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    Clinical Trial Results:
    The Effect of LY2409021 on Blood Pressure and Pulse Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Subjects with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2013-003834-33
    Trial protocol
    		 CZ   PL  
    Global end of trial date
    20 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Jun 2018
    First version publication date
    27 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I1R-MC-GLDI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02091362
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15261
    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
    20 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.
    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
    24 Mar 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
    Czech Republic: 41
    Country: Number of subjects enrolled
    United States: 146
    Country: Number of subjects enrolled
    Poland: 36
    Country: Number of subjects enrolled
    Mexico: 47
    Worldwide total number of subjects
    270
    EEA total number of subjects
    77
    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)
    207
    From 65 to 84 years
    63
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No text entered

    Pre-assignment
    Screening details
    		 No text entered

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY2409021/Placebo
    Arm description
    		 Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single daily dose of placebo administered orally for 6 weeks.

    Investigational medicinal product name
    LY2409021
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks

    Arm title
    		 Placebo/LY2409021
    Arm description
    		 Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.

    Number of subjects in period 1
    		LY2409021/Placebo Placebo/LY2409021
    Started
    133
    137
    Completed
    128
    133
    Not completed
    5
    4
         Consent withdrawn by subject
    2
    3
         Adverse event, non-fatal
    2
    -
         Lost to follow-up
    -
    1
         Protocol deviation
    1
    -
    Period 2
    Period 2 title
    Wash-out
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY2409021/Placebo
    Arm description
    		 Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
    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
    No drug administered during wash out period.

    Arm title
    		 Placebo/LY2409021
    Arm description
    		 Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
    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
    Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single daily dose of placebo administered orally for 6 weeks.

    Number of subjects in period 2
    		LY2409021/Placebo Placebo/LY2409021
    Started
    128
    133
    Completed
    127
    130
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    2
         Lost to follow-up
    1
    1
    Period 3
    Period 3 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY2409021/Placebo
    Arm description
    		 Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.
    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
    Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks

    Arm title
    		 Placebo/LY2409021
    Arm description
    		 Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.

    Investigational medicinal product name
    LY2409021
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks

    Number of subjects in period 3
    		LY2409021/Placebo Placebo/LY2409021
    Started
    127
    130
    Completed
    125
    128
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY2409021/Placebo
    Reporting group description
    		 Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.

    Reporting group title
    Placebo/LY2409021
    Reporting group description
    		 Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.

    Reporting group values
    		 LY2409021/Placebo Placebo/LY2409021 Total
    Number of subjects
    		 133 137 270
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.3 ± 8.9 57.2 ± 8.9 -
    Gender, Male/Female
    Units: Participants
        Female
    		 57 60 117
        Male
    		 76 77 153
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 63 62 125
        Not Hispanic or Latino
    		 61 69 130
        Unknown or Not Reported
    		 9 6 15
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 20 22 42
        Asian
    		 2 3 5
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 12 23 35
        White
    		 92 87 179
        More than one race
    		 7 2 9
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Czech Republic
    		 19 22 41
        United States
    		 72 74 146
        Poland
    		 18 18 36
        Mexico
    		 24 23 47
    Diagnosis of Hypertension
    Units: Subjects
        Yes
    		 89 93 182
        No
    		 44 44 88
    HBA1c Categories
    Units: Subjects
        ≥ 7.5 %
    		 49 51 100
        < 7.5%
    		 84 86 170

    End points

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    End points reporting groups
    Reporting group title
    LY2409021/Placebo
    Reporting group description
    		 Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.

    Reporting group title
    Placebo/LY2409021
    Reporting group description
    		 Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
    Reporting group title
    LY2409021/Placebo
    Reporting group description
    		 Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.

    Reporting group title
    Placebo/LY2409021
    Reporting group description
    		 Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.
    Reporting group title
    LY2409021/Placebo
    Reporting group description
    		 Period 1: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of placebo administered orally for 6 weeks.

    Reporting group title
    Placebo/LY2409021
    Reporting group description
    		 Period 1: Single daily dose of placebo administered orally for 6 weeks; Wash-out: 4 weeks; Period 2: Single daily dose of 20 milligrams (mg) LY2409021 administered orally for 6 weeks.

    Subject analysis set title
    LY2409021 20 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Single daily dose of 20 milligrams (mg) LY2409021 administered orally in 1 of 2 treatment periods

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Single daily dose of placebo matching LY2409021 administered orally in 1 of 2 treatment periods

    Subject analysis set title
    Population PK
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug and had at least one measureable drug concentration..

    Primary: Change from Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure

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    End point title
    		 Change from Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure
    End point description
    Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). Analysis Population Description: Randomized participants who received at least 1 dose of study drug and had an ABPM reading, only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
    End point type
    Primary
    End point timeframe
    Baseline, 6 Weeks
    End point values
    		 LY2409021 20 mg Placebo
    Number of subjects analysed
    241 [1]
    239 [2]
    Units: mmHg
        least squares mean (confidence interval 95%)
    2.79 (1.62 to 3.95)
    0.53 (-0.70 to 1.76)
    Notes
    [1] - See Description.
    [2] - See description.
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    LY2409021 20 mg v Placebo
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change from Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure

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    End point title
    		 Change from Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure
    End point description
    Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate. Analysis Population Description: Randomized participants who received at least 1 dose of study drug and had an ABPM reading, only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Weeks
    End point values
    		 LY2409021 20 mg Placebo
    Number of subjects analysed
    241 [3]
    239 [4]
    Units: mmHg
        least squares mean (confidence interval 95%)
    1.37 (0.61 to 2.14)
    0.00 (-0.76 to 0.77)
    Notes
    [3] - See description.
    [4] - See description.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate

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    End point title
    		 Change from Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate
    End point description
    Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Weeks
    End point values
    		 LY2409021 20 mg Placebo
    Number of subjects analysed
    241 [5]
    239 [6]
    Units: beats/minute
    least squares mean (confidence interval 95%)
        24 Hour Pulse Rate
    0.46 (-0.46 to 1.37)
    0.43 (-0.53 to 1.40)
        Mean Daytime Pulse Rate
    0.74 (-0.26 to 1.75)
    0.56 (-0.48 to 1.61)
        Mean Nighttime Pulse Rate
    -0.39 (-1.35 to 0.57)
    -0.04 (-1.03 to 0.96)
    Notes
    [5] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    [6] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures

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    End point title
    		 Change from Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures
    End point description
    Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Weeks
    End point values
    		 LY2409021 20 mg Placebo
    Number of subjects analysed
    241 [7]
    239 [8]
    Units: mmHg
    least squares mean (confidence interval 95%)
        24-Hour Pulse Pressure
    1.51 (0.76 to 2.25)
    0.62 (-0.13 to 1.38)
        Daytime Pulse Pressure
    1.49 (0.68 to 2.29)
    0.54 (-0.29 to 1.38)
        Nighttime Pulse Pressure
    1.51 (0.69 to 2.32)
    0.80 (0.00 to 1.60)
    Notes
    [7] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    [8] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    No statistical analyses for this end point

    Secondary: Change from Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)

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    End point title
    		 Change from Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)
    End point description
    Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Weeks
    End point values
    		 LY2409021 20 mg Placebo
    Number of subjects analysed
    241 [9]
    239 [10]
    Units: mmHg
    least squares mean (confidence interval 95%)
        24 Hour MAP
    1.83 (0.99 to 2.68)
    0.17 (-0.17 to 1.04)
        Daytime MAP
    2.04 (1.14 to 2.94)
    0.08 (-0.86 to 1.03)
        Nighttime MAP
    1.31 (0.33 to 2.29)
    0.33 (-0.68 to 1.33)
    Notes
    [9] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    [10] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Hemoglobin A1c (HbA1c)

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    End point title
    		 Change from Baseline in Hemoglobin A1c (HbA1c)
    End point description
    LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, 6 Weeks
    End point values
    		 LY2409021 20 mg Placebo
    Number of subjects analysed
    241 [11]
    239 [12]
    Units: percentage of HbA1c
        least squares mean (confidence interval 95%)
    -0.65 (-0.72 to -0.58)
    -0.16 (-0.23 to -0.08)
    Notes
    [11] - Randomized participants who received at least 1 dose of study drug and had post baseline data.
    [12] - Randomized participants who received at least 1 dose of study drug and had post baseline 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
    End point description
    Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups. Analysis Population Description (APD)All randomized participants who received at least 1 one dose of study drug and had at least one measureable drug concentration.
    End point type
    Secondary
    End point timeframe
    Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.
    End point values
    		 Population PK
    Number of subjects analysed
    249 [13]
    Units: Liter per hour (L/hr)
        geometric mean (geometric coefficient of variation)
    0.406 ± 30.7
    Notes
    [13] - See Description.
    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
    End point description
    Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups. Analysis Population Description (APD): All randomized patients who received at least 1 one dose of study drug and had at least one measurable drug concentration.
    End point type
    Secondary
    End point timeframe
    Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.
    End point values
    		 Population PK
    Number of subjects analysed
    249 [14]
    Units: Liters
        geometric mean (geometric coefficient of variation)
    36.7 ± 23.2
    Notes
    [14] - See Description.
    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
    All randomized participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    LY2409021 20 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Wash-out
    Reporting group description
    		 -

    Reporting group title
    Follow-up
    Reporting group description
    		 -

    Serious adverse events
    		 LY2409021 20 mg Placebo Wash-out Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 258 (1.55%)
    2 / 256 (0.78%)
    2 / 249 (0.80%)
    4 / 253 (1.58%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    breast cancer
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    plasma cell myeloma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 256 (0.00%)
    1 / 249 (0.40%)
    0 / 253 (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
    Investigations
    liver function test abnormal
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    forearm fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 256 (0.39%)
    0 / 249 (0.00%)
    1 / 253 (0.40%)
         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
    lower limb fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 256 (0.39%)
    0 / 249 (0.00%)
    1 / 253 (0.40%)
         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
    road traffic accident
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 256 (0.39%)
    0 / 249 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    cardiac failure congestive
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    1 / 256 (0.39%)
    0 / 249 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    febrile neutropenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    1 / 253 (0.40%)
         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
    Respiratory, thoracic and mediastinal disorders
    epistaxis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 258 (0.39%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary hypertension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 256 (0.00%)
    1 / 249 (0.40%)
    0 / 253 (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
    Musculoskeletal and connective tissue disorders
    pathological fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 256 (0.00%)
    1 / 249 (0.40%)
    0 / 253 (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
    Infections and infestations
    diverticulitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    0 / 258 (0.00%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    1 / 253 (0.40%)
         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: 1%
    Non-serious adverse events
    		 LY2409021 20 mg Placebo Wash-out Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 258 (18.99%)
    32 / 256 (12.50%)
    25 / 249 (10.04%)
    30 / 253 (11.86%)
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    12 / 258 (4.65%)
    1 / 256 (0.39%)
    4 / 249 (1.61%)
    7 / 253 (2.77%)
         occurrences all number
    12
    1
    4
    7
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 258 (2.33%)
    2 / 256 (0.78%)
    2 / 249 (0.80%)
    3 / 253 (1.19%)
         occurrences all number
    6
    2
    2
    3
    blood pressure diastolic increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 258 (1.16%)
    3 / 256 (1.17%)
    2 / 249 (0.80%)
    2 / 253 (0.79%)
         occurrences all number
    3
    3
    2
    2
    heart rate decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 258 (1.16%)
    2 / 256 (0.78%)
    0 / 249 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    4
    3
    0
    0
    heart rate increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 258 (1.55%)
    3 / 256 (1.17%)
    1 / 249 (0.40%)
    1 / 253 (0.40%)
         occurrences all number
    6
    3
    1
    1
    hepatic enzyme increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 258 (1.16%)
    1 / 256 (0.39%)
    2 / 249 (0.80%)
    1 / 253 (0.40%)
         occurrences all number
    3
    1
    2
    1
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 258 (0.78%)
    3 / 256 (1.17%)
    2 / 249 (0.80%)
    5 / 253 (1.98%)
         occurrences all number
    2
    3
    2
    5
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 258 (1.16%)
    1 / 256 (0.39%)
    1 / 249 (0.40%)
    1 / 253 (0.40%)
         occurrences all number
    4
    1
    1
    1
    headache
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 258 (1.55%)
    4 / 256 (1.56%)
    2 / 249 (0.80%)
    3 / 253 (1.19%)
         occurrences all number
    5
    4
    3
    5
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 258 (0.78%)
    4 / 256 (1.56%)
    2 / 249 (0.80%)
    2 / 253 (0.79%)
         occurrences all number
    2
    4
    2
    2
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 258 (1.16%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    4
    0
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 258 (2.33%)
    3 / 256 (1.17%)
    3 / 249 (1.20%)
    0 / 253 (0.00%)
         occurrences all number
    6
    3
    3
    0
    dyspepsia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 258 (1.16%)
    0 / 256 (0.00%)
    0 / 249 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    3
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    muscle spasms
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 258 (1.16%)
    1 / 256 (0.39%)
    2 / 249 (0.80%)
    0 / 253 (0.00%)
         occurrences all number
    3
    1
    2
    0
    pain in extremity
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 258 (2.33%)
    3 / 256 (1.17%)
    3 / 249 (1.20%)
    3 / 253 (1.19%)
         occurrences all number
    6
    3
    5
    3
    Infections and infestations
    influenza
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 258 (1.55%)
    1 / 256 (0.39%)
    0 / 249 (0.00%)
    2 / 253 (0.79%)
         occurrences all number
    4
    1
    0
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 258 (0.78%)
    3 / 256 (1.17%)
    3 / 249 (1.20%)
    3 / 253 (1.19%)
         occurrences all number
    2
    3
    3
    3

    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.
    None reported
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    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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