Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes
NCT ID: NCT01606007
Last Updated: 2017-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1282 participants
INTERVENTIONAL
2012-07-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: Saxagliptin+Metformin XR+Placebo
Saxagliptin
Tablets, Oral, 5mg , Once daily, 24 weeks
Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Placebo matching with Dapagliflozin
Tablets, Oral, 0mg, Once daily, 24 weeks
Arm 2: Dapagliflozin+Metformin XR+Placebo
Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Dapagliflozin
Tablets, Oral, 10mg , Once daily, 24 weeks
Placebo matching with Saxagliptin
Tablets, Oral, 0mg, Once daily, 24 weeks
Arm 3: Saxagliptin+Dapagliflozin+Metformin XR
Saxagliptin
Tablets, Oral, 5mg , Once daily, 24 weeks
Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Dapagliflozin
Tablets, Oral, 10mg , Once daily, 24 weeks
Interventions
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Saxagliptin
Tablets, Oral, 5mg , Once daily, 24 weeks
Metformin XR
Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
Dapagliflozin
Tablets, Oral, 10mg , Once daily, 24 weeks
Placebo matching with Dapagliflozin
Tablets, Oral, 0mg, Once daily, 24 weeks
Placebo matching with Saxagliptin
Tablets, Oral, 0mg, Once daily, 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
* Body mass index (BMI) ≤ 45.0kg/m2
Exclusion Criteria
* Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
* Hepatic disease
* Cardiovascular disease within 3 months
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Central Alabama Research
Homewood, Alabama, United States
Terence T. Hart, Md
Muscle Shoals, Alabama, United States
International Institute Of Clinical Research
Ozark, Alabama, United States
Clinical Research Advantage
Mesa, Arizona, United States
Elite Clinical Studies, Llc
Phoenix, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Medical Investigations, Inc.
Little Rock, Arkansas, United States
Aureus Research, Inc.
Little Rock, Arkansas, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Torrance Clinical Research
Lomita, California, United States
National Research Inst
Los Angeles, California, United States
Providence Clinical Research
North Hollywood, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Mehrdad Kevin Ariani Md, Inc.
Northridge, California, United States
Lucita M. Cruz,Md.,Inc.
Norwalk, California, United States
Center For Clinical Trials, Llc.
Paramount, California, United States
Center For Clinical Trials Of Sacramento, Inc.
Sacramento, California, United States
Trinitas Research, Inc
San Jose, California, United States
Orange County Research Center
Tustin, California, United States
Clinical Research Advantage
Colorado Springs, Colorado, United States
Infocus Clinical Research
Denver, Colorado, United States
Lynn Institute Of Denver
Denver, Colorado, United States
Southeast Clinical Research, Llc
Chiefland, Florida, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, United States
Southeast Clinical Research, Llc
Jacksonville, Florida, United States
Fpa Clinical Research
Kissimmee, Florida, United States
Clinical Research Of Miami, Inc.
Miami, Florida, United States
Advanced Pharma Cr, Llc
Miami, Florida, United States
Newphase Clinical Trials, Inc.
Miami Beach, Florida, United States
Omega Research Consultants, Llc
Orlando, Florida, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, United States
Andres Patron, Do Pa
Pembroke Pines, Florida, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Clinical Research Advantage
Council Bluffs, Iowa, United States
Horizon Research Group Of Opelousas, Llc
Eunice, Louisiana, United States
Associated Internal Medicine Specialists
Battle Creek, Michigan, United States
Harris And Associates, P.C.
Detroit, Michigan, United States
Patterson Medical Clinic
Florissant, Missouri, United States
Bellevue Family Practice
Bellevue, Nebraska, United States
Clinical Research Advantage
Elkhorn, Nebraska, United States
Clinical Research Advantage
Fremont, Nebraska, United States
Clinical Research Advantage
Omaha, Nebraska, United States
South Jersey Medical Associates, P.A.
Blackwood, New Jersey, United States
Central Jersey Health And Medical Research
Elizabeth, New Jersey, United States
Southgate Medical Group
West Seneca, New York, United States
Metrolina Internal Medicine
Charlotte, North Carolina, United States
Triad Clinical Trials, Llc
Greensboro, North Carolina, United States
Diabetes & Endocrinology Consultants
Morehead City, North Carolina, United States
Pmg Research Of Winston-Salem, Llc
Winston-Salem, North Carolina, United States
Daystar Clinical Resarch, Inc.
