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    Clinical Trial Results:
    Treatment of hypoglycemia following gastric bypass surgery

    Summary
    EudraCT number
    		 2015-001086-50
    Trial protocol
    		 DK  
    Global end of trial date
    08 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2020
    First version publication date
    06 Apr 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    HypoGB2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dorte Lindqvist Hansen
    Sponsor organisation address
    lykkevækvej 1, Køge, Denmark, 4600
    Public contact
    Caroline Christfort Gormsen, Køge Sygehus, cacg@regionsjaelland.dk
    Scientific contact
    Caroline Christfort Gormsen, Køge Sygehus, cacg@regionsjaelland.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
    01 Sep 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the effects of 5 different pharmacological treatments on glucosemetabolism in patients with postprandial hypoglycemia following gastric bypass surgery.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 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
    Denmark: 11
    Worldwide total number of subjects
    11
    EEA total number of subjects
    11
    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)
    11
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was performed as planned, although it was not possible to recruit the planned number of 16 participants within the given time period for the study conduction, and thus, only 11 participants were included in the study.

    Pre-assignment
    Screening details
    		 At screening, all participants underwent at 6-day continuous glucose monitoring (CGM) to verify postprandial hypoglycemia. Furthermore, participants were examined for fasting hypoglycemia, fasting hyperinsulinemia and anemia.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinding was not perfomed due to different formulations and dosage frequencies of the studied therapeutics

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Baseline
    Arm description
    		 The baseline arm consisted of a 6-day CGM recording and a mixed meal tolerance test (MMT) without treatment intervention.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Acarbose
    Arm description
    		 Participants completed 1 week treatment with acarbose 50 mg at every meal together with CGM. After 1 week treatment, participants underwent a MMT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    acarbose
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg administered at every meal for 7 days.

    Arm title
    		 Sitagliptin
    Arm description
    		 Participants completed 1 week treatment with sitagliptin 100 mg once daily together with CGM. After 1 week treatment, participants underwent a MMT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg taken once daily for 7 days.

    Arm title
    		 Verapamil
    Arm description
    		 Participants completed 1 week treatment with verapamil 120 mg once daily together with CGM. After 1 week treatment, participants underwent a MMT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    verapamil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg taken once daily for 7 days.

    Arm title
    		 Liraglutide
    Arm description
    		 Participants completed three weeks treatment with liraglutide, titrated from 0.6 to 1.2 mg once daily. During the last week of liraglutide treatment, participants also wore CGM. After the three weeks treatment period, participants underwent a MMT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.6 mg once daily for 7 days and then 1.2 mg once daily for 14 days.

    Arm title
    		 Pasireotide
    Arm description
    		 Participants received a 300 ug pasireotide injection 30 minutes prior to a MMT.
    Arm type
    		 Experimental

    Investigational medicinal product name
    pasireotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 ug given as a single dose prior to a mixed meal tolerance test.

    Number of subjects in period 1
    		Baseline Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Started
    11
    11
    11
    11
    11
    11
    Completed
    11
    10
    11
    11
    11
    11
    Not completed
    0
    1
    0
    0
    0
    0
         Adverse event, non-fatal
    -
    1
    -
    -
    -
    -

    Baseline characteristics

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

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 11 11
    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)
    		 11 11
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45 ± 8 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 The baseline arm consisted of a 6-day CGM recording and a mixed meal tolerance test (MMT) without treatment intervention.

    Reporting group title
    Acarbose
    Reporting group description
    		 Participants completed 1 week treatment with acarbose 50 mg at every meal together with CGM. After 1 week treatment, participants underwent a MMT.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 Participants completed 1 week treatment with sitagliptin 100 mg once daily together with CGM. After 1 week treatment, participants underwent a MMT.

    Reporting group title
    Verapamil
    Reporting group description
    		 Participants completed 1 week treatment with verapamil 120 mg once daily together with CGM. After 1 week treatment, participants underwent a MMT.

    Reporting group title
    Liraglutide
    Reporting group description
    		 Participants completed three weeks treatment with liraglutide, titrated from 0.6 to 1.2 mg once daily. During the last week of liraglutide treatment, participants also wore CGM. After the three weeks treatment period, participants underwent a MMT.

    Reporting group title
    Pasireotide
    Reporting group description
    		 Participants received a 300 ug pasireotide injection 30 minutes prior to a MMT.

