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    Clinical Trial Results:
    A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of MK-3102 Compared with the Addition of Sitagliptin in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on 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
    2013-000059-42
    Trial protocol
    HU   EE   PL   HR  
    Global end of trial date
    17 Nov 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Feb 2016
    First version publication date
    19 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-3102-026
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01841697
    WHO universal trial number (UTN)
    -
    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
    17 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a non-inferiority study comparing omarigliptin with sitagliptin in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control on metformin therapy. The primary hypothesis is that after 24 weeks, the mean change from baseline in hemoglobin A1c (A1C) in participants treated with omarigliptin is non-inferior to that in participants treated with sitagliptin. There will be a 2-week run-in period with placebo + metformin prior to the double-blind treatment period.
    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. The following additional measure defined for this individual study was in place for the protection of trial subjects: participants exceeding pre-specified glycemic thresholds after Day 1 of the double-blind treatment period will have rescue therapy initiated with open-label glimepiride.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    13 Jun 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
    Argentina: 27
    Country: Number of subjects enrolled
    Canada: 41
    Country: Number of subjects enrolled
    Croatia: 2
    Country: Number of subjects enrolled
    Estonia: 52
    Country: Number of subjects enrolled
    Georgia: 73
    Country: Number of subjects enrolled
    Hungary: 78
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Malaysia: 17
    Country: Number of subjects enrolled
    Philippines: 26
    Country: Number of subjects enrolled
    Poland: 60
    Country: Number of subjects enrolled
    Romania: 65
    Country: Number of subjects enrolled
    South Africa: 32
    Country: Number of subjects enrolled
    United States: 167
    Worldwide total number of subjects
    642
    EEA total number of subjects
    257
    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)
    494
    From 65 to 84 years
    148
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Eligibility requirements include male and female participants with type 2 diabetes mellitus who were currently on a stable dose of metformin monotherapy (≥1500 mg per day) for at least 12 weeks prior to study participation.

    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 25 mg once weekly
    Arm description
    Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
    Arm type
    Experimental

    Investigational medicinal product name
    Omarigliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Omarigliptin 25 mg oral capsule once a week for 24 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin oral tablet(s) total daily dose of ≥1500 mg daily

    Investigational medicinal product name
    Placebo to sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride oral tablet(s) total daily dose of 1 to 6 mg once a day as rescue therapy

    Arm title
    Sitagliptin 100 mg once daily
    Arm description
    Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
    Arm type
    Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sitagliptin 100 mg oral tablet once a day for 24 weeks

    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
    Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin oral tablet(s) total daily dose of ≥1500 mg daily

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Glimepiride oral tablet(s) total daily dose of 1 to 6 mg once a day as rescue therapy

    Number of subjects in period 1
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily
    Started
    322
    320
    Completed
    302
    302
    Not completed
    20
    18
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    16
    16
         Lost to follow-up
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omarigliptin 25 mg once weekly
    Reporting group description
    Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.

    Reporting group title
    Sitagliptin 100 mg once daily
    Reporting group description
    Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.

    Reporting group values
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily Total
    Number of subjects
    322 320 642
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    57 ± 9.8 57.6 ± 9.8 -
    Gender, Male/Female
    Units: Participants
        Female
    171 145 316
        Male
    151 175 326
    Hemoglobin A1c (A1C)
    Units: Percent
        arithmetic mean (standard deviation)
    7.52 ± 0.77 7.49 ± 0.74 -
    Fasting plasma glucose (FPG)
    Units: mg/dL
        arithmetic mean (standard deviation)
    160.1 ± 35.7 153.9 ± 32.8 -

    End points

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    End points reporting groups
    Reporting group title
    Omarigliptin 25 mg once weekly
    Reporting group description
    Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.

    Reporting group title
    Sitagliptin 100 mg once daily
    Reporting group description
    Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.

    Primary: Change from baseline in A1C at Week 24

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    End point title
    Change from baseline in A1C at Week 24
    End point description
    A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline. Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily
    Number of subjects analysed
    322
    320
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.47 (-0.55 to -0.38)
    -0.43 (-0.51 to -0.35)
    Statistical analysis title
    Comparison of treatment groups
    Statistical analysis description
    Difference in least squares mean is omarigliptin minus sitagliptin.
    Comparison groups
    Omarigliptin 25 mg once weekly v Sitagliptin 100 mg once daily
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    Constrained longitudinal data analysis
    Parameter type
    Difference in least squares mean
    Point estimate
    -0.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.15
         upper limit
    0.08
    Notes
    [1] - If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.

