A Pilot Study of BMS-512148 in Subjects With Type 2 Diabetes
NCT ID: NCT00357370
Last Updated: 2017-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
163 participants
INTERVENTIONAL
2006-10-31
2008-03-31
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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Cohort 1
20 mg
Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Cohort 2 - Arm 1
10 mg
Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Cohort 2 - Arm 2
20 mg
Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Cohort 2 - Arm 3
Placebo
Tablets, Oral, 0 mg, once daily, up to 12 weeks
Interventions
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Dapagliflozin
Tablets, Oral, once daily, up to 12 weeks
Placebo
Tablets, Oral, 0 mg, once daily, up to 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects receiving insulin and metformin and/or a thiazolidinedione
* Body Mass Index \<=45.0 kg/m2
* Serum creatinine \<1.5 mg/dL for men or \<1.4 mg/dL for women
* No overt proteinuria (in subjects with a microalbumin/creatinine ratio ≥300 mg/g, the 24-hour urinary excretion of total protein must be \<3 g/24 hrs)
Exclusion Criteria
* AST and/or ALT \>2.5 times the upper limit of normal
* Creatinine kinase ≥3 times the upper limit of normal
* Symptoms of severely uncontrolled diabetes
* History of hypoglycemic unawareness
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
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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Nea Clinic
Jonesboro, Arkansas, United States
Valley Research
Fresno, California, United States
Bernstein, Richard
Greenbrae, California, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Model Clinical Research Llc
Baltimore, Maryland, United States
University Of Michigan
Ann Arbor, Michigan, United States
St. Louis Center For Clinical Research
St Louis, Missouri, United States
Suny Upstate Medical University
Syracuse, New York, United States
Mountain Diabetes And Endocrine Center
Asheville, North Carolina, United States
Your Diabetes Endocrine Nutrition Group
Mentor, Ohio, United States
Research Institute Of Dallas, P.A.
Dallas, Texas, United States
Diabetes And Glandular Disease Research Associates, P.A.
San Antonio, Texas, United States
Rainier Clinical Research Center
Renton, Washington, United States
Advanced Healthcare S.C.
Milwaukee, Wisconsin, United States
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Bathurst, New Brunswick, Canada
Local Institution
Gatineau, Quebec, Canada
Local Institution
Laval, Quebec, Canada
Local Institution
Longueuil, Quebec, Canada
Local Institution
Pointe-Claire, Quebec, Canada
Local Institution
Sherbrooke, Quebec, Canada
Countries
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References
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Wilding JP, Norwood P, T'joen C, Bastien A, List JF, Fiedorek FT. A study of dapagliflozin in patients with type 2 diabetes receiving high doses of insulin plus insulin sensitizers: applicability of a novel insulin-independent treatment. Diabetes Care. 2009 Sep;32(9):1656-62. doi: 10.2337/dc09-0517. Epub 2009 Jun 15.
Mellander A, Billger M, Johnsson E, Traff AK, Yoshida S, Johnsson K. Hypersensitivity Events, Including Potentially Hypersensitivity-Related Skin Events, with Dapagliflozin in Patients with Type 2 Diabetes Mellitus: A Pooled Analysis. Clin Drug Investig. 2016 Nov;36(11):925-933. doi: 10.1007/s40261-016-0438-3.
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.
Other Identifiers
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MB102-009
Identifier Type: -
Identifier Source: org_study_id
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