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    Clinical Trial Results:
    A Multicenter, Phase III, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of MK-3102 Monotherapy in Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control

    Summary
    EudraCT number
    		 2012-003626-24
    Trial protocol
    		 HU   DE   NL   IT   BG  
    Global end of trial date
    19 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Jun 2016
    First version publication date
    26 Jun 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3102-011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01717313
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Protocol number: MK-3102-011
    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
    19 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this study were to assess the effect of treatment with omarigliptin (MK-3102) compared with placebo on hemoglobin A1C (A1C) after 24 weeks and to assess the safety and tolerability of omarigliptin. The primary hypothesis of this study is that after 24 weeks, treatment with omarigliptin compared with placebo provides greater reduction in A1C. Care must be taken in the interpretation of the results in this study as the non-protocol-specific prohibited use of metformin among a number of participants may have impacted the safety and efficacy results disproportionally among study groups.
    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 measures defined for this individual study were in place for the protection of trial subjects. In Phase A, glycemic rescue was with open-label metformin. In Phase B, glycemic rescue was with open-label glimepiride; if glimepiride was not available in the country of the investigator site, another locally available sulfonylurea (SU) was used.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 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
    Bulgaria: 10
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Hungary: 44
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Philippines: 36
    Country: Number of subjects enrolled
    Romania: 49
    Country: Number of subjects enrolled
    Korea, Republic of: 12
    Country: Number of subjects enrolled
    Taiwan: 40
    Country: Number of subjects enrolled
    United States: 72
    Worldwide total number of subjects
    329
    EEA total number of subjects
    169
    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)
    255
    From 65 to 84 years
    74
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants had Type 2 diabetes mellitus (T2DM) and must be >=18 years of age (for India >=18 and <=65 years of age) on the day of signing the informed consent form.

    Pre-assignment
    Screening details
    		 The double-blind treatment period included a 24-week placebo-controlled (omarigliptin/omarigliptin-matching placebo) period (Phase A) and a 30-week active-controlled period with blinded metformin/metformin matching placebo (Phase B).

    Period 1
    Period 1 title
    Phase A (Weeks 0 to 24)
    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 (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin
    Investigational medicinal product code
    Other name
    MK-3102
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Omarigliptin 25 mg, oral, once a week for 54 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary, participants may have glycemic rescue therapy initiated with open-label metformin in Phase A. Participants in the placebo treatment group who were not rescued with open-label metformin will be switched to blinded metformin (starting at 500 mg b.i.d with up-titration to 1000 mg b.i.d) in a blinded manner in Phase B. Subjects who were previously rescued with open-label metformin in Phase A will continue in the trial on open-label metformin.

    Investigational medicinal product name
    Placebo to metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Armaryl®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy.

    Arm title
    		 Placebo to Omarigliptin
    Arm description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to omarigliptin, oral, for 54 weeks.

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary, participants may have glycemic rescue therapy initiated with open-label metformin. Participants in the placebo treatment group who were not rescued with open-label metformin will be switched to blinded metformin (starting at 500 mg b.i.d with up-titration to 1000 mg b.i.d) in a blinded manner. Subjects who were previously rescued with open-label metformin in Phase A will continue in the trial on open-label metformin.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Armaryl®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy.

    Number of subjects in period 1
    		Omarigliptin Placebo to Omarigliptin
    Started
    165
    164
    Completed
    147
    151
    Not completed
    18
    13
         Consent withdrawn by subject
    12
    6
         Adverse event, non-fatal
    4
    2
         Non-Compliance with study Drug
    1
    1
         Death
    -
    1
         Lost to follow-up
    1
    3
    Period 2
    Period 2 title
    Interphase
    Is this the baseline period?
    		 No
    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 (Phase A) followed by omarigliptin 25 mg administered orally plus placebo to metformin (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin
    Investigational medicinal product code
    Other name
    MK-3102
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Omarigliptin 25 mg, oral, once a week for 54 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary, participants may have glycemic rescue therapy initiated with open-label metformin in Phase A. Participants in the placebo treatment group who were not rescued with open-label metformin will be switched to blinded metformin (starting at 500 mg b.i.d with up-titration to 1000 mg b.i.d) in a blinded manner in Phase B. Subjects who were previously rescued with open-label metformin in Phase A will continue in the trial on open-label metformin.

    Investigational medicinal product name
    Placebo to metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Armaryl®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy.

