Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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.

    Summary
    EudraCT number
    		 2012-005093-54
    Trial protocol
    		 DK   FR  
    Global end of trial date
    12 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2016
    First version publication date
    26 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CV202-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01752985
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Bristol-Myers Squibb International Corporation, Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to determine efficacy of BMS-813160 in reducing urinary albumin excretion as measured by the urine albumin-to-creatinine ratio (UACR) during 12 weeks of double-blinded treatment in subjects with type 2 diabetes mellitus and diabetic kidney disease (DKD) and persistent baseline macro-albuminuria on the background of stable angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 Subjects remained on their background treatment regimen with an oral ACEI or ARB that has been established prior to their enrollment.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 60
    Country: Number of subjects enrolled
    United States: 209
    Country: Number of subjects enrolled
    Denmark: 17
    Country: Number of subjects enrolled
    France: 33
    Worldwide total number of subjects
    319
    EEA total number of subjects
    50
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    172
    From 65 to 84 years
    147
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 57 centers in 4 countries.

    Pre-assignment
    Screening details
    		 Out of 319 subjects who were enrolled, 110 subjects completed the screening period. Reasons for 209 subjects for not completing the screening periods were: Subjects did not meet study criteria-178, Subjects withdrew consent-8, Lost to follow-up-1, Administrative reason by Sponsor-6, Subject request to discontinue treatment-1, and other reasons-15.

    Period 1
    Period 1 title
    Pretreatment / Screening Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 All Subjects
    Arm description
    		 Subjects with type 2 diabetes mellitus were enrolled and screened for 27 days.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		All Subjects
    Started
    319
    Completed
    110
    Not completed
    209
         Subject request to discontinue treatment
    1
         Consent withdrawn by subject
    8
         other reasons
    15
         Lost to follow-up
    1
         Subject no longer meets study criteria
    178
         Administrative reason by sponsor
    6
    Period 2
    Period 2 title
    Lead-in Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Arm title
    		 Placebo matching with BMS-813160
    Arm description
    		 Subjects received BMS-813160 matching placebo capsules, orally, twice daily for 2 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    BMS-813160 matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with BMS-813160 matching placebo capsules, twice daily for 2 weeks.

    Number of subjects in period 2 [1]
    		Placebo matching with BMS-813160
    Started
    98
    Completed
    89
    Not completed
    9
         Adverse event, non-fatal
    2
         Lost to follow-up
    2
         Subject no longer meets study criteria
    3
         Administrative reason
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 110 subjects who completed the Screening period, 98 subjects entered the Lead-in period. 12 subjects did not entered the Lead-in period.
    Period 3
    Period 3 title
    Treatment Period
    Is this the baseline period?
    		 Yes [2]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-813160 150 mg QD
    Arm description
    		 Subjects received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with BMS-813160 150 mg capsule once daily in AM for 12 weeks.

    Investigational medicinal product name
    Placebo matching with BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsules matching with BMS-813160 were administered orally (1 in AM and 2 in PM) for 12 weeks.

    Arm title
    		 BMS-813160 300 mg BID
    Arm description
    		 Subjects received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    2 BMS-813160 150-mg capsules were administered orally twice daily in AM and PM (Total daily dose of 600 mg) for 12 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    BMS-813160 matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    2 BMS-813160 matching placebo capsules were administered twice daily in AM and PM for 12 weeks.

    Notes
    [2] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Subjects were enrolled and screened to enter into a 2-week placebo lead-in period before they entered into the treatment period.
    Number of subjects in period 3 [3] [4]
    		BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Started
    29
    30
    29
    Completed
    25
    27
    24
    Not completed
    4
    3
    5
         Subject request to discontinue treatment
    1
    -
    1
         Consent withdrawn by subject
    1
    1
    -
         Adverse event, non-fatal
    2
    1
    2
         Lost to follow-up
    -
    -
    1
         Subject no longer meets study criteria
    -
    1
    1
    Notes
    [3] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 319 subjects enrolled worldwide, 98 subjects entered in the Lead-in period. Out of 89 subjects who completed the Lead-in period, 88 subjects entered in the treatment period (baseline period).
    [4] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 89 subjects who completed the Lead-in period, 88 subjects entered the Treatment period. One subject did not enter the Treatment period.
    Period 4
    Period 4 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-813160 150 mg QD
    Arm description
    		 Subjects were followed up for 4 weeks after receiving BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 BMS-813160 300 mg BID
    Arm description
    		 Subjects were followed up for 4 weeks after receiving 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo
    Arm description
    		 Subjects were followed up for 4 weeks after receiving BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Started
    25
    27
    24
    Completed
    28
    27
    26
    Joined
    3
    0
    2
         Re-joined for follow-up
    3
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    BMS-813160 150 mg QD
    Reporting group description
    		 Subjects received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks.

