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    Clinical Trial Results:
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of MK-3102 to Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy with Glimepiride and Metformin

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2012-002612-10
    Trial protocol
    		 PL  
    Global end of trial date
    23 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Dec 2016
    First version publication date
    23 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3102-022
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01704261
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol number: MK-3102-022
    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
    23 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    After 24 weeks, to assess the effect of the addition of treatment with omarigliptin (MK-3102) compared with the addition of placebo on hemoglobin A1C.
    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
    		 Participants should remain on a stable dose of metformin (≥1500 mg/day) throughout the trial. Participants should remain on a stable dose of glimepiride (≥4 mg/day) throughout the trial. In the event of hypoglycemia, the glimepiride dose can be down-titrated to a minimum dose of 1 mg/day.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2012
    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
    Poland: 20
    Country: Number of subjects enrolled
    Romania: 130
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    South Africa: 40
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 35
    Country: Number of subjects enrolled
    United States: 69
    Worldwide total number of subjects
    307
    EEA total number of subjects
    150
    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)
    238
    From 65 to 84 years
    69
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Fifty-one sites received IEC/IRB approval and were shipped clinical supplies.

    Pre-assignment
    Screening details
    		 In total, 583 participants were screened and 276 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were not meeting the metformin and glimepiride dose requirements inclusion criterion or meeting exclusionary laboratory values.

    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
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin 25 mg
    Investigational medicinal product code
    Other name
    MK-3102
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to Omarigliptin
    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 a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Number of subjects in period 1
    		Omarigliptin Placebo
    Started
    154
    153
    Completed
    141
    138
    Not completed
    13
    15
         Consent withdrawn by subject
    12
    15
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Reporting group values
    		 Omarigliptin Placebo Total
    Number of subjects
    		 154 153 307
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 126 112 238
        From 65-84 years
    		 28 41 69
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 57.2 ( 8.4 ) 58.4 ( 9.4 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 81 79 160
        Male
    		 73 74 147

    End points

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    End points reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Primary: Change from baseline in hemoglobin A1c (A1C) at Week 24

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    End point title
    		 Change from baseline in hemoglobin A1c (A1C) at Week 24
    End point description
    A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C. The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin Placebo
    Number of subjects analysed
    153
    153
    Units: %A1C
        least squares mean (confidence interval 95%)
    -0.67 (-0.84 to -0.5)
    -0.06 (-0.23 to 0.12)
    Statistical analysis title
    		 Difference in the least squares means
    Statistical analysis description
    Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.
    Comparison groups
    Omarigliptin v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Difference in the least squares means
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 -0.38

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

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    End point title
    		 Percentage of Participants Who Experienced at Least One Adverse Event (AE)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 27
    End point values
    		 Omarigliptin Placebo
    Number of subjects analysed
    153
    153
    Units: Percentage of participants
        number (not applicable)
    57.5
    47.7
    Statistical analysis title
    		 Difference in % Omarigliptin vs Placebo
    Comparison groups
    Omarigliptin v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in % Omarigliptin vs Placebo
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 20.8

    Primary: Percentage of Participants Who Discontinued from the Study Due to an AE

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    End point title
    		 Percentage of Participants Who Discontinued from the Study Due to an AE
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.
    End point type
    Primary
    End point timeframe
    Up to Week 24
    End point values
    		 Omarigliptin Placebo
    Number of subjects analysed
    153
    153
    Units: Percentage of participants
        number (not applicable)
    2.6
    2.6
    Statistical analysis title
    		 Difference in % Omarigliptin vs Placebo
    Comparison groups
    Omarigliptin v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in % Omarigliptin vs Placebo
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 4.3

    Secondary: Change from baseline in fasting plasma glucose (FPG) at Week 24

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    End point title
    		 Change from baseline in fasting plasma glucose (FPG) at Week 24
    End point description
    Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline). The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin Placebo
    Number of subjects analysed
    153
    153
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -19.6 (-26.7 to -12.5)
    -3 (-10.2 to 4.1)
    Statistical analysis title
    		 Difference in the least squares means
    Statistical analysis description
    Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.
    Comparison groups
    Omarigliptin v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Difference in the least squares means
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -16.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.5
         upper limit
    		 -7.8

    Secondary: Percentage of participants attaining A1C glycemic goals of <7% and <6.5% at Week 24

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    End point title
    		 Percentage of participants attaining A1C glycemic goals of <7% and <6.5% at Week 24
    End point description
    The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24. The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.
    End point type
    Secondary
    End point timeframe
    24 weeks
    End point values
    		 Omarigliptin Placebo
    Number of subjects analysed
    153
    153
    Units: Percentage of participants
    number (confidence interval 95%)
        <7.0%
    23.8 (17.5 to 31.5)
    4.4 (2.1 to 9.3)
        <6.5%
    10.1 (6.1 to 16.4)
    2.1 (0.7 to 6)
    Statistical analysis title
    		 Between-group Rate Difference
    Statistical analysis description
    Between-group confidence intervals and p-value (%) A1C <7.0%; estimated using standard multiple imputation techniques. Miettinen & Nurminen method.
    Comparison groups
    Omarigliptin v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.005
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Between-group Rate Difference (%)
    Point estimate
    8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 14.5
    Statistical analysis title
    		 Between-group Rate Difference
    Statistical analysis description
    Between-group confidence intervals and p-value (%) A1C <7.0%; estimated using standard multiple imputation techniques. Miettinen & Nurminen method.
    Comparison groups
    Omarigliptin v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Between-group Rate Difference (%)
    Point estimate
    19.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.7
         upper limit
    		 27.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 27
    Adverse event reporting additional description
    The ASaT Population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Reporting group title
    Omarigliptin
    Reporting group description
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).

    Serious adverse events
    		 Placebo Omarigliptin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 153 (3.27%)
    3 / 153 (1.96%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 153 (0.65%)
    0 / 153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 153 (0.00%)
    1 / 153 (0.65%)
         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
    		 Placebo Omarigliptin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 153 (15.03%)
    29 / 153 (18.95%)
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 153 (5.88%)
    4 / 153 (2.61%)
         occurrences all number
    11
    4
    Urinary tract infection
         subjects affected / exposed
    3 / 153 (1.96%)
    9 / 153 (5.88%)
         occurrences all number
    4
    9
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    13 / 153 (8.50%)
    18 / 153 (11.76%)
         occurrences all number
    44
    65

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jan 2013
    AM1 - Modification of inclusion criteria regarding contraception
    26 Apr 2013
    AM4 - Addition of amylase and lipase to the chemistry panel

    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.

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