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    Clinical Trial Results:
    Effect of treatment with testosterone undecaonat in patients with Diabetes Mellitus Type 1 (DM-1) and hipogonadotrophic hypogonadism

    Summary
    EudraCT number
    		 2012-000291-42
    Trial protocol
    		 ES  
    Global end of trial date
    31 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2020
    First version publication date
    21 Feb 2020
    Other versions
    Summary report(s)
    		 Summary TEST-DM1

    Trial information

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    Trial identification
    Sponsor protocol code
    TEST-DM1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Parc de Salut Mar
    Sponsor organisation address
    Passeig Maritim 23, Barcelona, Spain,
    Public contact
    Servicio de Endocrinología, Hospital del Mar, 0034 932483902, JChillaron@parcdesalutmar.cat
    Scientific contact
    Servicio de Endocrinología, Hospital del Mar, 0034 932483902, JChillaron@parcdesalutmar.cat
    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
    04 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on insulin sensitivity, measured by eGDR (estimated Glucose Disposal Rate) and evaluate the effectiveness of testosterone replacement therapy in patients with DM1 and hypogonadotropic hypogonadism on the control anthropometric parameters glycemic blood pressure and lipid profile.
    Protection of trial subjects
    The three injections administered during the trial were administered according to the usual technique, trying to minimize pain in the area.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2012
    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
    Spain: 13
    Worldwide total number of subjects
    13
    EEA total number of subjects
    13
    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)
    13
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment process: July 2012-Feb 2015 in 3 endocrinology departments (Hospital del Mar, Hospital Dos de Maig, Hospital Moisès Broggi)

    Pre-assignment
    Screening details
    		 Screening was performed in 202 T1D patients of whom 21 had hypogonadotropic hypogonadism, constituting a prevalence of 10.4% (95% CI: 6.2-14.6%). Six patients were excluded owing to contraindications for TU treatment (5 benign prostatic hyperplasia, 1 polyglobulia), one had an empty sella on MRI and one refused to give his consent.

    Period 1
    Period 1 title
    Overall trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Reandron/placebo had exactly the same appearance

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Baseline, 6 and 16 week.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo administration by intramuscular route at 0, 6 and 16 weeks

    Arm title
    		 Undecanoate testosterone
    Arm description
    		 1000 mg undecanoate testosterone at baseline, 6 and 16 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Testosterone undecanoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1000 mg at baseline, 6 and 16 week.

    Number of subjects in period 1
    		Placebo Undecanoate testosterone
    Started
    7
    6
    Completed
    6
    5
    Not completed
    1
    1
         Lost to follow-up
    1
    1
    Period 2
    Period 2 title
    22 weeks
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Reandron/placebo had exactly the same appearance

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Undecanoate testosterone
    Arm description
    		 1000 mg testosterone undecanoate at week 0, 6 and 16 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Undecanoate testosterone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection/infusion
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1000 mg undecanoate testosterone

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection at 0, 6 and 16 weeks

    Number of subjects in period 2
    		Undecanoate testosterone Placebo
    Started
    5
    6
    Completed
    5
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Overall group

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 13 13
    Age categorical
    Recruited patients were 30-65 years old
    Units: Subjects
        30-65
    		 13 13
    Age continuous
    46.3 +- 9.8 y
    Units: years
        arithmetic mean (standard deviation)
    		 46.3 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 13 13

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Baseline, 6 and 16 week.

    Reporting group title
    Undecanoate testosterone
    Reporting group description
    		 1000 mg undecanoate testosterone at baseline, 6 and 16 weeks
    Reporting group title
    Undecanoate testosterone
    Reporting group description
    		 1000 mg testosterone undecanoate at week 0, 6 and 16 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Insulin sensitivity

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    End point title
    		 Insulin sensitivity
    End point description
    End point type
    Primary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: mg/Kg*min
        arithmetic mean (standard deviation)
    4.9 ± 1.3
    6.12 ± 2.2
    6.42 ± 1.8
    5.05 ± 1.3
    Statistical analysis title
    		 t Student
    Comparison groups
    Placebo v Undecanoate testosterone v Placebo v Undecanoate testosterone
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.276
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Primary: Glycemic control-HbA1c

