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    Clinical Trial Results:
    A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of LY2409021 Compared to Sitagliptin in Subjects with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2013-004275-12
    Trial protocol
    		 GR  
    Global end of trial date
    28 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2018
    First version publication date
    15 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I1R-MC-GLDJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02111096
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15286
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center , Indianapolis, IN, United States, 46285
    Public contact
    Available Mon-Fri 9 AM- 5 PM EST, Eli Lilly and Company, 1 877-CTLilly,
    Scientific contact
    Available Mon-Fri 9 AM- 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    28 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The intent of this study is to assess the safety of LY2409021 in participants with Type 2 diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal physician. The study treatment is expected to last 12 months (52 weeks).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Apr 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Greece: 16
    Country: Number of subjects enrolled
    Puerto Rico: 26
    Country: Number of subjects enrolled
    United States: 124
    Country: Number of subjects enrolled
    Taiwan: 8
    Worldwide total number of subjects
    174
    EEA total number of subjects
    16
    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)
    142
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 No text entered.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY2409021
    Arm description
    		 20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2409021
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin administered orally at doses prescribed by physician as background drug.

    Investigational medicinal product name
    Sulfonylurea
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sulfonylurea is administered orally as doses prescribed by personal physician.

    Arm title
    		 Sitagliptin
    Arm description
    		 100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin administered orally at doses prescribed by physician as background drug.

    Investigational medicinal product name
    Sulfonylurea
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sulfonylurea is administered orally as doses prescribed by personal physician.

    Arm title
    		 Placebo
    Arm description
    		 Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Metformin administered orally at doses prescribed by physician as background drug.

    Investigational medicinal product name
    Sulfonylurea
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sulfonylurea is administered orally as doses prescribed by personal physician.

    Number of subjects in period 1
    		LY2409021 Sitagliptin Placebo
    Started
    65
    41
    68
    Received at Least 1 Dose of Study Drug
    65
    41
    68
    Completed
    1
    0
    2
    Not completed
    64
    41
    66
         Lost to Follow Up
    1
    1
    1
         Terminated by Sponsor
    53
    35
    54
         Consent withdrawn by subject
    4
    2
    8
         Physician decision
    -
    1
    -
         Non-Compliance with Study Drug
    1
    1
    -
         Adverse event, non-fatal
    4
    1
    2
         Protocol deviation
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY2409021
    Reporting group description
    		 20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Reporting group values
    		 LY2409021 Sitagliptin Placebo Total
    Number of subjects
    		 65 41 68 174
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 54 33 55 142
        From 65-84 years
    		 11 8 13 32
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.9 ( 8.33 ) 57.1 ( 8.99 ) 57.8 ( 8.21 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 24 10 31 65
        Male
    		 41 31 37 109
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 30 19 42 91
        Not Hispanic or Latino
    		 34 21 25 80
        Unknown or Not Reported
    		 1 1 1 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 4 2 5 11
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 14 6 11 31
        White
    		 42 31 51 124
        More than one race
    		 5 2 1 8
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Greece
    		 6 4 6 16
        Puerto Rico
    		 8 5 13 26
        United States
    		 48 31 45 124
        Taiwan
    		 3 1 4 8

    End points

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    End points reporting groups
    Reporting group title
    LY2409021
    Reporting group description
    		 20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remained on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.

    Primary: Change from Baseline to 6 Months in Hepatic Fat Fraction

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    End point title
    		 Change from Baseline to 6 Months in Hepatic Fat Fraction
    End point description
    The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline hemoglobin A1c (HbA1c) stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Primary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    62 [1]
    30 [2]
    67 [3]
    Units: percentage
        least squares mean (confidence interval 95%)
    3.65 (2.13 to 5.17)
    -0.07 (-1.94 to 1.79)
    -0.79 (-2.28 to 0.70)
    Notes
    [1] - Participants who received 1 dose of study drug, MRI HFF baseline and 1 post-baseline data.
    [2] - Participants who received 1 dose of study drug, MRI HFF baseline and 1 post-baseline data.
    [3] - Participants who received 1 dose of study drug, MRI HFF baseline and 1 post-baseline data.
    Statistical analysis title
    		 Statistical Analysis for Hepatic Fat Fraction
    Comparison groups
    Placebo v LY2409021
    Number of subjects included in analysis
    129
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Confidence interval
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 3.4

    Secondary: Change from Baseline to 6 Months in Alanine Aminotransferase Levels

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    End point title
    		 Change from Baseline to 6 Months in Alanine Aminotransferase Levels
    End point description
    Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    64 [4]
    39 [5]
    67 [6]
    Units: microgram per Liter (µ/L)
        least squares mean (confidence interval 95%)
    9.4 (4.6 to 14.2)
    2.6 (-3.1 to 8.3)
    -1.3 (-6.0 to 3.4)
    Notes
    [4] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [5] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [6] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    No statistical analyses for this end point

