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    Clinical Trial Results:
    A phase III, multicenter, randomized, double-blind study to evaluate the efficacy and safety of MK-3102 versus placebo in subjects with type 2 diabetes mellitus with moderate or severe chronic kidney disease or kidney failure on dialysis who have inadequate glycemic control

    Summary
    EudraCT number
    		 2012-002332-85
    Trial protocol
    		 CZ   HU   PL   ES   GB  
    Global end of trial date
    19 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2017
    First version publication date
    22 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3102-019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01698775
    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
    19 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jan 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of omarigliptin in participants with type 2 diabetes mellitus and moderate or severe chronic renal insufficiency or end stage renal disease on dialysis with inadequate glycemic control. The primary hypothesis of the study is that omarigliptin compared to placebo produces greater reduction in glycosylated hemoglobin (A1C) after 24 weeks.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure defined for this individual study was in place for the protection of trial participants: participants not meeting protocol-specified glycemic goals may be rescued with open-label glipizide during Phase A only and/or insulin glargine therapy.
    Background therapy
    		 Participants on insulin therapy at screening will continue insulin therapy during the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Croatia: 11
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Georgia: 27
    Country: Number of subjects enrolled
    Hong Kong: 25
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Israel: 5
    Country: Number of subjects enrolled
    Malaysia: 24
    Country: Number of subjects enrolled
    Philippines: 17
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Russian Federation: 7
    Country: Number of subjects enrolled
    Serbia: 16
    Country: Number of subjects enrolled
    South Africa: 7
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 47
    Worldwide total number of subjects
    213
    EEA total number of subjects
    33
    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)
    96
    From 65 to 84 years
    114
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants with type 2 diabetes mellitus and at least 30 years of age with moderate or severe chronic renal insufficiency or end stage renal disease on dialysis.

    Pre-assignment
    Screening details
    		 All eligible participants were randomly allocated to trial treatment and received a randomization number.

    Period 1
    Period 1 title
    Phase A
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omarigliptin (Phase A)
    Arm description
    		 Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    12.5 or 25 mg capsule orally once a week

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pre-screening insulin therapy will be continued during the study. Insulin glargine may be adminstered as rescue therapy.

    Investigational medicinal product name
    Glipizide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Open-label glipizide as rescue therapy

    Arm title
    		 Placebo to omarigliptin (Phase A)
    Arm description
    		 Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to omarigliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule orally once a week

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pre-screening insulin therapy will be continued during the study. Insulin glargine may be adminstered as rescue therapy.

    Investigational medicinal product name
    Glipizide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Open-label glipizide as rescue therapy

    Number of subjects in period 1
    		Omarigliptin (Phase A) Placebo to omarigliptin (Phase A)
    Started
    107
    106
    Completed
    98
    97
    Not completed
    9
    9
         Adverse event, serious fatal
    1
    1
         Consent withdrawn by subject
    3
    4
         Adverse event, non-fatal
    2
    1
         Kidney [transplant]
    -
    1
         Lost to follow-up
    1
    2
         Lack of efficacy
    1
    -
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    Phase B
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Arm description
    		 Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    12.5 or 25 mg capsule orally once a week

    Investigational medicinal product name
    Placebo to glipizide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo tablet(s) daily

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pre-screening insulin therapy will be continued during the study. Insulin glargine may be adminstered as rescue therapy.

    Arm title
    		 Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
    Arm description
    		 Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo to omarigliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo capsule orally once a week

    Investigational medicinal product name
    Insulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pre-screening insulin therapy will be continued during the study. Insulin glargine may be adminstered as rescue therapy.

    Investigational medicinal product name
    Glipizide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg once daily up to a maximum of 20 mg daily

    Number of subjects in period 2
    		Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
    Started
    98
    97
    Completed
    84
    86
    Not completed
    14
    11
         Hyperglycemia Discontinuation Criteria
    -
    1
         Adverse event, serious fatal
    -
    1
         Physician decision
    1
    1
         Consent withdrawn by subject
    6
    2
         Adverse event, non-fatal
    6
    3
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    1
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omarigliptin (Phase A)
    Reporting group description
    		 Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.

    Reporting group title
    Placebo to omarigliptin (Phase A)
    Reporting group description
    		 Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.

    Reporting group values
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A) Total
    Number of subjects
    		 107 106 213
    Age categorical
    Units: Subjects
        Under 45 years of age
    		 1 5 6
        45 to less than 65 years of age
    		 47 43 90
        Over 65 years of age
    		 59 58 117
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 65.9 ( 9.4 ) 64.5 ( 9.7 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 39 43 82
        Male
    		 68 63 131

    End points

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    End points reporting groups
    Reporting group title
    Omarigliptin (Phase A)
    Reporting group description
    		 Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.

    Reporting group title
    Placebo to omarigliptin (Phase A)
    Reporting group description
    		 Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
    Reporting group title
    Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Reporting group description
    		 Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

    Reporting group title
    Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
    Reporting group description
    		 Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

    Subject analysis set title
    Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

    Subject analysis set title
    Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

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

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    End point title
    		 Change from baseline in glycosylated hemoglobin (A1C) at Week 24
    End point description
    A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A)
    Number of subjects analysed
    106
    106
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.77 (-1 to -0.54)
    -0.44 (-0.67 to -0.21)
    Statistical analysis title
    		 Comparison of treatment groups
    Comparison groups
    Omarigliptin (Phase A) v Placebo to omarigliptin (Phase A)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 ANCOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 -0.02

    Primary: Percentage of participants who experienced at least one adverse event (Phase A: 24-week placebo controlled period)

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    End point title
    		 Percentage of participants who experienced at least one adverse event (Phase A: 24-week placebo controlled period)
    End point description
    An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. All-Participants-as-Treated (APaT) population consisted of all randomized participants who took at least 1 dose of trial treatment.
    End point type
    Primary
    End point timeframe
    Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)
    End point values
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A)
    Number of subjects analysed
    106
    106
    Units: Percentage of participants
        number (not applicable)
    66
    69.8
    Statistical analysis title
    		 Comparison of treatment groups
    Statistical analysis description
    Difference in percentages was based on Miettinen & Numinen method stratified by renal status stratum.
    Comparison groups
    Omarigliptin (Phase A) v Placebo to omarigliptin (Phase A)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    -3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.3
         upper limit
    		 8.8

    Primary: Percentage of participants who discontinued study drug due to an adverse event (Phase A: 24-week placebo controlled period)

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    End point title
    		 Percentage of participants who discontinued study drug due to an adverse event (Phase A: 24-week placebo controlled period)
    End point description
    An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. APaT population consisted of all randomized participants who took at least 1 dose of trial treatment.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    End point values
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A)
    Number of subjects analysed
    106
    106
    Units: Percentage of participants
        number (not applicable)
    2.8
    0.9
    Statistical analysis title
    		 Comparision of treatment groups
    Statistical analysis description
    Difference in percentages was based on Miettinen & Numinen method stratified by renal status stratum.
    Comparison groups
    Omarigliptin (Phase A) v Placebo to omarigliptin (Phase A)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentages
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 7.2

    Primary: Percentage of participants who experienced at least one adverse event (Phase A: 24-week placebo controlled period + Phase B: 30-week active controlled period)

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    End point title
    		 Percentage of participants who experienced at least one adverse event (Phase A: 24-week placebo controlled period + Phase B: 30-week active controlled period)
    End point description
    An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. APaT population consisted of all randomized participants who took at least 1 dose of trial treatment.
    End point type
    Primary
    End point timeframe
    Up to 58 weeks (including 28 days following the last dose of study therapy)
    End point values
    		 Omarigliptin (Phase A) → Omarigliptin (Phase B) Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Number of subjects analysed
    106
    106
    Units: Percentage of participants
        number (not applicable)
    77.4
    78.3
    Statistical analysis title
    		 Comparison of treatment groups
    Statistical analysis description
    Difference in percentages was based on Miettinen & Numinen method stratified by renal status stratum
    Comparison groups
    Omarigliptin (Phase A) → Omarigliptin (Phase B) v Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 10.3