    Primary: Nadir blood glucose

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    End point title
    		 Nadir blood glucose
    End point description
    Nadir blood glucose concentration during a mixed meal tolerance test with and without prior treatment intervention
    End point type
    Primary
    End point timeframe
    End point was assessed during each study arm
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Number of subjects analysed
    11
    10
    11
    11
    11
    11
    Units: mmol/l
        arithmetic mean (standard error)
    3.4 ± 0.2
    3.9 ± 0.2
    3.0 ± 0.2
    3.3 ± 0.2
    3.3 ± 0.2
    7.9 ± 0.4
    Statistical analysis title
    		 linear mixed models
    Statistical analysis description
    The effects of treatment intervention was analysed using a linear mixed model analysis comparing treatment effect to baseline.
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide v Pasireotide
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Time in hypoglycemia

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    End point title
    		 Time in hypoglycemia
    End point description
    Time in hypoglycemia was assessed as minutes spend with blood glucose values <3.9 mmoL/l during a mixed meal tolerance test with and without treatment intervention.
    End point type
    Secondary
    End point timeframe
    during each study arm
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Number of subjects analysed
    11
    10
    11
    11
    11
    11
    Units: minutes
        arithmetic mean (standard error)
    48 ± 12
    5 ± 3
    67 ± 10
    46 ± 11
    55 ± 9
    0 ± 0
    Statistical analysis title
    		 mixed models analysis
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide v Pasireotide
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Peak blood glucose

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    End point title
    		 Peak blood glucose
    End point description
    Peak blood glucose level during a mixed meal tolerance test with and without treatment intervention
    End point type
    Secondary
    End point timeframe
    During each study arm
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Number of subjects analysed
    11
    10
    11
    11
    11
    11
    Units: mmol/l
        arithmetic mean (standard error)
    10 ± 0.4
    6.6 ± 0.6
    9.6 ± 0.5
    9.3 ± 0.4
    9.4 ± 0.4
    14.5 ± 0.5
    Statistical analysis title
    		 linear mixed models
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide v Pasireotide
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.5
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Time in hyperglycemia

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    End point title
    		 Time in hyperglycemia
    End point description
    Minutes spend with glucose levels >7.9 mmol/l during a mixed meal tolerance test with and without treatment intervention
    End point type
    Secondary
    End point timeframe
    during each study arm
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Number of subjects analysed
    11
    10
    11
    11
    11
    11
    Units: minutes
        arithmetic mean (standard error)
    29 ± 4
    5 ± 5
    22 ± 6
    29 ± 6
    29 ± 5
    159 ± 6
    Statistical analysis title
    		 linear mixed models
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide v Pasireotide
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Other pre-specified: Time in hypoglycemia (CGM)

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    End point title
    		 Time in hypoglycemia (CGM) [1]
    End point description
    Percentage of total recording time spend with glucose levels < 3.9 mmol/l during a 6-day continuous glucose monitorin with an without treatment intervention.
    End point type
    Other pre-specified
    End point timeframe
    during each study arm except f (treatment with pasireotide)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Continuous glucose monitoring (CGM) was not performed for the pasireotide arm, and thus this arm was not included in the statistics for all CGM outcomes.
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide
    Number of subjects analysed
    11
    11
    11
    11
    11
    Units: percent
        arithmetic mean (standard error)
    6.2 ± 1.3
    4.9 ± 1.1
    9.4 ± 2.5
    7.5 ± 3.1
    9.4 ± 2.6
    Statistical analysis title
    		 linear mixed models
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Other pre-specified: Time in hyperglycemia (CGM)

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    End point title
    		 Time in hyperglycemia (CGM) [2]
    End point description
    Percentage of total recording time spend with glucose levels < 3.9 mmol/l during a 6-day continuous glucose monitoring with an without treatment intervention.
    End point type
    Other pre-specified
    End point timeframe
    during each study arm except f (treatment with pasireotide)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Continuous glucose monitoring (CGM) was not performed for the pasireotide arm, and thus this arm was not included in the statistics for all CGM outcomes.
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide
    Number of subjects analysed
    11
    11
    11
    11
    11
    Units: percentage time
        arithmetic mean (standard error)
    8.8 ± 1.3
    4.2 ± 0.9
    4.8 ± 1.3
    10.4 ± 1.6
    4.8 ± 1.0
    Statistical analysis title
    		 linear mixed models
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Other pre-specified: Hypoglycemic events (CGM)

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    End point title
    		 Hypoglycemic events (CGM) [3]
    End point description
    Number of hypoglycemic events per day during a 6-day continuous glucose monitoring with an without treatment intervention.
    End point type
    Other pre-specified
    End point timeframe
    during each study arm except f (treatment with pasireotide
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Continuous glucose monitoring (CGM) was not performed for the pasireotide arm, and thus this arm was not included in the statistics for all CGM outcomes.
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide
    Number of subjects analysed
    11
    11
    11
    11
    11
    Units: events/day
        arithmetic mean (standard error)
    1.5 ± 0.2
    1.4 ± 0.3
    1.9 ± 0.3
    1.4 ± 0.3
    1.8 ± 0.4
    Statistical analysis title
    		 linear mixed models
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Other pre-specified: Stanard deviation (CGM)

