An Efficacy & Safety Study of BMS-512148 in Combination With Metformin Extended Release Tablets
NCT ID: NCT00643851
Last Updated: 2023-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
994 participants
INTERVENTIONAL
2008-06-30
2009-08-31
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
DOUBLE
Study Groups
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Arm 1
Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg)
Dapagliflozin
Tablets, Oral, Once daily, 24 weeks
Metformin XR
Tablets, Oral, Once daily, 24 weeks
Arm 2
Dapagliflozin (5 mg)
Dapagliflozin
Tablets, Oral, Once daily, 24 weeks
Arm 3
Metformin XR (500 mg up to 2000 mg)
Metformin XR
Tablets, Oral, Once daily, 24 weeks
Interventions
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Dapagliflozin
Tablets, Oral, Once daily, 24 weeks
Metformin XR
Tablets, Oral, Once daily, 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Drug naive or treated with anti-diabetic medication for \< 24 weeks since original diagnosis
* C-peptide ≥ 1.0 ng/mL
* Body Mass Index ≤ 45.0 kg/m
* Serum creatinine \< 1.50 mg/dL for men or \< 1.40 mg/dL for women
Exclusion Criteria
* Serum total bilirubin \> 2.0 mg/dL
* Creatine kinase \> 3X the upper limit of normal (ULN)
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric or rheumatic diseases
18 Years
77 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
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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Greystone Medical Research, Llc
Birmingham, Alabama, United States
Winston Technology Research, Llc
Haleyville, Alabama, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Valley Research
Fresno, California, United States
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, United States
Florida Research Network, Llc
Gainesville, Florida, United States
Fpa Clinical Research
Kissimmee, Florida, United States
Nextphase Clinical Trials, Inc.
Miami, Florida, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Jackson Clinic
Rolling Fork, Mississippi, United States
Mercy Medical Group/Dba Woodlake Research
Chesterfield, Missouri, United States
Hudson Valley Clinical Research Center
Kingston, New York, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Community Health Care, Inc.
Canal Fulton, Ohio, United States
Wells Institute For Health Awareness
Kettering, Ohio, United States
Newark Physician Associates
Newark, Ohio, United States
Physician Research, Inc.
Zanesville, Ohio, United States
Gilbert Medical Research, Llc
Bethany, Oklahoma, United States
Integris Family Care South Penn
Oklahoma City, Oklahoma, United States
Integris Family Care Yukon
Yukon, Oklahoma, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Commonwealth Primary Care, Pc / Fleetwood Clinical Research
Fleetwood, Pennsylvania, United States
Biomedical Research Associates, Llc
Shippensburg, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Southeastern Research Associates, Inc.
Greenville, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Middle Tennessee Clinical Research
Fayetteville, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Endocrine Associates
Houston, Texas, United States
Village Family Practice
Houston, Texas, United States
Non-Invasive Cardiovascular, Pa
Houston, Texas, United States
Excel Clinical Research, Llc
Houston, Texas, United States
Texas Center For Drug Development
Houston, Texas, United States
Inst. Of Clin. Research At The Diabetes Cntr. Of The Sw
Midland, Texas, United States
Hill Country Medical Associates
New Braunfels, Texas, United States
Southwest Clinical Research Center, Llc
Pearland, Texas, United States
Covenant Clinical Research, Pa
San Antonio, Texas, United States
S.A.M. Clinical Research Center
San Antonio, Texas, United States
Local Institution
Pachuca, Hidelgo, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Morelia, Michioacan, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nl, Nuevo León, Mexico
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Tampico, Tamaulipas, Mexico
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Mérida, Yucatán, Mexico
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Aguascalientes, , Mexico
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Durango, , Mexico
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Veracruz, , Mexico
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Cebu City, , Philippines
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Jaro Iloilo City, , Philippines
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Las Piñas, , Philippines
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Marikina City, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Villa Fontana, Carolina, Puerto Rico
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Ponce, , 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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Arkhangelsk, , Russia
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Dzerzhinskiy, , Russia
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Kemerovo, , Russia
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Moscov, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Volgograd, , Russia
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Voronezh, , Russia
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Yaroslav, , Russia
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Guri-si, Gyeonggi-do, South Korea
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Seoul, Nowon-Gu, South Korea
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Bucheon-si, , South Korea
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Incheon, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Sungnam-Si, Gyeonggi-Do, , South Korea
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Dnipro, , Ukraine
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Donetsk, , Ukraine
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Kiev, , Ukraine
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Kiev, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
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Zhytomyr, , Ukraine
Countries
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References
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Henry RR, Murray AV, Marmolejo MH, Hennicken D, Ptaszynska A, List JF. Dapagliflozin, metformin XR, or both: initial pharmacotherapy for type 2 diabetes, a randomised controlled trial. Int J Clin Pract. 2012 May;66(5):446-56. doi: 10.1111/j.1742-1241.2012.02911.x. Epub 2012 Mar 13.
Kohan DE, Fioretto P, Johnsson K, Parikh S, Ptaszynska A, Ying L. The effect of dapagliflozin on renal function in patients with type 2 diabetes. J Nephrol. 2016 Jun;29(3):391-400. doi: 10.1007/s40620-016-0261-1. Epub 2016 Feb 19.
Related Links
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Other Identifiers
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MB102-021
Identifier Type: -
Identifier Source: org_study_id
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