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    Clinical Trial Results:
    Glycemic control with GlucoTab using an ultra-long acting insulin analogue in non-critically ill patients with type 2 diabetes at the general ward

    Summary
    EudraCT number
    		 2015-003669-27
    Trial protocol
    		 AT  
    Global end of trial date
    12 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GlucoTab_U300
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, 8010
    Public contact
    Julia Mader, Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology, 43 31638580254, julia.mader@medunigraz.at
    Scientific contact
    Julia Mader, Medical University of Graz/Department of Internal Medicine/Division of Endocrinology and Diabetology, +43 31638512383, 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
    30 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Oct 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2016
    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 glargine U300 in non-critically ill patients with type 2 diabetes at the general ward
    Protection of trial subjects
    This study was conducted in full accordance with the principles of the “Declaration of Helsinki” (as amended in Tokyo, Venice, Hong Kong, Somerset West, and Edinburgh) and with the laws and regulations of the respective European countries.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2016
    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)
    9
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 It was the responsibility of the investigator to obtain oral and written informed consent prior to any study-related procedures. In obtaining and documenting informed consent, the investigator complied with applicable regulatory documents and adhered to the ICH GCP guideline and to the requirements in the Declaration of Helsinki.

    Pre-assignment
    Screening details
    		 This study included patients with type 2 diabetes mellitus or newly diagnosed hyperglycemia, both male and female, treated initially with oral agents, non-insulin injected antidiabetic medicine, insulin, diet or any combination of the four, and who were hospitalized for any condition at the Medical University of Graz.

    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
    		 GlucoTab U300
    Arm description
    		 .Glinide, sulfonylureas and glitazones were stopped. Metformin, SGLT2-inhibitors, GLP-1 analoga and DPP-4-inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. Participants were treated with the GlucoTab® and its REACTION-Algorithm for basal bolus therapy using insulin glargine U300 and insulin glulisine. The algorithm had been tested previously using insulin glargine and had shown to safely establish glycemic control. Insulin therapy prescription for every following 24 hours was suggested once daily by the GlucoTab® system taking previous insulin doses, glucose readings, patient age, renal function and insulin sensitivity into account. The goal of the GlucoTab® system is to maintain fasting and pre-meal glucose concentrations between 70-140 mg/dL.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Toujeo 300 Einheiten/ml-Injektionslösung in einem Fertigpen
    Investigational medicinal product code
    ATC-Code: A10A E04
    Other name
    Toujeo, Sanofi-Aventis (insuline glargine U300)
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to GlucoTab®, insulin therapy was initiated at a daily dose of 0.5 units/kg. Half of this dose was administered as long acting once daily (glargine U300) and the other half as short acting insulin (glulisine) before meals. A bedtime glucose >180 mg/dL was not corrected by GlucoTab®. The initial total daily dose was reduced to 0.3 units/kg in patients ≥70 years of age and/or serum creatinine ≥ 2.0 mg/dL. In case the patient was already on insulin therapy it was possible to pre-set the doses manually.

    Investigational medicinal product name
    Apidra Solostar 100 Einheiten/ml-Injektionslösung in einem Fertigpen
    Investigational medicinal product code
    A10A
    Other name
    Apidra, Sanofi Aventis (Insulin glulisine)
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to GlucoTab®, insulin therapy was initiated at a daily dose of 0.5 units/kg. Half of this dose was administered as long acting once daily (glargine U300) and the other half as short acting insulin (glulisine) before meals. A bedtime glucose >180 mg/dL was not corrected by GlucoTab®. The initial total daily dose was reduced to 0.3 units/kg in patients ≥70 years of age and/or serum creatinine ≥ 2.0 mg/dL. In case the patient was already on insulin therapy it was possible to pre-set the doses manually.

    Number of subjects in period 1
    		GlucoTab U300
    Started
    30
    Completed
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GlucoTab U300
    Reporting group description
    		 .Glinide, sulfonylureas and glitazones were stopped. Metformin, SGLT2-inhibitors, GLP-1 analoga and DPP-4-inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. Participants were treated with the GlucoTab® and its REACTION-Algorithm for basal bolus therapy using insulin glargine U300 and insulin glulisine. The algorithm had been tested previously using insulin glargine and had shown to safely establish glycemic control. Insulin therapy prescription for every following 24 hours was suggested once daily by the GlucoTab® system taking previous insulin doses, glucose readings, patient age, renal function and insulin sensitivity into account. The goal of the GlucoTab® system is to maintain fasting and pre-meal glucose concentrations between 70-140 mg/dL.

