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    Clinical Trial Results:
    Treat-To-Target Trial of Continuous Subcutaneous , sensor-augmented insulin-pump therapy in new-onset diabetes after transplantation (SAPT-NODAT): Efficacy and Safety of an Intensive Insulin Protocol in Renal Transplant Recipients Receiving a Tacrolimus-based Immunosuppression

    Summary
    EudraCT number
    		 2012-000216-28
    Trial protocol
    		 AT  
    Global end of trial date
    22 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2021
    First version publication date
    01 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KIMIII
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Spitalgasse 23, Vienna, Austria, 1090
    Public contact
    Staff Physician, Med. Univ. Wien, UK für Innere III, manfred.hecking@meduniwien.ac.at
    Scientific contact
    Staff Physician, Med. Univ. Wien, UK für Innere III, manfred.hecking@meduniwien.ac.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
    06 Nov 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate superiority of continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation, and aiming for a pre-supper target capillary blood glucose level of 110 mg/dL against post-transplant hyperglycemia, in comparison to conventional treatment, and as evaluated by HbA1c at 3 months post-transplantation (comparison will be made against the simultaneously monitored control group of the ITP-NODAT study [=arm B])
    Protection of trial subjects
    regularly blood sugar control, glycemic profiles, monitoring of adverse events at regularly visits
    Background therapy
    		 standard of care therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Apr 2013
    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: 85
    Worldwide total number of subjects
    85
    EEA total number of subjects
    85
    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)
    69
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All non-diabetic patients who were scheduled for transplantation (both deceased and living donors) were informed and invited to participate in either ITP-NODAT or SAPT-NODAT. Patients were randomized for participation in either SAPT-NODAT or ITP-NODAT.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 85
    Number of subjects completed
    		 85

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 basal insulin treatment
    Arm description
    		 patients who received basal insulin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    insulin isophane Humulin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    according to pre- specified protocol, starting point: blood glucose > 140 mg /dl at pre-supper measurement

    Arm title
    		 control group
    Arm description
    		 standard of care for hyperglycemia (sliding scale for short acting insulin as pre-specified in the protocol) - no product has been specified
    Arm type
    		 standard of care for hyperglycemia (sliding scale

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Insulin Pump
    Arm description
    		 MiniMed Paradigm Veo Insulin Pump with the Sure-T
    Arm type
    		 Experimental

    Investigational medicinal product name
    MiniMed Paradigm Veo Insulin Pump with the Sure-T
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    MiniMed Paradigm Veo Insulin Pump with the Sure-T was implanted to administer short acting insulin according to pre-specified protocol

    Number of subjects in period 1
    		basal insulin treatment control group Insulin Pump
    Started
    26
    31
    28
    Completed
    19
    27
    23
    Not completed
    7
    4
    5
         Consent withdrawn by subject
    3
    2
    2
         exitus
    1
    -
    -
         Post-operative complications
    1
    -
    2
         Lost to follow-up
    -
    2
    -
         nephrectomy
    2
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    basal insulin treatment
    Reporting group description
    		 patients who received basal insulin

    Reporting group title
    control group
    Reporting group description
    		 standard of care for hyperglycemia (sliding scale for short acting insulin as pre-specified in the protocol) - no product has been specified

    Reporting group title
    Insulin Pump
    Reporting group description
    		 MiniMed Paradigm Veo Insulin Pump with the Sure-T

    Reporting group values
    		 basal insulin treatment control group Insulin Pump Total
    Number of subjects
    		 26 31 28 85
    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)
    		 20 25 24 69
        From 65-84 years
    		 6 6 4 16
        85 years and over
    		 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 13 4 26
        Male
    		 17 18 24 59

    End points

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    End points reporting groups
    Reporting group title
    basal insulin treatment
    Reporting group description
    		 patients who received basal insulin

    Reporting group title
    control group
    Reporting group description
    		 standard of care for hyperglycemia (sliding scale for short acting insulin as pre-specified in the protocol) - no product has been specified

    Reporting group title
    Insulin Pump
    Reporting group description
    		 MiniMed Paradigm Veo Insulin Pump with the Sure-T

