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   44235   clinical trials with a EudraCT protocol, of which   7336   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

    Print Download

    Summary
    EudraCT Number:2014-001441-24
    Sponsor's Protocol Code Number:CUI_001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2014-001441-24
    A.3Full title of the trial
    Short-term effect of SGLT 2-inhibitor dapagliflozin on postprandial glucose excursion and insulin sensitivity in type 1 diabetic patients.
    Kurzzeiteffekt des SGLT 2- Inhibitors Dapagliflozin auf die postprandiale Glucose-Exkursion und Insulinsensitivität bei Typ 1 Diabetikern.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Short-term effects of the substance dapagliflozin on the increase of blood sugar concentrations after meal and insulinsensitivity in type 1 diabetic patients.
    Kurzzeiteffekte der Substanz Dapagliflozin auf den Anstieg der Blutzuckerkonzentration nach dem Essen und die Insulinsensitivität in Patienten mit Typ 1 Diabetes.
    A.4.1Sponsor's protocol code numberCUI_001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University Innsbruck
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical University Innsbruck
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University Innsbruck
    B.5.2Functional name of contact pointClinical Trial Center (OE CTC)
    B.5.3 Address:
    B.5.3.1Street AddressAnichstraße 29
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number0043512900370086
    B.5.5Fax number0043512900373086
    B.5.6E-mailctc@i-med.ac.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Forxiga
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDapagliflozin, Forxiga (trade name)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDapagliflozin
    D.3.9.1CAS number 461432-26-8
    D.3.9.2Current sponsor codeBMS-512148-05
    D.3.9.3Other descriptive nameDAPAGLIFLOZIN
    D.3.9.4EV Substance CodeSUB31650
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    effects of Dapagliflozin on postprandial glucose excursion and fasting glucose homeostasis
    Effekt von Dapagliflozin auf postprandiale Glukoseexkursion und Fasten-Glucosehomeostase
    E.1.1.1Medical condition in easily understood language
    effects of Dapagliflozin on blood sugar increase after a meal and maintainance of a favourable blood sugar concentration during fasting
    Effekt von Dapagliflozin auf die Blutzuckerkonzentration nach dem Essen und den Erhalt einer gesunden Blutzuckerkonzenzentration während dem Fasten
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Changes in postprandial glucose excursion and fasting glucose homeostasis
    Änderungen der postprandialen Glukoseexkursion und der Fasten-Glukosehomeostase
    E.2.2Secondary objectives of the trial
    not applicable
    nicht anwendbar
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Typ 1 Diabetes Mellitus (duration at least 5 years)
    - C-Peptid < 0.2µg/l
    - male sex
    - aged 18 to 60 years
    - Body Mass Index 20 – 25 kg/m2
    - absence of clinically relevant ketonuria
    - Typ 1 Diabetes Mellitus (Erkrankungsdauer mindestens 5 Jahre)
    - C-Peptid < 0.2µg/l
    - Geschlecht: männlich
    - Alter: 18 bis 60 Jahre
    - Body Mass Index 20 – 25 kg/m2
    - Keine nachweisbare, relevante Ketonurie
    E.4Principal exclusion criteria
    - insufficient venous conditions on both forearms and cubita
    - renal or hepatic insuffiency (including presence of mikroalbuminuria and determination of albumin/creatinin-ratio)
    - History of malignant disease
    - concomitant medicaion/ substances that may influence postprandial glucose excursion and/or fasting glucose-homeostasis within 3 months prior to study entry
    - alcoholabuse and/or drugabuse, nikotinconsumption > 5 cigarettes per day
    - brittle-diabetes
    - history of severe hypoglycemia, defined as hypoglycemia the need for forein assistance independent of the effectively measured blood glucose concentration within 12 months prior to study entry
    - any medical/individual condition that may jeopardize patients safety while participating in the study
    - Für die Untersuchung unzureichender Venenstatus an beiden Unterarmen
    - Jegliche Nieren- und Leberfunktionsstörungen (inklusive Mikroalbuminurie und Albumin/Kreatinin-Ratio)
    - Anamnese maligner Erkrankungen, insbesondere Harnblase, Prostata und Mamma betreffend
    - Einnahme von Medikamenten / Substanzen, welche die Insulinsensitivität beeinflussen (z.B. systemische Steroide) innerhalb der letzten 3 Monate
    - Alkoholabusus, Drogenabusus, Nikotinkonsum > 5 Zigaretten / Tag
    - Brittle-Diabetes
    - Eine oder mehrere schwere Hypoglykämie(n) innerhalb des letzten Jahres vor dem Zeitpunkt des Studieneinschlusses, definiert als Hypoglykämie mit Bedarf an Fremdhilfe unabhängig der effektiv gemessenen Blutglukosekonzentration.
    - Alle Personen, welche nach Einschätzung des Studienarztes/ der Studienärztin die Voraussetzungen der vorliegenden Studie abseits der oben genannten Ausschlusskriterien nicht erfüllen.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in postprandial glucose excursion and fasting glucose homeostasis
    Änderungen der postprandialen Glukoseexkursion und der Fasten-Glukosehomeostase
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after the first intake of either dapagliflozin or placebo
    48 Stunden nach der ersten Einnahme von entweder Dapagliflozin oder Placebo
    E.5.2Secondary end point(s)
    not applicable
    nicht anwendbar
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    nicht anwendbar
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    safety-visit 14 days after the last intake of either dapagliflozin or placebo including clinical examination, evaluation of patients´ diary and data of continuous glucose monitoring system applied during the last study visit
    Safety-Visite 14 Tage nach der letzten Einnahme von entweder Dapagliflozin oder Plazebo, klinische Untersuchung, Besprechung des Patiententagebuches sowie der Daten des kontinuierlichen Glukose-Monitorung-Systems, welche im Rahmen der letzten Studienvisite appliziert wurde.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-01
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA