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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Diabetic Kidney Disease

Treatments: Drug: BMS-813160; Drug: Placebo matching with BMS-813160

Study type: Interventional

Funder types: Industry

Identifiers

NCT01752985

2012-005093-54 (EudraCT Number)

CV202-010

Details and patient eligibility

About

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

Enrollment: 319 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200 and 3500 mg/g)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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319 participants in 3 patient groups, including a placebo group

Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160

Experimental group

Description:

BMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks

Treatment:

Drug: Placebo matching with BMS-813160

Drug: BMS-813160

Arm B: BMS-813160 300 mg

Experimental group

Description:

BMS-813160 300 mg capsules by mouth twice daily for 12 weeks

Treatment:

Drug: BMS-813160

Arm C: Placebo matching with BMS-813160

Placebo Comparator group

Description:

Placebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks

Treatment:

Drug: Placebo matching with BMS-813160