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    End point title
    		 Stanard deviation (CGM) [4]
    End point description
    Stanard deviation of the mean glucose value during a 6-day continuous glucose monitoring with an without treatment intervention.
    End point type
    Other pre-specified
    End point timeframe
    during each study arm except f (treatment with pasireotide)
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Continuous glucose monitoring (CGM) was not performed for the pasireotide arm, and thus this arm was not included in the statistics for all CGM outcomes.
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide
    Number of subjects analysed
    11
    11
    11
    11
    11
    Units: mmol/l
        arithmetic mean (standard error)
    1.5 ± 0.1
    1.1 ± 0.1
    1.2 ± 0.1
    1.6 ± 0.1
    1.2 ± 0.1
    Statistical analysis title
    		 linear mixed models
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Other pre-specified: iAUC for GLP-1

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    End point title
    		 iAUC for GLP-1
    End point description
    The baseline subtracted area under the curve for GLP-1 (glucagon-like peptide 1) during a mixed meal test with an without treatment intervention
    End point type
    Other pre-specified
    End point timeframe
    During all study arms.
    End point values
    		 Baseline Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Number of subjects analysed
    11
    10
    11
    11
    11
    11
    Units: (nmol/L)/min
        arithmetic mean (standard error)
    4829 ± 632
    5113 ± 750
    4996 ± 717
    4372 ± 694
    6295 ± 930
    1379 ± 290
    Statistical analysis title
    		 linear mixed models
    Comparison groups
    Baseline v Acarbose v Sitagliptin v Verapamil v Liraglutide v Pasireotide
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout each study arm (=treatment period)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Acarbose
    Reporting group description
    		 Participants completed 1 week treatment with acarbose 50 mg at every meal together with CGM. After 1 week treatment, participants underwent a MMT.

    Reporting group title
    Sitagliptin
    Reporting group description
    		 Participants completed 1 week treatment with sitagliptin 100 mg once daily together with CGM. After 1 week treatment, participants underwent a MMT.

    Reporting group title
    Verapamil
    Reporting group description
    		 Participants completed 1 week treatment with verapamil 120 mg once daily together with CGM. After 1 week treatment, participants underwent a MMT.

    Reporting group title
    Liraglutide
    Reporting group description
    		 Participants completed three weeks treatment with liraglutide, titrated from 0.6 to 1.2 mg once daily. During the last week of liraglutide treatment, participants also wore CGM. After the three weeks treatment period, participants underwent a MMT.

    Reporting group title
    Pasireotide
    Reporting group description
    		 Participants received a 300 ug pasireotide injection 30 minutes prior to a MMT.

    Serious adverse events
    		 Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Acarbose Sitagliptin Verapamil Liraglutide Pasireotide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 11 (81.82%)
    4 / 11 (36.36%)
    2 / 11 (18.18%)
    8 / 11 (72.73%)
    4 / 11 (36.36%)
    Vascular disorders
    Palpitations
    Additional description: s
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    9
    0
    Nervous system disorders
    dizziness
         subjects affected / exposed
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    9
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 11 (9.09%)
    2 / 11 (18.18%)
    2 / 11 (18.18%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    9
    18
    18
    9
    0
    General disorders and administration site conditions
    Tiredness
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    2 / 11 (18.18%)
    4 / 11 (36.36%)
         occurrences all number
    0
    0
    0
    18
    36
    Gastrointestinal disorders
    nausea
         subjects affected / exposed
    1 / 11 (9.09%)
    4 / 11 (36.36%)
    1 / 11 (9.09%)
    5 / 11 (45.45%)
    1 / 11 (9.09%)
         occurrences all number
    9
    36
    9
    45
    9
    Abdominal pain
         subjects affected / exposed
    6 / 11 (54.55%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    55
    0
    0
    0
    0
    Reduced appetite
         subjects affected / exposed
    1 / 11 (9.09%)
    3 / 11 (27.27%)
    0 / 11 (0.00%)
    5 / 11 (45.45%)
    0 / 11 (0.00%)
         occurrences all number
    9
    27
    0
    45
    0
    Abdominal bloating
         subjects affected / exposed
    6 / 11 (54.55%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    55
    0
    0
    9
    0
    vomiting
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    1 / 11 (9.09%)
         occurrences all number
    0
    0
    0
    9
    9
    Diarrhoea
         subjects affected / exposed
    2 / 11 (18.18%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    18
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Allergic skin reaction
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    0 / 11 (0.00%)
    1 / 11 (9.09%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    9
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2015
    Change of inclusion and exclusion criteria.

    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.
    It was not possible to recruit 16 participants (as decided by protocol) and thus only 11 particpants were included in the study. One participant did not complete the full study arm with acarbose treatment.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/31144430
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