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    Summary
    EudraCT Number:2016-001644-19
    Sponsor's Protocol Code Number:NUIG-2016-01
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-10
    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 ConcernedIreland - HPRA
    A.2EudraCT number2016-001644-19
    A.3Full title of the trial
    A Randomised Placebo Controlled Trial of the effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial of Metformin Versus Placebo for the Treatment of High Blood Sugars During Pregnancy
    A.4.1Sponsor's protocol code numberNUIG-2016-01
    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 SponsorNational University of ireland Galway
    B.1.3.4CountryIreland
    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 supportHealth Research Board
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHRB Clinical Research Facility Galway
    B.5.2Functional name of contact pointMarie Browne
    B.5.3 Address:
    B.5.3.1Street AddressNUI Galway, Newcastle Road
    B.5.3.2Town/ cityGalway
    B.5.3.3Post codeCo. Galway
    B.5.3.4CountryIreland
    B.5.6E-mailmarie.b.browne@nuigalway.ie
    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 Glucophage
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Santé
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGlucophage 500mg IR tablets
    D.3.4Pharmaceutical form 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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboCoated 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
    Gestational Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    High blood sugars during pregnancy
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10018210
    E.1.2Term Gestational diabetes mellitus
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine if metformin (a) reduces the requirement for insulin or (b) reduces fasting glucose at gestational weeks 32 and 38.
    E.2.2Secondary objectives of the trial
    Additional secondary objectives of this study are to determine if metformin; delays the initiation of insulin; reduces the insulin dose required; impacts on maternal body weight, BMI, waist circumference, blood glucose status, insulin resistance status and metabolic syndrome postpartum; reduces the proportion of infants with morbidities; in addition to standard care reduces infant birth weight when compared to standard care alone; reduces the proportion of maternal morbidities when compared to standard care alone; in addition to standard care reduces excessive maternal gestational weight gain; to determine if women consider metformin a more acceptable treatment than insulin; to determine the cost, cost effectiveness, and budget impact of metformin in addition to standard care for gestational diabetes mellitus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    a) Willing and able to provide written informed consent
    b) Participants aged 18-50 years
    c) Pregnancy gestation up to 28 weeks (+ 6 days) confirmed by positive pregnancy test
    d) Singleton pregnancy as determined by scan
    e) Positive diagnosis of Gestational Diabetes Mellitus on a OGTT according to IADPSG criteria if any one of the following are achieved:
    a. Fasting glucose >/= 5.1mmol/l and <7mmol/l, or
    b. 1 hour post glucose load of >/=10mmol/l, or
    c. 2 hour post glucose load of >/=8.5 mmol/l and <11.1mmol/l
    f) Resident in the locality and intending to deliver within the trial site
    E.4Principal exclusion criteria
    Exclusion Criteria:
    Women who meet any one or more of the following exclusion criteria will not be eligible to take part in the trial:
    a) Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
    b) Participants with a fasting glucose ≥ 7mmol/l or a 2h value ≥ 11.1 mmol/l
    c) Multiple pregnancies (twins, triplets etc.) as determined by scan
    d) Known intolerance to metformin
    e) Known contraindication to the use of metformin which include:
    i. renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance <60 ml/min)
    ii. moderate to severe liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal)
    iii. shock or sepsis, and
    iv. previous hypersensitivity to metformin
    f) Major congenital malformations or an abnormality deemed unsuitable for metformin by the site PI or attending consultant
    g) Known small for gestational age1
    h) Known current gestational hypertension, pre-eclampsia, or ruptured membranes
    i) Participants who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
    j) Participants with significant gastrointestinal problems such as severe vomiting, Crohn’s disease or colitis which will inadvertently affect absorption of the study drug
    k) Participants with congestive heart failure or history of congestive heart failure
    l) Participants with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator
    m) Women with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

    1Small for gestational age (SGA) refers to fetal growth less than the 10th percentile (RCOG, 2014), or if foetal growth is deemed unsatisfactory by the treating obstetrician.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome is a composite of:
    • Insulin initiation (Yes/No)
    • Fasting glucose value </=5.1 mmol/l and >5.1 mmol/l
    E.5.1.1Timepoint(s) of evaluation of this end point
    Insulin initiation will be measured at all time points throughout the trial
    Fasting glucose will be evaluated at gestational weeks 32 and 38.
    E.5.2Secondary end point(s)
    Secondary efficacy outcomes include:
    1. Time to insulin initiation and insulin dose required
    2. Maternal morbidity at delivery (hypertensive disorders, antepartum and postpartum haemorrhage, polyhydramnios)
    3. Mode and time of delivery
    4. Postpartum glucose status, insulin resistance, and metabolic syndrome
    5. Postpartum BMI, gestational weight gain, and waist circumference
    6. Infant birth weight
    7. Neonatal height and head circumference at delivery
    8. Neonatal morbidities (Need for neonatal care unit, respiratory distress, jaundice, congenital anomalies, Apgar score)
    9. Neonatal hypoglycaemia (defined as plasma glucose <2.6 mmoL/L on one or more occasions starting 30-60 minutes after birth).
    10. Cost effectiveness and budget impact of metformin treatment in addition to standard care
    11. Treatment acceptability (DTSQ and Rowan questionnaires)
    12. Quality of Life determined by EQ5D-5L questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to insulin initiation and insulin dose required will be measured at all time points throughout the trial.
    Maternal morbidity, mode and time of delivery, infant birth weight, neonatal morbidities and hypoglycaemia, and neonatal height and head circumference will be measured at delivery.
    Postpartum BMI, gestational weight gain, waist circumference, glucose status, insulin resistance, and metabolic syndrome will be measured at 12-16 weeks post-partum.
    Cost effectiveness of metformin treatment in addition to standard care will be measured at 12 weeks post-partum.
    Treatment acceptability will be measured at week 12 post randomisation and at 4 weeks post-partum.
    Quality of Life determined by EQ5D-5L questionnaire measured at baseline, 4 weeks post-partum, and 12 weeks post-partum.
    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 No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 concerned2
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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.1.2.1Number of subjects for this age range: 535
    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 No
    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 state535
    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 Decision2016-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-04-13
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