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    The EU Clinical Trials Register currently displays   37978   clinical trials with a EudraCT protocol, of which   6230   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-004875-61
    Sponsor's Protocol Code Number:15778303
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-03
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2015-004875-61
    A.3Full title of the trial
    Influence of apelin on insulin sensitivity in type 2 diabetic volunteers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of apelin on insulin sensitivity in type 2 diabetic volunteers
    A.3.2Name or abbreviated title of the trial where available
    APELINS 2
    A.4.1Sponsor's protocol code number15778303
    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 SponsorCHU TOULOUSE
    B.1.3.4CountryFrance
    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 supportSociété Française du Diabète
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU TOULOUSE
    B.5.2Functional name of contact pointCLINICAL RESEARCH ASSOCIATE
    B.5.3 Address:
    B.5.3.1Street Address2 rue viguerie
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31052
    B.5.3.4CountryFrance
    B.5.6E-mailpauze.a@chu-toulouse.fr
    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 No
    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 name(pyr1)-Apeline-13
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous 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
    E.1.1.1Medical condition in easily understood language
    type 2 diabetes
    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
    The main objective of this study is to compare the insulin sensitivity in volunteers with type 2 diabetes during a continuous infusion (pyr1) -Apeline-13 versus a placebo infusion.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to: 1) Get the tolerance and safety data for the administration of (pyr1) -Apeline-13 in humans, complementing data from published and ongoing studies, 2) Measure the plasma concentration of apelin depending on the administered dose, 3) Perform a serum bank for hormonal and metabolic posteriori trials (insulin, glucagon, apelin, other cytokines and hormones involved in energy metabolism).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient aged 40-65 years.
    Type 2 diabetes
    Diabetes treated with oral antidiabetic agents only
    BMI between 27 and 33 Kg / cm².
    HbA1c <8.5%
    Non-pathological ECG
    Resting heart rate of between 50 and 80 beats per minute
    Complete Blood Count (CBC) without clinically significant abnormalities in terms of the investigator.
    Liver function tests without clinically significant abnormalities in terms of the investigator.
    Renal function tests without clinically significant abnormalities in terms of the investigator .
    Serum electrolytes without clinically significant abnormalities in terms of the investigator.
    Good peripheral venous system (forearm and back of the hand)
    Acceptance to participate in the establishment of a serum bank
    Ability to sign an informed consent.
    Affiliation to a social security scheme or equivalent.
    E.4Principal exclusion criteria
    Patients experiencing secondary cardiovascular prevention.
    Diabetes treated by insulin or GLP-1 in the 6 months prior to inclusion
    Risk factor, treatment or ECG as recommended ICH E14 "Clinical Evaluation of QT / QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs":
    - Repeated measurement of a QTc interval> 450 ms
    - Torsade de pointes risk factor: myocardial infarction, hypokalemia, family history of long QT syndrome
    Personal history of cancer.
    Positive HIV serology.
    Hepatitis B serology positive.
    Hepatitis C serology positive.
    Cognitive impairment or mental illness (at the discretion of the investigator)
    Excessive alcohol chronic use (consumption> 30g / day or 210g / week)
    Subject having a systolic blood pressure greater than the rest to 140 mm Hg and 90 mm Hg diastolic
    Smoking> 10 cig / day and can not be interrupted during 24 hours
    About participating in another research protocol or exclusion period from another protocol
    Nobody in safeguarding justice, guardianship
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the measure of the difference between recent glucose infusion rate measured in the last 30 minutes of a hyperinsulinemic euglycemic clamp in the presence of a continuous infusion (pyr1) -Apeline-13 infusion rate glucose measured under the same conditions in the presence of a continuous infusion of placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    in the last 30 minutes of a hyperinsulinemic euglycemic clamp
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    - Calculation of the M factor (glucose metabolism) according ref De Fronzo (12, 37)
    - Variations of the measurement of the systolic blood pressure
    - Variations of the measurement of the diastolic blood pressure
    - Changes in heart rate measurement
    - Route of ECG Changes
    - Clinical signs of intolerance / allergy / toxicity
    - Determination of plasma insulin
    - Determination of glucagon
    - Determination of apelin
    - Determination of leptin
    - Determination of adiponectin
    E.5.2.1Timepoint(s) of evaluation of this end point
    during each clamp
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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
    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 months2
    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 months2
    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: 14
    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 state14
    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 Decision2016-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-20
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