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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 Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin

    Summary
    EudraCT number
    		 2012-002309-23
    Trial protocol
    		 HU   LT   DE   PL  
    Global end of trial date
    26 Jan 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-3102-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01682759
    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
    26 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2015
    Was the trial ended prematurely?
    No
    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 with inadequate glycemic control on metformin monotherapy. The primay hypothesis of the study is that after 54 weeks, the mean change from baseline in hemoglobin A1C (A1C) in participants treated with omarigliptin is non-inferior 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
    		 Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Sep 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
    Argentina: 34
    Country: Number of subjects enrolled
    Croatia: 51
    Country: Number of subjects enrolled
    Germany: 48
    Country: Number of subjects enrolled
    Hungary: 90
    Country: Number of subjects enrolled
    Lithuania: 30
    Country: Number of subjects enrolled
    Poland: 43
    Country: Number of subjects enrolled
    United States: 242
    Country: Number of subjects enrolled
    Malaysia: 24
    Country: Number of subjects enrolled
    Romania: 78
    Country: Number of subjects enrolled
    Korea, Republic of: 65
    Country: Number of subjects enrolled
    Lebanon: 46
    Worldwide total number of subjects
    751
    EEA total number of subjects
    340
    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)
    571
    From 65 to 84 years
    180
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 One hundred twenty-seven sites received IEC/IRB approval and were shipped clinical supplies and 115 sites in 11 countries screened at least 1 participant. Seven-hundred and fifty-one participants were randomized Enrollment at each study center ranged from 1 to 29 participants.

    Pre-assignment
    Screening details
    		 In total, 1197 participants at 115 clinical sites were screened and 446 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 participants not meeting the metformin inclusion criteria 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
    		 Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 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
    Participants will receive omarigliptin, 25 mg once weekly for up to 54 weeks

    Investigational medicinal product name
    Placebo matching glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily for up to 54 weeks

    Arm title
    		 Glimepiride
    Arm description
    		 Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo matching omarigliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Once weekly for up to 54 weeks

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, for up to 54 weeks

    Number of subjects in period 1
    		Omarigliptin Glimepiride
    Started
    376
    375
    Treated
    375
    375
    Completed
    307
    305
    Not completed
    69
    70
         Adverse event, serious fatal
    2
    1
         Physician decision
    1
    1
         Consent withdrawn by subject
    56
    55
         Lost to follow-up
    10
    13

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.

    Reporting group title
    Glimepiride
    Reporting group description
    		 Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

    Reporting group values
    		 Omarigliptin Glimepiride Total
    Number of subjects
    		 376 375 751
    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)
    		 289 282 571
        From 65-84 years
    		 87 93 180
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 57.9 ± 9.6 57.6 ± 9.3 -
    Gender, Male/Female
    Units: Participants
        Female
    		 173 164 337
        Male
    		 203 211 414
    Hemoglobin A1C
    Units: A1C (%)
        arithmetic mean (standard deviation)
    		 7.49 ± 0.75 7.43 ± 0.72 -
    Body Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 87.5 ± 18.1 88.7 ± 18.7 -
    Fasting Plasma Glucose (FPG) |
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 155.3 ± 31.4 152.7 ± 30 -

    End points

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    End points reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.

    Reporting group title
    Glimepiride
    Reporting group description
    		 Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

    Primary: Change from Baseline in Hemoglobin A1C at Week 54

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    End point title
    		 Change from Baseline in Hemoglobin A1C at Week 54
    End point description
    Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 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.
    End point type
    Primary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: Percent change
        number (confidence interval 95%)
    -0.3 (-0.39 to -0.21)
    -0.48 (-0.57 to -0.39)
    Statistical analysis title
    		 Non-inferior Analysis
    Statistical analysis description
    Constrained longitudinal data analysis (cLDA) model including 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.
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in the least squares means
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 0.3
    Notes
    [1] - Omarigliptin was considered non-inferior to glimepiride if the upper bound of the two-sided 95% confidence interval (CI) of the between-treatment difference in least-squares (LS) means for change from baseline in A1C at Week 54 (omarigliptin vs. glimepiride) was lower than 0.35%.