    Arm title
    		 Placebo to Omarigliptin
    Arm description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin for an additional 30 weeks (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to omarigliptin, oral, for 54 weeks.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Armaryl®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy.

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary, participants may have glycemic rescue therapy initiated with open-label metformin. Participants in the placebo treatment group who were not rescued with open-label metformin will be switched to blinded metformin (starting at 500 mg b.i.d with up-titration to 1000 mg b.i.d) in a blinded manner. Subjects who were previously rescued with open-label metformin in Phase A will continue in the trial on open-label metformin.

    Number of subjects in period 2
    		Omarigliptin Placebo to Omarigliptin
    Started
    147
    151
    Completed
    146
    151
    Not completed
    1
    0
         Completed Phase A Did Not Enter Phase B
    1
    -
    Period 3
    Period 3 title
    Phase B (Weeks 24 to 54)
    Is this the baseline period?
    		 No
    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 (Phase A) followed by omarigliptin 25 mg administered orally plus placebo to metformin (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin
    Investigational medicinal product code
    Other name
    MK-3102
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Omarigliptin 25 mg, oral, once a week for 54 weeks

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary, participants may have glycemic rescue therapy initiated with open-label metformin in Phase A. Participants in the placebo treatment group who were not rescued with open-label metformin will be switched to blinded metformin (starting at 500 mg b.i.d with up-titration to 1000 mg b.i.d) in a blinded manner in Phase B. Subjects who were previously rescued with open-label metformin in Phase A will continue in the trial on open-label metformin.

    Investigational medicinal product name
    Placebo to metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Armaryl®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy.

    Arm title
    		 Placebo to Omarigliptin
    Arm description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin for an additional 30 weeks (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to omarigliptin, oral, for 54 weeks.

    Investigational medicinal product name
    Glimepiride
    Investigational medicinal product code
    Other name
    Armaryl®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy.

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    If necessary, participants may have glycemic rescue therapy initiated with open-label metformin. Participants in the placebo treatment group who were not rescued with open-label metformin will be switched to blinded metformin (starting at 500 mg b.i.d with up-titration to 1000 mg b.i.d) in a blinded manner. Subjects who were previously rescued with open-label metformin in Phase A will continue in the trial on open-label metformin.

    Number of subjects in period 3
    		Omarigliptin Placebo to Omarigliptin
    Started
    146
    151
    Completed
    134
    135
    Not completed
    12
    16
         Consent withdrawn by subject
    7
    9
         Study Terminated by Sponsor
    4
    4
         Lost to follow-up
    1
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.

    Reporting group title
    Placebo to Omarigliptin
    Reporting group description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.

    Reporting group values
    		 Omarigliptin Placebo to Omarigliptin Total
    Number of subjects
    		 165 164 329
    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)
    		 129 126 255
        From 65-84 years
    		 36 38 74
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 57.4 ( 9.2 ) 57 ( 9.7 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 70 67 137
        Male
    		 95 97 192

    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 (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.

    Reporting group title
    Placebo to Omarigliptin
    Reporting group description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally plus placebo to metformin (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.

    Reporting group title
    Placebo to Omarigliptin
    Reporting group description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin for an additional 30 weeks (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally plus placebo to metformin (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.

    Reporting group title
    Placebo to Omarigliptin
    Reporting group description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin for an additional 30 weeks (Phase B). Open-label metformin may be initiated as glycemic rescue therapy during Phase A. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.

    Subject analysis set title
    Omarigliptin - Overall Study (Phase A+B) - FAS Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) comprised of all participants who received at least one dose of trial therapy and have a baseline measurement or a post-randomization measurement.

    Subject analysis set title
    Placebo to Omar. - Overall Study (Phase A+B) - FAS Pop.
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS comprised of all participants who received at least one dose of trial therapy and have a baseline measurement or a post-randomization measurement.

    Subject analysis set title
    Omarigliptin - Overall Study (Phase A+B) - Safety Pop.
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The APaT population included all participants who received at least one dose of study drug.

    Subject analysis set title
    Placebo to Omar. - Overall Study (Phase A+B) - Safety Pop.
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The APaT population included all participants who received at least one dose of study drug.

    Subject analysis set title
    Omarigliptin - Overall Study (Phase A+B) - Per-Protocol Pop.
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).

    Subject analysis set title
    PBO to Omar. - Overall Study (Phase A+B) - Per-Protocol Pop.
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).

    Primary: Change from baseline in hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population)

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    End point title
    		 Change from baseline in hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population)
    End point description
    The Full Analysis Set (FAS) population was all participants who received at least 1 dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis).
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    165
    164
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.49 (-0.73 to -0.24)
    -0.1 (-0.34 to 0.14)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Constrained Longitudinal Data Analysis included terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 -0.19

    Primary: Percentage of participants who experienced at least one adverse event in Phase A (excluding data after glycemic rescue, Safety Population)

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    End point title
    		 Percentage of participants who experienced at least one adverse event in Phase A (excluding data after glycemic rescue, Safety Population)
    End point description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. The All-Participants-as-Treated (APaT) population included all participants who received at least one dose of study drug. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Primary
    End point timeframe
    Up to 27 weeks
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (not applicable)
    41.8
    50
    Statistical analysis title
    		 Differences in Percentages
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Differences in percentages
    Point estimate
    -8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.8
         upper limit
    		 2.6

    Primary: Percentage of participants who discontinued from the study drug due to an adverse event in Phase A (excluding data after glycemic rescue, Safety Population)

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    End point title
    		 Percentage of participants who discontinued from the study drug due to an adverse event in Phase A (excluding data after glycemic rescue, Safety Population)
    End point description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. The APaT population included all participants who received at least one dose of study drug. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (not applicable)
    2.4
    1.8
    Statistical analysis title
    		 Difference in Percentages
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Difference in percentages
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 4.5

    Primary: Percentage of participants who experienced at least one adverse event (Phase A + Phase B, excluding data after glycemic rescue, Safety Population)

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    End point title
    		 Percentage of participants who experienced at least one adverse event (Phase A + Phase B, excluding data after glycemic rescue, Safety Population)
    End point description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. The APaT population included all participants who received at least one dose of study drug. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Primary
    End point timeframe
    Up to 57 weeks
    End point values
    		 Omarigliptin - Overall Study (Phase A+B) - Safety Pop. Placebo to Omar. - Overall Study (Phase A+B) - Safety Pop.
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (not applicable)
    54.5
    60.4
    Statistical analysis title
    		 Difference in percentages vs. placebo
    Comparison groups
    Omarigliptin - Overall Study (Phase A+B) - Safety Pop. v Placebo to Omar. - Overall Study (Phase A+B) - Safety Pop.
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentages vs. placebo
    Point estimate
    -5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.4
         upper limit
    		 4.9

    Primary: Percentage of participants who discontinued from the study drug due to an adverse event (Phase A + Phase B, excluding data after glycemic rescue, Safety Population)

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    End point title
    		 Percentage of participants who discontinued from the study drug due to an adverse event (Phase A + Phase B, excluding data after glycemic rescue, Safety Population)
    End point description
    An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions. The APaT population included all participants who received at least one dose of study drug. This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Primary
    End point timeframe
    Up to 54 weeks
    End point values
    		 Omarigliptin - Overall Study (Phase A+B) - Safety Pop. Placebo to Omar. - Overall Study (Phase A+B) - Safety Pop.
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (not applicable)
    3
    2.4
    Statistical analysis title
    		 Difference in percentages vs. placebo
    Comparison groups
    Omarigliptin - Overall Study (Phase A+B) - Safety Pop. v Placebo to Omar. - Overall Study (Phase A+B) - Safety Pop.
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentages vs. placebo
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 4.8

    Primary: Change from baseline in hemoglobin A1c (A1C) at Week 24 (Phase A, Per-Protocol population)

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    End point title
    		 Change from baseline in hemoglobin A1c (A1C) at Week 24 (Phase A, Per-Protocol population)
    End point description
    A1C is a 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 24 A1C minus the Week 0 A1C. The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin). A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin).
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin - Overall Study (Phase A+B) - Per-Protocol Pop. PBO to Omar. - Overall Study (Phase A+B) - Per-Protocol Pop.
    Number of subjects analysed
    149
    131
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.54 (-0.68 to -0.39)
    0 (-0.17 to 0.16)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Constrained Longitudinal Data Analysis included terms for treatment, time, prior antihyperglycemic agent (AHA) therapy status, interaction of time by treatment, and time by prior AHA therapy status
    Comparison groups
    Omarigliptin - Overall Study (Phase A+B) - Per-Protocol Pop. v PBO to Omar. - Overall Study (Phase A+B) - Per-Protocol Pop.
    Number of subjects included in analysis
    280
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.75
         upper limit
    		 -0.32

