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    Clinical Trial Results:
    An Open-Label, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients with Type 1 Diabetes Mellitus

    Summary
    EudraCT number
    		 2017-001162-21
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Aug 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Mar 2019
    First version publication date
    23 Feb 2019
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Adjustments needed and record being corrected.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    F3Z-MC-IOPV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01109316
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 12174
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Aug 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a 6-sequence, 3-period (8 weeks each), 3-arm, 24-week crossover study. The purpose of this study is to provide information on the use of insulin lispro in insulin pumps (Continuous Subcutaneous Insulin Infusion [CSII]) compared to insulin aspart over 6 days of pump reservoir in-use. The study will also compare the in-use characteristics of insulin lispro infused at 6 days with insulin lispro infused at 2 days.
    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
    21 Apr 2010
    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: 132
    Worldwide total number of subjects
    132
    EEA total number of subjects
    0
    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)
    15
    Adults (18-64 years)
    105
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Study Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A
    Arm description
    		 Participants received Insulin Lispro 2D (2 Days), Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Lispro 6 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Aspart 6 Day
    Investigational medicinal product code
    Other name
    Novorapid
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence B
    Arm description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Lispro 6 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Aspart 6 Day
    Investigational medicinal product code
    Other name
    Novorapid
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence C
    Arm description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Lispro 6 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Aspart 6 Day
    Investigational medicinal product code
    Other name
    Novorapid
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence D
    Arm description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Lispro 6 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Aspart 6 Day
    Investigational medicinal product code
    Other name
    Novorapid
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence E
    Arm description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Lispro 6 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Aspart 6 Day
    Investigational medicinal product code
    Other name
    Novorapid
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence F
    Arm description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Lispro 6 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.

    Investigational medicinal product name
    Insulin Aspart 6 Day
    Investigational medicinal product code
    Other name
    Novorapid
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.

    Number of subjects in period 1
    		Sequence A Sequence B Sequence C Sequence D Sequence E Sequence F
    Started
    22
    22
    22
    22
    22
    22
    Received at Least One Dose of Study Drug
    22
    22
    22
    22
    22
    22
    Completed
    22
    22
    19
    21
    20
    20
    Not completed
    0
    0
    3
    1
    2
    2
         Consent withdrawn by subject
    -
    -
    1
    -
    2
    -
         Adverse event, non-fatal
    -
    -
    1
    -
    -
    -
         Sponsor Decision
    -
    -
    -
    -
    -
    2
         Lost to follow-up
    -
    -
    1
    1
    -
    -
    Period 2
    Period 2 title
    Study Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Humalog 6D and Period 3: Aspart 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence B
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Aspart 6D and Period 3: Humalog 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence C
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Humalog 2D and Period 3: Aspart 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence D
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Aspart 6D and Period 3: Humalog 2D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence E
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 2D and Period 3: Humalog 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence F
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 6D and Period 3: Humalog 2D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Number of subjects in period 2
    		Sequence A Sequence B Sequence C Sequence D Sequence E Sequence F
    Started
    22
    22
    19
    21
    20
    20
    Completed
    21
    21
    18
    20
    20
    19
    Not completed
    1
    1
    1
    1
    0
    1
         Entry Criteria not met
    -
    1
    -
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    -
    -
    1
         Physician decision
    -
    -
    -
    1
    -
    -
         Protocol deviation
    1
    -
    -
    -
    -
    -
    Period 3
    Period 3 title
    Study Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Humalog 6D and Period 3: Aspart 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence B
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Aspart 6D and Period 3: Humalog 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence C
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Humalog 2D and Period 3: Aspart 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence D
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Aspart 6D and Period 3: Humalog 2D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence E
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 2D and Period 3: Humalog 6D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Arm title
    		 Sequence F
    Arm description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 6D and Period 3: Humalog 2D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin Lispro 2 Day
    Investigational medicinal product code
    Other name
    Humalog, LY275585
    Pharmaceutical forms
    Infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Number of subjects in period 3
    		Sequence A Sequence B Sequence C Sequence D Sequence E Sequence F
    Started
    21
    21
    18
    20
    20
    19
    Completed
    20
    21
    18
    20
    18
    19
    Not completed
    1
    0
    0
    0
    2
    0
         Consent withdrawn by subject
    1
    -
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    -
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Study Period 1 Total
    Number of subjects
    		 132 132
    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)
    		 41.4 ( 16.7 ) -
    Gender, Male/Female
    Units:
        Female
    		 96 96
        Male
    		 36 36
    Region of Enrollment
    Units: Subjects
        United States
    		 132 132
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 12 12
        Not Hispanic or Latino
    		 120 120
        Unknown or Not Reported
    		 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 1 1
        More than one race
    		 2 2
        Unknown or Not Reported
    		 0 0
        White
    		 129 129

