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    Summary
    EudraCT Number:2015-005288-17
    Sponsor's Protocol Code Number:ESR-15-10964
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-17
    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 ConcernedGreece - EOF
    A.2EudraCT number2015-005288-17
    A.3Full title of the trial
    A study of the effects of dapagliflozin on ambulatory aortic pressure, arterial stiffness and urine albumin excretion in patients with type 2 diabetes.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study is designed to test the hypothesis that the treatment-induced reductions in the ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the group of placebo (benefit/risk and ethical assessment) and its effects on arterial stiffness and urine albumin excretion in patients with type 2 diabetes.
    A.3.2Name or abbreviated title of the trial where available
    DAPA
    A.4.1Sponsor's protocol code numberESR-15-10964
    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 SponsorΕΛΛΗΝΙΚΗ ΕΤΑΙΡΕΙΑ ΙΑΤΡΙΚΗΣ ΕΚΠΑΙΔΕΥΣΗΣ (Hellenic Society of Medical Education)
    B.1.3.4CountryGreece
    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 supportΕΛΛΗΝΙΚΗ ΕΤΑΙΡΕΙΑ ΙΑΤΡΙΚΗΣ ΕΚΠΑΙΔΕΥΣΗΣ (Hellenic Society of Medical Education)
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCREATIVE PHARMA SERVICES S.A.
    B.5.2Functional name of contact pointHead of Clinical Operations
    B.5.3 Address:
    B.5.3.1Street Address286 KIFISIAS AVENUE
    B.5.3.2Town/ cityCHALANDRI ATTIKIS
    B.5.3.3Post code15232
    B.5.3.4CountryGreece
    B.5.4Telephone number00302103259350
    B.5.5Fax number00302103259380
    B.5.6E-maildtsapoga@creativephs.com
    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 SE-151 85 Sodertalje Sweden
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameFORXIGA
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 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 placeboFilm-coated tablet
    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
    A study of the effects of dapagliflozin on ambulatory aortic pressure, arterial stiffness and urine albumin excretion in patients with type 2 diabetes mellitus.
    E.1.1.1Medical condition in easily understood language
    Type 2 Diabetes Mellitus
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10029505
    E.1.2Term Non-insulin-dependent diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level SOC
    E.1.2Classification code 10027433
    E.1.2Term Metabolism and nutrition disorders
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the present study is to investigate the effect of dapagliflozin on ambulatory aortic pressure in patients with type 2 DM.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to investigate the effects of dapagliflozin on ambulatory arterial stiffness, and urine albumin excretion.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age >18 and <70 years old
    2. Type 2 diabetes mellitus
    3. Glycated hemoglobin >7% and <9%
    4. Patients on stable dose of metformin of at least 1500 mg for the past 3 months.
    5. Patient to provide informed consent
    E.4Principal exclusion criteria
    1. Hypovolemic patients.
    2. Patients on loop diuretics.
    3. Patients with low BP (office SBP <110 mmHg) or orthostatic hypotension (BP drop >20 mmHg and SBP <110 mmHg in standing position at 1 min).
    4. Patients on antidiabetic drugs other than metformin.
    5. Secondary hypertension.
    6. Stage 2 hypertension or higher (office SBP ≥160 mmHg or DBP ≥100 mmHg).
    7. Chronic kidney disease stage 3 or higher (GFR<60 mL/min/1.73 m2).
    8. Myocardial infarction or unstable angina episode within the past 3 months, or congestive heart failure class III-IV according to New York Heart Association criteria.
    9. Pregnancy or childbearing potential [defined as women which have entered menses and are not post-menopausal (menopause is defined as the absence of menses for at least 12 months without any other medical cause in women of typical age) or women that have been subjected to permanent sterilization (ie. tubal ligation, hysterectomy, bilateral oophorectomy or bilateral salpingectomy)].
    10. History of liver disease or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN or total bilirubin >2.0 mg/dL.
    11. History of malignancy of any organ system (resected basal cell carcinoma considered cured is exempted) within the past 5 years prior to Visit 1 (V1).
    12. History of drug or alcohol abuse within the last one year.
    13. Any contraindication or history of hypersensitivity to the study drug or to drugs with similar chemical structures.
    14. Any other surgical or medical condition that, in the opinion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period.
    15. Intake of an investigational drug in another trial within 30 days prior to Visit 1 (V1).
    E.5 End points
    E.5.1Primary end point(s)
    The difference between the groups of dapagliflozin and placebo in the change of 24-hour systolic aortic pressure at study-end
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be recorded with Mobil-O-Graph for the period between visit 1 and end of study (12 weeks treatment)
    E.5.2Secondary end point(s)
    Secondary end-points would include the difference between the groups of dapagliflozin and placebo in the change of the following parameters between visit 1 and end of study (12 weeks treatment):
    1. 24-hour central aortic DBP.
    2. 24-hour brachial SBP and DBP.
    3. 24-hour AIx.
    4. 24-hour PWV.
    5. Office brachial SBP and DBP.
    6. Albumin/creatinine ratio (ACR).
    7. Lipid profile (Total-Cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides).
    8. HbA1c.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Period between visit 1 and end of study (12 weeks treatment)
    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 Yes
    E.6.5Efficacy Yes
    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 Yes
    E.8.1.6Cross over No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    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 state160
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 160
    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)
    None
    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 Decision2016-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
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