Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease
NCT ID: NCT01752985
Last Updated: 2019-07-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
319 participants
INTERVENTIONAL
2013-03-18
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Glycemic Efficacy and Renal Safety Study of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment
NCT00663260
Renal Mechanism of Action/Splay vs. TmG
NCT00726505
Characterization of the Kinetics of Renal Glucose Reabsorption in Response to Dapagliflozin in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus (T2DM)
NCT01165268
Efficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes
NCT06415214
A Study in Participants With Diabetic Kidney Disease
NCT01113801
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160
BMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks
BMS-813160
Placebo matching with BMS-813160
Arm B: BMS-813160 300 mg
BMS-813160 300 mg capsules by mouth twice daily for 12 weeks
BMS-813160
Arm C: Placebo matching with BMS-813160
Placebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks
Placebo matching with BMS-813160
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-813160
Placebo matching with BMS-813160
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) therapy
Exclusion Criteria
* Unstable cardiovascular, metabolic, or other chronic disease status
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
* High risk of infection or immune compromise
* Clinically significant ECG conduction abnormalities
* Drugs with significant potential to affect BMS-813160 exposure
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Uab Hospital
Birmingham, Alabama, United States
Univ Of Al At Birmingham
Birmingham, Alabama, United States
Akdhc Medical Research Services Llc
Phoenix, Arizona, United States
Academic Medical Research Institute
Los Angeles, California, United States
Ucla
Los Angeles, California, United States
Providence Clinical Research
North Hollywood, California, United States
Diabetes Medical Center Of California
Northridge, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
All Medical Research, Llc
Cooper City, Florida, United States
International Research Associates, Llc
Hialeah, Florida, United States
Genesis Clinical Research, Inc.
Tampa, Florida, United States
Emory University School Of Medicine
Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
John H. Stroger, Jr. Hospital Of Cook County
Chicago, Illinois, United States
Research By Design, Llc
Evergreen Park, Illinois, United States
St Louis Center Clinl Res
St Louis, Missouri, United States
St. Louis Center For Clinical Research
St Louis, Missouri, United States
Va Nebraska-Western Iowa Health Care System (Nwihcs)
Omaha, Nebraska, United States
Southern Nh Diab And Endo
Nashua, New Hampshire, United States
Premier Research, Inc.
Trenton, New Jersey, United States
Albany Medical College
Albany, New York, United States
The Endocrine Group Llp
Albany, New York, United States
Nephrology Associates
Flushing, New York, United States
Medispect Medical Research, Llc
Boone, North Carolina, United States
Metrolina Internal Medicine
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States
Physician Research, Inc.
Zanesville, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Piedmont Health Grp, Llc-Twr Pt Res Ctr
Hodges, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Doctors Hospital At Renaissance
Edinburg, Texas, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States
Northeast Clinical Research Of San Antonio, Llc
Schertz, Texas, United States
Burke Internal Medicine And Research
Burke, Virginia, United States
Virginia Endocrinology Research
Chesapeake, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Mcguire Va Medical Center
Richmond, Virginia, United States
Health Sciences Centre Diabetes Research Centre
Winnipeg, Manitoba, Canada
Eastern Health Sciences Center
St. John's, Newfoundland and Labrador, Canada
Aggarwal And Associates
Brampton, Ontario, Canada
Clinical Research Solutions, Inc
Kitchener, Ontario, Canada
Lmc Diabetes & Endocrinology (Thornhill)
Thornhill, Ontario, Canada
Lmc Diabetes & Endocrinology (Bayview)
Toronto, Ontario, Canada
Centre De Recherche Clinique De Laval
Laval, Quebec, Canada
Recherche Gcp Research
Montreal, Quebec, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Frederiksberg, , Denmark
Local Institution
Gentofte Municipality, , Denmark
Local Institution
Hillerød, , Denmark
Local Institution
Holstebro, , Denmark
Local Institution
Amiens, , France
Local Institution
Grenoble, , France
Local Institution
Nantes, , France
Local Institution
Paris, , France
Local Institution
Poitiers, , France
Local Institution
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012-005093-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV202-010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.