    Secondary: Change from baseline in fasting plasma glucose (FPG) at Week 24 (Phase A, FAS Population)

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    End point title
    		 Change from baseline in fasting plasma glucose (FPG) at Week 24 (Phase A, FAS Population)
    End point description
    The FAS population received at least 1 dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    165
    164
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -12.8 (-25.2 to -0.3)
    -2.5 (-15 to 10.1)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Constrained Longitudinal Data Analysis included terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.036
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.9
         upper limit
    		 -0.7

    Secondary: Percentage of participants who achieve an A1C goal of <7% (53 mmol/mol) at Week 24 (Phase A, FAS Population)

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    End point title
    		 Percentage of participants who achieve an A1C goal of <7% (53 mmol/mol) at Week 24 (Phase A, FAS Population)
    End point description
    The FAS population received at least 1 dose of study treatment and had a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment, and estimated using standard multiple imputation techniques. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (confidence interval 95%)
    36.5 (29.3 to 44.5)
    16.3 (11.3 to 22.9)
    Statistical analysis title
    		 Between-group Rate Difference
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Between-group rate difference
    Point estimate
    20.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.5
         upper limit
    		 29.8

    Secondary: Percentage of participants who achieve an A1C goal of <7% at Week 54 (Phase A + Phase B, FAS Population)

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    End point title
    		 Percentage of participants who achieve an A1C goal of <7% at Week 54 (Phase A + Phase B, FAS Population)
    End point description
    The FAS population was comprised of all participants who received at least 1 dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 Omarigliptin - Overall Study (Phase A+B) - FAS Population Placebo to Omar. - Overall Study (Phase A+B) - FAS Pop.
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (confidence interval 95%)
    33.8 (26.8 to 41.5)
    43.8 (36.2 to 51.7)
    No statistical analyses for this end point

    Secondary: Change from baseline in 2-hour post meal glucose (PMG) at Week 24 (Phase A, FAS Population)

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    End point title
    		 Change from baseline in 2-hour post meal glucose (PMG) at Week 24 (Phase A, FAS Population)
    End point description
    The FAS population was comprised of all participants who received at least 1 dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    106
    102
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -25.6 (-56 to 4.8)
    -13.9 (-43.5 to 15.6)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Constrained Longitudinal Data Analysis included terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.177
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -11.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.6
         upper limit
    		 5.3

    Secondary: Change from baseline in A1C at Week 54 (Phase A + Phase B, FAS Population)

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    End point title
    		 Change from baseline in A1C at Week 54 (Phase A + Phase B, FAS Population)
    End point description
    A1C (%) reports average blood glucose levels over prolonged periods of time. The FAS population received at least 1 dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin - Overall Study (Phase A+B) - FAS Population Placebo to Omar. - Overall Study (Phase A+B) - FAS Pop.
    Number of subjects analysed
    165
    164
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.4 (-0.67 to -0.13)
    -0.8 (-1.07 to -0.53)
    No statistical analyses for this end point

    Secondary: Change from baseline in FPG at Week 54 (Phase A + Phase B, FAS Population)

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    End point title
    		 Change from baseline in FPG at Week 54 (Phase A + Phase B, FAS Population)
    End point description
    Blood glucose was measured on a fasting basis (FPG Week 54 - Week 0). The FAS population received at least 1 dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin - Overall Study (Phase A+B) - FAS Population Placebo to Omar. - Overall Study (Phase A+B) - FAS Pop.
    Number of subjects analysed
    165
    164
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -8.3 (-19.8 to 3.2)
    -21.1 (-32.7 to -9.5)
    No statistical analyses for this end point

    Secondary: Percentage of participants who achieve an A1C goal of <6.5% (48 mmol/mol) at Week 24 (Phase A, FAS Population)

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    End point title
    		 Percentage of participants who achieve an A1C goal of <6.5% (48 mmol/mol) at Week 24 (Phase A, FAS Population)
    End point description
    A1C (%) reports average blood glucose levels over prolonged periods of time. The FAS population received at least 1 dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (confidence interval 95%)
    16.4 (11.4 to 23.1)
    5 (2.5 to 9.6)
    Statistical analysis title
    		 Between-group Rate Difference
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    329
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Between-group rate difference
    Point estimate
    11.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.8
         upper limit
    		 18.6

