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    Summary
    EudraCT Number:2014-001244-38
    Sponsor's Protocol Code Number:14SM1971
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-05-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-001244-38
    A.3Full title of the trial
    Preventing Recurrent Gestational Diabetes Mellitus with Early Metformin Intervention
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preventing Recurrent Gestational Diabetes Mellitus with Early Metformin Intervention
    A.3.2Name or abbreviated title of the trial where available
    Preventing Recurrent Gestational Diabetes with Metformin
    A.4.1Sponsor's protocol code number14SM1971
    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 SponsorImperial College London
    B.1.3.4CountryUnited Kingdom
    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 supportNovo Nordisk UK Research Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMetformin
    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 INNMetformin hydrochloride
    D.3.9.1CAS number 657-24-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 placeboTablet
    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
    Gestational diabetes mellitus is defined as an intolerance to carbohydrate first recognised in pregnancy.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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 ascertain if intervention with metformin therapy early in pregnancy prevents recurrent gestational diabetes mellitus (GDM) in women with a history of pregnancies previously complicated by GDM.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effect of early metformin intervention on the following:
    • Maternal factors (weight gain, requirement for insulin therapy, post-partum glucose measurements and levels of health and satisfaction).
    • Neonatal features (fetal birthweight/ birthweight centile and a composite of outcomes related to complications of gestational diabetes)
    • Cost effectiveness in the prevention of GDM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Confirmed singleton viable pregnancy
    2. Between 8 and 22 weeks gestation
    3. History of a previous pregnancy complicated by gestational diabetes mellitus
    E.4Principal exclusion criteria
    1. Established pre-existing diabetes (including unrecognised diabetes defined as FPG ≥ 7.0mmol/L and/ or HbA1c ≥ 48mmol/mol)
    2. Contraindications to metformin therapy
    a. Renal impairment: creatinine ≥ 130μmol/L
    b. Impaired liver function (ALT ≥ 2.0 x upper limit normal)
    c. Previous intolerance to metformin
    3. Planned continued antenatal care/ delivery at centre not included in trial
    4. Planned fast for cultural/ religious reasons e.g. Ramadan
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is development of gestational diabetes mellitus at any point during pregnancy.
    E.5.1.1Timepoint(s) of evaluation of this end point
    An 75g oral glucose tolerance test will be conducted at 28 weeks gestation and a diagnosis of GDM will be made if the IADPSG criteria are fulfilled (i.e. fasting plasma glucose > 5.1mmol/L or 2 hour post-glucose load > 8.5mmol/L).

    Assessments of glucose tolerance will otherwise be ongoing from 18 weeks till 36 weeks gestation. Women will be instructed to monitor their capillary glucose values at home. On each of their two weekly clinic attendances, a fasting plasma glucose will be measured. If values are elevated, a diagnostic 75g oral glucose tolerance test will be completed.
    E.5.2Secondary end point(s)
    1. Maternal outcomes: A. Gestational weight gain
    B. Requirement for insulin therapy during pregnancy
    C. Six-week maternal postpartum glucose
    D. Levels of physical and psychological health/ satisfaction

    2. Fetal outcomes: A. Fetal birthweight
    B. Fetal birthweight centile
    C. Composite of neonatal outcomes (hypoglycaemia, birth trauma, respiratory distress syndrome, birth related injuries)

    3. Cost effectiveness analysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Maternal outcomes: A. Gestational weight gain: Difference between weight measured at initial study visit (8-22 weeks gestation) and 36 week study visit. B. Review of glycaemic parameters will be ongoing throughout pregnancy from 18 weeks gestation. If GDM is diagnosed, treatment will be established as per clinician preference (either metformin and/or insulin). C. Maternal postpartum glucose: 6 weeks post delivery. D. Levels of physical and psychological health/ satisfaction: Screening (8-22 weeks gestation), the 28 week clinic visit, 36 week visit and 6 weeks postpartum.
    2. Fetal outcomes: All will be assessed in the immediate postpartum period.
    3. Cost effectiveness analysis: Screening (8-22 weeks gestation), the 28 week clinic visit, 36 week visit and 6 weeks postpartum.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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
    The trial will be considered complete when the last patient recruited completes the final 6-week post-partum visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 112
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    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 state112
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 112
    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)
    The intervention will not continue after the end of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-17
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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