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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43719   clinical trials with a EudraCT protocol, of which   7255   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 ).  
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    EudraCT Number:2014-005377-36
    Sponsor's Protocol Code Number:D1690C00025
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2014-005377-36
    A.3Full title of the trial
    An 8-week, single centre, randomized, parallel-group, double-blind, placebo controlled phase IV study to evaluate Dapagliflozin 10 mg once daily effects on insulin resistance in subjects with type 2 diabetes mellitus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial investigating the effects of dapagliflozin 10 mg on insulin resistance in patients with type 2 diabetes mellitus.
    A.4.1Sponsor's protocol code numberD1690C00025
    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 SponsorAstraZeneca AB, R&D Mölndal
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB R&D
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB R&D
    B.5.2Functional name of contact pointGlobal Medicines Development CVMD
    B.5.3 Address:
    B.5.3.1Street AddressPepparedsleden 1
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post code431 83
    B.5.4Telephone number+4631776 10 00
    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. name Forxiga 10
    D. 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
    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.3.9.3Other 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    type 2 diabetes mellitus.
    E.1.1.1Medical condition in easily understood language
    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
    To evaluate if dapagliflozin 10 mg once daily when compared to placebo improves insulin sensitivity in skeletal muscle after 8 weeks of treatment in type 2 diabetes mellitus patients.
    E.2.2Secondary objectives of the trial
    To evaluate if dapagliflozin 10 mg once daily when compared to placebo improves insulin sensitivity in adipose tissue after 8 weeks of treatment in type 2 diabetes mellitus patients.

    To evaluate if dapagliflozin 10 mg once daily when compared to placebo improves insulin sensitivity in liver after 8 weeks of treatment in type 2 diabetes mellitus patients.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study subjects should fulfil the following criteria:
    1) Provision of signed informed consent prior to any study specific procedures.
    2) Female or male aged 35 to 70 years inclusive with suitable veins for cannulation or repeated venepuncture
    3) Type 2 Diabetes mellitus defined as HbA1c of ≥ 6.5% and ≤ 10.5%.
    4) Be on stable (≥ 3 months) T2D treatment with
    • either metformin, sulphonylurea or dipeptidyl peptidase-4 inhibitors (DPP-IV) alone
    • metformin in combination with sulphonylurea or DPP-IV
    5) Have a body mass index (BMI) (measured as body weight (kg)/(height (m))2) ≤ 40 kg/m2.
    6) Female subjects must be of non-childbearing potential, meeting at least one of the following criteria:
    a) Hysterectomized females
    b) Postmenopausal women, defined as women who have not had a menstrual period within 1 year
    E.4Principal exclusion criteria
    1) Involvement in the planning and/or conduct of the study.
    2) Previous enrolment in the present study.
    3) Participation in another clinical study with an IP during the last 3 months prior to Visit 1.
    4) Has any condition that is contraindicated with MRI such as, but not limited to, having a pacemaker or claustrophobia.
    5) History of or presence of (as found at Visit 1) any clinically significant disease, disorder or condition which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study.
    6) Volume depleted patients. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.
    7) Recent Cardiovascular Events in a patient:
    - Acute Coronary Syndrome (ACS) within 2 months prior to enrolment
    - Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment
    - Acute Stroke or Transient Ischemic Attack (TIA) within two months prior to enrolment
    - Less than two months post coronary artery revascularization
    8) Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure.

    Note: eligible patients with congestive heart failure, especially those who are on diuretic therapy, should have careful monitoring of their volume status throughout the study.
    9) Blood pressure at enrolment: Systolic BP ≥165 mm Hg and/or diastolic BP ≥100 mm Hg
    10)Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of the first administration of IP.
    11)On insulin, GLP-1 or other oral antidiabetic drug treatment (metformin, sulphonylurea or DPP-IV, or a combination of metformin with sulphonylurea or DPP-IV allowed) or using other medications known to affect glucose metabolism.
    12)Any clinically significant abnormalities in physical examination, Electrocardiography (ECG) or clinical chemistry results at as judged by the investigator. The following specific exclusion criteria apply to the selected Clinical Chemistry results:
    a) Creatinine clearance <60mL/min (estimated with Cockroft-Gault formula).
    b) Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN.
    c) Total bilirubin (TB) >2.0 mg/dL (34.2 ╬╝mol/L).
    13) Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse is defined as >14 drinks per week (1 drink= 35 cl beer, 14 cl wine or 4 cl hard liquor) or as judged by the investigator.
    14) Body weight loss greater than 5% within 3 months prior to Visit 1.
    15)Any other condition the investigator believe would interfere with the subject’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk.
    16) Plasma donation within one month of Visit 2 or any blood donation/blood loss > 500 mL during 3 months prior to Visit 2.
    17) Previous PET scan
    E.5 End points
    E.5.1Primary end point(s)
    Body weight and other anthropometric measures
    E.5.1.1Timepoint(s) of evaluation of this end point
    week -4 to -1
    week 0
    week 4
    week 8
    E.5.2Secondary end point(s)
    Glycemic efficacy laboratory variables,
    Magnetic Resonance Imaging
    Euglycemic hyperinsulinemic clamp with PET-CT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Glycemic efficacy laboratory variables: w -4 to -1, w0 w4, w8
    Magnetic Resonance Imagingan Euglycemic hyperinsulinemic clamp with PET-CT: w0 and w8
    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. 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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state32
    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)
    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 Decision2015-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-29
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