    Primary: Percentage of participants who discontinued study drug due to an adverse event (Phase A: 24-week placebo controlled period + Phase B: 30-week active controlled period)

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    End point title
    		 Percentage of participants who discontinued study drug due to an adverse event (Phase A: 24-week placebo controlled period + Phase B: 30-week active controlled period)
    End point description
    An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue. APaT population consisted of all randomized participants who took at least 1 dose of trial treatment.
    End point type
    Primary
    End point timeframe
    Up to 54 weeks
    End point values
    		 Omarigliptin (Phase A) → Omarigliptin (Phase B) Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Number of subjects analysed
    106
    106
    Units: Percentage of participants
        number (not applicable)
    6.6
    3.8
    Statistical analysis title
    		 Comparison of treatment groups
    Comparison groups
    Omarigliptin (Phase A) → Omarigliptin (Phase B) v Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.6
         upper limit
    		 9.8

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

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    End point title
    		 Change from baseline in fasting plasma glucose (FPG) at Week 24
    End point description
    Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. FAS population included all randomized participants who received at least 1 dose of study medication and had abaseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A)
    Number of subjects analysed
    106
    106
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -24.6 (-35.6 to -13.6)
    -20.7 (-31.8 to -9.5)
    Statistical analysis title
    		 Comparision of treatment groups
    Comparison groups
    Omarigliptin (Phase A) v Placebo to omarigliptin (Phase A)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.54
    Method
    		 ANCOVA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.5
         upper limit
    		 8.7

    Secondary: Change from baseline in A1C at Week 54

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    End point title
    		 Change from baseline in A1C at Week 54
    End point description
    A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin (Phase A) → Omarigliptin (Phase B) Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Number of subjects analysed
    106
    106
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.79 (-1.1 to -0.47)
    -0.83 (-1.16 to -0.49)
    No statistical analyses for this end point

    Secondary: Change from baseline in FPG at Week 54

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    End point title
    		 Change from baseline in FPG at Week 54
    End point description
    Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum. FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose ofstudy medication.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin (Phase A) → Omarigliptin (Phase B) Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Number of subjects analysed
    106
    106
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -19.3 (-36.5 to -2.1)
    -16.4 (-34.4 to 1.6)
    No statistical analyses for this end point

    Secondary: Change from baseline in estimated glomerular filtration rate (eGFR) at Week 24

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    End point title
    		 Change from baseline in estimated glomerular filtration rate (eGFR) at Week 24
    End point description
    Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue. APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A)
    Number of subjects analysed
    85
    83
    Units: mL/min/1.73 m^2
        least squares mean (confidence interval 95%)
    -0.5 (-2.1 to 1.2)
    0 (-1.8 to 1.7)
    Statistical analysis title
    		 Comparison of treatment groups
    Comparison groups
    Omarigliptin (Phase A) v Placebo to omarigliptin (Phase A)
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.72
    Method
    		 cLDA
    Parameter type
    		 Difference in least squares means
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 1.9

    Secondary: Change from baseline in eGFR at Week 54

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    End point title
    		 Change from baseline in eGFR at Week 54
    End point description
    Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue. APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 54
    End point values
    		 Omarigliptin (Phase A) → Omarigliptin (Phase B) Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Number of subjects analysed
    86
    83
    Units: mL/min/1.73 m^2
        least squares mean (confidence interval 95%)
    -2 (-4 to -0.1)
    -2.3 (-4.3 to -0.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Phase A: up to 28 weeks (including 28-day follow-up); Phase A+B: up to 58 weeks (including 28-day follow-up)
    Adverse event reporting additional description
    APaT population consists of all randomized participants who took at least 1 dose of study drug. Serious adverse events (SAEs) include data after glycemic rescue; non-serious adverse events exclude data after glycemic rescue. The AEs reported in the (Phase A) → (Phase B) columns are a total of the AEs (SAEs) that occurred in Phases A and B.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Omarigliptin (Phase A)
    Reporting group description
    		 Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.

    Reporting group title
    Placebo to omarigliptin (Phase A)
    Reporting group description
    		 Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.

