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    Clinical Trial Results:
    A Comparison of Pharmacodynamics When Receiving a Double Dose of Insulin Peglispro or Insulin Glargine in Patients with Type 2 Diabetes Mellitus: A Double-Blind, Crossover Design Study: The IMAGINE 8 Study

    Summary
    EudraCT number
    		 2012-005174-56
    Trial protocol
    		 DE  
    Global end of trial date
    10 Jul 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    12R-MC-BIDD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02132637
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14288
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Eli Lilly and Company, Available Mon - Fri 9 AM - 5 PM EST, 1 877-285-4559,
    Scientific contact
    Eli Lilly and Company, Available Mon - Fri 9 AM - 5 PM EST, 1 877-CTLilly,
    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
    10 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that clinically significant hypoglycemia (defined as blood glucose <54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia) is significantly less frequent following a double dose of insulin peglispro than following a double dose of insulin glargine within 84 hours of double dosing in patients with Type 2 Diabetes Mellitus (T2DM).
    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
    19 May 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
    United States: 10
    Country: Number of subjects enrolled
    Germany: 58
    Worldwide total number of subjects
    68
    EEA total number of subjects
    58
    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)
    56
    From 65 to 84 years
    12
    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
    Study 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
    		 Insulin Peglispro/Insulin Glargine
    Arm description
    		 Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Peglispro
    Investigational medicinal product code
    Other name
    LY2605541
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

    Arm title
    		 Insulin Glargine/Insulin Peglispro
    Arm description
    		 Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Glargine
    Investigational medicinal product code
    Other name
    LY2605541
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

    Number of subjects in period 1
    		Insulin Peglispro/Insulin Glargine Insulin Glargine/Insulin Peglispro
    Started
    34
    34
    Completed
    33
    30
    Not completed
    1
    4
         Physician decision
    1
    -
         Withdrawn by subject
    -
    4
    Period 2
    Period 2 title
    Study Period 2 (Crossover)
    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
    		 Insulin Peglispro/Insulin Glargine
    Arm description
    		 Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Glargine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

    Arm title
    		 Insulin Glargine/Insulin Peglispro
    Arm description
    		 Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Peglispro
    Investigational medicinal product code
    Other name
    LY2605541
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

    Number of subjects in period 2
    		Insulin Peglispro/Insulin Glargine Insulin Glargine/Insulin Peglispro
    Started
    33
    30
    Completed
    31
    29
    Not completed
    2
    1
         Physician decision
    2
    -
         Withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Insulin Peglispro/Insulin Glargine
    Reporting group description
    		 Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

    Reporting group title
    Insulin Glargine/Insulin Peglispro
    Reporting group description
    		 Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

    Reporting group values
    		 Insulin Peglispro/Insulin Glargine Insulin Glargine/Insulin Peglispro Total
    Number of subjects
    		 34 34 68
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.82 ( 8.06 ) 57.74 ( 5.86 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10 20
        Male
    		 24 24 48
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 4 5 9
        Not Hispanic or Latino
    		 30 29 59
        Unknown or Not Reported
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 1 0 1
        Native Hawaiian or Other
    		 1 0 1
        Black or African American
    		 0 0 0
        White
    		 32 34 66
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Insulin Peglispro/Insulin Glargine
    Reporting group description
    		 Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

    Reporting group title
    Insulin Glargine/Insulin Peglispro
    Reporting group description
    		 Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.
    Reporting group title
    Insulin Peglispro/Insulin Glargine
    Reporting group description
    		 Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

    Reporting group title
    Insulin Glargine/Insulin Peglispro
    Reporting group description
    		 Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in the first study period. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay. Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in the second study period. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

    Subject analysis set title
    Insulin Peglispro
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

    Subject analysis set title
    Insulin Glargine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

    Primary: Percentage of Participants With Clinically Significant Hypoglycemia

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    End point title
    		 Percentage of Participants With Clinically Significant Hypoglycemia [1]
    End point description
    The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 milligrams per deciliter (mg/dL) (3.0 millimole per liter [mmol/L]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. Analysis Population Description: All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.
    End point type
    Primary
    End point timeframe
    Predose to 84 Hours Post Double Dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: System limitation- cannot accurately enter the number of participants enrolled in each treatment arm of this cross-over design. The statistical analysis included a total 62 participants. The method was a generalized linear model with fixed effect of treatment, period, sequence and baseline basal insulin dose strata, and random effect of participant. The P-value was <.001. The odds ratio was 0.13 at 95% confidence interval (0.04, 0.39).
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    61
    62
    Units: percentage of participants
        number (not applicable)
    6.6
    35.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose

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    End point title
    		 Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose
    End point description
    The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100. Analysis Population Description: All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Predose to 12 Hours Post Double Dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    61
    62
    Units: percentage of participants
        number (not applicable)
    1.6
    22.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Hypoglycemia

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    End point title
    		 Percentage of Participants With Hypoglycemia
    End point description
    The percentage was calculated by dividing the number of participants with hypoglycemia events defined as blood glucose ≤70 mg/dL (3.9 mmol/L) by the total number of participants analyzed, multiplied by 100. Analysis Population Description: All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    61
    62
    Units: percentage of participants
    number (not applicable)
        12 Hours Post Double Dose
    19.7
    64.5
        84 Hours Post Double Dose
    42.6
    82.3
    No statistical analyses for this end point

    Secondary: Nadir Glucose

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    End point title
    		 Nadir Glucose
    End point description
    Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. Analysis Population Description: All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Predose to 84 Hours Post Double Dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    26
    51
    Units: mg/dL
        least squares mean (standard error)
    61.7 ( 1.36 )
    55.93 ( 0.97 )
    No statistical analyses for this end point

    Secondary: Time to the Nadir Glucose

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    End point title
    		 Time to the Nadir Glucose
    End point description
    Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). The average time was calculated by dividing the sum of time from double dose to the nadir glucose for participants with blood glucose ≤70 mg/dL (3.9 mmol/L) by the number of participants with blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose. Analysis Population Description: All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Predose to 84 Hours Post Double Dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    26
    51
    Units: hours
        median (full range (min-max))
    27.93 (3.17 to 76.67)
    27.33 (1.00 to 81.97)
    No statistical analyses for this end point

    Secondary: Duration of Glucose ≤70 mg/dL

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    End point title
    		 Duration of Glucose ≤70 mg/dL
    End point description
    The duration in minutes of each hypoglycemia episode with glucose ≤70 mg/dL (3.9 mmol/L) was calculated from start time to end time. The duration for a participant was the sum of the durations over the multiple hypoglycemia episodes. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. Analysis Population Description: All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Predose to 84 Hours Post Double Dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    61
    62
    Units: Minutes per participant
        least squares mean (standard error)
    95.28 ( 37.57 )
    362.26 ( 37.26 )
    No statistical analyses for this end point

    Secondary: Fasting Blood Glucose

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    End point title
    		 Fasting Blood Glucose
    End point description
    Fasting blood glucose (FBG) was measured by self-monitored blood glucose. LS means were calculated by MMRM analysis with fixed effects of treatment, dosing day, sequence, period, interaction of treatment and dosing day, baseline basal insulin dose stratification factor, and baseline FBG. Analysis Population Description: All randomized participants who received the double dose of study drug and had evaluable fasting blood glucose data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 2, and Day 3 Following Double Dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    62
    62
    Units: mg/dL
    least squares mean (standard error)
        Day 1 (n=61, 62)
    102.03 ( 2.9 )
    85.61 ( 2.87 )
        Day 2 (n=62, 61)
    100.94 ( 2.92 )
    86.16 ( 2.91 )
        Day 3 (n=62, 61)
    102.18 ( 2.99 )
    86.27 ( 3 )
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)

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    End point title
    		 Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)
    End point description
    Glucose AUC within 3 hours after each meal assessed by the AUC of glucose from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Preprandial to 3 Hours Postprandial during the day following the standard dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    62
    63
    Units: mg/dL*h
    least squares mean (standard error)
        Breakfast (n=62, 63)
    633.5 ( 15.59 )
    568.64 ( 15.51 )
        Lunch (n=62, 63)
    566 ( 19.92 )
    568.2 ( 19.84 )
        Dinner (n=62, 62)
    564.68 ( 15.95 )
    577.46 ( 15.95 )
    No statistical analyses for this end point

    Secondary: Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion

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    End point title
    		 Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion
    End point description
    Glucose AUC excursion within 3 hours after each meal assessed by the AUC of adjusted glucose (= observed glucose - preprandial glucose) from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Preprandial to 3 Hours Postprandial during the day following the standard dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    62
    63
    Units: mg/dL*h
    least squares mean (standard error)
        Breakfast (n=62, 63)
    266.33 ( 12.04 )
    270.32 ( 11.98 )
        Lunch (n=62, 63)
    -2.38 ( 11.42 )
    36.92 ( 11.34 )
        Dinner (n=62, 62)
    134.4 ( 10.2 )
    150.23 ( 10.2 )
    No statistical analyses for this end point

    Secondary: Beta Cell Function

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    End point title
    		 Beta Cell Function
    End point description
    Beta cell function assessed by the change between pre meal tolerance test and 30 minutes post meal tolerance test in C-peptide corrected insulin/Glucose (ΔC-peptide corrected insulin/ΔGlucose). LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable ΔC-peptide data were included in the analysis.
    End point type
    Secondary
    End point timeframe
    0-30 minutes during the meal tolerance test on the day following the standard dose
    End point values
    		 Insulin Peglispro Insulin Glargine
    Number of subjects analysed
    64
    67
    Units: pmol/L/(mmol/L)
        least squares mean (standard error)
    88.65 ( 8.43 )
    103.62 ( 8.32 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Analysis Period 2 (AP2)
    Adverse event reporting additional description
    I2R-MC-BIDD
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Insulin Glargine
    Reporting group description
    		 Standard dose of insulin glargine administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin glargine administered once, SQ on day 3 of the inpatient stay.

    Reporting group title
    Insulin Peglispro
    Reporting group description
    		 Standard dose of insulin peglispro administered subcutaneously (SQ) once daily for 4 weeks in one of two study periods. Double dose of insulin peglispro administered once, SQ on day 3 of the inpatient stay.

    Serious adverse events
    		 Insulin Glargine Insulin Peglispro
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 64 (3.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    gastritis erosive
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    otitis media
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Insulin Glargine Insulin Peglispro
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 67 (38.81%)
    31 / 64 (48.44%)
    Vascular disorders
    phlebitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    fatigue
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    infusion site extravasation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    peripheral swelling
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Psychiatric disorders
    irritability
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    ligament sprain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Cardiac disorders
    tachycardia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    2
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    7 / 67 (10.45%)
    11 / 64 (17.19%)
         occurrences all number
    7
    16
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    deafness unilateral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    vertigo
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 64 (4.69%)
         occurrences all number
    1
    3
    constipation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    diarrhoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 67 (2.99%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    nausea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    3 / 64 (4.69%)
         occurrences all number
    0
    4
    vomiting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    ecchymosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 67 (4.48%)
    2 / 64 (3.13%)
         occurrences all number
    5
    3
    Renal and urinary disorders
    bladder pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    pollakiuria
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    arthritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    back pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 67 (5.97%)
    4 / 64 (6.25%)
         occurrences all number
    4
    5
    joint swelling
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    myalgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    pain in extremity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    3 / 64 (4.69%)
         occurrences all number
    1
    3
    Infections and infestations
    cellulitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    conjunctivitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 67 (2.99%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    cystitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    gastroenteritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    6 / 67 (8.96%)
    5 / 64 (7.81%)
         occurrences all number
    6
    5
    oral herpes
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    paronychia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    rhinitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 67 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    hyperglycaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    hypoglycaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 67 (1.49%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0

    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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    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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