Akron, Ohio, United States
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Primed Clinical Research
Dayton, Ohio, United States
Physicians Research, Inc.
Zanesville, Ohio, United States
Lynn Institute Of Norman
Norman, Oklahoma, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Oregon Clinical Research
Portland, Oregon, United States
Heritage Valley Medical Group
Beaver, Pennsylvania, United States
Wellmon Family Practice
Shippensburg, Pennsylvania, United States
Tlm Medical Services
Columbia, South Carolina, United States
Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina, United States
Holston Medical Group
Bristol, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Pmg Research Of Knoxville
Knoxville, Tennessee, United States
Arlington Family Research Center, Inc.
Arlington, Texas, United States
Padre Coast Clinical Research
Corpus Christi, Texas, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
Excel Clinical Research, Llc
Houston, Texas, United States
North Hills Medical Research, Inc.
North Richland Hills, Texas, United States
Med-Olam Clinical Research
Pasadena, Texas, United States
Sam Clinical Research Center
San Antoinio, Texas, United States
Covenant Clinical Research, Pa
San Antonio, Texas, United States
Hillcrest Family Health Center
Waco, Texas, United States
Val R. Hansen, M.D.
Bountiful, Utah, United States
Highland Clinical Research
Salt Lake City, Utah, United States
Southwestern Vermont Med Cntr
Bennington, Vermont, United States
Hampton Roads Center For Clinical Research, Inc.
Suffolk, Virginia, United States
Local Institution
Coquitlam, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Brampton, Ontario, Canada
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Smiths Falls, Ontario, Canada
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Toronto, Ontario, Canada
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Granby, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Aguascalientes, Aguascalientes, Mexico
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Chihuahua City, Chihuahua, Mexico
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Durango, Durango, Mexico
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Guadalajara, Jalisco, Mexico
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Cuautla, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Mérida, Yucatán, Mexico
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Gdansk, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Opole, , Poland
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Poznan, , Poland
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Puławy, , Poland
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Warsaw, , Poland
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Cidra, , Puerto Rico
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Manatí, , Puerto Rico
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
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San Juan, , Puerto Rico
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San Juan, , Puerto Rico
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Villa Fontana, , Puerto Rico
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Galati, Galați County, Romania
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Ploieşti, Prahova, Romania
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Ploieşti, Prahova, Romania
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Timișoara, Timiș County, Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj Napoca Cluj, , Romania
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Craiova, , Romania
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Soweto, Gauteng, South Africa
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Gauteng, Johannesburg, South Africa
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Johannesburg, Johannesburg, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Goodwood, Western Cape, South Africa
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Paarl, Western Cape, South Africa
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Rondebosch, Western Cape, South Africa
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Somerset West, Western Cape, South Africa
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Johannesburg, , South Africa
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Bucheon-si, Gyeonggi-do, South Korea
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Sungnam-si, Gyeonggi-do, South Korea
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Daegu, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
Local Institution
Seoul, , South Korea
Countries
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References
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Rosenstock J, Hansen L, Zee P, Li Y, Cook W, Hirshberg B, Iqbal N. Dual add-on therapy in type 2 diabetes poorly controlled with metformin monotherapy: a randomized double-blind trial of saxagliptin plus dapagliflozin addition versus single addition of saxagliptin or dapagliflozin to metformin. Diabetes Care. 2015 Mar;38(3):376-83. doi: 10.2337/dc14-1142. Epub 2014 Oct 28.
Bailey CJ, Del Prato S, Wei C, Reyner D, Saraiva G. Durability of glycaemic control with dapagliflozin, an SGLT2 inhibitor, compared with saxagliptin, a DPP4 inhibitor, in patients with inadequately controlled type 2 diabetes. Diabetes Obes Metab. 2019 Nov;21(11):2564-2569. doi: 10.1111/dom.13841. Epub 2019 Aug 26.
Rosenstock J, Mathieu C, Chen H, Garcia-Sanchez R, Saraiva GL. Dapagliflozin versus saxagliptin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin. Arch Endocrinol Metab. 2018 Aug;62(4):424-430. doi: 10.20945/2359-3997000000056.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2012-000679-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV181-169
Identifier Type: -
Identifier Source: org_study_id
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