Study to evaluate the effects of BMS-813160 on protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease

• Conditions: Diabetic kidney disease; MedDRA version: 18.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-005093-54-FR
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-22
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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 antiotensin receptor blocker (ARB) therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

-Clinical diagnosis of type 1 diabetes
-Unstable cardiovascular, metabolic, or other chronic disease status
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: - To assess the plasma and urinary pharmacokinetics (PK) of BMS-813160 and to examine the relationship between BMS-813160 exposure and UACR change during 12 weeks of double-blinded treatment in subjects with DKD.<br>- To examine the relationship between BMS-813160 dose and UACR change during 12 weeks of doubleblinded treatment in subjects with DKD.<br>- To assess the safety and tolerability of BMS-813160 during 12 weeks of double-blinded treatment and 4 weeks of post-treatment follow up.;Primary end point(s): Percent change from baseline (Day -4 to Day -1) in Urinary Albumin-to-Creatinine Ratio (UACR) across 12 weeks of treatment with BMS-813160.;Timepoint(s) of evaluation of this end point: At Weeks 2, 4, 8, and 12.