    Secondary: Percentage of participants who achieve an A1C goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population)

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    End point title
    		 Percentage of participants who achieve an A1C goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population)
    End point description
    A1C (%) reports average blood glucose levels over prolonged periods of time. The FAS population received at least 1 dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint after at least 1 dose of study treatment. The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin).
    End point type
    Secondary
    End point timeframe
    Week 54
    End point values
    		 Omarigliptin - Overall Study (Phase A+B) - FAS Population Placebo to Omar. - Overall Study (Phase A+B) - FAS Pop.
    Number of subjects analysed
    165
    164
    Units: Percentage of participants
        number (confidence interval 95%)
    14.5 (9.7 to 21.2)
    20.6 (14.8 to 28)
    No statistical analyses for this end point

    Secondary: Change from baseline in FPG at Week 24 (Phase A, Per-Protocol population)

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    End point title
    		 Change from baseline in FPG at Week 24 (Phase A, Per-Protocol population)
    End point description
    Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    149
    131
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -15.5 (-22.5 to -8.4)
    -2.2 (-10.9 to 6.4)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Constrained Longitudinal Data Analysis included terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    280
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.014
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -13.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.7
         upper limit
    		 -2.7

    Secondary: Change from baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population)

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    End point title
    		 Change from baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population)
    End point description
    Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-Hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG. The Per Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin). A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin Placebo to Omarigliptin
    Number of subjects analysed
    95
    80
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -40.1 (-53.4 to -26.9)
    -19.6 (-34.1 to -5.2)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Constrained Longitudinal Data Analysis included terms for treatment, time, prior AHA therapy status, the interaction of time by treatment, and time by prior AHA therapy status
    Comparison groups
    Omarigliptin v Placebo to Omarigliptin
    Number of subjects included in analysis
    175
    Analysis specification
    Post-hoc
    Analysis type
    		 other
    P-value
    		 = 0.031
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -20.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39
         upper limit
    		 -1.9

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 57 weeks for serious adverse events (SAE, including 3-week follow-up) and up to 54 weeks for non-serious adverse events.
    Adverse event reporting additional description
    SAE tables include data after glycemic rescue. Non-serious adverse event tables exclude data after glycemic rescue. This analysis may have been confounded by use of prohibited metformin (see use of prohibited metformin).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Omarigliptin
    Reporting group description
    		 Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally plus placebo to metformin (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.

    Reporting group title
    Placebo to Omarigliptin
    Reporting group description
    		 Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin for an additional 30 weeks (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride may be initiated as glycemic rescue therapy during Phase B.

    Serious adverse events
    		 Omarigliptin Placebo to Omarigliptin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 165 (4.85%)
    8 / 164 (4.88%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Vulval cancer
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         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
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Tendon rupture
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 164 (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
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 164 (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 / 165 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 165 (0.00%)
    1 / 164 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    0 / 165 (0.00%)
    2 / 164 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 165 (0.61%)
    0 / 164 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Omarigliptin Placebo to Omarigliptin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 165 (18.79%)
    25 / 164 (15.24%)
    Investigations
    Blood glucose increased
         subjects affected / exposed
    14 / 165 (8.48%)
    13 / 164 (7.93%)
         occurrences all number
    14
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    17 / 165 (10.30%)
    12 / 164 (7.32%)
         occurrences all number
    21
    16

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2013
    AM1 - Added an upper age limit of 65 years to the inclusion criteria for participants enrolled in India; added use of sodium-glucose cotransporter (SGLT2) inhibitor within12 weeks prior to signing informed consent to the exclusion criteria; added that participants who could not tolerate the minimum dose of metformin should be discontinued; added that participants with pancreatitis should be discontinued; and clarified that in specific circumstances, participants should be discontinued from blinded study medication (not the trial)
    05 Apr 2013
    AM2 - added use of omarigliptin at any time prior to signing informed consent to the exclusion criteria; added a 6 month timeframe to the weight loss medication exclusion; included weight loss medications under prohibited medications; and added amylase and lipase to the chemistry panel at the request of regulatory authorities in the European Union
    18 Feb 2014
    AM3 - reduced the sample size from 200 participants per treatment group (400 total participants) to 150 participants per treatment group (300 total participants).

    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.
    Care must be taken in the interpretation of the results in this study as the non-protocol-specific prohibited use of metformin among a significant number of participants may have impacted the safety and efficacy results.
    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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