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    Clinical Trial Results:
    A phase IIa, dose-finding, double-blind, placebo-controlled, double-dummy, randomized, eightfold cross-over study to investigate the glucose lowering effects of dextromethorphan alone or in combination with sitagliptin in subjects with type 2 diabetes mellitus (T2DM) after an oral glucose tolerance test

    Summary
    EudraCT number
    		 2013-003356-21
    Trial protocol
    		 DE  
    Global end of trial date
    01 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2020
    First version publication date
    19 Feb 2020
    Other versions
    Summary report(s)
    		 Publication to DXM2

    Trial information

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    Trial identification
    Sponsor protocol code
    00/0648-DXM2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01936025
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Profil Institut für Stoffwechselforschung GmbH
    Sponsor organisation address
    Hellersbergstr. 9, Neuss, Germany, 41460
    Public contact
    Regulatory Affairs, Profil Institut für Stoffwechselforschung GmbH, +49 21314018411, regulatory@profil.com
    Scientific contact
    Regulatory Affairs, Profil Institut für Stoffwechselforschung GmbH, +49 21314018411, regulatory@profil.com
    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 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    First primary objective: to find the lowest dose of DXM that, compared to placebo, exerts BG lowering effects related to an OGTT Second primary objective: to demonstrate whether the administration of DXM on top of sitagliptin exerts additive BG lowering effects related to an OGTT as compared to sitagliptin alone and DXM alone.
    Protection of trial subjects
    While the risk for hypoglycemia might theoretically increase related to an OGTT and treatment with DXM and sitagliptin, subjects will be under tight blood glucose control for several hours post-dosing and will not be discharged unless they will have lunch and their blood glucose is stable. The in-house stay will be prolonged at the discretion of the investigator and according to the individual situation in case of side-effects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Nov 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
    Germany: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    8
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment occured in one trial site

    Pre-assignment
    Screening details
    		 Eligible subjects were male individuals with a diagnosis of T2DM according to ADA criteria at least 4 months prior to screening and on a stable regimen of metformin monotherapy, for at least 3 months, 20 subjects completed the clinical trial.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 DXM30
    Arm description
    		 Treatment with 30 mg Dextromethorphan
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dextromethorphan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 capsule DXM 30 mg (+ 2 capsules DXM placebo + 1 tablet sita placebo)

    Investigational medicinal product name
    Sita Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 tablet sita placebo (+ 1 capsule DXM 30 mg + 2 capsules DXM placebo)

    Investigational medicinal product name
    DXM Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 2 capsules DXM placebo (+ 1 capsule DXM 30 mg + 1 tablet sita placebo)

    Arm title
    		 Sitagliptin
    Arm description
    		 Treatment with 100 mg Sitagliptin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 100 mg sita (+ 3 capsules DXM placebo)

    Investigational medicinal product name
    DXM Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 3 capsules DXM placebo (+ 100 mg sita)

    Arm title
    		 DXM 30/Sita
    Arm description
    		 Treatment with 30 mg Dextrometorphan and 100 mg Sitagliptin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dextromethorphan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 capsule DXM 30 mg (+ 2 capsules DXM placebo + 100 mg sita)

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 100 mg sita (+ 1 capsule DXM 30 mg + 2 capsules DXM placebo)

    Investigational medicinal product name
    DXM Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 2 capsules DXM placebo (+ 1 capsule DXM 30 mg + 100 mg sita )

    Arm title
    		 DXM60
    Arm description
    		 Treatment with 60 mg Dextromethorphan
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dextromethorphan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 2 capsules DXM 30 mg (+ 1 capsule DXM placebo + 1 tablet sita placebo)

    Investigational medicinal product name
    DXM Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 capsule DXM placebo (+ 2 capsules DXM 30 mg + 1 tablet sita placebo)

    Investigational medicinal product name
    Sita Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 tablet sita placebo (+ 2 capsules DXM 30 mg + 1 capsule DXM placebo)

    Arm title
    		 DXM90
    Arm description
    		 Treatment with 90 mg Dextromethorphan
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dextromethorphan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 3 capsules DXM 30 mg (+ 1 tablet sita placebo)

    Investigational medicinal product name
    Sita Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 tablet sita placebo (+ 3 capsules DXM 30 mg)

    Arm title
    		 DXM 60/Sita
    Arm description
    		 Treatment with 60 mg Dextrometorphan and 100 mg Sitagliptin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dextromethorphan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 2 capsules DXM 30 mg (1 capsule DXM placebo + 100 mg sita)

