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    Clinical Trial Results:
    The Effect of Sitagliptin on Glucagon Dynamics and Incretin Hormones During Mild Hypoglycemia in Elderly Patients with Metformin-Treated Type 2 Diabetes

    Summary
    EudraCT number
    		 2014-002685-70
    Trial protocol
    		 SE  
    Global end of trial date
    13 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2021
    First version publication date
    10 Mar 2021
    Other versions
    Summary report(s)
    		 2014-002685-70 Results

    Trial information

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    Trial identification
    Sponsor protocol code
    300A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02256189
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lund university
    Sponsor organisation address
    Sölvegatan 19, Lund, Sweden, 22184
    Public contact
    Bo Ahrén, Lund university, 46 462220758, Bo.Ahren@med.lu.se
    Scientific contact
    Bo Ahrén, Lund university, 46 462220758, Bo.Ahren@med.lu.se
    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
    15 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess if sitagliptin can improve the glucagon secretory response to mild hypoglycemia in elderly patients with metformin-treated type 2 diabetes.
    Protection of trial subjects
    Subjects with type 2 diabetes
    Background therapy
    		 Metformin
    Evidence for comparator
    		 Sitagliptin versus placebo
    Actual start date of recruitment
    15 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    28
    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)
    0
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 28 subjects were recruited through hospitals

    Pre-assignment
    Screening details
    		 Subjects were examined by physician and lab tests were taken

    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
    		 Investigator, Monitor, Data analyst, Subject
    Blinding implementation details
    Patients received sitagliptin or placebo first, then placebo or sitagliptin. Randomization and blinding were handled by the University hospital pharmacist.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sitagliptin
    Arm description
    		 Sitagliptin 100mg once daily for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by placebo treatment for 4 weeks followed by a hypoglycaemic clamp.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Sitagliptin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg once daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo treatment for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by treatment with sitagliptin 100 mg daily for four weeks followed by a hypoglycaemic clamp.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo tablet Daily for four weeks

    Number of subjects in period 1
    		Sitagliptin Placebo
    Started
    15
    13
    Completed
    15
    13

    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
    		 28 28
    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)
    		 0 0
        From 65-84 years
    		 28 28
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.6 ( 5.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 17 17
    HbA1c
    Units: mmol/mol
        arithmetic mean (standard deviation)
    		 51.5 ( 7.2 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 30.2 ( 4.7 ) -
    Diabetes duration
    Units: years
        arithmetic mean (standard deviation)
    		 9.2 ( 6.6 ) -

    End points

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    End points reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 Sitagliptin 100mg once daily for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by placebo treatment for 4 weeks followed by a hypoglycaemic clamp.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo treatment for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by treatment with sitagliptin 100 mg daily for four weeks followed by a hypoglycaemic clamp.

    Primary: Glucagon levels at 3.5 mmol/L glucose during hypoglycaemic clamp

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    End point title
    		 Glucagon levels at 3.5 mmol/L glucose during hypoglycaemic clamp
    End point description
    End point type
    Primary
    End point timeframe
    30 min after start of hypoglycaemia clamp
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    15
    13
    Units: pmol/L
        arithmetic mean (standard error)
    27.2 ( 1.7 )
    32.2 ( 2.1 )
    Statistical analysis title
    		 t-test
    Comparison groups
    Sitagliptin v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Glucagon levels at 3.1 mmol/L glucose during hypoglycaemic clamp

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    End point title
    		 Glucagon levels at 3.1 mmol/L glucose during hypoglycaemic clamp
    End point description
    End point type
    Primary
    End point timeframe
    60 min after start of hypoglycaemia clamp
    End point values
    		 Sitagliptin Placebo
    Number of subjects analysed
    15
    13
    Units: pmol/L
        arithmetic mean (standard error)
    41.7 ( 3.4 )
    43.2 ( 2.2 )
    Statistical analysis title
    		 t-test
    Comparison groups
    Sitagliptin v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.18
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Four weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Sitagliptin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Sitagliptin 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
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Sitagliptin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 14 (35.71%)
    5 / 14 (35.71%)
    Musculoskeletal and connective tissue disorders
    Joint stiffness
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Infections and infestations
    Common cold
         subjects affected / exposed
    4 / 14 (28.57%)
    4 / 14 (28.57%)
         occurrences all number
    4
    4

    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/29645341
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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