A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

Overview[ - collapse ][ - ]

Purpose The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can improve (decrease) blood glucose values in patients with Type 2 Diabetes who have never been treated with medication or have been on medication for less than 24 weeks since their original diagnosis of Diabetes. The safety of this treatment will also be studied.
ConditionType 2 Diabetes
InterventionDrug: Dapagliflozin
Drug: Dapagliflozin
Drug: Dapagliflozin
Drug: Dapagliflozin
Drug: Dapagliflozin
Drug: Dapagliflozin
Drug: Dapagliflozin matching Placebo
Drug: Metformin
Drug: Metformin (as needed for rescue based on protocol specific criteria)
PhasePhase 3
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT00528372
First ReceivedSeptember 11, 2007
Last UpdatedDecember 15, 2010
Last verifiedDecember 2010

Tracking Information[ + expand ][ + ]

First Received DateSeptember 11, 2007
Last Updated DateDecember 15, 2010
Start DateSeptember 2007
Estimated Primary Completion DateJuly 2010
Current Primary Outcome MeasuresChange from baseline in hemoglobin A1C [Time Frame: at Week 24] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Change from baseline in fasting plasma glucose for each dose of dapagliflozin vs placebo [Time Frame: after 24 weeks of oral administration of double-blind treatment] [Designated as safety issue: No]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC < 7.0% [Time Frame: at Week 24] [Designated as safety issue: No]
  • Change from baseline in total body weight [Time Frame: at Week 24] [Designated as safety issue: No]
  • Change from baseline in fasting plasma glucose [Time Frame: at Week 1] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleA Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
Official TitleA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
Brief Summary
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can
improve (decrease) blood glucose values in patients with Type 2 Diabetes who have never been
treated with medication or have been on medication for less than 24 weeks since their
original diagnosis of Diabetes. The safety of this treatment will also be studied.
Detailed Description
All eligible subjects will receive single-blind placebo medication during the 2 week lead-in
period. All arms may include the addition of open label metformin 500-2000 mg (as needed
for rescue based on protocol specific criteria)
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Dapagliflozin
Tablets, Oral, 2.5 mg, QAM, once daily, up to 102 weeks
Other Names:
BMS-512148Drug: Dapagliflozin
Tablets, Oral, 2.5 mg, QPM, once daily, up to 102 weeks
Other Names:
BMS-512148Drug: Dapagliflozin
Tablets, Oral, 5 mg, QAM, once daily, up to 102 weeks
Other Names:
BMS-512148Drug: Dapagliflozin
Tablets, Oral, 5 mg, QPM, once daily, up to 102 weeks
Other Names:
BMS-512148Drug: Dapagliflozin
Tablets, Oral, 10 mg, QAM, once daily, up to 102 weeks
Other Names:
BMS-512148Drug: Dapagliflozin
Tablets, Oral, 10 mg, QPM, once daily, up to 102 weeks
Other Names:
BMS-512148Drug: Dapagliflozin matching Placebo
Tablets, Oral, 0 mg, QAM & QPM, once daily, up to 102 weeks
Drug: Metformin
Tablets, Oral, 500 mg, QAM, starting at week 24 up to 102 weeks
Drug: Metformin (as needed for rescue based on protocol specific criteria)
Open Label Tablets, Oral, 500-2000 mg
Study Arm (s)
  • Experimental: Group 1 - Dapagliflozin 2.5 mg QAM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Experimental: Group 1 - Dapagliflozin 2.5 mg QPM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Experimental: Group 1 - Dapagliflozin 5 mg QAM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Experimental: Group 1 - Dapagliflozin 5 mg QPM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Experimental: Group 1 - Dapagliflozin 10 mg QAM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Experimental: Group 1 - Dapagliflozin 10 mg QPM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Placebo Comparator: Group 1 - Dapagliflozin Placebo QAM/QPM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Experimental: OL Arm - Dapagliflozin 5 mg QAM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)
  • Experimental: OL Arm - Dapagliflozin 10 mg QAM
    Open Label Metformin 500-2000 mg (as needed for rescue based on protocol specific criteria)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment560
Estimated Completion DateJuly 2010
Estimated Primary Completion DateFebruary 2009
Eligibility Criteria
Inclusion Criteria:

- Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate
glycemic control

- Drug naive or treated with anti-diabetic medication for < 24 weeks

- C-peptide ≥ 1.0 ng/mL

- Body Mass Index ≤ 45.0 kg/m2\

- Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women

Exclusion Criteria:

- AST and /or ALT > 3.0 times the upper limit of normal

- Serum total bilirubin > 1.5 times ULN

- Creatinine kinase ≥ 3 times the upper limit of normal

- Symptoms of severely uncontrolled diabetes

- Currently unstable or serious cardiovascular, renal, hepatic, hematological,
oncological, endocrine, psychiatric, or rheumatic diseases
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Canada, Mexico, Russian Federation

Administrative Information[ + expand ][ + ]

