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    Clinical Trial Results:
    A randomized, double blind, two-period cross-over trial investigating the effect of liraglutide as add on to intensive insulin treatment on the endogenous glucose production in subjects with C-peptide positive type 1 diabetes mellitus

    Summary
    EudraCT number
    		 2014-001381-96
    Trial protocol
    		 AT  
    Global end of trial date
    04 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2020
    First version publication date
    13 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LG_T1_EGP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02408705
    WHO universal trial number (UTN)
    		 U1111-1151-3332
    Sponsors
    Sponsor organisation name
    Medical University Graz, Univ. Prof. Thomas Pieber, Department of Internal Medicine, Division of Endocrinology and Metabolism
    Sponsor organisation address
    Auenbruggerplatz 15, Graz, Austria, 8036
    Public contact
    Zentrum f. Med. Grundlagenforschung, Medizinische Universität Graz / Endokrinologie und Stoffwechsel, +43 316385 72833, sabine.zenz@medunigraz.at
    Scientific contact
    Zentrum f. Med. Grundlagenforschung, Medizinische Universität Graz / Endokrinologie und Stoffwechsel, +43 316385 72833, sabine.zenz@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
    20 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of liraglutide as add on to intensive insulin treatment on the change of EGP during a hypoglycaemic clamp in C-peptide positive subjects with type 1 diabetes mellitus
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2015
    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: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Single-Center Study - 1 Site in Austria - 14 Subjects For recruitment, we used an electronical diabetes database and contacted hospitals in the region. The recruitment lasted 9 months, and 14 type 1 diabetes patients were enrolled and randomized to the study.

    Pre-assignment
    Screening details
    		 33 Patients have been screened and a total 14 randomizations were performed. 14 subjects completed the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Data analyst
    Blinding implementation details
    Liraglutide and placebo were supplied in similar 3 mL pre-filled injection pens and were visually identical, and packed and labelled to fulfil the requirements for double-blind procedures. Equal volumes of liraglutide and placebo were administered. Blinding was maintained for the whole study period.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Liraglutide
    Arm description
    		 Liraglutide was administered once daily by subcutaneous injection at 10:00 pm. Starting dose of liraglutide was 0.3 mg and the dose was increased weekly by 0.3 mg to reach a dose of 1.2 mg after 4weeks. This final dose was then kept stable for 8 weeks. Insulin-treatment was adjusted depending on the treatment dose and the patient ́s demand. Patients had to document the daily study product administration and each hypoglycaemic event during the study. Each randomized subject was allocated to one of the two treatment sequences (liraglutide/placebo orplacebo/liraglutide) adjunct to intensive insulin treatment for 12 weeks. A wash-out period of 4 week sbetween the two periods was carried out
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liraglutide, 6 mg/mL, 3 mL pre-filled pen
    Investigational medicinal product code
    Other name
    Victoza
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide, 6.0 mg/mL in a 3 mL pre-filled pen was administered once daily by subcutaneous injection at 10:00 pm.

    Arm title
    		 Placebo
    Arm description
    		 Placebo was administered once daily by subcutaneous injection at 10:00 pm. Starting dose of placebo was 0.3 mg and the dose was increased weekly by 0.3 mg to reach a dose of 1.2 mg after 4 weeks. This final dose was then kept stable for 8 weeks. Insulin-treatment was adjusted depending on the treatment dose and the patient ́s demand. Patients had to document the daily study product administration and each hypoglycaemic event during the study. Each randomized subject was allocated to one of the two treatment sequences (liraglutide/placebo or placebo/liraglutide) adjunct to intensive insulin treatment for 12 weeks. A wash-out period of 4 weeks between the two periods was carried out.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Liraglutide placebo, 3 mL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide placebo was administered once daily by subcutaneous injection at 10:00 pm.

