Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    DPP4 inhibitors in Type 1 Diabetes

    Summary
    EudraCT number
    		 2012-002407-18
    Trial protocol
    		 GB  
    Global end of trial date
    23 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jun 2017
    First version publication date
    22 Jun 2017
    Other versions
    Summary report(s)
    		 DPPIV inhibitors manusript

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    2012DM07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01922817
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor No: 2012DM07
    Sponsors
    Sponsor organisation name
    University of Dundee/NHS Tayside
    Sponsor organisation address
    Tayside Medical Science Centre, Dundee, United Kingdom, DD1 9SY
    Public contact
    Catrina Forde, University of Dundeee, 44 01382 383890, c.forde@dundee.ac.uk
    Scientific contact
    Catrina Forde, University of Dundeee, 44 01382 383890, c.forde@dundee.ac.uk
    Sponsor organisation name
    University of Dundee/NHS Tayside
    Sponsor organisation address
    Tayside Medical Science Centre, Dundee, United Kingdom, DD1 9SY
    Public contact
    Dr Catrina Forde, University of Dundee, 44 01382 383890, c.forde@dundee.ac.uk
    Scientific contact
    Dr Catrina Forde, University of Dundee, 44 01382 383890, c.forde@dundee.ac.uk
    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
    30 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The body secretes hormones such as adrenaline as a response to low blood sugars. Patients who have had insulin dependant diabetes for over 5 years rely heavily on adrenaline release, to produce symptoms, so that they can respond appropriately to low blood sugars. However, this response is blunted in those with Type 1 diabetes. Our question is whether the degree of this response can be increased by use of 3 months of the DPP4inhibitor, so that patients become better aware of hypoglycaemia.
    Protection of trial subjects
    All patients notes were scrutinized thoroughly before enrolling on the trial, to ensure their suitability for the trial, and that they satisfied all inclusion and exclusion criteria. Once they entered the trial, there was regular contact between PI and patient to ensure there were no emerging AEs. There was good training of all personnel, to ensure the hypoglycaemic clamp was performed safely.
    Background therapy
    		 Type 1 diabetes patients to continue with their usual insulin regime. IMP was saxagliptin 5mg once daily.
    Evidence for comparator
    		 Comparator was Placebo (lactose filled hard gelatin capsules).
    Actual start date of recruitment
    03 Sep 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
    United Kingdom: 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

    		 Close Top of page
    Recruitment
    Recruitment details
    		 September 2012 to July 2013 Recruited mainly from the diabetes clinics at Ninewells Hospital and from the SCI-Diabetes database.

    Pre-assignment
    Screening details
    		 Screening for eligibility carried out and signed off by the PI. 4 week run in period to optimize diabetes therapy prior to the start of the randomised treatment period.

    Pre-assignment period milestones
    Number of subjects started
    		 14
    Number of subjects completed
    		 14

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer
    Blinding implementation details
    Matched placebo

    Arms
    Arm title
    		 Treatment arm 1
    Arm description
    		 12 weeks treatment followed by 2 week wash out followed by cross over to opposite treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    saxagliptin
    Investigational medicinal product code
    Other name
    Onglyza
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5mg once daily

    Number of subjects in period 1
    		Treatment arm 1
    Started
    14
    Completed
    14
    Period 2
    Period 2 title
    Treatment period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Arm title
    		 Treatment arm 1
    Arm description
    		 12 weeks treatment followed by 2 week wash out followed by cross over to opposite treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    saxagliptin
    Investigational medicinal product code
    Other name
    Onglyza
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5mg once daily

    Number of subjects in period 2
    		Treatment arm 1
    Started
    14
    Completed
    14

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 12 weeks treatment followed by 2 week wash out followed by cross over to opposite treatment

    Reporting group values
    		 Treatment arm 1 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
    Age at consent
    Units: years
        arithmetic mean (full range (min-max))
    		 45 (35 to 53) -
    Gender categorical
    Male or female
    Units: Subjects
        Female
    		 6 6
        Male
    		 8 8

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 12 weeks treatment followed by 2 week wash out followed by cross over to opposite treatment
    Reporting group title
    Treatment arm 1
    Reporting group description
    		 12 weeks treatment followed by 2 week wash out followed by cross over to opposite treatment

    Primary: Magnitude of epinephrine response at blood glucose of 2.5mmol/L

    		 Close Top of page
    End point title
    		 Magnitude of epinephrine response at blood glucose of 2.5mmol/L
    End point description
    End point type
    Primary
    End point timeframe
    During clamp period
    End point values
    		 Treatment arm 1 Treatment arm 1
    Number of subjects analysed
    14
    14
    Units: pmol/L
        number (not applicable)
    14
    14
    Statistical analysis title
    		 Paired T test
    Statistical analysis description
    Prior power calculations indicated that 12 participants were needed for a matched analysis, with 80% power to detect a difference in change of 450 pmol/l, with a standard deviation of 500 and a two-sided a value of 0.05. This difference in the adrenaline response was chosen based on previous published work
    Comparison groups
    Treatment arm 1 v Treatment arm 1
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    450
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 132
         upper limit
    		 767
    Variability estimate
    Standard deviation

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Consent to last study visit
    Adverse event reporting additional description
    Recorded all AEs and SAEs but will not report on the common side effects of the drug such as upper respiratory/urinary tract infections, gastroenteritis, hypoglycaemia, headache, vomiting and rash.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Saxagliptin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Saxagliptin 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: 1%
    Non-serious adverse events
    		 Saxagliptin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 14 (28.57%)
    8 / 14 (57.14%)
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    1 / 14 (7.14%)
    1 / 14 (7.14%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 14 (0.00%)
    3 / 14 (21.43%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Invertebral disc protrusion
         subjects affected / exposed
    1 / 14 (7.14%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    2 / 14 (14.29%)
    3 / 14 (21.43%)
         occurrences all number
    2
    3
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 14 (0.00%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    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/26642301
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Apr 25 07:21:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA