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    Clinical Trial Results:
    A Single Center, Double-Blind, Placebo-Controlled, Randomized, Crossover, Phase II Study to Assess the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Uncomplicated Type 2 Diabetes Mellitus (T2D) and no History of Coronary Artery Disease (CAD) who are Drug-Naïve or Treated With Stable Metformin Monotherapy

    Summary
    EudraCT number
    		 2012-001639-29
    Trial protocol
    		 GB  
    Global end of trial date
    03 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Mar 2016
    First version publication date
    16 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BC25445
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01680978
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche Ltd
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, 41 616878333, global.trial_information@roche.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
    17 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate if aleglitazar improves cardiac energetics, by means of magnetic resonance spectroscopy (MRS), in uncomplicated type 2 diabetes mellitus (T2D) participants with no history of coronary artery disease (CAD), after 6 weeks of treatment
    Protection of trial subjects
    The study was conducted in accordance with the principles of the Declaration of Helsinki or with the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual. Written informed consent was obtained from each participant before they participated in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Oct 2012
    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
    United Kingdom: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    13
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 18 participants were recruited from 1 center in UK.

    Pre-assignment
    Screening details
    		 A total of 18 participants were enrolled, of which 13 participants (uncomplicated T2DM and no CAD who were drug-naïve or treated with stable metformin monotherapy) were randomized to receive either aleglitazar or placebo and 5 participants were non-diabetic control.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Eligible T2D participants were randomized in a 1:1 ratio to the order of receiving 150 μg aleglitazar and matching placebo, in a blinded fashion. No stratification was applied. The Randomization List was not be available at the study center, to the monitors, project statisticians, or to the project team at Roche.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 T2DM Participants
    Arm description
    		 Eligible T2DM participants were randomized in a 1:1 ratio to one of the two possible sequences: 150 microgram (μg) aleglitazar followed by matching placebo or placebo followed by 150 μg aleglitazar. Each treatment (aleglitazar and placebo) was received for 6 consecutive weeks, in a randomized order, separated by a 6-week treatment-free wash-out period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablets orally once-a-day for 6 weeks.

    Investigational medicinal product name
    Aleglitazar
    Investigational medicinal product code
    RO0728804
    Other name
    dual PPAR alpha/gamma agonist
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received 150 μg aleglitazar once daily for 6 weeks followed by a 6-week washout period.

    Arm title
    		 Non-diabetic Control
    Arm description
    		 Non-diabetic controls (referred to as the calibration group) underwent only the assessments at screening and baseline and did not receive any study drug.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		T2DM Participants Non-diabetic Control
    Started
    13
    5
    Completed
    8
    5
    Not completed
    5
    0
         Non compliance
    1
    -
         STUDY TERMINATED BY SPONSOR
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    T2DM Participants
    Reporting group description
    		 Eligible T2DM participants were randomized in a 1:1 ratio to one of the two possible sequences: 150 microgram (μg) aleglitazar followed by matching placebo or placebo followed by 150 μg aleglitazar. Each treatment (aleglitazar and placebo) was received for 6 consecutive weeks, in a randomized order, separated by a 6-week treatment-free wash-out period.

    Reporting group title
    Non-diabetic Control
    Reporting group description
    		 Non-diabetic controls (referred to as the calibration group) underwent only the assessments at screening and baseline and did not receive any study drug.

    Reporting group values
    		 T2DM Participants Non-diabetic Control Total
    Number of subjects
    		 13 5 18
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.1 ± 9.6 54.6 ± 7.8 -
    Gender categorical
    Units: Subjects
        Female
    		 6 2 8
        Male
    		 7 3 10
    Cardiac PCr/ATP ratio
    Cardiac phosphocreatine/adenosine triphosphate (PCr/ATP)
    Units: ratio
        arithmetic mean (standard deviation)
    		 1.45 ± 0.35 1.89 ± 0.32 -
    Cardiac Fat/Water ratio
    Units: ratio
        arithmetic mean (standard deviation)
    		 1.06 ± 0.62 0.47 ± 0.31 -
    Hepatic Fat/Water ratio
    Units: ratio
        arithmetic mean (standard deviation)
    		 14.99 ± 10.77 1.6 ± 1.48 -

    End points

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    End points reporting groups
    Reporting group title
    T2DM Participants
    Reporting group description
    		 Eligible T2DM participants were randomized in a 1:1 ratio to one of the two possible sequences: 150 microgram (μg) aleglitazar followed by matching placebo or placebo followed by 150 μg aleglitazar. Each treatment (aleglitazar and placebo) was received for 6 consecutive weeks, in a randomized order, separated by a 6-week treatment-free wash-out period.

    Reporting group title
    Non-diabetic Control
    Reporting group description
    		 Non-diabetic controls (referred to as the calibration group) underwent only the assessments at screening and baseline and did not receive any study drug.

    Primary: Change From Baseline to 6 Weeks After Treatment in Phosphocreatine/Adenosine Triphosphate (PCr/ATP) Ratio

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    End point title
    		 Change From Baseline to 6 Weeks After Treatment in Phosphocreatine/Adenosine Triphosphate (PCr/ATP) Ratio [1]
    End point description
    Participants underwent a cardiovascular magnetic resonance (CMR) scan performed on a 3 Tesla magnetic resonance (MR) system to assess cardiac mass, volumes (global function and dilatation), strain and torsion, cardiac and liver lipid content and cardiac energy metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Due to the early termination of the study by the sponsor, insufficient data were available to perform all planned analyses. Only available baseline values are reported in the baseline characteristics.
    End point type
    Primary
    End point timeframe
    Baseline, 6 Weeks after treatment
    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: Due to the early termination of the study by the sponsor, insufficient data were available to perform all planned statistical analyses.
    End point values
    		 T2DM Participants Non-diabetic Control
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: ratio
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [2] - Due to early termination of study, insufficient data were available to perform all planned analyses.
    [3] - Due to early termination of study, insufficient data were available to perform all planned analyses.
    No statistical analyses for this end point

    Secondary: Change From Baseline to 6 Weeks in Left Ventricular Diastolic Function

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    End point title
    		 Change From Baseline to 6 Weeks in Left Ventricular Diastolic Function
    End point description
    Transthoracic echocardiography (Phillips iE33) was used to assess diastolic function. For determination of E/A, E deceleration times, and E/E', participants were scanned in a left lateral position with pulse wave velocities obtained at the mitral valve tips and tissue Doppler as an average of the basal septum and lateral walls. Due to the early termination of the study by the sponsor, insufficient data were available to perform all planned analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Weeks after treatment
    End point values
    		 T2DM Participants Non-diabetic Control
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: ratio
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [4] - Due to early termination of study, insufficient data were available to perform all planned analyses.
    [5] - Due to early termination of study, insufficient data were available to perform all planned analyses.
    No statistical analyses for this end point

    Secondary: Change From Baseline to 6 Weeks in Cardiac and Hepatic Triglyceride Content

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    End point title
    		 Change From Baseline to 6 Weeks in Cardiac and Hepatic Triglyceride Content
    End point description
    Measurement of myocardial triglycerides were performed using spin echo imaging for localization of the voxels in the septum followed by 31P and 1H MR to obtain spectra. To obtain hepatic proton MR spectra, a voxel will was positioned in the liver, avoiding gross vascular structures and adipose tissue deposits. Spectra with and without water suppression was obtained to calculate hepatic triglyceride content as a percentage of water. Due to the early termination of the study by the sponsor, insufficient data were available to perform all planned analyses. Only available baseline values are reported in the baseline characteristics.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Weeks after treatment
    End point values
    		 T2DM Participants Non-diabetic Control
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: ratio
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [6] - Due to early termination of study, insufficient data were available to perform all planned analyses.
    [7] - Due to early termination of study, insufficient data were available to perform all planned analyses.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to follow-up (6 weeks after the last dose of study medication)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    T2DM Participants
    Reporting group description
    		 Eligible T2DM participants were randomized in a 1:1 ratio to one of two possible sequences: 150 microgram (μg) aleglitazar followed by matching placebo or placebo followed by 150 μg aleglitazar. Each treatment (aleglitazar and placebo) was received for 6 consecutive weeks, in a randomized order, separated by a 6-week treatment-free wash-out period. All adverse events which were observed across both the treatment group (placebo/aleglitazar) and during wash-out/follow-up after treatment completion reported.

    Serious adverse events
    		 T2DM Participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 T2DM Participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 13 (38.46%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Joint Injury
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Dry Skin
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Psoriasis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Viral Infection
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jun 2012
    Modified liver disease characteristic and specified the use of metformin as background therapy. The reasons for participant’s discontinuation have been clarified and 2 withdrawal rules were implemented.

    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.
    Due to the early termination of the study by the sponsor, insufficient data were available to perform all planned analyses.
    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.

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