Research Center | San Antonio, Texas, United States, 78229 |
Abbott Clinical Research Group, Inc. | San Antonio, Texas, United States, 78224 |
Taylor/Wade Medical | Bountiful, Utah, United States, 84010 |
J. Lewis Research, Inc | Salt Lake City, Utah, United States, 84121 |
Optimum Clinical Research, Inc. | Salt Lake City, Utah, United States, 84102 |
Tidewater Integrated Medical Research | Virginia Beach, Virginia, United States, 23454 |
William L. Gray, Md | Spokane, Washington, United States, 99216 |
Local Institution | Calgary, Alberta, Canada, T2R 0X7 |
Local Institution | Kelowna, British Columbia, Canada, V1Y 2H4 |
Local Institution | Winnipeg, Manitoba, Canada, R3E 3P4 |
Local Institution | Bathurst, New Brunswick, Canada, E2A 4X7 |
Local Institution | Moncton, New Brunswick, Canada, E1G 1A7 |
Local Institution | Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7 |
Local Institution | St-John, Newfoundland and Labrador, Canada, A1E 2E2 |
Local Institution | St. John'S, Newfoundland and Labrador, Canada, A1A 3R5 |
Local Institution | Oakville, Ontario, Canada, L6H 3P1 |
Local Institution | Sarnia, Ontario, Canada, N7T 4X3 |
Local Institution | Thornhill, Ontario, Canada, L4J 8L7 |
Local Institution | Toronto, Ontario, Canada, M4R 2G4 |
Local Institution | Toronto, Ontario, Canada, M9W 4L6 |
Local Institution | Charlottetown, Prince Edward Island, Canada, C1A 5Y9 |
Local Institution | Drummondville, Quebec, Canada, J2B 7T1 |
Local Institution | Granby, Quebec, Canada, J2G 8Z9 |
Local Institution | L'Ancienne Lorette, Quebec, Canada, G2E 2X1 |
Local Institution | Mirabel, Quebec, Canada, J7J 2K8 |
Local Institution | St-Leonard, Quebec, Canada, H1S 3A9 |
Local Institution | Saskatoon, Saskatchewan, Canada, S7K 7H9 |
Local Institution | Saskatoon, Saskatchewan, Canada, S7K 3H3 |
Local Institution | Tijuana, Baja California, Mexico, 22320 |
Local Institution | Guadalajara, Distrito Federal, Mexico, 44670 |
Local Institution | Mexico, D. F., Distrito Federal, Mexico, 06726 |
Local Institution | Guadalajara, Jalisco, Mexico, 44600 |
Local Institution | Guadalajara, Jalisco, Mexico, 44100 |
Local Institution | Guadalajara, Jalisco, Mexico, 44680 |
Local Institution | Morelia, Michioacan, Mexico, 58070 |
Local Institution | Monterrey, Nuevo Leon, Mexico, 64060 |
Local Institution | Monterrrey, Nuevo Leon, Mexico, 64700 |
Local Institution | Merida, Yucatan, Mexico, 97070 |
Local Institution | Aguascalientes, Mexico, 20230 |
Local Institution | Durango, Mexico, 34000 |
Local Institution | Kursk, Russian Federation, 305035 |
Local Institution | Moscow, Russian Federation, 115093 |
Local Institution | Saint-Petersburg, Russian Federation, 191015 |
Local Institution | Smolensk, Russian Federation, 214019 |
Local Institution | St. Petersburg, Russian Federation, 195257 |
Local Institution | St.Petersburg, Russian Federation, 195112 |
Local Institution | Yaroslaval, Russian Federation, 150003 |