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    Clinical Trial Results:
    The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in subjects with type 1 diabetes and high risk of nocturnal severe hypoglycaemia

    Summary
    EudraCT number
    		 2014-001942-24
    Trial protocol
    		 DK  
    Global end of trial date
    01 Mar 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jul 2021
    First version publication date
    18 Jul 2021
    Other versions
    Summary report(s)
    		 Abstract sent to Diabetologia

    Trial information

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    Trial identification
    Sponsor protocol code
    HypoDeg
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02192450
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Regional Committee on Biomedical Research Ethics : #H-3-2014-101, Danish Medicines Agency : (#2014071615, Danish Data Protection Agency: I-suite no: 02945; #NOH-2014-018
    Sponsors
    Sponsor organisation name
    Nordsjællands Hospital
    Sponsor organisation address
    Dyrehavevej 29, Hilleroed, Denmark,
    Public contact
    Nordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology, +45 48294810, ulrik.pedersen-bjergaard@regionh.dk
    Scientific contact
    Nordsjællands Hospital, Department of Cardiology, Nephrology and Endocrinology, +45 48294810, ulrik.pedersen-bjergaard@regionh.dk
    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
    21 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test the hypothesis that insulin degludec, compared to insulin glargine, reduces the risk of symptomatic nocturnal hypoglycaemia in subjects with the greatest potential benefit from optimised insulin treatment - which is patients with type 1 diabetes and high risk of nocturnal severe hypoglycaemia.
    Protection of trial subjects
    None. This was a pragmatic clinical trial, mimicking regular clinical practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2014
    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
    Denmark: 149
    Worldwide total number of subjects
    149
    EEA total number of subjects
    149
    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)
    149
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 HypoDeg trial was an investigator-initiated, two-year, cross-over study conducted in a PROBE (prospective, randomised, open, blinded endpoint) design, carried out at ten centres in Denmark. Recruitment Period: December 1st. 2015 - March 20th 2017.

    Pre-assignment
    Screening details
    		 Patients were eligible if they had been diagnosed clinically with type 1 diabetes for more than five years, were aged 18 years or older and had reported one or more episodes of nocturnal severe hypoglycaemia in the previous two years (defined by need for treatment assistance from another person).

    Period 1
    Period 1 title
    First insulin
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 To receive insulin degludec first
    Arm description
    		 -
    Arm type
    		 Experimental

    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
    Once a day

    Arm title
    		 To receive insulin glargine U100 first
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine U100
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once a day

    Number of subjects in period 1
    		To receive insulin degludec first To receive insulin glargine U100 first
    Started
    73
    76
    Completed
    61
    73
    Not completed
    12
    3
         Physician decision
    2
    -
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    2
    -
         Did not want to cross-over
    4
    -
         Unknown
    1
    1
         Non-comliance
    3
    -
    Period 2
    Period 2 title
    Second insulin
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 To receive insulin glargine U100 second
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Insulin glargine U100
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Once a day

    Arm title
    		 To receive insulin degludec second
    Arm description
    		 -
    Arm type
    		 Experimental

    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
    Once a day

    Number of subjects in period 2
    		To receive insulin glargine U100 second To receive insulin degludec second
    Started
    61
    73
    Completed
    56
    72
    Not completed
    5
    1
         Consent withdrawn by subject
    2
    -
         Fulfilled withdrawn criteria
    1
    -
         Unknown
    1
    -
         Died
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    First insulin
    Reporting group description
    		 -

    Reporting group values
    		 First insulin Total
    Number of subjects
    		 149 149
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 149 149
    Gender categorical
    Units: Subjects
        Female
    		 44 44
        Male
    		 105 105

    End points

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    End points reporting groups
    Reporting group title
    To receive insulin degludec first
    Reporting group description
    		 -

    Reporting group title
    To receive insulin glargine U100 first
    Reporting group description
    		 -
    Reporting group title
    To receive insulin glargine U100 second
    Reporting group description
    		 -

    Reporting group title
    To receive insulin degludec second
    Reporting group description
    		 -

    Primary: Number of episodes of nocturnal symptomatic hypoglycaemia reported by the patients during the maintenance periods, i.e., the last nine months of each treatment arm

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    End point title
    		 Number of episodes of nocturnal symptomatic hypoglycaemia reported by the patients during the maintenance periods, i.e., the last nine months of each treatment arm [1]
    End point description
    End point type
    Primary
    End point timeframe
    Number of episodes of nocturnal symptomatic hypoglycaemia reported by the patients during the maintenance periods, i.e., the last nine months
    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: No specification
    End point values
    		 To receive insulin degludec first To receive insulin glargine U100 first
    Number of subjects analysed
    56
    72
    Units: Episodes of nocturnal symptomatic hypogl
    319
    408
    No statistical analyses for this end point

    Secondary: Incidence of severe hypoglycaemia

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    End point title
    		 Incidence of severe hypoglycaemia
    End point description
    End point type
    Secondary
    End point timeframe
    incidence of severe hypoglycaemia (total, night-time, daytime) as defined by ADA as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions
    End point values
    		 To receive insulin degludec first To receive insulin glargine U100 first
    Number of subjects analysed
    56
    72
    Units: Episodes of severe hypoglycaemia
    56
    80
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From randomization to one month after study end.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Customized
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No specification

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31337371
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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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