    Reporting group title
    BMS-813160 300 mg BID
    Reporting group description
    		 Subjects received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.

    Reporting group values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo Total
    Number of subjects
    		 29 30 29 88
    Age categorical
    Units: Subjects
        <65 years
    		 14 17 17 48
        >=65 years
    		 15 13 12 40
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.9 ( 9.58 ) 60.2 ( 8.31 ) 60.6 ( 11.52 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 7 8 17
        Male
    		 27 23 21 71
    Urinary Albumin-to-Creatinine Ratio (UACR)
    Here number of subjects evaluated for each arms are 29, 28, 28 respectively.
    Units: Milligrams/grams
        arithmetic mean (standard deviation)
    		 997.94 ( 657.367 ) 944.98 ( 670.313 ) 1052.99 ( 719.969 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    All Subjects
    Reporting group description
    		 Subjects with type 2 diabetes mellitus were enrolled and screened for 27 days.
    Reporting group title
    Placebo matching with BMS-813160
    Reporting group description
    		 Subjects received BMS-813160 matching placebo capsules, orally, twice daily for 2 weeks.
    Reporting group title
    BMS-813160 150 mg QD
    Reporting group description
    		 Subjects received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks.

    Reporting group title
    BMS-813160 300 mg BID
    Reporting group description
    		 Subjects received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.
    Reporting group title
    BMS-813160 150 mg QD
    Reporting group description
    		 Subjects were followed up for 4 weeks after receiving BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks.

    Reporting group title
    BMS-813160 300 mg BID
    Reporting group description
    		 Subjects were followed up for 4 weeks after receiving 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were followed up for 4 weeks after receiving BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.

    Primary: Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment with BMS-813160

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment with BMS-813160 [1]
    End point description
    The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The analysis was performed in all the subjects who received any study drug. Here, 'n' signifies evaluable subjects for specified categories in respective treatment arms.
    End point type
    Primary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics were planned for this outcome measure.
    End point values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Number of subjects analysed
    29
    30
    29
    Units: Percent Change
    arithmetic mean (standard deviation)
        Week 2 (n=28, 27, 28)
    5.78 ( 48.994 )
    3.79 ( 62.795 )
    2.05 ( 30.771 )
        Week 4 (n=28, 26, 28)
    18.43 ( 62.661 )
    5.81 ( 83.274 )
    1.46 ( 40.051 )
        Week 8 (n=26, 26, 26)
    19.49 ( 65.381 )
    9.87 ( 56.557 )
    5.68 ( 43.659 )
        Week 12 (n=22, 26, 24)
    6.91 ( 56.666 )
    29.16 ( 78.69 )
    8.91 ( 54.025 )
        Week 16 (n=26, 24, 23)
    0.97 ( 61.72 )
    20.63 ( 85.578 )
    23.77 ( 70.411 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Out-of-Range Electrocardiogram (ECG) Interval

    		 Close Top of page
    End point title
    		 Number of Subjects With Out-of-Range Electrocardiogram (ECG) Interval
    End point description
    12-lead ECGs were performed before and 1 hour after dosing at Weeks 0, 2 and 4. ECGs were recorded after the subject has been supine for at least 5 minutes. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. Subjects were evaluated for abnormal ECG intervals. Criteria's for abnormality were PR >200, QRS >120, QT >500, QTcF >450, Change From Baseline >30 milliseconds (msec). The analysis was performed in all the subjects who received any study drug.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16
    End point values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Number of subjects analysed
    29
    30
    29
    Units: Subjects
        PR >200 msec
    8
    8
    4
        QRS >120 msec
    3
    3
    3
        QT >500 msec
    0
    1
    0
        QTcF >450 msec
    7
    5
    6
        Change from baseline in QT >30 msec
    8
    6
    4
        Change from baseline in QTcF >30 msec
    4
    3
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With On-treatment Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), and Who Died (Treatment Period)

    		 Close Top of page
    End point title
    		 Number of Subjects With On-treatment Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), and Who Died (Treatment Period)
    End point description
    An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event. The analysis was performed in all the subjects who received any study drug.
    End point type
    Secondary
    End point timeframe
    Treatment Period: From initiation of dosing up to 12 weeks of study treatment
    End point values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Number of subjects analysed
    29
    30
    29
    Units: Subjects
        AEs
    17
    15
    11
        AEs Leading to Discontinuation
    2
    1
    2
        SAEs
    3
    3
    1
        Death
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Trough Observed Plasma Concentration (Ctrough) of BMS-813160

