Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied. |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Saxagliptin Drug: Metformin XR Drug: Dapagliflozin Drug: Placebo matching with Dapagliflozin Drug: Placebo matching with Saxagliptin |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01606007 |
| First Received | May 23, 2012 |
| Last Updated | March 20, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 23, 2012 |
|---|---|
| Last Updated Date | March 20, 2014 |
| Start Date | July 2012 |
| Estimated Primary Completion Date | January 2014 |
| Current Primary Outcome Measures | Mean change from baseline in HbA1c at Week 24 [Time Frame: Baseline (Week 0) and at Week 24] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes |
|---|---|
| Official Title | A Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy With Saxagliptin and Dapagliflozin Added to Metformin Compared to Add-On Therapy With Saxagliptin in Combination With Metformin or Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone |
| Brief Summary | The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: OnglyzaDrug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XRDrug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS-512148Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 536 |
| Estimated Completion Date | January 2014 |
| Estimated Primary Completion Date | January 2014 |
| Eligibility Criteria | Inclusion Criteria: - Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0% - Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening - Body mass index (BMI) ≤ 45.0kg/m2 Exclusion Criteria: - Estimated glomerular filtration rate (eGFR) < 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females - Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg - Hepatic disease - Cardiovascular disease within 3 months |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Canada, Korea, Republic of, Mexico, Poland, Puerto Rico, Romania, South Africa |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01606007 |
|---|---|
| Other Study ID Numbers | CV181-169 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | AstraZeneca |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| Central Alabama Research | Birmingham, Alabama, United States, 35209 |
|---|---|
| Central Alabama Research | Homewood, Alabama, United States, 35244 |
| Terence T. Hart, Md | Muscle Shoals, Alabama, United States, 35662 |
| International Institute Of Clinical Research | Ozark, Alabama, United States, 36360 |
| Clinical Research Advantage | Mesa, Arizona, United States, 85206 |
| Elite Clinical Studies, Llc | Phoenix, Arizona, United States, 85018 |
| Genova Clinical Research | Tucson, Arizona, United States, 85704 |
| Medical Investigations, Inc. | Little Rock, Arkansas, United States, 72205 |
| Aureus Research, Inc. | Little Rock, Arkansas, United States, 72211 |
| Southland Clinical Research Center, Inc. | Fountain Valley, California, United States, 92708 |
| Torrance Clinical Research | Lomita, California, United States, 90717 |
| National Research Inst | Los Angeles, California, United States, 90057 |
| Providence Clinical Research | North Hollywood, California, United States, 91606 |
| Mehrdad Kevin Ariani Md, Inc. | Northridge, California, United States, 91325 |
| Diabetes Medical Center Of California | Northridge, California, United States, 91325 |
| Lucita M. Cruz,Md.,Inc. | Norwalk, California, United States, 90650 |
| Center For Clinical Trials, Llc. | Paramount, California, United States, 90723 |
| Center For Clinical Trials Of Sacramento, Inc. | Sacramento, California, United States, 95823 |
| Trinitas Research, Inc | San Jose, California, United States, 95116 |
| Orange County Research Center | Tustin, California, United States, 92780 |
| Clinical Research Advantage | Colorado Springs, Colorado, United States, 80906 |
| Infocus Clinical Research | Denver, Colorado, United States, 80211 |
| Lynn Institute Of Denver | Denver, Colorado, United States, 80246 |
| Southeast Clinical Research, Llc | Chiefland, Florida, United States, 32626 |
| Clinical Therapeutics Corporation | Coral Gables, Florida, United States, 33134 |
| Southeast Clinical Research, Llc | Jacksonville, Florida, United States, 32216 |
| Fpa Clinical Research | Kissimmee, Florida, United States, 34741 |
| Clinical Research Of Miami, Inc. | Miami, Florida, United States, 33126 |
| Advanced Pharma Cr, Llc | Miami, Florida, United States, 33136 |
| Newphase Clinical Trials, Inc. | Miami Beach, Florida, United States, 33140 |
| Omega Research Consultants, Llc | Orlando, Florida, United States, 32804 |
| Palm Harbor Medical Associates | Palm Harbor, Florida, United States, 34684 |
| Andres Patron, Do Pa | Pembroke Pines, Florida, United States, 33026 |
| Endocrine Research Solutions, Inc. | Roswell, Georgia, United States, 30076 |
| Cedar Crosse Research Center | Chicago, Illinois, United States, 60607-4559 |
| Deerbrook Medical Associates | Vernon Hills, Illinois, United States, 60061 |
| Clinical Research Advantage | Council Bluffs, Iowa, United States, 51503 |
| Horizon Research Group Of Opelousas, Llc | Eunice, Louisiana, United States, 70535 |
| Associated Internal Medicine Specialists | Battle Creek, Michigan, United States, 49015 |
| Harris And Associates, P.C. | Detroit, Michigan, United States, 48235 |
| Patterson Medical Clinic | Florissant, Missouri, United States, 63031 |
| Bellevue Family Practice | Bellevue, Nebraska, United States, 68005 |
| Clinical Research Advantage | Elkhorn, Nebraska, United States, 68022 |
| Clinical Research Advantage | Fremont, Nebraska, United States, 68025 |
| Clinical Research Advantage | Omaha, Nebraska, United States, 68130 |
| South Jersey Medical Associates, P.A. | Blackwood, New Jersey, United States, 08012 |
| Central Jersey Health And Medical Research | Elizabeth, New Jersey, United States, 07205 |
| Southgate Medical Group | West Seneca, New York, United States, 14224 |
| Metrolina Internal Medicine | Charlotte, North Carolina, United States, 28204 |
| Triad Clinical Trials, Llc | Greensboro, North Carolina, United States, 27410 |
| Diabetes & Endocrinology Consultants | Morehead City, North Carolina, United States, 28557 |
| Pmg Research Of Winston-Salem, Llc | Winston-salem, North Carolina, United States, 27103 |
| Daystar Clinical Resarch, Inc. | Akron, Ohio, United States, 44313 |
| Sterling Research Grp, Ltd. | Cincinnati, Ohio, United States, 45246 |
| Rapid Medical Research, Inc. | Cleveland, Ohio, United States, 44122 |
| Primed Clinical Research | Dayton, Ohio, United States, 45419 |
| Physicians Research, Inc. | Zanesville, Ohio, United States, 43701 |
| Lynn Institute Of Norman | Norman, Oklahoma, United States, 73069 |
| Willamette Valley Clinical Studies | Eugene, Oregon, United States, 97404 |
| Oregon Clinical Research | Portland, Oregon, United States, 97220 |
| Heritage Valley Medical Group | Beaver, Pennsylvania, United States, 15009 |
| Wellmon Family Practice | Shippensburg, Pennsylvania, United States, 17257 |
| Tlm Medical Services | Columbia, South Carolina, United States, 29204 |
| Palmetto Clinical Trial Services Llc | Fountain Inn, South Carolina, United States, 29644 |
| Holston Medical Group | Bristol, Tennessee, United States, 37620 |
| Holston Medical Group | Kingsport, Tennessee, United States, 37660 |
| Pmg Research Of Knoxville | Knoxville, Tennessee, United States, 37912 |
| Arlington Family Research Center, Inc. | Arlington, Texas, United States, 76012 |
| Padre Coast Clinical Research | Corpus Christi, Texas, United States, 78404 |
| Dallas Diabetes & Endocrine Center | Dallas, Texas, United States, 75230-2548 |
| Excel Clinical Research, Llc | Houston, Texas, United States, 77035 |
| North Hills Medical Research, Inc. | North Richland Hills, Texas, United States, 76180 |
