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    Clinical Trial Results:
    A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2019-003339-53
    Trial protocol
    		 DE   PL  
    Global end of trial date
    08 Oct 2021

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

    Trial information

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    Trial identification
    Sponsor protocol code
    I8H-MC-BDCL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04450394
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17056
    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
    08 Oct 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 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 2 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
    01 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
    Argentina: 56
    Country: Number of subjects enrolled
    Puerto Rico: 15
    Country: Number of subjects enrolled
    United States: 126
    Country: Number of subjects enrolled
    Poland: 42
    Country: Number of subjects enrolled
    Germany: 39
    Worldwide total number of subjects
    278
    EEA total number of subjects
    81
    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)
    199
    From 65 to 84 years
    79
    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. (cont'd below)

    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 baseline median fasting glucose and body weight 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 baseline median fasting glucose and body weight 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 of 10 units, 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 of 10 units, during the 26-week treatment period, to achieve target fasting blood 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 baseline median fasting glucose and body weight 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 baseline median fasting glucose and body weight 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.

    Number of subjects in period 1
    		LY3209590 Algorithm 1 (Paper) Insulin Degludec LY3209590 Algorithm 2 (Digital)
    Started
    129
    135
    14
    Received at Least One Dose of Study Drug
    129
    135
    14
    Completed
    119
    121
    14
    Not completed
    10
    14
    0
         Consent withdrawn by subject
    6
    9
    -
         Physician decision
    -
    1
    -
         Adverse event, non-fatal
    2
    1
    -
         Lost to follow-up
    -
    3
    -
         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 baseline median fasting glucose and body weight 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
    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 of 10 units, during the 26-week treatment period, to achieve target fasting blood 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 baseline median fasting glucose and body weight 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 values
    		 LY3209590 Algorithm 1 (Paper) Insulin Degludec LY3209590 Algorithm 2 (Digital) Total
    Number of subjects
    		 129 135 14 278
    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)
    		 95 92 12 199
        From 65-84 years
    		 34 43 2 79
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.4 ± 9.9 59.4 ± 9.1 56.3 ± 8.8 -
    Gender categorical
    Units: Subjects
        Female
    		 58 59 9 126
        Male
    		 71 76 5 152
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 61 59 8 128
        Not Hispanic or Latino
    		 68 76 6 150
        Unknown or Not Reported
    		 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 2 1 1 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 4 14 1 19
        White
    		 123 119 12 254
        More than one race
    		 0 1 0 1
        Unknown or Not Reported
    		 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Argentina
    		 29 27 0 56
        Puerto Rico
    		 9 4 2 15
        United States
    		 53 61 12 126
        Poland
    		 20 22 0 42
        Germany
    		 18 21 0 39
    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)
    		 8.05 ± 0.77 7.95 ± 0.75 8.38 ± 0.83 -

    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 baseline median fasting glucose and body weight 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
    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 of 10 units, during the 26-week treatment period, to achieve target fasting blood 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 baseline median fasting glucose and body weight 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.

    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, Dipeptidyl peptidase IV (DPPIV) (yes/no), Sodium-glucose Cotransporter-2 (SGLT2) (yes/no), baseline body mass index (BMI) [<30, >=30]), 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
    127
    130
    Units: Percentage of HbA1c
        least squares mean (standard error)
    -1.20 ± 0.076
    -1.26 ± 0.075
    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
    257
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.06
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.24
    Notes
    [2] - The non-inferiority margin is 0.4%. Non-inferiority is achieved if the upper limit of the 90% 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 MMRM model with treatment, country, DPPIV (yes/no), SGLT2 (yes/no), baseline BMI [<30, >=30]), 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
    126
    130
    Units: milligrams per deciliter (mg/dL)
        least squares mean (standard error)
    -50.7 ± 2.81
    -58.7 ± 2.83
    No statistical analyses for this end point

    Secondary: Rate of Documented Hypoglycemia

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    End point title
    		 Rate of Documented Hypoglycemia [4]
    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)). Rate of documented hypoglycemia per year during defined period is calculated by the number of documented hypoglycemia events within the period divided by the number of days participant at risk within the period*365.25 days. 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
    [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
    129
    135
    Units: Events per participant per year
        number (not applicable)
    0.21
    0.15
    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 [5]
    End point description
    AUC of LY3209590 was calculated for individual participants using the participants' 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
    [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: 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
    110
    Units: Nanomole*hour per Liter (nmol*hr/L)
        geometric mean (geometric coefficient of variation)
    5890 ± 66
    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
    All randomized participants who received at least one dose of study drug. 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 baseline median fasting glucose and body weight 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 of 10 units, during the 26-week treatment period, to achieve target fasting blood 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 baseline median fasting glucose and body weight 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.

    Serious adverse events
    		 LY3209590 Algorithm 1 (Paper) Insulin Degludec LY3209590 Algorithm 2 (Digital)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 129 (4.65%)
    4 / 135 (2.96%)
    1 / 14 (7.14%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    lipoma
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    0 / 14 (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
    prostatic adenoma
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed [1]
    0 / 71 (0.00%)
    1 / 76 (1.32%)
    0 / 5 (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
    Injury, poisoning and procedural complications
    foot fracture
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    0 / 14 (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
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         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 disease
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 135 (0.74%)
    0 / 14 (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
    myocardial infarction
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    0 / 14 (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
    Nervous system disorders
    carotid artery stenosis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    0 / 14 (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
    Ear and labyrinth disorders
    middle ear inflammation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    0 / 14 (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
    Respiratory, thoracic and mediastinal disorders
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    0 / 14 (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
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 135 (0.74%)
    0 / 14 (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
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 135 (0.74%)
    0 / 14 (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
    Infections and infestations
    covid-19 pneumonia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    1 / 135 (0.74%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    meningitis aseptic
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    0 / 14 (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
    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) Insulin Degludec LY3209590 Algorithm 2 (Digital)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 129 (13.95%)
    19 / 135 (14.07%)
    8 / 14 (57.14%)
    Injury, poisoning and procedural complications
    skin laceration
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    6 / 129 (4.65%)
    2 / 135 (1.48%)
    1 / 14 (7.14%)
         occurrences all number
    6
    2
    1
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    injection site pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    2 / 135 (1.48%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    1
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    constipation
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    2 / 129 (1.55%)
    1 / 135 (0.74%)
    1 / 14 (7.14%)
         occurrences all number
    3
    1
    1
    diarrhoea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 129 (2.33%)
    7 / 135 (5.19%)
    1 / 14 (7.14%)
         occurrences all number
    3
    8
    1
    impaired gastric emptying
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    infrequent bowel movements
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    nausea
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 129 (2.33%)
    7 / 135 (5.19%)
    0 / 14 (0.00%)
         occurrences all number
    4
    7
    0
    toothache
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    productive cough
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    1
    respiratory disorder
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    dermatitis contact
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    skin odour abnormal
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    insomnia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    3 / 129 (2.33%)
    7 / 135 (5.19%)
    0 / 14 (0.00%)
         occurrences all number
    3
    7
    0
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    tendonitis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    fungal skin infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    mastoiditis
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    0 / 129 (0.00%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    0
    1
    urinary tract infection
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    3 / 135 (2.22%)
    1 / 14 (7.14%)
         occurrences all number
    1
    3
    1
    Metabolism and nutrition disorders
    hyperglycaemia
    alternative dictionary used: MedDRA 24.1
         subjects affected / exposed
    1 / 129 (0.78%)
    0 / 135 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    0
    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.
    14 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.
    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 tech
    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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