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Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease

This study is not yet open for participant recruitment.
Verified December 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01752985
First received: December 17, 2012
Last updated: March 28, 2013
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease


Condition Intervention Phase
Diabetic Kidney Disease
 Drug: BMS-813160
Drug: Placebo matching with BMS-813160
 Phase 2

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 Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment With an Inhibitor of the Renin-Angiotensin System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percent change from baseline (Day -4 to Day -1) in Urinary Albumin-to-Creatinine Ratio (UACR) across 12 weeks of treatment with BMS-813160 [ Time Frame: Baseline (up to Day -1) ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Percent change from baseline (Day -4 to Day -1) in UACR across 12 weeks of treatment with BMS-813160 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough observed plasma concentration (Ctrough) of BMS-813160 [ Time Frame: Baseline (up to Day -1), weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    Exposure-response relationship between the geometric mean of measured BMS-813160 Ctrough values during the 12-week treatment period and percent change from baseline (Day -4 to Day -1) in UACR

  • Percent change from baseline (Day -4 to Day -1) in UACR during the 12-week treatment [ Time Frame: Baseline (up to Day -1), weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]

    Exposure-response relationship between the geometric mean of measured BMS-813160 Ctrough values during the 12-week treatment period and percent change from baseline (Day -4 to Day -1) in UACR

    Dose-response relationship between BMS-813160 dose and percent change from baseline (Day -4 to Day -1) in UACR during the 12-week treatment period


  • Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), physical examinations, and clinical laboratory tests [ Time Frame: Upto week 16 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: March 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: BMS-813160 150 mg
BMS-813160 150 mg capsules by mouth once daily for 12 weeks
 Drug: BMS-813160
Experimental: Arm B: BMS-813160 300 mg
BMS-813160 300 mg capsules by mouth twice daily for 12 weeks
 Drug: BMS-813160
Placebo Comparator: Arm C: Placebo matching with BMS-813160
Placebo matching with BMS-813160 0 mg capsules by mouth once daily for 12 weeks
 Drug: Placebo matching with BMS-813160

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 300 and 3500 mg/g)
  • Clinical diagnosis of stable diabetic retinopathy
  • Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) therapy

Exclusion Criteria:

  • Clinical diagnosis of type 1 diabetes
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752985

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, Illinois
Local Institution Not yet recruiting
Evergreen Park, Illinois, United States, 60805
Contact: Site 0050            
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01752985     History of Changes
Other Study ID Numbers: CV202-010, 2012-005093-54
Study First Received: December 17, 2012
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on May 23, 2013