Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
NCT ID: NCT00859898
Last Updated: 2016-07-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1093 participants
INTERVENTIONAL
2009-04-30
2010-05-31
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
QUADRUPLE
Study Groups
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Dapagliflozin + Metformin XR
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks
Dapagliflozin
Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR
Tablets, Oral, up to 2000 mg, once daily, 24 weeks
Dapagliflozin + Placebo
Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.
Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks.
Dapagliflozin
Tablets, Oral, 10 mg, once daily, 24 weeks
metformin HCl Modified Release matching Placebo
Tablets
Metformin XR + Placebo
Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks
Metformin XR
Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
dapagliflozin matching Placebo
Tablets
Interventions
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Dapagliflozin
Tablets, Oral, 10 mg, once daily, 24 weeks
Metformin XR
Tablets, Oral, up to 2000 mg, once daily, 24 weeks
Metformin XR
Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks
dapagliflozin matching Placebo
Tablets
metformin HCl Modified Release matching Placebo
Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\<= 77 years old, with type 2 diabetes mellitus
* Subjects must have central laboratory pre-randomization hemoglobin A1C \>= 7.5 and \<= 12.0%
* C-peptide \>= 1.0 ng/mL (0.34 nmol/L)
* Body Mass Index \<= 45 kg/m2
* Must be able to perform self monitoring of blood glucose
Exclusion Criteria
* Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
* Creatinine kinase \>3\*ULN
* Serum creatinine \>= 1.50 mg/dL (133 µmol/L) for male subjects, \>= 1.40 mg/dL (124 µmol/L) for female subjects
* Calcium value outside of the central laboratory normal reference range
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
* Urine albumin:creatinine ratio (UACR) \>1800 mg/g (203.4 mg/mmol Cr)
* Severe uncontrolled hypertension defined as systolic blood pressure (SBP) \>=180 mmHg and/or diastolic blood pressure (DBP) \>=110 mmHg
* Hemoglobin \>=11.0 g/dL (110 g/L) for men; hemoglobin \>=10.0 g/dL (100 g/L) for women
* Positive for hepatitis B surface antigen
* Positive for anti-hepatitis C virus antibody
* History of diabetes insipidus
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma
* Symptoms of poorly controlled diabetes that would preclude participation in this trial
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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International Institute Of Clinical Research
Ozark, Alabama, United States
Clinical Research Advantage, Inc./Mesa Family Med Ctr, Pc
Tempe, Arizona, United States
Clinical Research Advantage, Inc.
Tempe, Arizona, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
Encompass Clinical Research-North Coast
Encinitas, California, United States
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States
Valley Research
Fresno, California, United States
Del Rosario Medical Clinic, Inc.
Huntington Park, California, United States
Irvine Center For Clinical Research, Inc.
Irvine, California, United States
Pacific Sleep Medicine Services (Avastra Clinical Trials)
Redlands, California, United States
Orange County Research Center
Tustin, California, United States
Lynn Institute Of The Rockies
Colorado Springs, Colorado, United States
Radiant Research, Inc.
Denver, Colorado, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, United States
Nextphase Clinical Trials, Inc.
Miami, Florida, United States
Baptist Diabetes Associates
Miami, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Lake Hartwell Family Medicine
Hartwell, Georgia, United States
Middle Georgia Drug Study Center, Llc
Perry, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Provident Clinical Research
Addison, Illinois, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Physicians Research Group
Indianapolis, Indiana, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Clinilabs, Inc.
New York, New York, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Pharmquest
Greensboro, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Community Health Care, Inc.
Canal Fulton, Ohio, United States
Holzer Clinic, Inc
Gallipolis, Ohio, United States
Wells Institute For Health Awareness
Kettering, Ohio, United States
Newark Physician Associates
Newark, Ohio, United States
Daniel G. Williams, Md
Perrysburg, Ohio, United States
Physician Research, Inc.
Zanesville, Ohio, United States
Gilbert Medical Research, Llc
Bethany, Oklahoma, United States
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, United States
Integris Family Care Yukon
Yukon, Oklahoma, United States
Williamette Valley Clinical Studies
Eugene, Oregon, United States
Dingmans Medical
Dingmans Ferry, Pennsylvania, United States
Integrated Medical Group Pc/Fleetwood Clinical Research
Fleetwood, Pennsylvania, United States
Wellmon Family Practice
Shippensburg, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Southeastern Research Associates, Inc.
Greenville, South Carolina, United States
Holston Medical Group
Bristol, Tennessee, United States
Parkway Medical Group
Fayetteville, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Southwind Medical Specialists
Memphis, Tennessee, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
Endocrine Associates
Houston, Texas, United States
Village Family Practice
Houston, Texas, United States
Juno Research, Llc.
Houston, Texas, United States
Non-Invasive Cardiovascular, Pa
Houston, Texas, United States
Excel Clinical Research
Houston, Texas, United States
Texas Center For Drug Development
Houston, Texas, United States
Midland Clinical Research Center
Midland, Texas, United States
Hill Country Medical Associates
New Braunfels, Texas, United States
Covenant Clinical Research, Pa
San Antonio, Texas, United States
S.A.M. Clinical Research Center
San Antonio, Texas, United States
Avastra Clinical Trials
Midvale, Utah, United States
Seven Corners Medical Center
Falls Church, Virginia, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Local Institution
Hyderabad, Andhra Pradesh, India
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Aminjikarai, Chennai, India
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Haryāna, Karnal, India
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Bangalore, Karnataka, India
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Indore, Madhya Pradesh, India
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Nagpur, Maharashtra, India
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Nagpur, Maharashtra, India
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Chennai, Tamil Nadu, India
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Ghaziabad, Uttar Pradesh, India
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Jaipur, , India
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Aguascalientes, Aguascalientes, Mexico
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Durango, Durango, 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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Morelia, Michioacan, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Veracruz, Veracruz, Mexico
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Mérida, Yucatán, Mexico
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Fajardo, , 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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San Juan, , Puerto Rico
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Ekaterinaburg, , Russia
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Kemerovo, , Russia
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Krasnoyarsk, , Russia
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Moscov, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , 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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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Tyumen, , Russia
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Vladimir, , Russia
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Volgograd, , Russia
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Voronezh, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Bucheon-si, Gyeonggi-do, South Korea
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Goyang-si, Gyeonggi-do, South Korea
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Guri-si, Gyeonggi-do, South Korea
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Sungnam, 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
Countries
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References
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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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Investigator Inquiry form
Other Identifiers
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Eudract #: 2008-007548-33
Identifier Type: -
Identifier Source: secondary_id
MB102-034
Identifier Type: -
Identifier Source: org_study_id
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