Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00663260
First received: April 18, 2008
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Dapagliflozin
Drug: Placebo
Phase 2
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, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The change in glycosylated hemoglobin (A1C) [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in estimated glomerular filtration rate (marker of kidney function) [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
  • The change in estimated creatinine clearance (marker of kidney function) [ Time Frame: after 52 weeks ] [ Designated as safety issue: No ]
  • The change in fasting plasma glucose [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
  • The change in body weight [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 202
Study Start Date: June 2008
Study Completion Date: June 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dapagliflozin (10 mg) Drug: Dapagliflozin
Tablets, Oral, 10 mg, Once Daily, 104 weeks
Other Name: BMS-512148
Active Comparator: Dapagliflozin (5 mg) Drug: Dapagliflozin
Tablets, Oral, 5 mg, Once Daily, 104 weeks
Other Name: BMS-512148
Placebo Comparator: Placebo Drug: Placebo
Tablets, Oral, 0 mg, Once Daily, 104 weeks

Detailed Description:

All eligible subjects will receive a single-blind placebo medication during a 1-week lead-in period prior to randomization. All arms may include the addition of open label medication described (as needed for rescue based on protocol specific criteria). Rescue medication is defined as the addition of an approved, appropriate antihyperglycemic agent, except metformin, used according to conventional standards of care, to treat hyperglycemia, which may therefore allow the subject to remain in the trial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females, ≥18 years old, with type 2 diabetes and with inadequate glycemic control
  • Clinical diagnosis of moderate renal impairment

Exclusion Criteria:

  • AST and /or ALT > 3.0 times the upper limit of normal
  • Serum total bilirubin > 1.5 times ULN
  • Symptoms of severely uncontrolled diabetes
  • Currently unstable or serious cardiovascular, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663260

