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:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00663260
First received: April 18, 2008
Last updated: October 24, 2012
Last verified: October 2012
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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 Bristol-Myers Squibb:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663260
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Hide Study LocationsLocations
| 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 | |
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| Capital Federal, Buenos Aires, Argentina, C1405BCJ | |
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| Mar Del Plata, Buenos Aires, Argentina, 7600 | |
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| 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 | |
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| 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 | |
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| 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 | |
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| 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 | |
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| Rajasthan, India, 302 001 | |
| Italy | |
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| 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 | |
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| Siena, Italy, 53100 | |
| Mexico | |
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| Df, Distrito Federal, Mexico, 11800 | |
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| Df, Distrito Federal, Mexico, 01120 | |
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| Df, Distrito Federal, Mexico, 06700 | |
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| Celaya, Guanajuato, Mexico, 38000 | |
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| Guadalajara, Jalisco, Mexico, 44670 | |
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| Monterrey, Nuevo Leon, Mexico, 64460 | |
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| Durango, Mexico, 34075 | |
| Peru | |
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| Cercado De Lima, Lima, Peru, 1 | |
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| Arequipa, Peru | |
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| Lima, Peru, 18 | |
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| Lima, Peru, LIMA 13 | |
| Puerto Rico | |
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| Caguas, Puerto Rico, 00725 | |
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| San Juan, Puerto Rico, 00909 | |
| Singapore | |
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| Singapore, Singapore, 119074 | |
| Spain | |
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| Barcelona, Spain, 08036 | |
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| San Sebastian De Los, Spain, 28702 | |
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| Vizcaya, Spain, 48903 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00663260 History of Changes |
| Other Study ID Numbers: | MB102-029 |
| Study First Received: | April 18, 2008 |
| Last Updated: | October 24, 2012 |
| 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 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013