    End points

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    End points reporting groups
    Reporting group title
    Sequence A
    Reporting group description
    		 Participants received Insulin Lispro 2D (2 Days), Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D.

    Reporting group title
    Sequence B
    Reporting group description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D.

    Reporting group title
    Sequence C
    Reporting group description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D.

    Reporting group title
    Sequence D
    Reporting group description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D.

    Reporting group title
    Sequence E
    Reporting group description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D.

    Reporting group title
    Sequence F
    Reporting group description
    		 Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D.
    Reporting group title
    Sequence A
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Humalog 6D and Period 3: Aspart 6D.

    Reporting group title
    Sequence B
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Aspart 6D and Period 3: Humalog 6D.

    Reporting group title
    Sequence C
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Humalog 2D and Period 3: Aspart 6D.

    Reporting group title
    Sequence D
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Aspart 6D and Period 3: Humalog 2D.

    Reporting group title
    Sequence E
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 2D and Period 3: Humalog 6D.

    Reporting group title
    Sequence F
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 6D and Period 3: Humalog 2D.
    Reporting group title
    Sequence A
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Humalog 6D and Period 3: Aspart 6D.

    Reporting group title
    Sequence B
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 2D, Period 2: Aspart 6D and Period 3: Humalog 6D.

    Reporting group title
    Sequence C
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Humalog 2D and Period 3: Aspart 6D.

    Reporting group title
    Sequence D
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Humalog 6D, Period 2: Aspart 6D and Period 3: Humalog 2D.

    Reporting group title
    Sequence E
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 2D and Period 3: Humalog 6D.

    Reporting group title
    Sequence F
    Reporting group description
    		 Participants received Humalog 2D, Humalog 6D and Aspart 6D as per below dosing schedule Period 1: Aspart 6D, Period 2: Humalog 6D and Period 3: Humalog 2D.

    Subject analysis set title
    Insulin Lispro 2 Day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.

    Subject analysis set title
    Insulin Lispro 6 Day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.

    Subject analysis set title
    Insulin Aspart 6 Day
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.

    Primary: Mean of last five 7-point Self Monitored Blood Glucose (SMBG) taken on day 6 for Insulin Lispro 6D and day 2 for Insulin Lispro 2D and day 6 for Insulin Aspart 6D pump reservoir in-use

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    End point title
    		 Mean of last five 7-point Self Monitored Blood Glucose (SMBG) taken on day 6 for Insulin Lispro 6D and day 2 for Insulin Lispro 2D and day 6 for Insulin Aspart 6D pump reservoir in-use
    End point description
    Analysis Population Description: All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.
    End point type
    Primary
    End point timeframe
    8 weeks of each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    119
    116
    117
    Units: millimoles per liter (mmol/L)
        arithmetic mean (standard deviation)
    9.03 ( 2.17 )
    9.33 ( 2.31 )
    8.72 ( 1.82 )
    Statistical analysis title
    		 SMBG
    Statistical analysis description
    This was the primary gated analysis.
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 0.76
    Notes
    [1] - Non-inferiority margin of 0.6 mmol/L was used.

    Secondary: Mean SMBG

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    End point title
    		 Mean SMBG
    End point description
    Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day. Analysis Population Description (APD): All randomized participants who completed at least one post-randomization visit and one SMBG measurement on Day 2 for insulin lispro 2 day or Day 6 for the respective treatment arm: insulin lispro 6 day and insulin aspart 6 day.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    122
    122
    122
    Units: mmol/L
        arithmetic mean (standard deviation)
    8.79 ( 2.73 )
    9.01 ( 2.87 )
    8.83 ( 2.71 )
    Statistical analysis title
    		 SMBG
    Comparison groups
    Insulin Aspart 6 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.07
         upper limit
    		 0.52
    Notes
    [2] - Non-inferiority margin of 0.6 mmol/L was used.
    Statistical analysis title
    		 SMBG
    Comparison groups
    Insulin Lispro 6 Day v Insulin Lispro 2 Day
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.56
    Notes
    [3] - Non-inferiority margin of 0.6 mmol/L was used.

    Secondary: Mean daily insulin dose (total, basal, and bolus)

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    End point title
    		 Mean daily insulin dose (total, basal, and bolus)
    End point description
    APD: All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    117
    117
    117
    Units: Units (U) of insulin
        arithmetic mean (standard deviation)
    14.33 ( 5.88 )
    14.51 ( 6.33 )
    14.44 ( 6.11 )
    Statistical analysis title
    		 Mean Daily Insulin Dose (Daily Bolus Insulin)
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.51
    Statistical analysis title
    		 Mean Daily Insulin Dose (Daily Bolus Insulin)
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.73
    Statistical analysis title
    		 Mean Daily Insulin Dose (Daily Basal Insulin)
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.24
    Statistical analysis title
    		 Mean Daily Insulin Dose (Daily Basal Insulin)
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.56
         upper limit
    		 0.27
    Statistical analysis title
    		 Mean Daily Insulin Dose (Daily Total Insulin)
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 0.6
    Statistical analysis title
    		 Mean Daily Insulin Dose (Daily Total Insulin)
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.85
         upper limit
    		 0.65

    Secondary: Change from baseline to 8 weeks endpoint for each treatment in Hemoglobin A1c (HbA1c) values

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    End point title
    		 Change from baseline to 8 weeks endpoint for each treatment in Hemoglobin A1c (HbA1c) values
    End point description
    APD: All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.
    End point type
    Secondary
    End point timeframe
    Baseline, 8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    121
    120
    121
    Units: percentage of glycosylated hemoglobin
        arithmetic mean (standard deviation)
    -0.04 ( 0.59 )
    0.06 ( 0.56 )
    0.00 ( 0.53 )
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) Values
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.02
         upper limit
    		 0.14
    Statistical analysis title
    		 Hemoglobin A1c (HbA1c) Values
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    0.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.18

    Secondary: Number of Participants who achieve or maintain an HbA1c less than or equal to 6.5% and less than 7%

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    End point title
    		 Number of Participants who achieve or maintain an HbA1c less than or equal to 6.5% and less than 7%
    End point description
    APD: All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    121
    120
    121
    Units: participants
    number (not applicable)
        HbA1c ≤6.5%
    21
    16
    18
        HbA1c <7%
    40
    38
    44
    Statistical analysis title
    		 HbA1c ≤6.5%
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.75
    Statistical analysis title
    		 HbA1c ≤6.5%
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 1.67
    Statistical analysis title
    		 HbA1c <7%
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.41
    Statistical analysis title
    		 HbA1c <7%
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.64

    Secondary: Percentage of Participants with Hyperglycemia

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    End point title
    		 Percentage of Participants with Hyperglycemia
    End point description
    Hyperglycemia was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. APD: All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    122
    127
    124
    Units: percentage of participants
        number (not applicable)
    99.2
    98.4
    98.4
    Statistical analysis title
    		 Percentage of Participants With Hyperglycemia
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [4]
    Method
    		 Gart's Test
    Confidence interval
         level
    		 95%
    Notes
    [4] - P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.

    Secondary: Hyperglycemic Episode Rate per 30 Days

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    End point title
    		 Hyperglycemic Episode Rate per 30 Days
    End point description
    Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration >300 mg/dL (16.7 mmol/L) and <3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days. APD: All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    122
    127
    124
    Units: hyperglycemic episodes per 30 days
        arithmetic mean (standard deviation)
    15.91 ( 12.78 )
    16.91 ( 13.98 )
    15.76 ( 12.04 )
    Statistical analysis title
    		 Hyperglycemic Episode Rate Per 30 Days
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.164 [5]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [5] - P-value computed using a negative binomial test including factors for treatment, period, and sequence.
    Statistical analysis title
    		 Hyperglycemic Episode Rate Per 30 Days
    Comparison groups
    Insulin Lispro 6 Day v Insulin Lispro 2 Day
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.185 [6]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [6] - P-value computed using a negative binomial test including factors for treatment, period, and sequence.

    Secondary: Percentage of Participants with Pump Complications

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    End point title
    		 Percentage of Participants with Pump Complications
    End point description
    Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. APD: All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    122
    127
    124
    Units: percentage of participants
        number (not applicable)
    23.8
    38.6
    36.3
    Statistical analysis title
    		 Pump Complication: Premature Reservoir Change
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.736 [7]
    Method
    		 Gart's Test
    Confidence interval
         level
    		 95%
    Notes
    [7] - P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
    Statistical analysis title
    		 Pump Complication: Premature Reservoir Change
    Comparison groups
    Insulin Lispro 6 Day v Insulin Lispro 2 Day
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [8]
    Method
    		 Gart's Test
    Confidence interval
         level
    		 95%
    Notes
    [8] - P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
    Statistical analysis title
    		 Pump Complication: Premature Infusion Set Change
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [9]
    Method
    		 Gart's Test
    Confidence interval
         level
    		 95%
    Notes
    [9] - P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
    Statistical analysis title
    		 Pump Complication: Premature Infusion Set Change
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017 [10]
    Method
    		 Gart's Test
    Confidence interval
         level
    		 95%
    Notes
    [10] - P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.

    Secondary: Pump Complication Rate per 30 Days

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    End point title
    		 Pump Complication Rate per 30 Days
    End point description
    Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change. APD: All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    122
    127
    124
    Units: pump complications per 30 days
    arithmetic mean (standard deviation)
        Pump Complication: Premature Reservoir Change
    0.16 ( 0.34 )
    0.40 ( 0.76 )
    0.51 ( 1.05 )
        Pump Complication: Premature Infusion Set Change
    0.44 ( 0.65 )
    0.84 ( 1.18 )
    0.94 ( 1.35 )
    Statistical analysis title
    		 Pump Complication: Premature Reservoir Change
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.471 [11]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [11] - P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.
    Statistical analysis title
    		 Pump Complication: Premature Infusion Set Change
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [12]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [12] - P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.
    Statistical analysis title
    		 Pump Complication: Premature Infusion Set Change
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [13]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [13] - P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.
    Statistical analysis title
    		 Pump Complication: Premature Reservoir Change
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.737 [14]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [14] - P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.

    Secondary: Percentage of Participants With Hypoglycemia

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    End point title
    		 Percentage of Participants With Hypoglycemia
    End point description
    Hypoglycemia was defined as an event which was associated with (1) reported signs and symptoms of hypoglycemia, and/or (2) a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). APD: All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    122
    127
    124
    Units: percentage of participants
        number (not applicable)
    100.0
    100.0
    99.2
    No statistical analyses for this end point

    Secondary: Hypoglycemia Episode Rate per 30 Days

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    End point title
    		 Hypoglycemia Episode Rate per 30 Days
    End point description
    Hypoglycemia was defined as an event which was associated with (1) reported signs and symptoms of hypoglycemia, and/or (2) a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days. APD: All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.
    End point type
    Secondary
    End point timeframe
    8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    122
    127
    124
    Units: hypoglycemic episodes per 30 days
        arithmetic mean (standard deviation)
    17.90 ( 11.13 )
    15.66 ( 12.29 )
    17.52 ( 11.76 )
    Statistical analysis title
    		 Hypoglycemia Episode Rate Per 30 Days
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    249
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [15]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [15] - P-value is computed using negative binomial test including factors for treatment, period and sequence.
    Statistical analysis title
    		 Hypoglycemia Episode Rate Per 30 Days
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    251
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002 [16]
    Method
    		 Negative Binomial Test
    Confidence interval
         level
    		 95%
    Notes
    [16] - P-value is computed using negative binomial test including factors for treatment, period and sequence.

    Secondary: Change from baseline to 8 weeks endpoint for each treatment in weight

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    End point title
    		 Change from baseline to 8 weeks endpoint for each treatment in weight
    End point description
    APD: All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline, 8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    121
    122
    122
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    0.44 ( 2.13 )
    0.34 ( 2.04 )
    0.65 ( 2.13 )
    Statistical analysis title
    		 Change from Baseline in Weight
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06 [17]
    Method
    		 Crossover Model
    Confidence interval
         level
    		 95%
    Notes
    [17] - P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.
    Statistical analysis title
    		 Change from Baseline in Weight
    Comparison groups
    Insulin Aspart 6 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    244
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.486 [18]
    Method
    		 Crossover Model
    Confidence interval
         level
    		 95%
    Notes
    [18] - P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.

    Secondary: Change from baseline to 8 weeks endpoint for each treatment in blood pressure

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    End point title
    		 Change from baseline to 8 weeks endpoint for each treatment in blood pressure
    End point description
    APD: All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.
    End point type
    Secondary
    End point timeframe
    Baseline, 8 weeks for each treatment
    End point values
    		 Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
    Number of subjects analysed
    121
    122
    123
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure (SBP)
    0.80 ( 12.82 )
    0.80 ( 12.52 )
    -1.07 ( 12.06 )
        Diastolic Blood Pressure (DBP)
    -0.14 ( 8.24 )
    1.37 ( 7.62 )
    -0.33 ( 7.88 )
    Statistical analysis title
    		 Systolic Blood Pressure
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.056 [19]
    Method
    		 Crossover Model
    Confidence interval
         level
    		 95%
    Notes
    [19] - P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.
    Statistical analysis title
    		 Systolic Blood Pressure
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.805 [20]
    Method
    		 Crossover Model
    Confidence interval
         level
    		 95%
    Notes
    [20] - P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.
    Statistical analysis title
    		 Diastolic Blood Pressure
    Comparison groups
    Insulin Lispro 6 Day v Insulin Aspart 6 Day
    Number of subjects included in analysis
    245
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.02 [21]
    Method
    		 Crossover Model
    Confidence interval
         level
    		 95%
    Notes
    [21] - P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.
    Statistical analysis title
    		 Diastolic Blood Pressure
    Comparison groups
    Insulin Lispro 2 Day v Insulin Lispro 6 Day
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051 [22]
    Method
    		 Crossover Model
    Confidence interval
         level
    		 95%
    Notes
    [22] - P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    F3Z-MC-IOPV
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Humalog 2D
    Reporting group description
    		 -