NCT Number NCT00528372
Other Study ID NumbersMB102-013
Has Data Monitoring CommitteeNo
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsAstraZeneca
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateDecember 2010

Locations[ + expand ][ + ]

43rd Medical Associates, P.C.
Phoenix, Arizona, United States, 85051
Clinical Research Advantage, Inc
Tempe, Arizona, United States, 85282
Clin Res Advantage, Inc/East Valley Family Physicians, Plc
Tempe, Arizona, United States, 85282
Valley Research
Fresno, California, United States, 93720
Cherlin, Richard
Los Gatos, California, United States, 95032
Ritchken & First M.D.'S
San Diego, California, United States, 92117
Torrance Clinical Research
Torrance, California, United States, 90717
Aurora Family Medicine Center, P.C.
Aurora, Colorado, United States, 80012
Expresscare Clinical Research
Colorado Springs, Colorado, United States, 80909
Denver Internal Medicine Group
Denver, Colorado, United States, 80209
Center For Internal Medicine
Denver, Colorado, United States, 80209
Central Florida Clinical Trials
Altamonte Springs, Florida, United States, 32701
Family Care Associates
Chipley, Florida, United States, 32428
Westside Center For Clinical Research
Jacksonville, Florida, United States, 32205
Panhandle Family Care Associates
Marianna, Florida, United States, 32446
Louisiana Heart Center
Slidell, Louisiana, United States, 70458
Jackson, Danny W.
Rolling Fork, Mississippi, United States, 39159
Woodlake Research
Chesterfield, Missouri, United States, 63017
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
Slocum-Dickson Medical Group, Pllc
New Hartford, New York, United States, 13413
Internist Associates Of Central New York, P. C.
Syracuse, New York, United States, 13210
Southgate Medical Group
West Seneca, New York, United States, 14224
Providence Health Partners
Dayton, Ohio, United States, 45439
Newark Physician Associates
Newark, Ohio, United States, 43055
Physician Research, Inc.
Zanesville, Ohio, United States, 43701
Gilbert Medical Research, Llc
Bethany, Oklahoma, United States, 73008
Integris Family Care Yukon
Yukon, Oklahoma, United States, 73109
Banksville Medical, Pc
Pittsburgh, Pennsylvania, United States, 15216
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States, 29687
Holston Medical Group
Kingsport, Tennessee, United States, 37660
Village Family Practice
Houston, Texas, United States, 77024
Sam Clinical Research Center
San Antonio, Texas, United States, 78229
Abbott Clinical Research Group, Inc.
San Antonio, Texas, United States, 78224
Taylor/Wade Medical
Bountiful, Utah, United States, 84010
J. Lewis Research, Inc
Salt Lake City, Utah, United States, 84121
Optimum Clinical Research, Inc.
Salt Lake City, Utah, United States, 84102
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23454
William L. Gray, Md
Spokane, Washington, United States, 99216
Local Institution
Calgary, Alberta, Canada, T2R 0X7
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Kelowna, British Columbia, Canada, V1Y 2H4
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Winnipeg, Manitoba, Canada, R3E 3P4
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Bathurst, New Brunswick, Canada, E2A 4X7
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Moncton, New Brunswick, Canada, E1G 1A7
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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St-John, Newfoundland and Labrador, Canada, A1E 2E2
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St. John'S, Newfoundland and Labrador, Canada, A1A 3R5
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Oakville, Ontario, Canada, L6H 3P1
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Sarnia, Ontario, Canada, N7T 4X3
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Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M4R 2G4
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Toronto, Ontario, Canada, M9W 4L6
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Charlottetown, Prince Edward Island, Canada, C1A 5Y9
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Drummondville, Quebec, Canada, J2B 7T1
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Granby, Quebec, Canada, J2G 8Z9
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L'Ancienne Lorette, Quebec, Canada, G2E 2X1
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Mirabel, Quebec, Canada, J7J 2K8
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St-Leonard, Quebec, Canada, H1S 3A9
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Saskatoon, Saskatchewan, Canada, S7K 7H9
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Saskatoon, Saskatchewan, Canada, S7K 3H3
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Tijuana, Baja California, Mexico, 22320
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Guadalajara, Distrito Federal, Mexico, 44670
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Mexico, D. F., Distrito Federal, Mexico, 06726
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Guadalajara, Jalisco, Mexico, 44600
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Guadalajara, Jalisco, Mexico, 44100
Local Institution
Guadalajara, Jalisco, Mexico, 44680
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Morelia, Michioacan, Mexico, 58070
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Monterrey, Nuevo Leon, Mexico, 64060
Local Institution
Monterrrey, Nuevo Leon, Mexico, 64700
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Merida, Yucatan, Mexico, 97070
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Aguascalientes, Mexico, 20230
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Durango, Mexico, 34000
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 115093
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Saint-Petersburg, Russian Federation, 191015
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Smolensk, Russian Federation, 214019
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St. Petersburg, Russian Federation, 195257
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St.Petersburg, Russian Federation, 195112
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Yaroslaval, Russian Federation, 150003