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 100 mg sita (+ 2 capsules DXM 30 mg + 1 capsule DXM placebo)

    Investigational medicinal product name
    DXM Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 capsule DXM placebo (+ 2 capsules DXM 30 mg + 100 mg sita)

    Arm title
    		 DXM 90/Sita
    Arm description
    		 Treatment with 90 mg Dextrometorphan and 100 mg Sitagliptin
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dextromethorphan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 3 capsules DXM 30 mg (+ 100 mg sita)

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 100 mg sita (+ 3 capsules DXM 30 mg)

    Arm title
    		 Placebo
    Arm description
    		 Placebo treatment only
    Arm type
    		 Placebo

    Investigational medicinal product name
    DXM Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 3 capsules DXM placebo (+ 1 tablet sita placebo)

    Investigational medicinal product name
    Sita Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    single dose: 1 tablet sita placebo (+ 3 capsules DXM placebo)

    Number of subjects in period 1
    		DXM30 Sitagliptin DXM 30/Sita DXM60 DXM90 DXM 60/Sita DXM 90/Sita Placebo
    Started
    20
    20
    20
    20
    20
    20
    20
    20
    Completed
    20
    20
    20
    20
    20
    20
    20
    20

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 20 20
    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)
    		 8 8
        From 65-84 years
    		 12 12
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.1 ± 7.1 -
    Gender categorical
    Units: Subjects
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    DXM30
    Reporting group description
    		 Treatment with 30 mg Dextromethorphan

    Reporting group title
    Sitagliptin
    Reporting group description
    		 Treatment with 100 mg Sitagliptin

    Reporting group title
    DXM 30/Sita
    Reporting group description
    		 Treatment with 30 mg Dextrometorphan and 100 mg Sitagliptin

    Reporting group title
    DXM60
    Reporting group description
    		 Treatment with 60 mg Dextromethorphan

    Reporting group title
    DXM90
    Reporting group description
    		 Treatment with 90 mg Dextromethorphan

    Reporting group title
    DXM 60/Sita
    Reporting group description
    		 Treatment with 60 mg Dextrometorphan and 100 mg Sitagliptin

    Reporting group title
    DXM 90/Sita
    Reporting group description
    		 Treatment with 90 mg Dextrometorphan and 100 mg Sitagliptin

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo treatment only

    Primary: AUCBG(1-3h)

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    End point title
    		 AUCBG(1-3h)
    End point description
    End point type
    Primary
    End point timeframe
    1-3h
    End point values
    		 DXM30 Sitagliptin DXM 30/Sita DXM60 DXM90 DXM 60/Sita DXM 90/Sita Placebo
    Number of subjects analysed
    20
    20
    20
    20
    20
    20
    20
    20
    Units: mg/dl/h
        arithmetic mean (standard deviation)
    430.2 ± 64.2
    412.4 ± 74.3
    393.2 ± 77.9
    425.2 ± 78.0
    433.4 ± 76.2
    393.3 ± 73.1
    391.0 ± 92.2
    444.7 ± 69.3
    Statistical analysis title
    		 PD analysis DMX vs Placebo
    Statistical analysis description
    DMX 30, 60 or 90 vs placebo
    Comparison groups
    DXM30 v Placebo v DXM90 v DXM60
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 > 0.05
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 PD analysis Sita vs Placebo
    Comparison groups
    Placebo v Sitagliptin
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 PD analysis DXM/Sita vs Placebo
    Statistical analysis description
    30, 60 or 90mg DMX + 100mg Sita vs placebo
    Comparison groups
    Placebo v DXM 30/Sita v DXM 60/Sita v DXM 90/Sita
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 PD analysis DMX30,60/Sita vs DXM30,60
    Statistical analysis description
    30 or 60 mg DXM + 100 mg Sita vs 30 or 60 mg DXM
    Comparison groups
    DXM30 v DXM 30/Sita v DXM60 v DXM 60/Sita
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Confidence interval
    Statistical analysis title
    		 PD analysis DMX90/Sita vs DXM90
    Statistical analysis description
    90 mg DXM + 100 mg Sita vs 90 mg DXM
    Comparison groups
    DXM90 v DXM 90/Sita
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 as reported
    Dictionary version
    n/a
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 20 (30.00%)
    Vascular disorders
    Painful lymphnode swellings under both armpits
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Husky voice
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Creaky sounds right basal lung and upper bronchi right and left
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Cutaneous abscess on the back
         subjects affected / exposed
    1 / 20 (5.00%)
         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
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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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