    Primary: HbA1c

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    End point title
    		 HbA1c
    End point description
    End point type
    Primary
    End point timeframe
    HbA1c at 3 months
    End point values
    		 basal insulin treatment control group Insulin Pump
    Number of subjects analysed
    19
    27
    23
    Units: percent
        median (inter-quartile range (Q1-Q3))
    5.3 (4.7 to 5.6)
    5.0 (4.7 to 6.3)
    5.6 (5.4 to 6.1)
    Statistical analysis title
    		 Mann-Whitney-U test
    Comparison groups
    control group v Insulin Pump v basal insulin treatment
    Number of subjects included in analysis
    69
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Median difference (final values)
    Confidence interval
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 years
    Adverse event reporting additional description
    Enrollment until end of follow up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no dictionary used
    Dictionary version
    n.a.
    Reporting groups
    Reporting group title
    basal insulin treatment
    Reporting group description
    		 patients who received basal insulin

    Reporting group title
    control group
    Reporting group description
    		 standard of care for hyperglycemia (sliding scale for short acting insulin as pre-specified in the protocol) - no product has been specified

    Reporting group title
    Insulin Pump
    Reporting group description
    		 MiniMed Paradigm Veo Insulin Pump with the Sure-T

    Serious adverse events
    		 basal insulin treatment control group Insulin Pump
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 31 (3.23%)
    2 / 28 (7.14%)
         number of deaths (all causes)
    2
    1
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Metabolism and nutrition disorders
    Hypoglycaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 31 (3.23%)
    2 / 28 (7.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 basal insulin treatment control group Insulin Pump
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 26 (92.31%)
    28 / 31 (90.32%)
    24 / 28 (85.71%)
    Investigations
    Other Adverse Events
         subjects affected / exposed
    3 / 26 (11.54%)
    4 / 31 (12.90%)
    6 / 28 (21.43%)
         occurrences all number
    3
    4
    6
    Injury, poisoning and procedural complications
    Injury, procedural complications
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 31 (6.45%)
    2 / 28 (7.14%)
         occurrences all number
    3
    2
    2
    Surgical and medical procedures
    Surgical complications
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 31 (3.23%)
    1 / 28 (3.57%)
         occurrences all number
    3
    1
    1
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 31 (6.45%)
    0 / 28 (0.00%)
         occurrences all number
    3
    2
    0
    Hypoglycaemia 41-60mg/dl
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 31 (0.00%)
    2 / 28 (7.14%)
         occurrences all number
    2
    0
    2
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 31 (6.45%)
    1 / 28 (3.57%)
         occurrences all number
    0
    3
    1
    Renal and urinary disorders
    Graft loss
         subjects affected / exposed
    2 / 26 (7.69%)
    4 / 31 (12.90%)
    3 / 28 (10.71%)
         occurrences all number
    2
    4
    3
    Rejection
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 31 (12.90%)
    1 / 28 (3.57%)
         occurrences all number
    4
    5
    1
    Other kidney disorders
         subjects affected / exposed
    4 / 26 (15.38%)
    3 / 31 (9.68%)
    1 / 28 (3.57%)
         occurrences all number
    4
    4
    1
    Infections and infestations
    Infections
         subjects affected / exposed
    6 / 26 (23.08%)
    6 / 31 (19.35%)
    7 / 28 (25.00%)
         occurrences all number
    8
    9
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jul 2015
    This amendment describes the number of the patients who will be recruited by each center. Originally 380 patients should be recruited of the ITP and the SAPT-NODAT study: 150 patients at the University of Michigan Transplant Center (US), 50 patients at the Medical University of Vienna + 25 patients for the SAPT-NODAT arm (A), 40 patients at the University Barcelona (Spain), 60 patients at the Campus Charité Mitte, Berlin (D), 40 patients at the Campus Charité Virchow-Klinikum, Berlin (D) and 40 patients at the Medical University Graz (A). This amendment concerns the number of the patients recruited: The University of Michigan was not able to recruit 150 patients, but recruited 50 patients. Therefore, the Medical University of Vienna should recruit 102 patients (34 patients for the control group, 34 patients for the basal insulin group and 34 patients for the pump therapy group).

    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.
    None reported
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