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    End point title
    		 Glycemic control-HbA1c
    End point description
    End point type
    Primary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: %
        arithmetic mean (standard deviation)
    8.6 ± 1.7
    7.6 ± 0.5
    7.2 ± 0.7
    7.7 ± 0.5
    Statistical analysis title
    		 t Student
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.977
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Body mass index

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    End point title
    		 Body mass index
    End point description
    Testosterone undecanoate + 0.13 +- 1.1 Placebo +0.28 +- 0.3 P 0.753
    End point type
    Primary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: Kg/m2
        arithmetic mean (standard deviation)
    34.5 ± 8.5
    30.2 ± 3.3
    30.3 ± 2.8
    37.1 ± 6.3
    Statistical analysis title
    		 t Student
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.753
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Primary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure
    End point description
    Testosterone undecanoate -9.6 +- 11.9 Placebo + 8.8 +- 22.8 P 0.138
    End point type
    Primary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: mm Hg
        arithmetic mean (standard deviation)
    139.9 ± 15.6
    144.8 ± 12.9
    135.2 ± 23.7
    149.5 ± 14.4
    Statistical analysis title
    		 t student
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.138
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure
    End point description
    Testosterone undecanoate +1.0 +- 4.5 Placebo +8.8 +- 22.8 P 0.819
    End point type
    Primary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: mm Hg
        arithmetic mean (standard deviation)
    83.4 ± 13.3
    81.4 ± 1.1
    76.4 ± 6.5
    86.2 ± 14.6
    Statistical analysis title
    		 t student
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.819
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: LDL-cholesterol

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    End point title
    		 LDL-cholesterol
    End point description
    Testosterone undecanoate -30.2 +- 22.1 Placebo +10.5 +- 13.4 P 0.004
    End point type
    Primary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: mg/dL
        arithmetic mean (standard deviation)
    118.9 ± 86.5
    114.2 ± 16.1
    84 ± 14.53
    97.7 ± 20.0
    Statistical analysis title
    		 t student
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Primary: HDL cholesterol

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    End point title
    		 HDL cholesterol
    End point description
    Testosterone undecanoate +2.2 +- 4.3 Placebo +0.9 +- 3.1 P 0.567
    End point type
    Primary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: mg/dL
        arithmetic mean (standard deviation)
    42.0 ± 6.1
    39.8 ± 9.1
    42 ± 8.4
    42.8 ± 6.7
    Statistical analysis title
    		 t student
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.567
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Triglycerides

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    End point title
    		 Triglycerides
    End point description
    End point type
    Primary
    End point timeframe
    22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: mg/dL
        median (full range (min-max))
    105 (61 to 700)
    105 (71 to 150)
    66 (49 to 92)
    108 (60 to 218)
    Statistical analysis title
    		 t student
    Statistical analysis description
    Change 22 weeks
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: International Index Erectile Function- 5 Test

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    End point title
    		 International Index Erectile Function- 5 Test
    End point description
    Testosterone undecanoate + 5.0 +- 7.5 Placebo +0.5 +- 2.1 P 0.800
    End point type
    Secondary
    End point timeframe
    Change at 22 weeks
    End point values
    		 Placebo Undecanoate testosterone Undecanoate testosterone Placebo
    Number of subjects analysed
    7
    6
    5
    6
    Units: Escale number
        arithmetic mean (standard deviation)
    17.3 ± 4.9
    13.4 ± 7.3
    18.4 ± 7.6
    17.8 ± 5.1
    Statistical analysis title
    		 t student
    Comparison groups
    Placebo v Undecanoate testosterone v Undecanoate testosterone v Placebo
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event assessment was evaluated in each visit.
    Adverse event reporting additional description
    One patient in the placebo group reported pain at the injection site, which resolved with conventional analgesia in less than 48 hours.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2012
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Pain at the injection site

    Serious adverse events
    		 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 7 (14.29%)
    Skin and subcutaneous tissue disorders
    Pain at injection site
         subjects affected / exposed
    1 / 7 (14.29%)
         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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27452372
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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
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