    		 Close Top of page
    End point title
    		 Trough Observed Plasma Concentration (Ctrough) of BMS-813160
    End point description
    Ctrough is the minimum estimated plasma concentration at steady state. The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all subjects who receive a dose of study drug and have adequate PK concentration-time data.
    End point type
    Secondary
    End point timeframe
    Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
    End point values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    ( )
    Notes
    [2] - Data were not analysed due to the termination of development of BMS-813160.
    [3] - Data were not analysed due to the termination of development of BMS-813160.
    [4] - Data were not analysed due to the termination of development of BMS-813160.
    No statistical analyses for this end point

    Secondary: Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)]

    		 Close Top of page
    End point title
    		 Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)]
    End point description
    AUC(0-6 h) is the area under the plasma concentration-time curve from pre-dose (0 h) to 6 h post-dose. The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all subjects who receive a dose of study drug and have adequate PK concentration-time data.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
    End point values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: μg/mL
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    ( )
    Notes
    [5] - Data were not analysed due to the termination of development of BMS-813160.
    [6] - Data were not analysed due to the termination of development of BMS-813160.
    [7] - Data were not analysed due to the termination of development of BMS-813160.
    No statistical analyses for this end point

    Secondary: Renal Clearance (CLr) of BMS-813160

    		 Close Top of page
    End point title
    		 Renal Clearance (CLr) of BMS-813160
    End point description
    CLr was calculated by dividing the total amount excreted in the urine from 0 to 6 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The renal function was classified based on estimated glomerular filtration rate as normal (>=90 mL/min/1.73 m^2), mildly impaired (60-89 mL/min/1.73 m^2), moderately impaired stage 3A (45-59 mL/min/1.73 m^2), and moderately impaired stage 3B (30-44 mL/min/1.73 m^2). The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all subjects who receive a dose of study drug and have adequate PK concentration-time data.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12
    End point values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: mL/min
        geometric mean (geometric coefficient of variation)
    ( )
    ( )
    ( )
    Notes
    [8] - Data were not analysed due to the termination of development of BMS-813160.
    [9] - Data were not analysed due to the termination of development of BMS-813160.
    [10] - Data were not analysed due to the termination of development of BMS-813160.
    No statistical analyses for this end point

    Secondary: Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment

    		 Close Top of page
    End point title
    		 Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment
    End point description
    The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The effect of BMS-813160 on urinary albumin excretion as measured by UACR values in subjects with diabetic kidney disease after 12 weeks of treatment was assessed. The model included treatment group as a main effect, and the log of baseline UACR values, as well as baseline values of eGFR, blood pressure, blood glucose and lipid levels, as covariates. The analysis was planned to be performed in all the subjects who received any study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8 and 12
    End point values
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: Percent change
        geometric mean (confidence interval 90%)
    ( to )
    ( to )
    ( to )
    Notes
    [11] - Data were not analysed due to the termination of development of BMS-813160.
    [12] - Data were not analysed due to the termination of development of BMS-813160.
    [13] - Data were not analysed due to the termination of development of BMS-813160.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    On-treatment non-serious adverse events: After first dose of study medication during 12-week treatment period and within 3 days of last dose On-treatment serious adverse events: After first dose of study medication during 12-week treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    BMS-813160 150 mg QD
    Reporting group description
    		 Subjects received BMS-813160 150 mg, capsule, orally once daily in Ante Meridiem (AM) and Placebo matching with BMS-813160, capsule, orally once daily in Post Meridiem (PM) for 12 weeks.

    Reporting group title
    BMS-813160 300 mg BID
    Reporting group description
    		 Subjects received BMS-813160 300 mg capsules, orally, twice daily for 12 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received BMS-813160 matching placebo capsules, orally, twice daily for 12 weeks.

    Serious adverse events
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 30 (10.00%)
    1 / 29 (3.45%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-cell lymphoma
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial occlusive disease
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Lobar pneumonia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS-813160 150 mg QD BMS-813160 300 mg BID Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 30 (6.67%)
    4 / 29 (13.79%)
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    3 / 29 (10.34%)
         occurrences all number
    1
    2
    3
    Fatigue
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 30 (3.33%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jan 2013
    The main purpose of this amendment was to clarify the urine albumine-to-creatine ratio (UACR) screening stratification requirements and the pharmacokinetic/pharmacodynamic collection schedule for subjects who discontinue early.
    29 Jul 2013
    The main purpose of this amendment was to update the inclusion and exclusion criteria, clinical procedures and lab test assessments.
    11 Nov 2013
    The main purpose of this amendment was to implement clinical and operational changes to aid sites in the execution of study.
    09 Jul 2014
    The main purpose of this amendment was to implement clinical and operational changes to aid sites in the execution of study.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 12:19:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA