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    Clinical Trial Results:
    A single-center, randomized, double-blind, placebo-controlled, Phase II study to assess the efficacy of aleglitazar on insulin sensitivity in patients with type 2 diabetes mellitus (T2D) who are inadequately controlled with metformin monotherapy

    Summary
    EudraCT number
    		 2012-002649-39
    Trial protocol
    		 DE  
    Global end of trial date
    03 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 May 2016
    First version publication date
    12 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WC28038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01729403
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    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
    03 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2013
    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 the effect of aleglitazar on whole body insulin sensitivity compared with placebo after 16 weeks of treatment in patients with type-2 diabetes inadequately controlled with metformin monotherapy, as assessed by hyperinsulinemic-euglycemic clamp. Patients will be randomized to receive either aleglitazar 150 µg or placebo orally daily for 16 weeks, in addition to their existing dose and regimen of metformin.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 Metformin
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 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
    Germany: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    39
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The target population consisted of male and female patients (30-70 years old) with type 2 diabetes inadequately controlled with stable metformin monotherapy for at least 12 weeks prior to screening.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aleglitazar 150 μg
    Arm description
    		 Participants received aleglitazar 150 μg orally once daily for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aleglitazar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Aleglitazar was supplied in tablets.

    Arm title
    		 Placebo
    Arm description
    		 Participants received placebo to aleglitazar orally once daily for 16 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was supplied in tablets.

    Number of subjects in period 1
    		Aleglitazar 150 μg Placebo
    Started
    29
    28
    Completed
    16
    22
    Not completed
    13
    6
         Study terminated by sponsor
    12
    6
         Subject dropped out due to personal reasons
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aleglitazar 150 μg
    Reporting group description
    		 Participants received aleglitazar 150 μg orally once daily for 16 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo to aleglitazar orally once daily for 16 weeks.

    Reporting group values
    		 Aleglitazar 150 μg Placebo Total
    Number of subjects
    		 29 28 57
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.4 ( 8.43 ) 60.1 ( 7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6 12
        Male
    		 23 22 45

    End points

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    End points reporting groups
    Reporting group title
    Aleglitazar 150 μg
    Reporting group description
    		 Participants received aleglitazar 150 μg orally once daily for 16 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo to aleglitazar orally once daily for 16 weeks.

    Primary: Change from Baseline in unadjusted M-value at Week 16

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    End point title
    		 Change from Baseline in unadjusted M-value at Week 16
    End point description
    Change from Baseline in whole-body insulin sensitivity was measured using the unadjusted M-value calculated at the end of step 2 of the hyperinsulinemic-euglycemic clamp procedure. During step 1, a primed insulin infusion (20 mU/min/m^2) is used for the assessment of peripheral insulin sensitivity while endogenous glucose production is only partly suppressed. During step 2, the insulin infusion is increased to 80 mU/min/m^2 to assess peripheral insulin sensitivity while endogenous glucose production is entirely suppressed. A higher M value indicates greater whole-body insulin sensitivity. A positive change score indicates an improvement in whole-body insulin sensitivity.
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Aleglitazar 150 μg Placebo
    Number of subjects analysed
    16
    24
    Units: mg/min
        arithmetic mean (standard deviation)
    668.14 ( 225.96 )
    739.98 ( 261.92 )
    Statistical analysis title
    		 Unadjusted M-value
    Comparison groups
    Aleglitazar 150 μg v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0157
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    118.204
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.61
         upper limit
    		 212.8

    Primary: Change from Baseline in body-weight corrected M-value at Week 16

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    End point title
    		 Change from Baseline in body-weight corrected M-value at Week 16
    End point description
    Change from Baseline in whole-body insulin sensitivity was measured using the body-weight corrected M-value calculated at the end of step 2 of the hyperinsulinemic-euglycemic clamp procedure. During step 1, a primed insulin infusion (20 mU/min/m^2) is used for the assessment of peripheral insulin sensitivity while endogenous glucose production is only partly suppressed. During step 2, the insulin infusion is increased to 80 mU/min/m^2 to assess peripheral insulin sensitivity while endogenous glucose production is entirely suppressed. A higher M value indicates greater whole-body insulin sensitivity. A positive change score indicates an improvement in whole-body insulin sensitivity.
    End point type
    Primary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Aleglitazar 150 μg Placebo
    Number of subjects analysed
    16
    24
    Units: mg/kg/min
        arithmetic mean (standard deviation)
    6.892 ( 2.1161 )
    8.099 ( 3.0354 )
    Statistical analysis title
    		 Body-weight corrected M-value
    Comparison groups
    Aleglitazar 150 μg v Placebo
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0468
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    1.012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.015
         upper limit
    		 2.0082

    Secondary: Change from Baseline in glycosylated hemoglobin A1c (HbA1c) at Week 16

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    End point title
    		 Change from Baseline in glycosylated hemoglobin A1c (HbA1c) at Week 16
    End point description
    HbA1C was measured in blood samples at a central laboratory. A higher HbA1c level indicates poorer control of blood glucose levels. A negative change score indicates an improvement in control of blood glucose levels.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Aleglitazar 150 μg Placebo
    Number of subjects analysed
    16
    24
    Units: Percent
        arithmetic mean (standard deviation)
    -0.38 ( 0.468 )
    -0.08 ( 0.721 )
    Statistical analysis title
    		 Change from Baseline in HbA1c at Week 16
    Comparison groups
    Placebo v Aleglitazar 150 μg
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.0159
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean difference
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.855
         upper limit
    		 -0.094

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected and reported from the time of randomization until the last study visit of each participant .
    Adverse event reporting additional description
    Safety population: All participants who have received at least 1 dose of the study medication (active or placebo).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Aleglitazar 150 μg
    Reporting group description
    		 Participants received aleglitazar 150 μg orally once daily for 16 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received placebo to aleglitazar orally once daily for 16 weeks.

    Serious adverse events
    		 Aleglitazar 150 μg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 28 (7.14%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 28 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Aleglitazar 150 μg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 29 (20.69%)
    6 / 28 (21.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 28 (10.71%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 29 (10.34%)
    4 / 28 (14.29%)
         occurrences all number
    3
    5
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 28 (3.57%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2013
    The protocol was amended to recommend the systematic and prospective collection of risk factors for gastrointestinal bleeding in each participant's medical history to enable characterization of this potential risk.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Sep 2013
    The study was terminated prematurely following the Sponsor’s decision to discontinue the clinical development program.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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