| Med-Olam Clinical Research | Pasadena, Texas, United States, 77504 |
| Sam Clinical Research Center | San Antoinio, Texas, United States, 78229 |
| Covenant Clinical Research, Pa | San Antonio, Texas, United States, 78229 |
| Hillcrest Family Health Center | Waco, Texas, United States, 76710 |
| Val R. Hansen, M.D. | Bountiful, Utah, United States, 84010 |
| Highland Clinical Research | Salt Lake City, Utah, United States, 84124 |
| Southwestern Vermont Med Cntr | Bennington, Vermont, United States, 05201 |
| Hampton Roads Center For Clinical Research, Inc. | Suffolk, Virginia, United States, 23435 |
| Local Institution | Coquitlam, British Columbia, Canada, V3K 3V9 |
| Local Institution | Winnipeg, Manitoba, Canada, R3E3P4 |
| Local Institution | Brampton, Ontario, Canada, L6T 0G1 |
| Local Institution | Smiths Falls, Ontario, Canada, K7A 4W8 |
| Local Institution | Toronto, Ontario, Canada, M9W 4L6 |
| Local Institution | Granby, Quebec, Canada, J2G 8Z9 |
| Local Institution | Saskatoon, Saskatchewan, Canada, S7K 3H3 |
| Local Institution | Quebec, Canada, G1N 4V3 |
| Local Institution | Bucheon, Gyeonggi-do, Korea, Republic of, 420-717 |
| Local Institution | Sungnam-si, Gyeonggi-do, Korea, Republic of, 463-712 |
| Local Institution | Daegu, Korea, Republic of, 700-721 |
| Local Institution | Incheon, Korea, Republic of, 405-760 |
| Local Institution | Seoul, Korea, Republic of, 110-774 |
| Local Institution | Seoul, Korea, Republic of, 120-752 |
| Local Institution | Seoul, Korea, Republic of, 137-701 |
| Local Institution | Guadalajara, Jalisco, Mexico, 44670 |
| Local Institution | Cuautla, Morelos, Mexico, 62744 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64460 |
| Local Institution | Monterrey, Nuevo Leon, Mexico, 64710 |
| Local Institution | Merida, Yucatan, Mexico, 97070 |
| Local Institution | Aguascalientes, Mexico, 20230 |
| Local Institution | Chihuahua, Mexico, 31217 |
| Local Institution | Durango, Mexico, 34000 |
| Local Institution | Gdansk, Poland, 80-546 |
| Local Institution | Katowice, Poland, 40954 |
| Local Institution | Katowice, Poland, 40-057 |
| Local Institution | Krakow, Poland, 30-015 |
| Local Institution | Lodz, Poland, 90-242 |
| Local Institution | Opole, Poland, 45-367 |
| Local Institution | Poznan, Poland, 61-655 |
| Local Institution | Pulawy, Poland, 24-100 |
| Local Institution | Warszawa, Poland, 03-580 |
| Local Institution | Cidra, Puerto Rico, 00739 |
| Local Institution | Manati, Puerto Rico, 00674 |
| Local Institution | Ponce, Puerto Rico, 00716 |
| Local Institution | San Juan, Puerto Rico, 00909 |
| Local Institution | San Juan, Puerto Rico, 00926 |
| Local Institution | San Juan, Puerto Rico, 00935 |
| Local Institution | Villa Fontana, Puerto Rico, 00983 |
| Local Institution | Ploiesti, Prahova, Romania, 100018 |
| Local Institution | Ploiesti, Prahova, Romania, 100163 |
| Local Institution | Timisoara, Timis, Romania, 300736 |
| Local Institution | Bucharest, Romania, 050538 |
| Local Institution | Bucuresti, Romania, 020475 |
| Local Institution | Bucuresti, Romania, 020359 |
| Local Institution | Bucuresti, Romania, 11794 |
| Local Institution | Cluj Napoca Cluj, Romania, 400006 |
| Local Institution | Craiova, Romania, 200349 |
| Local Institution | Galati, Romania, 800098 |
| Local Institution | Soweto, Gauteng, South Africa, 2013 |
| Local Institution | Gauteng, Johannesburg, South Africa, 1818 |
| Local Institution | Durban, Kwa-Zulu Natal, South Africa, 4001 |
| Local Institution | Cape Town, Western Cape, South Africa, 7500 |
| Local Institution | Goodwood, Western Cape, South Africa, 7460 |
| Local Institution | Paarl, Western Cape, South Africa, 7646 |
| Local Institution | Rondebosch, Western Cape, South Africa, 7700 |
| Local Institution | Somerset West, Western Cape, South Africa, 7130 |
| Local Institution | Johannesburg, South Africa, 1829 |
| Local Institution | Johannesburg, South Africa, 2129 |