Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
972 participants
INTERVENTIONAL
2008-07-31
2010-06-30
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
Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
Thiazolidinedione (Pioglitazone)
Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Arm 2
Dapagliflozin
Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
Thiazolidinedione (Pioglitazone)
Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Arm 3
Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, once daily, up to 48 weeks
Thiazolidinedione (Pioglitazone)
Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Interventions
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Dapagliflozin
Tablets, Oral, 5.0 mg, once daily, up to 48 weeks
Dapagliflozin
Tablets, Oral, 10.0 mg, once daily, up to 48 weeks
Placebo matching Dapagliflozin
Tablets, Oral, 0 mg, once daily, up to 48 weeks
Thiazolidinedione (Pioglitazone)
Tablets, ≥ 30 mg, Once daily, up to 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All subjects must have central laboratory pre-randomization A1C ≥ 7.0 and ≤ 10.5%
* C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
* Body Mass Index ≤ 45.0 kg/m²
Exclusion Criteria
* Serum total bilirubin \> 2 mg/dL (34.2 µmol/L)
* Creatinine kinase \> 3.0 times the upper limit of normal
* Symptoms of severely uncontrolled diabetes
* Serum creatinine ≥ 2.0 mg/dL
* Calculated Cr-Clearance \< 50 ml/min (calculated by Cockroft-Gault formula)
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
18 Years
ALL
No
Sponsors
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Astra Zeneca, Bristol-Myers Squibb
OTHER
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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Pinnacle Research Group, Llc
Anniston, Alabama, United States
Iicr
Ozark, Alabama, United States
43rd Medical Associates, P.C.
Phoenix, Arizona, United States
Clinical Research Advantage Inc / Desert Clinical Res, Llc
Tempe, Arizona, United States
Clinical Research Advantage, Inc
Tempe, Arizona, United States
Little Rock Family Practice Clinic
Little Rock, Arkansas, United States
Searcy Medical Center
Searcy, Arkansas, United States
Clinical Innovations, Inc.
Costa Mesa, California, United States
Marin Endocrine Care And Research, Inc.
Greenbrae, California, United States
Torrance Clinical Research
Lomita, California, United States
Randall Shue, D.O.
Los Angeles, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Desert Medical Advances
Palm Desert, California, United States
Avastra Clinical Trials
Redlands, California, United States
Sierra Clinical Research
Roseville, California, United States
Ritchken & First M.D.'S
San Diego, California, United States
Advantage Clinical Research
Santa Ana, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Diabetes Research Center
Tustin, California, United States
Aurora Family Medicine Center, P.C.
Aurora, Colorado, United States
Denver Internal Medicine
Denver, Colorado, United States
Central Florida Clinical Trials
Altamonte Springs, Florida, United States
Health First Clinical Research Group, Inc.
Chipley, Florida, United States
Clinical Therapeutics Corporation
Coral Gables, Florida, United States
Westside Center For Clinical Research
Jacksonville, Florida, United States
Panhandle Family Care Associates
Marianna, Florida, United States
Baptist Diabetes Associates, Pa
Miami, Florida, United States
Suncoast Clinical Res Inc.
New Port Richey, Florida, United States
Stone Mountain Clinical Research
Stone Mountain, Georgia, United States
Cedar Crosse Research Center
Chicago, Illinois, United States
Northwest Indiana Center For Clinical Research
Valparaiso, Indiana, United States
Professional Research Network Of Kansas
Wichita, Kansas, United States
St. Mary'S Center For Diabetes And Endocrinology
Grand Rapids, Michigan, United States
Endocrine Research Associates
Jackson, Mississippi, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Danny W. Jackson P.A.
Rolling Fork, Mississippi, United States
Association Of International Professionals
Las Vegas, Nevada, United States
Physicians Research Center
Toms River, New Jersey, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Metrolina Internal Medicine
Charlotte, North Carolina, United States
The Center For Nutrition & Preventive Medicine, Pllc
Charlotte, North Carolina, United States
Northstate Clinical Research
Lenoir, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
Providence Health Partners - Center For Clinical Research
Dayton, Ohio, United States
Physician Research, Inc.
Zanesville, Ohio, United States
Family Medical Associates
Levittown, Pennsylvania, United States
Banksville Medical, Pc
Pittsburgh, Pennsylvania, United States
Brookside Family Practice & Pediatrics
Pottstown, Pennsylvania, United States
Columbia Clinical Research, Inc.
Columbia, South Carolina, United States
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
Village Family Practice
Houston, Texas, United States
Office Of Dr. Michelle Zaniewski Singh
Houston, Texas, United States
Diabetes & Glandular Disease Research Assoc,, Inc.
San Antonio, Texas, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States
William L. Gray, Md
Spokane, Washington, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
Local Institution
Ciudad Auton, Buenos Aires, Argentina
Local Institution
Zárate, Buenos Aires, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Moncton, New Brunswick, Canada
Local Institution
Mount Pearl, Newfoundland and Labrador, Canada
Local Institution
Halifax, Nova Scotia, Canada
Local Institution
Sarnia, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Mirabel, Quebec, Canada
Local Institution
Hariyāna, , India
Local Institution
Mumbai, , India
Local Institution
Vellore, , India
Local Institution
Chihuahua City, Chihuahua, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Zapopan, Jalisco, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Local Institution
Monterrey, Nl, Nuevo León, Mexico
Local Institution
Veracruz, Veracruz, Mexico
Local Institution
Mérida, Yucatán, Mexico
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Lima, Lima Province, Peru
Local Institution
Cebu City, , Philippines
Local Institution
Manila, , Philippines
Local Institution
Pasig, , Philippines
Local Institution
Ponce, , Puerto Rico
Local Institution
Changhua, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taipei, , Taiwan
Countries
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References
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Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25.
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.
Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012 Jul;35(7):1473-8. doi: 10.2337/dc11-1693. Epub 2012 Mar 23.
Other Identifiers
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MB102-030
Identifier Type: -
Identifier Source: org_study_id
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