    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
    End point description
    An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy. All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.
    End point type
    Primary
    End point timeframe
    Up to 27 weeks (including 3-week follow-up)
    End point values
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily
    Number of subjects analysed
    322
    320
    Units: Percentage of participants
        number (not applicable)
    36.3
    40.6
    Statistical analysis title
    Comparison of treatment groups
    Statistical analysis description
    Difference in percent is omarigliptin minus sitagliptin.
    Comparison groups
    Omarigliptin 25 mg once weekly v Sitagliptin 100 mg once daily
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in percent
    Point estimate
    -4.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.8
         upper limit
    3.2

    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
    End point description
    An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy. All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily
    Number of subjects analysed
    322
    320
    Units: Percentage of participants
        number (not applicable)
    0.9
    2.2
    Statistical analysis title
    Comparison of Treatment Groups
    Statistical analysis description
    Difference in percent is omarigliptin minus sitagliptin.
    Comparison groups
    Omarigliptin 25 mg once weekly v Sitagliptin 100 mg once daily
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in percent
    Point estimate
    -1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    0.8

    Secondary: Change from baseline in FPG at Week 24

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    End point title
    Change from baseline in FPG at Week 24
    End point description
    Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG. Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily
    Number of subjects analysed
    322
    320
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -13.7 (-17.3 to -10.1)
    -9.5 (-13.2 to -5.9)
    Statistical analysis title
    Comparison of Treatment Groups
    Statistical analysis description
    Difference in least squares mean is omarigliptin minus sitagliptin.
    Comparison groups
    Omarigliptin 25 mg once weekly v Sitagliptin 100 mg once daily
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.089 [2]
    Method
    Constrained longitudinal data analysis
    Parameter type
    Difference in least squares mean
    Point estimate
    -4.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9
         upper limit
    0.6
    Notes
    [2] - Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.

    Secondary: Percentage of participants achieving an A1C goal <7.0% after 24 weeks of treatment

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    End point title
    Percentage of participants achieving an A1C goal <7.0% after 24 weeks of treatment
    End point description
    Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24. Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily
    Number of subjects analysed
    322
    320
    Units: Percentage of participants
        number (not applicable)
    50.9
    49.1
    Statistical analysis title
    Comparison of Treatment Groups
    Statistical analysis description
    Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.
    Comparison groups
    Omarigliptin 25 mg once weekly v Sitagliptin 100 mg once daily
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.619
    Method
    Miettinen & Nurminen method
    Parameter type
    Between-group rate difference
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.9
         upper limit
    9.9

    Secondary: Percentage of participants achieving an A1C goal <6.5% after 24 weeks of treatment

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    End point title
    Percentage of participants achieving an A1C goal <6.5% after 24 weeks of treatment
    End point description
    Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24. Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Omarigliptin 25 mg once weekly Sitagliptin 100 mg once daily
    Number of subjects analysed
    322
    320
    Units: Percentage of participants
        number (not applicable)
    27
    22.8
    Statistical analysis title
    Comparison of Treatment Groups
    Statistical analysis description
    Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.
    Comparison groups
    Omarigliptin 25 mg once weekly v Sitagliptin 100 mg once daily
    Number of subjects included in analysis
    642
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.212
    Method
    Miettinen & Nurminen method
    Parameter type
    Between-group rate difference
    Point estimate
    4.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    11.4

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 27 weeks (including 3-week follow-up)
    Adverse event reporting additional description
    All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Sitagliptin 100 mg
    Reporting group description
    Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.

    Reporting group title
    Omarigliptin 25 mg
    Reporting group description
    Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.

    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
    Sitagliptin 100 mg Omarigliptin 25 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 320 (2.81%)
    11 / 322 (3.42%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 320 (0.00%)
    2 / 322 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sebaceous adenoma
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 320 (0.31%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (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 disorder
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 320 (0.31%)
    0 / 322 (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 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dematitis contact
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pyelohephritis acute
         subjects affected / exposed
    0 / 320 (0.00%)
    1 / 322 (0.31%)
         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
    Sitagliptin 100 mg Omarigliptin 25 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 320 (0.00%)
    0 / 322 (0.00%)

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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? No

    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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