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    Clinical Trial Results:
    A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy

    Summary
    EudraCT number
    		 2019-003589-41
    Trial protocol
    		 ES   DE   AT  
    Global end of trial date
    01 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Oct 2022
    First version publication date
    15 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I8H-MC-BDCP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04450407
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17183
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.
    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
    06 Jul 2020
    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
    Puerto Rico: 11
    Country: Number of subjects enrolled
    Austria: 12
    Country: Number of subjects enrolled
    United States: 179
    Country: Number of subjects enrolled
    Germany: 34
    Country: Number of subjects enrolled
    Spain: 30
    Worldwide total number of subjects
    266
    EEA total number of subjects
    76
    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)
    232
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was initially designed as 3 arms: LY3209590 Algorithm 1 (Paper), LY3209590 Algorithm 2 (Digital), and Insulin Degludec. However, it was amended to terminate the "LY3209590 Algorithm 2 (Digital)" arm during early enrollment phase due to technical issues with data entry.

    Pre-assignment
    Screening details
    		 (cont'd) Thus, this arm was excluded from the outcome measure analyses, but safety data was analysed and reported.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LY3209590 Algorithm 1 (Paper)
    Arm description
    		 Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 milligrams per deciliter (mg/dL).
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3209590
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.

    Arm title
    		 LY3209590 Algorithm 2 (Digital)
    Arm description
    		 Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY3209590
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.

    Arm title
    		 Insulin Degludec
    Arm description
    		 Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin Degludec
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.

    Number of subjects in period 1
    		LY3209590 Algorithm 1 (Paper) LY3209590 Algorithm 2 (Digital) Insulin Degludec
    Started
    124
    16
    126
    Received at Least One Dose of Study Drug
    123
    16
    126
    Completed
    107
    15
    118
    Not completed
    17
    1
    8
         Consent withdrawn by subject
    10
    1
    4
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    -
    -
    1
         Investigational site terminated by sponsor
    3
    -
    2
         Pregnancy
    1
    -
    -
         Lost to follow-up
    1
    -
    -
         Protocol deviation
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LY3209590 Algorithm 1 (Paper)
    Reporting group description
    		 Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 milligrams per deciliter (mg/dL).

    Reporting group title
    LY3209590 Algorithm 2 (Digital)
    Reporting group description
    		 Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.

    Reporting group title
    Insulin Degludec
    Reporting group description
    		 Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.

    Reporting group values
    		 LY3209590 Algorithm 1 (Paper) LY3209590 Algorithm 2 (Digital) Insulin Degludec Total
    Number of subjects
    		 124 16 126 266
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 113 9 110 232
        From 65-84 years
    		 11 7 16 34
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.4 ± 14.8 53.4 ± 16.3 47.4 ± 13.7 -
    Gender categorical
    Units: Subjects
        Female
    		 50 4 48 102
        Male
    		 74 12 78 164
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 23 5 10 38
        Not Hispanic or Latino
    		 100 11 116 227
        Unknown or Not Reported
    		 1 0 0 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 0 2 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 2 2 4 8
        White
    		 119 14 120 253
        More than one race
    		 1 0 0 1
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Puerto Rico
    		 7 1 3 11
        Austria
    		 6 0 6 12
        United States
    		 80 15 84 179
        Germany
    		 16 0 18 34
        Spain
    		 15 0 15 30
    Haemoglobin A1c (HbA1c)
    HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time.
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    		 7.52 ± 0.85 7.64 ± 0.70 7.45 ± 0.87 -

    End points

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    End points reporting groups
    Reporting group title
    LY3209590 Algorithm 1 (Paper)
    Reporting group description
    		 Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 milligrams per deciliter (mg/dL).

    Reporting group title
    LY3209590 Algorithm 2 (Digital)
    Reporting group description
    		 Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.

    Reporting group title
    Insulin Degludec
    Reporting group description
    		 Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.