    Number of subjects in period 1
    		Liraglutide Placebo
    Started
    14
    14
    Completed
    14
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 -

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 14 14
    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)
    		 14 14
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.6 ( 12.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 7 7
    Fasting C-Peptide
    Baseline characteristics for Fasting C-peptide
    Units: nmol/l
        arithmetic mean (standard deviation)
    		 0.23 ( 0.12 ) -
    HbA1c
    Baseline characteristics HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 50.3 ( 7.2 ) -
    Diabetis duration
    Units: years
        arithmetic mean (standard deviation)
    		 3.43 ( 2.44 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 70.5 ( 12.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 Liraglutide was administered once daily by subcutaneous injection at 10:00 pm. Starting dose of liraglutide was 0.3 mg and the dose was increased weekly by 0.3 mg to reach a dose of 1.2 mg after 4weeks. This final dose was then kept stable for 8 weeks. Insulin-treatment was adjusted depending on the treatment dose and the patient ́s demand. Patients had to document the daily study product administration and each hypoglycaemic event during the study. Each randomized subject was allocated to one of the two treatment sequences (liraglutide/placebo orplacebo/liraglutide) adjunct to intensive insulin treatment for 12 weeks. A wash-out period of 4 week sbetween the two periods was carried out

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo was administered once daily by subcutaneous injection at 10:00 pm. Starting dose of placebo was 0.3 mg and the dose was increased weekly by 0.3 mg to reach a dose of 1.2 mg after 4 weeks. This final dose was then kept stable for 8 weeks. Insulin-treatment was adjusted depending on the treatment dose and the patient ́s demand. Patients had to document the daily study product administration and each hypoglycaemic event during the study. Each randomized subject was allocated to one of the two treatment sequences (liraglutide/placebo or placebo/liraglutide) adjunct to intensive insulin treatment for 12 weeks. A wash-out period of 4 weeks between the two periods was carried out.

    Primary: Area under the curve of endogenous glucose production

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    End point title
    		 Area under the curve of endogenous glucose production
    End point description
    The primary endpoint was defined based on results from a previously performed study as comparison between the AUC values for EGP (AUCEGP) from begin of the 5.5 mmol/l plateau until the end of recovery period (3.9 mmol/l) of the liraglutide-treatment group and those of the placebo-treatment group.
    End point type
    Primary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: mg/kg
    arithmetic mean (standard deviation)
        Liraglutide/Placebo sequence
    45.12 ( 15.36 )
    37.62 ( 14.96 )
        Placebo/Liraglutide sequence
    43.99 ( 15.64 )
    36.86 ( 18.06 )
    Attachments
    		 Untitled (Filename: Study design and Hypoglycaemic design.PNG)
    Untitled (Filename: EGP.PNG)
    Statistical analysis title
    		 Mixed effects model
    Statistical analysis description
    Hypoglycaemic levels were compared with a Kruskal-Wallis test and in case of a statistically significant Kruskal-Wallis test, a pairwise Wilcoxon signed rank tests was performed.
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Treatment effect on Glucose, C-peptide, Glucagon and Gastric emptying (from the paracetamol concentrations) 0-240 min (change after treatment vs. pre-treatment)

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    End point title
    		 Treatment effect on Glucose, C-peptide, Glucagon and Gastric emptying (from the paracetamol concentrations) 0-240 min (change after treatment vs. pre-treatment)
    End point description
    - Area under the C-peptide concentration curve (AUC C-peptide) from time point 0 until 240 min during MMTT - Area under the glucose curve above the average baseline glucose value (average of the -5 and 0 min values) from time point 0 until 240 min during MMTT (AUCglu) - Area under the glucagon curve above the average baseline glucagon value (average of the -5 and 0 min values) from time point 0 until 240 min during MMTT (AUCglucagon) - Gastric emptying calculated from the paracetamol concentrations as the area under the paracetamol concentration curve from time point 0 until 240 min (AUCpara240).
    End point type
    Secondary
    End point timeframe
    During MMTT - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: nmol/l
    arithmetic mean (standard deviation)
        Delta AUC C-peptide 240 min
    7.79 ( 116.19 )
    -9.76 ( 216.73 )
        Delta AUCglu 240 min
    -2582.84 ( 17368.70 )
    -358.13 ( 12154.58 )
        Delta AUCglucagon 240 min
    -240.71 ( 1417.45 )
    -82.33 ( 1557.94 )
        Delta AUCpara 240 min
    16.58 ( 453.41 )
    -13.21 ( 585.60 )
    No statistical analyses for this end point

    Secondary: EGP during Hypoglycaemic clamp

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    End point title
    		 EGP during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: mg/kg/min
    arithmetic mean (standard deviation)
        5.5 mmol/L
    0.65 ( 0.57 )
    0.45 ( 0.22 )
        3.5 mmol/L
    0.58 ( 0.38 )
    0.41 ( 0.30 )
        2.5 mmol/L
    1.03 ( 0.54 )
    0.93 ( 0.54 )
        4.0 mmol/L
    2.19 ( 0.73 )
    1.93 ( 0.81 )
    No statistical analyses for this end point

    Secondary: PGU during Hypoglycaemic clamp

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    End point title
    		 PGU during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: mg/kg/min
    arithmetic mean (standard deviation)
        5.5 mmol/L
    9.33 ( 4.14 )
    9.06 ( 3.85 )
        3.5 mmol/L
    6.11 ( 2.16 )
    6.70 ( 2.92 )
        2.5 mmol/L
    4.08 ( 1.62 )
    4.38 ( 2.11 )
        4.0 mmol/L
    4.63 ( 2.08 )
    3.96 ( 1.27 )
    No statistical analyses for this end point

    Secondary: Glucagon during Hypoglycaemic clamp

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    End point title
    		 Glucagon during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: pmol/l
    arithmetic mean (standard deviation)
        5.5 mmol/L
    1.79 ( 2.16 )
    3.37 ( 2.67 )
        3.5 mmol/L
    4.58 ( 5.31 )
    5.20 ( 4.62 )
        2.5 mmol/L
    17.40 ( 16.47 )
    14.77 ( 15.91 )
        4.0 mmol/L
    12.11 ( 10.24 )
    11.88 ( 9.03 )
    Attachments
    		 Untitled (Filename: Glucagon.PNG)
    No statistical analyses for this end point

    Secondary: C-Peptide during Hypoglycaemic clamp

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    End point title
    		 C-Peptide during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: nmol/l
    arithmetic mean (standard deviation)
        5.5 mmol/L
    0.38 ( 0.44 )
    0.17 ( 0.16 )
        3.5 mmol/L
    0.22 ( 0.20 )
    0.10 ( 0.10 )
        2.5 mmol/L
    0.11 ( 0.14 )
    0.05 ( 0.06 )
        4.0 mmol/L
    0.09 ( 0.13 )
    0.06 ( 0.07 )
    Attachments
    		 Untitled (Filename: C-Peptide.PNG)
    No statistical analyses for this end point

    Secondary: Epinephrine during Hypoglycaemic clamp

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    End point title
    		 Epinephrine during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: pg/ml
    arithmetic mean (standard deviation)
        5.5 mmol/L
    46.07 ( 52.82 )
    46.46 ( 46.25 )
        3.5 mmol/L
    61.57 ( 65.97 )
    64.08 ( 68.25 )
        2.5 mmol/L
    406.00 ( 285.76 )
    401.07 ( 346.98 )
        4.0 mmol/L
    229.79 ( 216.95 )
    219.86 ( 293.71 )
    Attachments
    		 Untitled (Filename: Epinephrine.PNG)
    No statistical analyses for this end point

    Secondary: Norepinephrine during Hypoglycaemic clamp

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    End point title
    		 Norepinephrine during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: pg/ml
    arithmetic mean (standard deviation)
        5.5 mmol/L
    114.57 ( 38.41 )
    108.86 ( 59.38 )
        3.5 mmol/L
    129.14 ( 66.84 )
    128.36 ( 101.98 )
        2.5 mmol/L
    231.00 ( 119.22 )
    226.93 ( 152.72 )
        4.0 mmol/L
    218.00 ( 117.15 )
    191.86 ( 127.17 )
    Attachments
    		 Untitled (Filename: Norepinephrine.PNG)
    No statistical analyses for this end point

    Secondary: Growth hormone during Hypoglycaemic clamp

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    End point title
    		 Growth hormone during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: ng/ml
    arithmetic mean (standard deviation)
        5.5 mmol/L
    2.73 ( 5.37 )
    1.81 ( 2.14 )
        3.5 mmol/L
    3.29 ( 9.31 )
    3.89 ( 6.09 )
        2.5 mmol/L
    8.43 ( 7.19 )
    11.63 ( 11.44 )
        4.0 mmol/L
    10.61 ( 7.93 )
    8.90 ( 7.34 )
    Attachments
    		 Untitled (Filename: Growth hormone.PNG)
    No statistical analyses for this end point

    Secondary: Cotisol during Hypoglycaemic clamp

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    End point title
    		 Cotisol during Hypoglycaemic clamp
    End point description
    End point type
    Secondary
    End point timeframe
    During hypoglycemic clamp - comparison liraglutide vs placebo
    End point values
    		 Liraglutide Placebo
    Number of subjects analysed
    14
    14
    Units: ng/ml
    arithmetic mean (standard deviation)
        5.5 mmol/L
    110.38 ( 53.17 )
    95.27 ( 29.08 )
        3.5 mmol/L
    95.74 ( 38.94 )
    101.26 ( 37.48 )
        2.5 mmol/L
    131.00 ( 55.04 )
    142.66 ( 48.43 )
        4.0 mmol/L
    194.35 ( 62.36 )
    196 ( 69.80 )
    Attachments
    		 Untitled (Filename: Cortisol.PNG)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit regardless of seriousness or relationship to investigational product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 14 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 14 (57.14%)
    7 / 14 (50.00%)
    Vascular disorders
    Anal thrombose
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Graves Disease
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Hematuria
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Reflux
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Uterus Prolaps
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Right shoulder pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Injury, poisoning and procedural complications
    Lower back injury
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Small ankle fracture right foot
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Phlebitis vena intermedia cubita left
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Supraventricular ectopic rhythmus
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Common cold
         subjects affected / exposed
    6 / 14 (42.86%)
    4 / 14 (28.57%)
         occurrences all number
    13
    13
    Tachycardia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 14 (14.29%)
    2 / 14 (14.29%)
         occurrences all number
    5
    5
    Numb left arm
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Blood and lymphatic system disorders
    Right eye bruising
    Additional description: Right eye bruising after bycicle
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Emesis
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Eye disorders
    Fever Blister
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    1 / 14 (7.14%)
    2 / 14 (14.29%)
         occurrences all number
    3
    3
    Nausea
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    3
    3
    Constipation
         subjects affected / exposed
    2 / 14 (14.29%)
    0 / 14 (0.00%)
         occurrences all number
    2
    2
    Vomiting
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Abdomen pain
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    2 / 14 (14.29%)
    1 / 14 (7.14%)
         occurrences all number
    3
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Infections and infestations
    Paronychia
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    2
    2
    Genital infection
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Metabolism and nutrition disorders
    Iron deficiencies
         subjects affected / exposed
    3 / 14 (21.43%)
    4 / 14 (28.57%)
         occurrences all number
    8
    8
    Muscle Pain
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    3
    3
    Hyperglycemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Loss of appetite
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    Hypokalemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2014
    I) The study protocol was amended regarding: 1) The timetable 2) Secondary objectives and Secondary Endpoints 3) Inclusion criterion of the BMI in this study was between 20.0 - 25.0 kg/m² and not as initial stated (28.0 kg/m²) 5) Table overview 6) Additional information added regarding blood analysis, blood sample of glucagon and deut. glucose, 7) Randomization information 7) The chapter Data analysis has been update II) The Patient Information and consent form has been updated regarding the total amount of blood drawn in one treatment period
    06 Mar 2015
    I) The Protocol has been amended regarding: 1) The timetable 2) The HbA1c range 3) The Body mass index range has been wided 4) The Amylase blood values has been changed from "outside normal range" to "above normal range" 5) The time for the intake of thyroid hormones has been changed f 6) The timeline for the intake of thyroid hormones has been changed 7) An additional laboratory examination of TSH has been added 8) Timepoint for blood sampling for the TSH examination has been added

    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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