    Secondary: Frequency of Hepatobiliary Adverse Events of Special Interest (AESI)

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    End point title
    		 Frequency of Hepatobiliary Adverse Events of Special Interest (AESI)
    End point description
    Number of participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal at a post-baseline visit. A summary of other non-serious serious adverse events, (AEs, and all SAE 's), regardless of causality, is located in the Reported Adverse Events section.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    65 [7]
    41 [8]
    68 [9]
    Units: participants
        number (not applicable)
    0
    1
    1
    Notes
    [7] - All randomized participants who received at least 1 dose of study drug.
    [8] - All randomized participants who received at least 1 dose of study drug.
    [9] - All randomized participants who received at least 1 dose of study drug.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in Fasting Lipids Levels

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    End point title
    		 Change from Baseline to 6 Months in Fasting Lipids Levels
    End point description
    Lipid values (cholesterol, high density lipid (HDL) cholesterol, low density lipid (LDL) cholesterol, and triglycerides) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    65 [10]
    41 [11]
    68 [12]
    Units: millimole per liter (mmol/L)
    least squares mean (confidence interval 95%)
        Cholesterol (n=58,38,60)
    0.468 (0.222 to 0.714)
    0.006 (-0.282 to 0.295)
    0.130 (-0.110 to 0.371)
        HDL Cholesterol (n=58,38,60)
    0.046 (-0.008 to 0.100)
    0.032 (-0.031 to 0.095)
    -0.021 (-0.032 to 0.074)
        Triglycerides (n=58,38,60)
    0.375 (0.087 to 0.644)
    0.078 (-0.264 to 0.420)
    0.099 (-0.183 to 0.381)
        LDL Cholesterol (n=55,36,57)
    0.244 (0.019 to 0.486)
    -0.075 (-0.342 to 0.192)
    0.019 (-0.200 to 0.239)
    Notes
    [10] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    [11] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    [12] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in Fasting Blood Glucagon

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    End point title
    		 Change from Baseline to 6 Months in Fasting Blood Glucagon
    End point description
    Glucagon values assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    65 [13]
    41 [14]
    68 [15]
    Units: picomole per liter (pmol/L)
        least squares mean (confidence interval 95%)
    44.06 (36.36 to 51.76)
    3.38 (-5.64 to 12.41)
    5.05 (-2.50 to 12.60)
    Notes
    [13] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    [14] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    [15] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in Body Weight

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    End point title
    		 Change from Baseline to 6 Months in Body Weight
    End point description
    Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    64 [16]
    40 [17]
    68 [18]
    Units: kilograms (kg)
        least squares mean (confidence interval 90%)
    0.37 (0.12 to 0.63)
    -0.08 (-0.39 to 0.22)
    -0.05 (-0.30 to 0.20)
    Notes
    [16] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [17] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [18] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in Hemoglobin A1c (HbA1c)

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    End point title
    		 Change from Baseline to 6 Months in Hemoglobin A1c (HbA1c)
    End point description
    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    63 [19]
    40 [20]
    68 [21]
    Units: percent of HbA1c
        least squares mean (confidence interval 95%)
    -0.63 (-0.94 to -0.32)
    -0.42 (-0.80 to -0.05)
    0.14 (-0.15 to 0.45)
    Notes
    [19] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [20] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [21] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in Fasting Plasma Glucose

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    End point title
    		 Change from Baseline to 6 Months in Fasting Plasma Glucose
    End point description
    Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    65 [22]
    41 [23]
    68 [24]
    Units: milligram per deciliter (mg/dL)
        least squares mean (confidence interval 95%)
    -20.5 (-34.3 to -6.6)
    -9.4 (-26.3 to 7.4)
    6.6 (-7.0 to 20.2)
    Notes
    [22] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    [23] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    [24] - Participants who received 1 dose of study drug and have baseline and 1 post-baseline time point.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in Blood Pressure

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    End point title
    		 Change from Baseline to 6 Months in Blood Pressure
    End point description
    Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured in triplicate throughout the study. At each visit, all available blood pressure measurements for a subject were averaged to provide the blood pressure for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    63 [25]
    40 [26]
    68 [27]
    Units: millimeters of mercury (mm/Hg)
    least squares mean (confidence interval 95%)
        Systolic Blood Pressure
    6.1 (2.7 to 9.5)
    1.1 (-2.9 to 5.2)
    1.8 (-1.5 to 5.1)
        Diastolic Blood Pressure
    2.9 (0.7 to 5.0)
    0.3 (-2.3 to 2.9)
    1.5 (-0.6 to 3.6)
    Notes
    [25] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [26] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [27] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in Pulse Rate