    Primary: Change from Baseline in Hemoglobin A1c (HbA1c)

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    End point title
    		 Change from Baseline in Hemoglobin A1c (HbA1c) [1]
    End point description
    HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate. Analysis Population Description (APD): All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug and had baseline, post-baseline HbA1c data prior to treatment discontinuation.
    End point type
    Primary
    End point timeframe
    Baseline, Week 26
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The "LY3209590 Algorithm 2 (Digital)" arm was terminated during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses.
    End point values
    		 LY3209590 Algorithm 1 (Paper) Insulin Degludec
    Number of subjects analysed
    118
    123
    Units: Percentage of HbA1c
        least squares mean (standard error)
    0.04 ± 0.068
    -0.13 ± 0.065
    Statistical analysis title
    		 Change from Baseline in Hemoglobin A1c (HbA1c)
    Comparison groups
    LY3209590 Algorithm 1 (Paper) v Insulin Degludec
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.17
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 0.32
    Notes
    [2] - The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% CI (Confidence Interval) is below 0.4.

    Secondary: Change from Baseline in Fasting Serum Glucose

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    End point title
    		 Change from Baseline in Fasting Serum Glucose [3]
    End point description
    LS mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline fasting serum glucose as a covariate. APD: All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug and had baseline, post-baseline fasting serum glucose data prior to treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The "LY3209590 Algorithm 2 (Digital)" arm was terminated during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses.
    End point values
    		 LY3209590 Algorithm 1 (Paper) Insulin Degludec
    Number of subjects analysed
    118
    124
    Units: milligrams per deciliter (mg/dL)
        least squares mean (standard error)
    -5.9 ± 5.65
    -16.7 ± 5.21
    No statistical analyses for this end point

    Secondary: Change from Baseline in Bolus Insulin Dose

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    End point title
    		 Change from Baseline in Bolus Insulin Dose [4]
    End point description
    Bolus insulin dose was the sum of doses for morning, midday, evening meals, snack and correction. LS mean change from baseline was analysed by MMRM model with treatment, country, HbA1c stratum, visit, and treatment by visit interaction as fixed effects and the baseline bolus insulin dose as a covariate. APD: All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug and had baseline, post-baseline bolus insulin dose data prior to treatment discontinuation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The "LY3209590 Algorithm 2 (Digital)" arm was terminated during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses.
    End point values
    		 LY3209590 Algorithm 1 (Paper) Insulin Degludec
    Number of subjects analysed
    79
    81
    Units: Units per kilogram per day (U/kg/day)
        least squares mean (standard error)
    0.04 ± 0.019
    0.05 ± 0.018
    No statistical analyses for this end point

    Secondary: Rate of Documented Hypoglycemia

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    End point title
    		 Rate of Documented Hypoglycemia [5]
    End point description
    Documented hypoglycemia is defined as any time a participant reports a self-monitoring blood glucose <54 mg/dL (3.0 millimole per liter (mmol/L)). Negative binomial model using baseline hypoglycaemia incidence, baseline HbA1c and treatment as independent variables was performed to estimate the event rate. Data presented is group mean. Group Mean is estimated by first taking the inverse link function on individual participant covariates, then averaging over all participants. APD: All participants randomized to either LY3209590 Algorithm 1 (Paper) or Insulin degludec, received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 26
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The "LY3209590 Algorithm 2 (Digital)" arm was terminated during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses.
    End point values
    		 LY3209590 Algorithm 1 (Paper) Insulin Degludec
    Number of subjects analysed
    123
    126
    Units: Events per participant per year
        arithmetic mean (standard error)
    20.7 ± 2.27
    18.4 ± 2.00
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590

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    End point title
    		 Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 [6]
    End point description
    AUC of LY3209590 was calculated for individual participants using the participant's Week 26 LY3209590 dose amount and estimated clearance value. APD: All participants randomized to LY3209590 Algorithm 1 (Paper), received at least one dose of study drug and had evaluable PK data at Week 26.
    End point type
    Secondary
    End point timeframe
    Week 26
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: PK was evaluated only for experimental arm (i.e,) LY3209590 Algorithm 1 (Paper). The "LY3209590 Algorithm 2 (Digital)" arm was terminated during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses.
    End point values
    		 LY3209590 Algorithm 1 (Paper)
    Number of subjects analysed
    99
    Units: Nanomole*hour per Liter (nmol*hr/L)
        geometric mean (geometric coefficient of variation)
    3520 ± 53
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to Follow-up (up to 31 weeks)
    Adverse event reporting additional description
    APD: All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    LY3209590 Algorithm 1 (Paper)
    Reporting group description
    		 Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.

