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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2014-000446-30
    Sponsor's Protocol Code Number:02-2014
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-04-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-000446-30
    A.3Full title of the trial
    Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial. The Medico-GDM trial.
    Metformin versus controle groep ter preventie van diabetes gravidarum (DG) bij vrouwen met een verhoogd risico op DG, een open label gerandomiseerde gecontrolleerde studie. The Medico-GDM trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial. The Medico-GDM trial.
    Metformin versus controle groep ter preventie van diabetes gravidarum (DG) bij vrouwen met een verhoogd risico op DG, een open label gerandomiseerde gecontrolleerde studie. The Medico-GDM trial
    A.3.2Name or abbreviated title of the trial where available
    Metformin to prevent gestational diabetes mellitus (GDM)
    Metformin ter preventie van diabetes gravidarum (DG)
    A.4.1Sponsor's protocol code number02-2014
    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 SponsorMaasstad Ziekenhuis
    B.1.3.4CountryNetherlands
    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 supportMaasstad Ziekenhuis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaasstad Ziekenhuis
    B.5.2Functional name of contact pointDr. J van der Linden
    B.5.3 Address:
    B.5.3.1Street AddressMaasstadweg 21
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3079 DZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031102912382
    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 Metformine HCl 500 PCH, filmomhulde tabletten 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pregnant women with a high risk of gestational diabetes mellitus (GDM)
    E.1.1.1Medical condition in easily understood language
    Pregnant women with a high risk of gestational diabetes mellitus (GDM)
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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 compare the incidence of gestational diabetes (GDM) in pregnant
    women with a high risk of GDM treated with Metformin from second
    trimester till delivery versus control group
    E.2.2Secondary objectives of the trial
    To compare pregnancy outcome in pregnant women treated with
    Metformin versus control group. To compare neonatal outcome in
    pregnant women treated with Metformin versus control group. To
    compare the number of neonatal complications in pregnant women
    treated with Metformin versus control group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    'High risk' is defined if one or more of the risk factors below is present,
    according to the Dutch national criteria for screening
    - Gestational diabetes in history
    - Body mass index > 30 (kg/m2) at the first prenatal screening
    - Birth weight previous child > P95 or > 4500 gram
    - First degree relative with diabetes mellitus
    - Certain ethnic groups with a high prevalence of diabetes mellitus
    (South Asians, like Hindustani, Afro-Caribbean people, women from the
    Middle East, Morocco and Egypt)
    - History of unexplained intra-uterine foetal death/stillbirth
    - Polycystic ovary syndrome (PCOS)

    And aged between 18 and 40 years, gestational age between 8 and 12 weeks, able to communicate and read in Dutch
    E.4Principal exclusion criteria
    No singleton pregnancy judged by ultrasonography, high fasting glucose
    at first trimester, cardiac insufficiency, renal insufficiency (MDRD < 60), liver disease, use of medication other than Paracetamol or vitamins and incompetent women.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of gestational diabetes mellitus
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 16 weeks of pregnancy in women with gestational diabetes mellitus in
    history (4-8 weeks after inclusion, 4 weeks after start medication)
    At 24 weeks of pregnancy in other subjects (16-12 weeks after inclusion,
    10 weeks after start medication)
    E.5.2Secondary end point(s)
    Maternal: pregnancy induced hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), weight gain during
    pregnancy, abnormal glucose daily curve (measurement of blood glucose concentration seven times daily).

    Neonatal: head circumference, birth weight and height, pH of umbilicalcord

    Neonatal complications: severe birth defects, stillbirth, neonatal
    hypoglycaemia that requires therapy, birth trauma, need for
    phototherapy, (respiratory distress), premature birth (< 37 weeks of gestation), small for gestational age (birth weight < 2 SD units), low 5-minutes Apgar score (< 7), birth weight > 90th percentile, birth weight < 10th percentile, admission to neonatal intensive care unit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Maternal endpoints:
    Evaluated during pregnancy on the regular visits with the obstretican.
    Abnormal glucose daily curve: dvaluated 4 weeks after pregnancy

    Neonatal outcomes: evaluated after delivery by the gynaecologist or obstretican
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No intervention
    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
    End of the trial is when the last subject gave birth
    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 months0
    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: 400
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    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 Yes
    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 state400
    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 Decision2014-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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