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    End point title
    		 Change from Baseline to 6 Months in Pulse Rate
    End point description
    Seated pulse rate was measured in triplicate throughout the study. At each visit, all available pulse measurements for a subject were averaged to provide the pulse for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    63 [28]
    40 [29]
    68 [30]
    Units: beats per minutes (bpm)
        least squares mean (confidence interval 95%)
    1.5 (-0.6 to 3.7)
    3.5 (0.9 to 6.0)
    1.2 (-0.9 to 3.3)
    Notes
    [28] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [29] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [30] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)

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    End point title
    		 Change from Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)
    End point description
    7-point profile consists of pre-meal and 2-hour postprandial SMBG measurements for the morning, midday, and evening meals in 1 day and at 3 AM (nocturnal blood glucose measurement). Pre-meal measurements were taken before the subject began eating the meal. Participants recorded their glucose measurements in their study diaries.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    65 [31]
    41 [32]
    68 [33]
    Units: mg/dL
    arithmetic mean (standard deviation)
        Morning Pre-Meal (n=52,28,48)
    -29.4 ( 40.36 )
    -8.13 ( 31.25 )
    -4.31 ( 26.69 )
        Mid-day Pre Meal (n=51,28,47)
    -28.43 ( 41.13 )
    -30.58 ( 48.98 )
    -9.30 ( 51.08 )
        Morning 2 Hour (Hr) Post Meal (n=48,28,44)
    -38.8 ( 47.71 )
    -30.76 ( 44.35 )
    -18.28 ( 46.20 )
        Midday 2 hr Post Meal (n=47,28,45)
    -24.22 ( 52.64 )
    -25.20 ( 61.57 )
    -10.49 ( 54.17 )
        Evening Pre Meal (n=51,28,47)
    -24.58 ( 50.78 )
    -16.78 ( 51.09 )
    -14.13 ( 50.01 )
        Evening 2 hr Post Meal (n=50,28,46)
    -28.36 ( 58.92 )
    -21.12 ( 48.19 )
    -9.50 ( 48.62 )
        Three AM (n=48,27,45)
    -22.78 ( 42.49 )
    -20.12 ( 57.39 )
    0.88 ( 41.94 )
    Notes
    [31] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [32] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [33] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021

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    End point title
    		 Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021 [34]
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,
    Notes
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint is only measuring for LY2409021 so only that arm is presented.
    End point values
    		 LY2409021
    Number of subjects analysed
    65 [35]
    Units: Liters (L)
        number (confidence interval 95%)
    31.9 (24.5 to 39.3)
    Notes
    [35] - All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetics: Apparent Clearance of LY2409021

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    End point title
    		 Population Pharmacokinetics: Apparent Clearance of LY2409021 [36]
    End point description
    Reported as a Population Estimate with % Standard Errors of Estimation (SEE), 5th-95th confidence interval.
    End point type
    Secondary
    End point timeframe
    Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,
    Notes
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint is only measuring for LY2409021 so only that arm is presented.
    End point values
    		 LY2409021
    Number of subjects analysed
    65 [37]
    Units: Liters per hour (L/h)
        number (confidence interval 95%)
    0.526 (0.454 to 0.598)
    Notes
    [37] - All randomized participants who received at least 1 dose of study drug and had evaluable PK data.
    No statistical analyses for this end point

    Secondary: Rate of Hypoglycemic Events Adjusted per 30 Days

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    End point title
    		 Rate of Hypoglycemic Events Adjusted per 30 Days
    End point description
    Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L),is presented. Rate: (30 days) is calculated as: (number of episodes during the time period divided by the number of days during the time period) multiplied by 30.
    End point type
    Secondary
    End point timeframe
    Baseline through 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    64
    40
    68
    Units: number of episodes per day
        number (not applicable)
    0.27
    0.19
    0.12
    No statistical analyses for this end point

    Secondary: Number of Participants with Hypoglycemic Events

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    End point title
    		 Number of Participants with Hypoglycemic Events
    End point description
    Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L), is presented. The number of subjects with an event are subjects who had at least one episode of documented symptomatic hypoglycemia during the time period.
    End point type
    Secondary
    End point timeframe
    Baseline through 6 months
    End point values
    		 LY2409021 Sitagliptin Placebo
    Number of subjects analysed
    64 [38]
    40 [39]
    68 [40]
    Units: participants
        number (not applicable)
    20
    40
    68
    Notes
    [38] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [39] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    [40] - Randomized participants, 1 dose of study drug and evaluable data at baseline and 1 postbaseline.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I1R-MC-GLDJ
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    LY2409021 20mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Sitagliptin 100mg
    Reporting group description
    		 -

