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    Clinical Trial Results:
    A Phase III, Multicenter, Double-Blind, Randomized Trial to Evaluate the Safety and Efficacy of MK-3102 Compared With Glimepiride in Subjects With Type 2 Diabetes Mellitus For Whom Metformin is Inappropriate due to Intolerance or Contraindication

    Summary
    EudraCT number
    		 2013-000301-23
    Trial protocol
    		 HU   IT   AT   BE   SK   ES   DE   EE   BG   PL  
    Global end of trial date
    03 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    05 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3102-027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01863667
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: MK-3102-027
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This trial will assess the safety and efficacy of omarigliptin (MK-3102) compared with the sulfonylurea, glimepiride, in type 2 diabetes mellitus participants who are metformin intolerant or who have a contraindication to the use of metformin. The primary hypothesis is that after 54 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is noninferior compared with that in participants treated with glimepiride.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jul 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 13
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    United States: 37
    Worldwide total number of subjects
    65
    EEA total number of subjects
    27
    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)
    45
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study included participants who were diagnosed with type 2 diabetes mellitus and had intolerability to metformin ≥1000 mg/day or had a contraindication to the use of metformin.

    Pre-assignment
    Screening details
    		 The study had a 1-week Screening Period; an oral antihyperglycemic agent (AHA) “wash-off” period of 8 weeks for participants on oral AHAs; a 2-week single-blind placebo run-in period; and a 54-week double-blind treatment period.

    Period 1
    Period 1 title
    Overall Study (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
    		 Omarigliptin
    Arm description
    		 Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin
    Investigational medicinal product code
    Other name
    MK-3102
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly.

    Investigational medicinal product name
    Glimepiride placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal.

    Arm title
    		 Glimepiride
    Arm description
    		 Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal.

    Investigational medicinal product name
    Omarigliptin placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo to omarigliptin capsule administered orally once weekly.

    Number of subjects in period 1
    		Omarigliptin Glimepiride
    Started
    33
    32
    Completed
    0
    0
    Not completed
    33
    32
         Consent withdrawn by subject
    2
    2
         Study terminated by Sponsor
    30
    30
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.

    Reporting group title
    Glimepiride
    Reporting group description
    		 Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.

    Reporting group values
    		 Omarigliptin Glimepiride Total
    Number of subjects
    		 33 32 65
    Age categorical
    Units: Subjects
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58 ( 14.1 ) 56.8 ( 9.9 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 19 16 35
        Male
    		 14 16 30

    End points

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    End points reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.

    Reporting group title
    Glimepiride
    Reporting group description
    		 Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.

    Primary: Percentage of Participants Who Experienced at Least One Adverse Event

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    End point title
    		 Percentage of Participants Who Experienced at Least One Adverse Event [1]
    End point description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions. All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to 57 weeks (including 3 weeks following the last dose of study drug)
    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: No statistical analysis was planned or performed for this end point.
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    33
    32
    Units: Percentage of participants
        number (not applicable)
    9.1
    15.6
    No statistical analyses for this end point

    Primary: Change from Baseline in Hemoglobin A1C (A1C) at Week 54

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    End point title
    		 Change from Baseline in Hemoglobin A1C (A1C) at Week 54 [2]
    End point description
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent. Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.
    End point type
    Primary
    End point timeframe
    Baseline and Week 54
    Notes
    [2] - 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, no statistical analysis was performed for this end point.
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Percent
        least squares mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [3] - Due to the early termination of the study, no participants completed Week 54.
    [4] - Due to the early termination of the study, no participants completed Week 54.
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event [5]
    End point description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions. All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.
    End point type
    Primary
    End point timeframe
    Up to 54 weeks
    Notes
    [5] - 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: No statistical analysis was planned or performed for this end point.
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    33
    32
    Units: Percentage of participants
        number (not applicable)
    3
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 54

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 54
    End point description
    This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0. Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: mg/dL
        least squares mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [6] - Due to the early termination of the study, no participants completed Week 54.
    [7] - Due to the early termination of the study, no participants completed Week 54.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment

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    End point title
    		 Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment
    End point description
    Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment. Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.
    End point type
    Secondary
    End point timeframe
    54 weeks
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [8] - Due to the early termination of the study, no participants completed Week 54.
    [9] - Due to the early termination of the study, no participants completed Week 54.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment

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    End point title
    		 Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment
    End point description
    Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment. Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.
    End point type
    Secondary
    End point timeframe
    54 weeks
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [10] - Due to the early termination of the study, no participants completed Week 54.
    [11] - Due to the early termination of the study, no participants completed Week 54.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an Adverse Event of Symptomatic Hypoglycemia

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    End point title
    		 Percentage of Participants with an Adverse Event of Symptomatic Hypoglycemia
    End point description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions. All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.
    End point type
    Secondary
    End point timeframe
    Up to 54 weeks
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [12] - Due to the early termination of the study, this endpoint was not analyzed.
    [13] - Due to the early termination of the study, this endpoint was not analyzed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Weight at Week 54

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    End point title
    		 Change from Baseline in Body Weight at Week 54
    End point description
    Body weight was to be measured (in duplicate) using a calibrated digital scale. All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: Kilograms
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [14] - Due to the early termination of the study, no participants completed Week 54.
    [15] - Due to the early termination of the study, no participants completed Week 54.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 57 weeks (including 3 weeks following last dose of study drug)
    Adverse event reporting additional description
    All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Participants receive an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.

    Reporting group title
    Glimepiride
    Reporting group description
    		 Participants receive glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events exceeded the 5% threshold for any treatment group.
    Serious adverse events
    		 Omarigliptin Glimepiride
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Omarigliptin Glimepiride
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 32 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Apr 2014
    The study was terminated based on business decisions only, and not due to any unexpected safety or efficacy concerns.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated based on business decisions only, and not due to any unexpected safety or efficacy concerns.
    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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