    Reporting group title
    Omarigliptin (Phase A) → Omarigliptin (Phase B)
    Reporting group description
    		 Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide in a blinded manner during Phase B of the study (Week 24 through Week 54).

    Reporting group title
    Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
    Reporting group description
    		 Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).

    Serious adverse events
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A) Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 106 (9.43%)
    13 / 106 (12.26%)
    22 / 106 (20.75%)
    22 / 106 (20.75%)
         number of deaths (all causes)
    1
    1
    2
    4
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Meningioma
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial thrombosis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    1 / 106 (0.94%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device malfunction
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent restenosis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    2 / 106 (1.89%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary congestion
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Aspiration
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Respiratory arrest
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Investigations
    Blood glucose decreased
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Coronary artery restenosis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula site complication
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorder
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Coronary artery stenosis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    2 / 106 (1.89%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    3 / 106 (2.83%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Gouty arthritis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 106 (0.94%)
    1 / 106 (0.94%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 106 (0.94%)
    1 / 106 (0.94%)
    1 / 106 (0.94%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 106 (0.00%)
    2 / 106 (1.89%)
    0 / 106 (0.00%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    2 / 106 (1.89%)
    0 / 106 (0.00%)
    2 / 106 (1.89%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 106 (0.94%)
    0 / 106 (0.00%)
    2 / 106 (1.89%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    0 / 106 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Omarigliptin (Phase A) Placebo to omarigliptin (Phase A) Omarigliptin (Phase A) → Omarigliptin (Phase B) Placebo to omarigliptin (Phase A) → Glipizide (Phase B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 106 (22.64%)
    25 / 106 (23.58%)
    44 / 106 (41.51%)
    52 / 106 (49.06%)
    Investigations
    Blood creatinine phosphokinase increased
         subjects affected / exposed
    4 / 106 (3.77%)
    3 / 106 (2.83%)
    6 / 106 (5.66%)
    2 / 106 (1.89%)
         occurrences all number
    4
    3
    6
    2
    Blood glucose increased
         subjects affected / exposed
    1 / 106 (0.94%)
    4 / 106 (3.77%)
    7 / 106 (6.60%)
    6 / 106 (5.66%)
         occurrences all number
    1
    4
    25
    6
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 106 (0.00%)
    2 / 106 (1.89%)
    4 / 106 (3.77%)
    7 / 106 (6.60%)
         occurrences all number
    0
    2
    4
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 106 (3.77%)
    2 / 106 (1.89%)
    6 / 106 (5.66%)
    3 / 106 (2.83%)
         occurrences all number
    5
    2
    7
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 106 (3.77%)
    8 / 106 (7.55%)
    4 / 106 (3.77%)
    12 / 106 (11.32%)
         occurrences all number
    4
    9
    4
    14
    Nasopharyngitis
         subjects affected / exposed
    2 / 106 (1.89%)
    4 / 106 (3.77%)
    3 / 106 (2.83%)
    6 / 106 (5.66%)
         occurrences all number
    2
    5
    3
    7
    Urinary tract infection
         subjects affected / exposed
    3 / 106 (2.83%)
    2 / 106 (1.89%)
    7 / 106 (6.60%)
    3 / 106 (2.83%)
         occurrences all number
    3
    2
    8
    3
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    21 / 106 (19.81%)
    19 / 106 (17.92%)
    27 / 106 (25.47%)
    25 / 106 (23.58%)
         occurrences all number
    84
    88
    138
    161

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2012
    Amendment 1: The primary reason for the amendment was to change the time frame for the primary endpoint from 18 weeks to 24 weeks.
    20 Nov 2012
    Amendment 2: The primary reasons for the amendment were to modify inclusion criteria regarding contraception, to modify text regarding the use of glipizide, and added details on enrollment of participants with moderate chronic renal insufficiency.
    13 Feb 2013
    Amendment 3: The primary reason for the amendment was to add discontinuation criteria of pancreatitis.
    26 Apr 2013
    Amendment 4: The primary reasons for the amendment were to modify objectives, hypotheses, power calculations and endpoints.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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