A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00528879
First received: September 11, 2007
Last updated: September 10, 2010
Last verified: May 2010
  Purpose

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.


Condition Intervention Phase
Type 2 Diabetes
Drug: Dapagliflozin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Alone

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Change from baseline in hemoglobin A1C [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: at Week 24 ] [ 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 ]
  • Proportion of subjects achieving a therapeutic glycemic response, defined as AIC ≤ 6.5% [ 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 ]

Enrollment: 546
Study Start Date: September 2007
Study Completion Date: May 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
2.5 mg
Drug: Dapagliflozin
Tablets, Oral, once daily, Up to 102 weeks
Other Name: BMS-512148
Experimental: Arm 2
5 mg
Drug: Dapagliflozin
Tablets, Oral, once daily, Up to 102 weeks
Other Name: BMS-512148
Experimental: Arm 3
10 mg
Drug: Dapagliflozin
Tablets, Oral, once daily, Up to 102 weeks
Other Name: BMS-512148
Placebo Comparator: Arm 4
0 mg
Drug: placebo
Tablets, Oral, once daily, Up to 102 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
  • Subjects who have been receiving metformin at a total daily dose ≥ 1500 mg/day for at least 8 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 > 2 mg/dL
  • Creatinine kinase > 3 times the upper limit of normal
  • Symptoms of severely uncontrolled diabetes
  • Serum creatinine ≥ 1.50 mg/dL (133 µmol/L) for men or ≥ 1.40 mg/dL for women (124 µmol/L)
  • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528879

  Hide Study Locations
Locations
United States, Arizona
Clinical Research Advantage / Desert Clinical Res, Llc
Tempe, Arizona, United States, 85282
United States, California
Medical Group Of Encino
Encino, California, United States, 91436
Valley Research
Fresno, California, United States, 93720
Randall Shue, D.O.
Los Angeles, California, United States, 90023
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Ritchken & First M.D.'S
San Diego, California, United States, 92117
Encompass Clinical Research
Spring Valley, California, United States, 91978
Raikhel, Marina
Torrance, California, United States, 90505
United States, Colorado
Express Care Clinical Res
Colorado Springs, Colorado, United States, 80909
Denver Internal Medicine
Denver, Colorado, United States, 80209
New West Physicians
Golden, Colorado, United States, 80401
United States, Florida
Central Florida Clinical Trials, Inc.
Altamonte Springs, Florida, United States, 32701
Family Care Associates Of Nw Florida
Chipley, Florida, United States, 32428
United States, Minnesota
Health Partners Research Foundation
Minneapolis, Minnesota, United States, 56440
United States, Missouri
Woodlake Research
Chesterfield, Missouri, United States, 63017
United States, Nevada
Nevada Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
United States, North Carolina
Diabetes & Endocrinology Consultants, Pc
Morehead City, North Carolina, United States, 28557
United States, Ohio
Newark Physician Associates
Newark, Ohio, United States, 43055
United States, Oklahoma
Integris Family Care S. Penn
Oklahoma City, Oklahoma, United States, 73159
United States, Pennsylvania
Cumberland Valley Endocrinology Center, Llc
Carlisle, Pennsylvania, United States, 17013
Banksville Medical Pc
Pittsburgh, Pennsylvania, United States, 15216
United States, South Carolina
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
Southeastern Research Assoc
Taylors, South Carolina, United States, 29687
United States, Texas
Texas Center For Drug Development, P.A.
Houston, Texas, United States, 77081
S.A.M. Clinical Research Center
San Antonio, Texas, United States, 78229
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, United States, 78229
United States, Utah
Optimum Clinical Research
Salt Lake City, Utah, United States, 84102
United States, Washington
Office Of Dr. Gray
Spokane, Washington, United States, 99216
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1429
Local Institution
Capital Federal, Buenos Aires, Argentina, C1425AGC
Local Institution
Capital Federal, Buenos Aires, Argentina, C1056ABJ
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Capital Federal, Buenos Aires, Argentina, 1034
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Ciudad Auton, Buenos Aires, Argentina, C1408INH
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Ciudad Auton., Buenos Aires, Argentina, C1505CWB
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Mar Del Plata, Buenos Aires, Argentina, 7600
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Zarate, Buenos Aires, Argentina, 2800
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Villa Carlos Paz, Cordoba, Argentina, 5152
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Buenos Aires, Argentina, 1431
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Cordoba, Argentina, 5000
Brazil
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Fortaleza, Ceara, Brazil, 60021
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Itajuba, Minas Gerais, Brazil, 37502
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Belem, Para, Brazil, 66073
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Caxias Do Sul, Rio Grande Do Sul, Brazil, 95070
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020090
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035
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Marilia, Sao Paulo, Brazil, 17519
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Rio De Janeiro, Brazil, 20211
Canada, Alberta
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Calgary, Alberta, Canada, T2R 0X7
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 2H4
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, New Brunswick
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Bathurst, New Brunswick, Canada, E2A 4X7
Canada, Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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St-John, Newfoundland and Labrador, Canada, A1E 2E2
Canada, Ontario
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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, M9W 4L6
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Toronto, Ontario, Canada, M4R 2G4
Canada, Prince Edward Island
Local Institution
Charlottetown, Prince Edward Island, Canada, C1A 5Y9
Canada, Quebec
Local Institution
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
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 7H9
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Saskatoon, Saskatchewan, Canada, S7K 3H3
Mexico
Local Institution
Df, Distrito Federal, Mexico, 11800
Local Institution
Guadalajara, Distrito Federal, Mexico, 44670
Local Institution
Zapopan, Distrito Federal, Mexico, 45150
Local Institution
Guadalajara, Jalisco, Mexico, 44650
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Monterrey, Nuevo Leon, Mexico, 64710
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Monterrrey, Nuevo Leon, Mexico, 64700
Local Institution
Tampico, Tamaulipas, Mexico, 89109
Local Institution
Durango, Mexico, 64710
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00528879     History of Changes
Other Study ID Numbers: MB102-014
Study First Received: September 11, 2007
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration
Argentina: Administración Nacional de Medicamentos Alimentos y Tecnología Médica
Brazil: Ministério da Saúde and Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency)
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
Russia: Ministry of Public Health and Social Development of Russian Federation and Ethic Committee of Federal Supervision Service for Public Health and Social Affairs

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014