    Reporting group values
    		 GlucoTab U300 Total
    Number of subjects
    		 30 30
    Age categorical
    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)
    		 9 9
        From 65-84 years
    		 21 21
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.3 ± 11.1 -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 18 18
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 78.7 ± 26.1 -
    Serum creatinine
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 1.3 ± 0.5 -

    End points

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    End points reporting groups
    Reporting group title
    GlucoTab U300
    Reporting group description
    		 .Glinide, sulfonylureas and glitazones were stopped. Metformin, SGLT2-inhibitors, GLP-1 analoga and DPP-4-inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. Participants were treated with the GlucoTab® and its REACTION-Algorithm for basal bolus therapy using insulin glargine U300 and insulin glulisine. The algorithm had been tested previously using insulin glargine and had shown to safely establish glycemic control. Insulin therapy prescription for every following 24 hours was suggested once daily by the GlucoTab® system taking previous insulin doses, glucose readings, patient age, renal function and insulin sensitivity into account. The goal of the GlucoTab® system is to maintain fasting and pre-meal glucose concentrations between 70-140 mg/dL.

    Primary: Mean percentage of blood glucose measurements restricted to blood glucose values measured ≥ 24 hours after start of therapy in the target range 70 to 140 mg/dL

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    End point title
    		 Mean percentage of blood glucose measurements restricted to blood glucose values measured ≥ 24 hours after start of therapy in the target range 70 to 140 mg/dL [1]
    End point description
    End point type
    Primary
    End point timeframe
    whole study duration ≥ 24 hours after start of therapy
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: All parameters were analysed by descriptive and explorative statistical methods. No hypotheses were tested. The primary endpoint was "the mean percentage of blood glucose measurements lying in the target range from 70 to 140 mg/dL."
    End point values
    		 GlucoTab U300
    Number of subjects analysed
    30
    Units: Percentage
        arithmetic mean (standard deviation)
    51.5 ± 26.2
    No statistical analyses for this end point

    Secondary: Overall mean BG values

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    End point title
    		 Overall mean BG values
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 GlucoTab U300
    Number of subjects analysed
    30
    Units: mg/dl
    arithmetic mean (standard deviation)
        Overall daily BG
    154 ± 26.7
        Overall pre-breakfast BG
    143 ± 30.1
        Overall pre-lunch BG
    170 ± 42.7
        Overall pre-dinner BG
    156 ± 30
        Overall bedtime BG
    146 ± 29.1
        Pre-enrolment BG
    189 ± 57.1
    No statistical analyses for this end point

    Secondary: BG measurements in different ranges (percentage)

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    End point title
    		 BG measurements in different ranges (percentage)
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 GlucoTab U300
    Number of subjects analysed
    30
    Units: Percentage
    number (not applicable)
        0-<40 mg/dL
    0.1
        40-<60 mg/dL
    0.3
        40-<70 mg/dL
    0.8
        70-<100 mg/dL
    13.8
        100-140 mg/dL
    37.7
        >140-<180 mg/dL
    24.9
        180-<300 mg/dL
    21
        >=300 mg/dL
    1.7
    No statistical analyses for this end point

    Secondary: Missed BG measurements and insulin injections

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    End point title
    		 Missed BG measurements and insulin injections
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration except first and last study day
    End point values
    		 GlucoTab U300
    Number of subjects analysed
    30
    Units: Percentage
    number (not applicable)
        missed BG measurements
    0.9
        missed bolus insulin injections
    1.3
        missed basal insulin injections
    0
    No statistical analyses for this end point

    Secondary: Overall mean numbers

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    End point title
    		 Overall mean numbers
    End point description
    Suggested dose: Insulin dose suggested by the first step of the algorithm before applying the sliding-scale correction Correction dose: Insulin dose added (or subtracted) by the second step of the algorithm Calculated dose: Insulin dose finally calculated by the algorithm Dose correction by user: Difference between calculated insulin by the algorithm and insulin dose finally administered Injected dose: Insulin dose finally administered
    End point type
    Secondary
    End point timeframe
    whole study duration
    End point values
    		 GlucoTab U300
    Number of subjects analysed
    30
    Units: number
    arithmetic mean (standard deviation)
        Number of BG measurements
    4 ± 0.2
        Number of pre-meal bolus injections
    2.8 ± 0.5
        Number of standard bolus injections
    3.1 ± 0.8
        Number of standard basal injections
    1 ± 0
        Injected bolus insulin dose (U)
    34.9 ± 19.9
        Calculated bolus insulin dose (U)
    35.1 ± 19.6
        Suggested bolus insulin dose (U)
    27.1 ± 20.5
        Bolus correction by the algorithm (U)
    8 ± 8.9
        Bolus correction by the user (U)
    -0.2 ± 1.4
        Injected basal insulin dose (U)
    29 ± 21
        Suggested basal insulin dose (U)
    29 ± 21
        Corrective basal insulin dose by the user (U)
    0 ± 0
    No statistical analyses for this end point

    Secondary: Basal and bolus insulin dose corrections (percentage)

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    End point title
    		 Basal and bolus insulin dose corrections (percentage)
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration except day 1
    End point values
    		 GlucoTab U300
    Number of subjects analysed
    30
    Units: Percentage
    number (not applicable)
        Basal corrections by the user
    4.5
        Bolus corrections by the user
    5.6
        Bolus morning corrections by the user
    4.9
        Bolus noon corrections by the user
    4.4
        Bolus evening corrections by the user
    6.7
        Bolus bedtime corrections by the user
    6.4
        Total daily insulin dose corrections
    4.3
    No statistical analyses for this end point

    Secondary: Health-care professional adherence to suggested insulin doses

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    End point title
    		 Health-care professional adherence to suggested insulin doses
    End point description
    End point type
    Secondary
    End point timeframe
    whole study duration after day 1
    End point values
    		 GlucoTab U300
    Number of subjects analysed
    30
    Units: Percentage
    number (not applicable)
        physician adherence to total daily dose suggestion
    97.3
        physician adherence with basal insulin doses
    99.1
        adherence for bolus insulin doses by nurses
    95.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were assessed during the whole study duration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    GlucoTab U300
    Reporting group description
    		 .Glinide, sulfonylureas and glitazones were stopped. Metformin, SGLT2-inhibitors, GLP-1 analoga and DPP-4-inhibitors were continued according local standard procedures. Insulin therapy was adjusted according to the GlucoTab® system with incorporated software algorithm. Participants were treated with the GlucoTab® and its REACTION-Algorithm for basal bolus therapy using insulin glargine U300 and insulin glulisine. The algorithm had been tested previously using insulin glargine and had shown to safely establish glycemic control. Insulin therapy prescription for every following 24 hours was suggested once daily by the GlucoTab® system taking previous insulin doses, glucose readings, patient age, renal function and insulin sensitivity into account. The goal of the GlucoTab® system is to maintain fasting and pre-meal glucose concentrations between 70-140 mg/dL.

    Serious adverse events
    		 GlucoTab U300
    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
    		 GlucoTab U300
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    Vascular disorders
    Peripheral artery disease left popliteal artery and left common iliac artery
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Diabetic foot
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Peripheral artery disease
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Subacute stroke
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Surgical and medical procedures
    Post-OP intraabdominal-organizing-hematoma
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Cardiac disorders
    Hypotension
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Collapse
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Coronary artery disease (2 vessels)
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Coronary artery disease (1 vessel)
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Nervous system disorders
    Diabetic neuropathy
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Acute onset of headache
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Cerumen obturans right ear
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Eye disorders
    Papilledema
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Intestinal wall thickening
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    3 Polyps of the colon
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Ileus/Subileus
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Hepatobiliary disorders
    Liver enzyme elevation and steatosis hepatis
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Gallstone disease
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Balanitis candida
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Drug eruption
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Vaginitis due to candida infection
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    3 / 30 (10.00%)
         occurrences all number
    3
    Renal cyst
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Detoriation of kidney insufficiency
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Endocrine disorders
    Hypoglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Fracture of the bridge of the nose
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Lumbar disk herniation
         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.
    limited number of patients; no randomization; study was only performed at one clinical ward
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