    Reporting group title
    LY3209590 Algorithm 2 (Digital)
    Reporting group description
    		 Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of <=100 mg/dL.

    Reporting group title
    Insulin Degludec
    Reporting group description
    		 Insulin degludec was provided as 100 U/mL in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of <=100 mg/dL.

    Serious adverse events
    		 LY3209590 Algorithm 1 (Paper) LY3209590 Algorithm 2 (Digital) Insulin Degludec
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 124 (4.03%)
    0 / 16 (0.00%)
    4 / 126 (3.17%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    maternal exposure during pregnancy
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed [1]
    1 / 50 (2.00%)
    0 / 4 (0.00%)
    0 / 48 (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
    patella fracture
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 16 (0.00%)
    1 / 126 (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
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 16 (0.00%)
    1 / 126 (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
    coronary artery stenosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 16 (0.00%)
    1 / 126 (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
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 16 (0.00%)
    0 / 126 (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
    Musculoskeletal and connective tissue disorders
    facet joint syndrome
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 16 (0.00%)
    0 / 126 (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
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 16 (0.00%)
    1 / 126 (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
    Infections and infestations
    pneumonia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 16 (0.00%)
    0 / 126 (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
    Metabolism and nutrition disorders
    hypoglycaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 16 (0.00%)
    1 / 126 (0.79%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 2
         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: There are gender specific adverse events occurring only in male or female participants. The number of participants exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LY3209590 Algorithm 1 (Paper) LY3209590 Algorithm 2 (Digital) Insulin Degludec
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 124 (16.94%)
    7 / 16 (43.75%)
    11 / 126 (8.73%)
    Investigations
    hepatic enzyme increased
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 16 (6.25%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    1
    sars-cov-2 test positive
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 16 (6.25%)
    0 / 126 (0.00%)
         occurrences all number
    2
    1
    0
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    4 / 124 (3.23%)
    1 / 16 (6.25%)
    3 / 126 (2.38%)
         occurrences all number
    4
    1
    3
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    10 / 124 (8.06%)
    0 / 16 (0.00%)
    5 / 126 (3.97%)
         occurrences all number
    14
    0
    5
    General disorders and administration site conditions
    injection site bruising
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 16 (6.25%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory, thoracic and mediastinal disorders
    nasal congestion
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 16 (6.25%)
    0 / 126 (0.00%)
         occurrences all number
    1
    1
    0
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 16 (6.25%)
    2 / 126 (1.59%)
         occurrences all number
    2
    1
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 124 (2.42%)
    1 / 16 (6.25%)
    1 / 126 (0.79%)
         occurrences all number
    4
    1
    1
    onychomycosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 16 (6.25%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    sinusitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 16 (6.25%)
    1 / 126 (0.79%)
         occurrences all number
    2
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2020
    Amendment [a]: This amendment addresses Food and Drug Administration (FDA) feedback.
    12 Jun 2020
    Amendment [b]: This provides guidance if COVID-19 related local restrictions impact the participant’s ability to attend their onsite study visits as originally scheduled.
    20 Aug 2020
    Amendment [c]: The amendment provides information to reflect and reinforce investigational medical device requirements absent in the initial study protocol for Algorithm 2. These requirements are consistent with country regulations where Algorithm 2 will be used.
    28 Oct 2020
    Amendment [d]: The amendment provides information to reflect termination of the investigational medical device study arm evaluating the individualized accruing data algorithm (Algorithm 2) investigational device in the study.

    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.
    "LY3209590 Algorithm 2 (Digital)" arm was terminated during early enrollment phase due to technical issues with data entry. Thus, it was excluded from the outcome measure analyses, but safety data was analysed and reported.
    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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