    Reporting group title
    Aspart 6D
    Reporting group description
    		 -

    Reporting group title
    Humalog 6D
    Reporting group description
    		 -

    Serious adverse events
    		 Humalog 2D Aspart 6D Humalog 6D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 122 (2.46%)
    10 / 124 (8.06%)
    8 / 127 (6.30%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    sternal fracture
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    1 / 127 (0.79%)
         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
    ovarian cyst
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed [1]
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 93 (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
    Nervous system disorders
    cervical myelopathy
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 124 (0.00%)
    0 / 127 (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
    hydrocephalus
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    1 / 127 (0.79%)
         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
    oesophagitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    1 / 127 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    diabetic ketoacidosis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    3 / 127 (2.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    9 / 124 (7.26%)
    4 / 127 (3.15%)
         occurrences causally related to treatment / all
    2 / 2
    7 / 11
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Humalog 2D Aspart 6D Humalog 6D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 122 (58.20%)
    71 / 124 (57.26%)
    68 / 127 (53.54%)
    Investigations
    smear cervix abnormal
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed [2]
    0 / 90 (0.00%)
    0 / 90 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    urine ketone body present
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 124 (1.61%)
    1 / 127 (0.79%)
         occurrences all number
    0
    3
    1
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 124 (0.81%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    1
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 124 (2.42%)
    1 / 127 (0.79%)
         occurrences all number
    1
    3
    1
    headache
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    6 / 122 (4.92%)
    3 / 124 (2.42%)
    3 / 127 (2.36%)
         occurrences all number
    7
    3
    3
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    1 / 124 (0.81%)
    2 / 127 (1.57%)
         occurrences all number
    0
    1
    2
    chills
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 124 (0.81%)
    0 / 127 (0.00%)
         occurrences all number
    2
    1
    0
    infusion site erythema
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 124 (1.61%)
    1 / 127 (0.79%)
         occurrences all number
    1
    2
    1
    infusion site haemorrhage
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 124 (1.61%)
    1 / 127 (0.79%)
         occurrences all number
    1
    3
    1
    infusion site mass
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 124 (1.61%)
    1 / 127 (0.79%)
         occurrences all number
    1
    2
    1
    pyrexia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 124 (1.61%)
    5 / 127 (3.94%)
         occurrences all number
    2
    2
    5
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 124 (1.61%)
    0 / 127 (0.00%)
         occurrences all number
    1
    2
    0
    nausea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    4 / 122 (3.28%)
    4 / 124 (3.23%)
    3 / 127 (2.36%)
         occurrences all number
    4
    4
    3
    toothache
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    2 / 124 (1.61%)
    0 / 127 (0.00%)
         occurrences all number
    0
    2
    0
    vomiting
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    5 / 122 (4.10%)
    4 / 124 (3.23%)
    2 / 127 (1.57%)
         occurrences all number
    5
    4
    2
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    5 / 122 (4.10%)
    1 / 124 (0.81%)
    3 / 127 (2.36%)
         occurrences all number
    5
    1
    3
    dyspnoea
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 124 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    0
    nasal congestion
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 124 (0.81%)
    3 / 127 (2.36%)
         occurrences all number
    1
    1
    3
    oropharyngeal pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    5 / 122 (4.10%)
    5 / 124 (4.03%)
    4 / 127 (3.15%)
         occurrences all number
    5
    5
    4
    paranasal sinus hypersecretion
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 124 (0.81%)
    0 / 127 (0.00%)
         occurrences all number
    2
    1
    0
    rhinitis seasonal
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 124 (1.61%)
    2 / 127 (1.57%)
         occurrences all number
    2
    2
    2
    sinus congestion
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 122 (2.46%)
    3 / 124 (2.42%)
    4 / 127 (3.15%)
         occurrences all number
    3
    3
    4
    throat irritation
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 124 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    subcutaneous nodule
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 124 (1.61%)
    1 / 127 (0.79%)
         occurrences all number
    1
    2
    1
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 124 (1.61%)
    2 / 127 (1.57%)
         occurrences all number
    2
    2
    2
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    3 / 124 (2.42%)
    4 / 127 (3.15%)
         occurrences all number
    2
    3
    4
    back pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    2 / 124 (1.61%)
    2 / 127 (1.57%)
         occurrences all number
    2
    2
    2
    muscle spasms
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    3 / 122 (2.46%)
    0 / 124 (0.00%)
    0 / 127 (0.00%)
         occurrences all number
    3
    0
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    0
    3
    myalgia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    0
    2
    neck pain
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 124 (0.81%)
    2 / 127 (1.57%)
         occurrences all number
    1
    1
    2
    rotator cuff syndrome
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 124 (1.61%)
    2 / 127 (1.57%)
         occurrences all number
    1
    2
    2
    tendonitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 124 (0.81%)
    2 / 127 (1.57%)
         occurrences all number
    2
    1
    2
    Infections and infestations
    ear infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 124 (0.81%)
    3 / 127 (2.36%)
         occurrences all number
    1
    1
    3
    fungal infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    0 / 124 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    3
    0
    2
    gastroenteritis viral
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    5 / 122 (4.10%)
    3 / 124 (2.42%)
    2 / 127 (1.57%)
         occurrences all number
    5
    3
    2
    influenza
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    2 / 124 (1.61%)
    1 / 127 (0.79%)
         occurrences all number
    1
    2
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    10 / 122 (8.20%)
    13 / 124 (10.48%)
    11 / 127 (8.66%)
         occurrences all number
    11
    14
    12
    pharyngitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    0
    2
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    0 / 122 (0.00%)
    0 / 124 (0.00%)
    2 / 127 (1.57%)
         occurrences all number
    0
    0
    2
    sinusitis
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    4 / 122 (3.28%)
    3 / 124 (2.42%)
    1 / 127 (0.79%)
         occurrences all number
    4
    3
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    10 / 122 (8.20%)
    9 / 124 (7.26%)
    6 / 127 (4.72%)
         occurrences all number
    10
    10
    6
    urinary tract infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    3 / 124 (2.42%)
    2 / 127 (1.57%)
         occurrences all number
    1
    4
    2
    viral infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    1 / 122 (0.82%)
    1 / 124 (0.81%)
    2 / 127 (1.57%)
         occurrences all number
    1
    1
    2
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed [3]
    0 / 90 (0.00%)
    1 / 90 (1.11%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    hyperlipidaemia
    alternative dictionary used: MedDRA 14.0
         subjects affected / exposed
    2 / 122 (1.64%)
    1 / 124 (0.81%)
    1 / 127 (0.79%)
         occurrences all number
    2
    1
    1
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.

    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.
    Input to primary endpoint measurements (SMBG) contained approximately 40% missing data. Several analyses to account for missing data have been conducted and results from these additional analyses were consistent with results of original analysis.
    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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