    Serious adverse events
    		 LY2409021 20mg Placebo Sitagliptin 100mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 65 (7.69%)
    1 / 68 (1.47%)
    5 / 41 (12.20%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    renal cell carcinoma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    femur fracture
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    joint dislocation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    hypertensive crisis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    malignant hypertension
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute coronary syndrome
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    atrial fibrillation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    small intestinal obstruction
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 68 (1.47%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    abscess limb
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    infectious colitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 LY2409021 20mg Placebo Sitagliptin 100mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 65 (40.00%)
    21 / 68 (30.88%)
    22 / 41 (53.66%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    basal cell carcinoma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    colon adenoma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    3 / 68 (4.41%)
    1 / 41 (2.44%)
         occurrences all number
    2
    3
    1
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    fatigue
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    oedema peripheral
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    3
    pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    polyp
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    2 / 68 (2.94%)
    0 / 41 (0.00%)
         occurrences all number
    0
    2
    0
    pyrexia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    allergy to vaccine
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    seasonal allergy
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    atrophic vulvovaginitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    epistaxis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 68 (1.47%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    blood pressure diastolic increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    free fatty acids increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 68 (1.47%)
    1 / 41 (2.44%)
         occurrences all number
    2
    1
    1
    glomerular filtration rate decreased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 68 (2.94%)
    1 / 41 (2.44%)
         occurrences all number
    1
    2
    1
    heart rate increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    0
    0
    2
    weight decreased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    weight increased
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 68 (1.47%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    Congenital, familial and genetic disorders
    type v hyperlipidaemia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 68 (2.94%)
    0 / 41 (0.00%)
         occurrences all number
    1
    2
    0
    Cardiac disorders
    coronary artery disease
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    sinus bradycardia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    ventricular extrasystoles
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    carotid arteriosclerosis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    dizziness
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 65 (6.15%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    5
    0
    0
    headache
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    6 / 65 (9.23%)
    1 / 68 (1.47%)
    2 / 41 (4.88%)
         occurrences all number
    8
    1
    8
    tension headache
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    1
    0
    1
    Ear and labyrinth disorders
    cerumen impaction
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Eye disorders
    blindness unilateral
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    diabetic retinal oedema
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    eye swelling
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    glaucoma
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 68 (1.47%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    constipation
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    2
    0
    3
    diarrhoea
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    3 / 65 (4.62%)
    3 / 68 (4.41%)
    1 / 41 (2.44%)
         occurrences all number
    3
    5
    1
    dry mouth
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    toothache
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    2 / 68 (2.94%)
    0 / 41 (0.00%)
         occurrences all number
    1
    2
    0
    Hepatobiliary disorders
    hepatic cyst
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    pruritus
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    rash
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    microalbuminuria
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    nephrolithiasis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 68 (1.47%)
    0 / 41 (0.00%)
         occurrences all number
    2
    2
    0
    arthritis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    back pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 68 (1.47%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    musculoskeletal pain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    myalgia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    2 / 41 (4.88%)
         occurrences all number
    2
    0
    3
    pain in extremity
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    2
    0
    1
    tendonitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 68 (0.00%)
    3 / 41 (7.32%)
         occurrences all number
    1
    0
    3
    conjunctivitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    influenza
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 68 (1.47%)
    2 / 41 (4.88%)
         occurrences all number
    2
    1
    2
    labyrinthitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 68 (1.47%)
    2 / 41 (4.88%)
         occurrences all number
    3
    1
    3
    pharyngitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    1 / 65 (1.54%)
    1 / 68 (1.47%)
    1 / 41 (2.44%)
         occurrences all number
    1
    1
    1
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    sinusitis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    1 / 68 (1.47%)
    0 / 41 (0.00%)
         occurrences all number
    2
    1
    0
    subcutaneous abscess
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    1 / 68 (1.47%)
    1 / 41 (2.44%)
         occurrences all number
    0
    1
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    4 / 65 (6.15%)
    3 / 68 (4.41%)
    3 / 41 (7.32%)
         occurrences all number
    6
    4
    3
    viral infection
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    4
    0
    0
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    abnormal weight gain
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    2 / 65 (3.08%)
    0 / 68 (0.00%)
    0 / 41 (0.00%)
         occurrences all number
    2
    0
    0
    hyperglycaemia
    alternative dictionary used: MedDRA 18.1
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 68 (0.00%)
    1 / 41 (2.44%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Terminated, The overall benefit-risk profile did not support continued development of LY2409021 for type 2 diabetes.
    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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