  Hide Study Locations
Locations
United States, Arizona
Vista Medical Research, Inc.
Mesa, Arizona, United States, 85206
United States, California
Valley Research
Fresno, California, United States, 93720
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States, 94904
Office Of Richard Cherlin, Md
Los Gatos, California, United States, 95032
Diabetes Medical Center Of California
Northridge, California, United States, 91325
Apex Research Of Riverside
Riverside, California, United States, 92505
La Biomed At Harbor Ucla Med Ctr.
Torrance, California, United States, 90502
United States, Colorado
Endocrine Associates Of The Rockies
Denver, Colorado, United States, 80220
United States, Florida
Panhandle Family Care Associates
Marianna, Florida, United States, 32446
Genesis Clinical Research
Tampa, Florida, United States, 33614
United States, Georgia
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States, 30076
United States, Minnesota
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
Kcva Medical Center Research Svc (151)
Kansas City, Missouri, United States, 64128
United States, Nebraska
Va Nebraska-Western Iowa Health Care System (Nwihcs)
Omaha, Nebraska, United States, 68105
United States, New Jersey
University Of Medicine And Dentistry Of New Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Slocum-Dickson Medical Group, Pllc
New Hartford, New York, United States, 13413
United States, Ohio
Community Health Care Of Manchester
Akron, Ohio, United States, 44319
Center For Thyroid Diseases And Endocrinology
Beachwood, Ohio, United States, 44122
Physician Research, Inc.
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Univ Of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Rogue Valley Clinical Research
Medford, Oregon, United States, 97504
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Drexel University College Of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Low Country Internal Medicine Of Sc, Pa
Charleston, South Carolina, United States, 29406
Carolina Health Specialists
Myrtle Beach, South Carolina, United States, 29572
Palmetto Clinical Research
Summerville, South Carolina, United States, 29485
United States, Texas
Research Institute Of Dallas
Dallas, Texas, United States, 75231
Westbury Medical Clinic P.A.
Houston, Texas, United States, 77005
United States, Virginia
The Strelitz Diabetes Center
Norfolk, Virginia, United States, 23510
United States, Washington
Capital Clinical Research Center
Olympia, Washington, United States, 98502
Cedar Research Llc
Tacoma, Washington, United States, 98405
United States, Wisconsin
Aurora Advanced Healthcare
Milwaukee, Wisconsin, United States, 53209
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, United States, 53295
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, C1405BCJ
Local Institution
Mar Del Plata, Buenos Aires, Argentina, 7600
Local Institution
Zarate, Buenos Aires, Argentina, 2800
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Buenos Aires, Argentina, C1012AAR
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Buenos Aires, Argentina, C1408INH
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Cordoba, Argentina, 5000
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Cordoba, Argentina, X5006CBI
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Salta, Argentina, A4406CLA
Australia, New South Wales
Local Institution
Camperdown, New South Wales, Australia, 2050
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St Leonards, New South Wales, Australia, 2065
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Woollongong, New South Wales, Australia, 2500
Australia, Tasmania
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Launceston, Tasmania, Australia, 7250
Canada, Alberta
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Calgary, Alberta, Canada, T3B 0M3
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
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Barrie, Ontario, Canada, L4M 7G1
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Thornhill, Ontario, Canada, L4J 8L7
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M4R 2G4
Canada, Quebec
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Gatineau, Quebec, Canada, J8V 2P5
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Laval, Quebec, Canada, H7T 2P5
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Sherbrooke, Quebec, Canada, J1G 5K2
Canada, Saskatchewan
Local Institution
Regina, Saskatchewan, Canada, S4P 0W5
Denmark
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Copenhagen Nv, Denmark, 2400
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Gentofte, Denmark, 2820
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Hvidovre, Denmark, 2650
France
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Besancon Cedex, France, 25030
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Brest Cedex, France, 29609
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Paris, France, 75877
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Paris Cedex 10, France, 75475
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Poitiers Cedex, France, 86021
India
Local Institution
Indore, Madhya Pradesh, India, 452001
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Pune, Maharashtra, India, 411 004
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Bangalore, India, 560034
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Bangalore, India, 560 052
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Chennai, India, 600029
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Pune, Maharashtra, India, 411011
Local Institution
Rajasthan, India, 302 001
Italy
Local Institution
Chieri, Italy, 10023
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Chieti Scalo, Italy, 66013
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Modena, Italy, 41100
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Padova, Italy, 35128
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Perugia, Italy, 06126
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Pisa, Italy, 56126
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Roma, Italy, 00189
Local Institution
Siena, Italy, 53100
Mexico
Local Institution
Df, Distrito Federal, Mexico, 11800
Local Institution
Df, Distrito Federal, Mexico, 01120
Local Institution
Df, Distrito Federal, Mexico, 06700
Local Institution
Celaya, Guanajuato, Mexico, 38000
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Durango, Mexico, 34075
Peru
Local Institution
Cercado De Lima, Lima, Peru, 1
Local Institution
Arequipa, Peru
Local Institution
Lima, Peru, 18
Local Institution
Lima, Peru, LIMA 13
Puerto Rico
Local Institution
Caguas, Puerto Rico, 00725
Local Institution
San Juan, Puerto Rico, 00909
Singapore
Local Institution
Singapore, Singapore, 119074
Spain
Local Institution
Barcelona, Spain, 08036
Local Institution
San Sebastian De Los, Spain, 28702
Local Institution
Vizcaya, Spain, 48903
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00663260     History of Changes
Other Study ID Numbers: MB102-029
Study First Received: April 18, 2008
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Brazil: National Health Surveillance Agency
Canada: Health Canada
Denmark: The Ministry of the Interior and Health
France: Ministry of Health
India: Central Drugs Standard Control Organization
India: Directorate General of Foreign Trade
India: Indian Council of Medical Research
Israel: Ministry of Health
Italy: Ministry of Health
Mexico: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Singapore: Health Sciences Authority
South Africa: Department of Health
Spain: Ministry of Health and Consumption

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014