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    Clinical Trial Results:
    Pilot study to evaluate glycemic control with GlucoTab using an ultra-long acting insulin analogue in non-critically ill patients with type 2 diabetes at the genaral ward

    Summary
    EudraCT number
    		 2018-002646-36
    Trial protocol
    		 AT  
    Global end of trial date
    24 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2022
    First version publication date
    18 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GlucoTab_Degludec
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical Univerity of Graz, Department of Internal Medicine, Division for Endocrinology & Diabetology
    Sponsor organisation address
    Auenbruggerplatz 215, Graz, Austria, 8036
    Public contact
    Assoc. Prof. PD Dr. Julia Mader, Medical University of Graz Department of Internal Medicine, Division for Endocrinology & Diabetolog, 0043 316385 80254, julia.mader@medunigraz.at
    Scientific contact
    Assoc. Prof. PD Dr. Julia Mader, Medical University of Graz Department of Internal Medicine, Division for Endocrinology & Diabetolog, 0043 316385 80254, julia.mader@medunigraz.at
    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
    29 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of the GlucoTab system for glycemic management using insulin degludec in non-critically ill patients with type 2 diabetes at the general ward
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice. All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 variable
    Evidence for comparator
    		 na
    Actual start date of recruitment
    16 Jan 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
    Austria: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    7
    From 65 to 84 years
    17
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 Hospitalized patients with Type 2 Diabetes at the Endocrinological ward of the Medical University of Graz were identified by the investigators for participation in this study.

    Pre-assignment
    Screening details
    		 30 subjects signed the Informed Consent and could be included in the study.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 single arm
    Arm description
    		 The investigational treatment is insulin therapy using the GlucoTab system with insulin degludec as the long-acting basal insulin and insulin aspart as bolus insulin to cover meals and correct elevated blood glucose levels.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Insulin degludec
    Investigational medicinal product code
    Other name
    Insulin degludec
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    variable

    Number of subjects in period 1
    		single arm
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Insulin therapy will be adjusted according to the GlucoTab system with incorporated software algorithm. Participants will be treated with the GlucoTab and its integrated algorithm for basal bolus therapy using insulin degludec and insulin aspart. The goal of the GlucoTab system was to maintain fasting and pre-meal glucose concentrations between 70-140mg/dl. The glucose measurements was be performed-prandially and at bedtime by nursing staff.

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 30 30
    Age categorical
    Adults
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 17 17
        From 65-84 years
    		 6 6
        85 years and over
    		 7 7
    Gender categorical
    all gender
    Units: Subjects
        Female
    		 18 18
        Male
    		 12 12
    all ethnic groups
    Units: Subjects
        caucasian
    		 30 30
    Subject analysis sets

    Subject analysis set title
    Total study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients with type 2 diabetes or newly diagnosed hyperglycemia requiring subcutaneous insulin therapy.

    Subject analysis set title
    Workaround for t-test
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    EudraCT & EU CTR Frequently asked questions (p.23): In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed.

    Subject analysis sets values
    		 Total study Workaround for t-test
    Number of subjects
    30
    30
    Age categorical
    Adults
    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)
    6
        From 65-84 years
    17
        85 years and over
    7
    Age continuous
    78+-11 years
    Units: years
        median (standard deviation)
    ±
    ±
    Gender categorical
    all gender
    Units: Subjects
        Female
    18
        Male
    12
    all ethnic groups
    Units: Subjects
        caucasian
    30

    End points

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    End points reporting groups
    Reporting group title
    single arm
    Reporting group description
    		 The investigational treatment is insulin therapy using the GlucoTab system with insulin degludec as the long-acting basal insulin and insulin aspart as bolus insulin to cover meals and correct elevated blood glucose levels.

    Subject analysis set title
    Total study
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients with type 2 diabetes or newly diagnosed hyperglycemia requiring subcutaneous insulin therapy.

    Subject analysis set title
    Workaround for t-test
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    EudraCT & EU CTR Frequently asked questions (p.23): In order to report a statistical analysis related to a specific endpoint it is required to define at least two comparison groups. In order to report a single arm trial, a workaround needs to be performed.

    Primary: Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl

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    End point title
    		 Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl
    End point description
    End point type
    Primary
    End point timeframe
    total study duration
    End point values
    		 Total study Workaround for t-test
    Number of subjects analysed
    30
    30
    Units: percentage
        number (not applicable)
    52.2
    42.0
    Statistical analysis title
    		 Weighted one-sided, one-sample t-test
    Comparison groups
    Total study v Workaround for t-test
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0093
    Method
    		 t-test, 1-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    10.2
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 3.5
         upper limit
    		 -
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed during the total study period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    total study
    Reporting group description
    		 -

    Serious adverse events
    		 total study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 total study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 30 (43.33%)
    Vascular disorders
    Thrombosis
    Additional description: superficial vein: V. saphena parva dext.
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Eye disorders
    anisocoria dextra
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Thoracic pain
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    inguinal intertriginous dermatitis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    2 / 30 (6.67%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Pain in extremity
    Additional description: Pain in left arm - suspected psoriatic arthritis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Osteoporosis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Infections and infestations
    Infection of unknown origin
    Additional description: elevated CRP
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1

    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.
    na
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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