    Primary: Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue

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    End point title
    		 Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue
    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.
    End point type
    Primary
    End point timeframe
    Up to Week 57
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: Percentage of participants
        number (not applicable)
    54.7
    61.6
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Miettinen & Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.9
         upper limit
    		 0.1

    Primary: Percentage of Participants Who Discontinued from the Study Due to an Adverse Event Excluding Data After Glycemic Rescue

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    End point title
    		 Percentage of Participants Who Discontinued from the Study Due to an Adverse Event Excluding Data After Glycemic Rescue
    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.
    End point type
    Primary
    End point timeframe
    Up to Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: Percentage of participants
        number (not applicable)
    3.7
    2.7
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Miettinen & Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 3.8

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

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose at Week 54
    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 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 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.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -2.7 (-6.7 to 1.3)
    -8.3 (-12.4 to -4.3)
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Other [Difference in the least squares means]
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the least squares means
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 11.2

    Secondary: Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54

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    End point title
    		 Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54
    End point description
    The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54. 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.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: Percentage of participants
        number (confidence interval 95%)
    25.1 (20.6 to 30.2)
    28.8 (24.1 to 34)
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    A1C <6.5%, between-group CIs are calculated via Miettinen & Nurminen method.
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Between-group Rate Difference (%)
    Point estimate
    -3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.6
         upper limit
    		 3.3

    Secondary: Percentage of Participants with an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue

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    End point title
    		 Percentage of Participants with an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue
    End point description
    Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required). The ASaT Population is 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.
    End point type
    Secondary
    End point timeframe
    Up to Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: Percentage of participants
        number (not applicable)
    5.3
    26.7
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    Miettinen & Nurminen method; the 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Difference in percentage
    Parameter type
    		 Difference in %
    Point estimate
    -21.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.5
         upper limit
    		 -16.4

    Secondary: Change from Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue

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    End point title
    		 Change from Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue
    End point description
    The ASaT Population is 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.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: kilograms
        least squares mean (confidence interval 95%)
    -0.4 (-0.8 to 0)
    1.5 (1.1 to 1.9)
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    cLDA model including 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.
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 -1.4

    Secondary: Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54

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    End point title
    		 Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54
    End point description
    The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54. The FAS Population (with multiple imputation) 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.
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 Omarigliptin Glimepiride
    Number of subjects analysed
    375
    375
    Units: Percentage of participants
        number (confidence interval 95%)
    47.7 (42.3 to 53.1)
    58 (52.7 to 63.1)
    Statistical analysis title
    		 Treatment Difference
    Statistical analysis description
    A1C < 7.0%, between-group CIs are calculated via Miettinen & Nurminen method.
    Comparison groups
    Omarigliptin v Glimepiride
    Number of subjects included in analysis
    750
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Between-group Rate Difference
    Point estimate
    -10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.8
         upper limit
    		 -2.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 57
    Adverse event reporting additional description
    Serious adverse events are presented, regardless of time from last dose of blinded study medication, including data after glycemic rescue. Non-serious adverse events are presented, regardless of time from last dose of blinded study medication, excluding data after glycemic rescue.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Glimepiride
    Reporting group description
    		 Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.

    Reporting group title
    Omarigliptin
    Reporting group description
    		 Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.

    Serious adverse events
    		 Glimepiride Omarigliptin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 375 (4.80%)
    24 / 375 (6.40%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiomyolipoma
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 375 (0.00%)
    2 / 375 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Dumping syndrome
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (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 coronary syndrome
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (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
    Epilepsy
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         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
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Loss of consciousness
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         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
    Impaired healing
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal obstruction
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (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 acute
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 375 (0.27%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 375 (0.00%)
    3 / 375 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic arthritis staphylococcal
         subjects affected / exposed
    0 / 375 (0.00%)
    1 / 375 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 375 (0.27%)
    0 / 375 (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
    		 Glimepiride Omarigliptin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    125 / 375 (33.33%)
    43 / 375 (11.47%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    23 / 375 (6.13%)
    24 / 375 (6.40%)
         occurrences all number
    30
    31
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    110 / 375 (29.33%)
    21 / 375 (5.60%)
         occurrences all number
    487
    45

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2013
    Amendment 1 - Modified inclusion criteria, pregnancy testing and contraception, and statistical methods.
    05 Apr 2013
    Amendment 2 - Additions 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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