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    Summary
    EudraCT Number:2013-004706-25
    Sponsor's Protocol Code Number:V1290413
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-11
    Trial results View 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 number2013-004706-25
    A.3Full title of the trial
    A Feasibility study looking at the use of Glibenclamide and metfoRmin versus stAndard Care in gEstational diabeteS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glibenclamide and metfoRmin versus stAndard Care in gEstational diabeteS (GRACES)– a feasibility open label randomised trial.
    A.3.2Name or abbreviated title of the trial where available
    GRACES
    A.4.1Sponsor's protocol code numberV1290413
    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 SponsorUniversity of Edinburgh (ACCORD)
    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 supportTommy's
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportCSO (to be confirmed)
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointNorman
    B.5.3 Address:
    B.5.3.1Street AddressCentre for reproductive health
    B.5.3.2Town/ cityQMRI, 47 Little France Crescent
    B.5.3.3Post codeEH16 4TJ
    B.5.4Telephone number0131 242 6623
    B.5.5Fax number0131 242 6610
    B.5.6E-mailjane.norman@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian (ACCORD)
    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 support
    B.4.2Country
    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 Yes
    D.2.1.1.1Trade name Glibenclamide
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGlibenclamide 2.5mg and 5mg tablets
    D.3.4Pharmaceutical form 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 INNGlibenclamide
    D.3.9.1CAS number 10238-21-8
    D.3.9.2Current sponsor codeGRACES, protocol Version 1.1
    D.3.9.3Other descriptive nameGlyburide
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit ng nanogram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30 to 50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gestational Diabetes Mellitus (GDM)
    E.1.1.1Medical condition in easily understood language
    GDM - carbohydrate intolerance of variable severity with onset or first recognition during pregnancy and is associated with increased risks of perinatal mortality and morbidity.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 aim of this feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of gestational diabetes. Additionally, we will compare glycaemic control in the two groups, and evaluate acceptability. Finally, we will collect information on a range of clinical and biochemical outcomes to inform the design of a large definitive randomised trial.

    Primary outcome: The number of women who agree to be randomised.
    E.2.2Secondary objectives of the trial
    Feasibility outcomes:
    • Uptake rate - proportion of eligible women who agree to be randomised (clearly correlated to primary outcome but key to planning larger trial)
    • Retention - proportion of women randomised who remain in the study to provide outcomes
    • Adherence - proportion of clinicians who adhere to the treatment regimen(s) and the protocol per se
    • Safety – number of hypoglycaemic episodes needing treatment, any other adverse events and SUSARs
    • Costs: (a) Basic drug cost (glibenclamide and insulin); (b) Costs associated with training women to deliver the treatment (glibenclamide and insulin)
    Glycaemic control:
    (Note all biochemical measures of maternal glycaemic control [with the exception of HbA1c] will be recorded from regular downloads from the participant’s own glucose meter)
    • Mean waking and post prandial blood glucose from randomisation to delivery.
    • Number and percentage of excursions in blood glucose below 3.5 mmol/l
    • Number and percentage of excursions
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pregnant women with gestational diabetes who fail to “achieve adequate glycaemic control” on maximum tolerated dose metformin or 2g metformin daily. Inadequate glycaemic control is defined according to the SIGN 116 guideline as outlined below:
    More than two readings over a fortnight of:
    Blood glucose
    Fasting ≥5.5mmol/L
    At <35 weeks gestation 2 hour post prandial ≥7mmol/L
    At >35 weeks gestation 2 hour post prandial ≥8mmol/L
    Or a post prandial value at any time ≥9mmol/L
    E.4Principal exclusion criteria
    • Pregnant women requiring insulin prior to 20 weeks’ gestation.
    • Pregnant women not taking at least 500mg metformin daily.
    • Women with suspected Type 1 diabetes mellitus presenting in pregnancy.
    • Women with allergies to either glibenclamide or insulin or any of their excipients.
    • Women with any contraindications to sulphonylurea therapy.
    • Women unable to give informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The number of eligible women who agree to be randomised
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial period, approximately 18 months however, will be aiming to recruit between 40 and 50 patients in total.
    E.5.2Secondary end point(s)
    Glycaemic control
    (Note: all biochemical measures of maternal glycaemic control will be recorded from regular downloads from the participant’s own glucose meter)
    • Mean waking and post prandial blood glucose from randomisation to delivery.
    • Number and percentage of excursions in blood glucose below 3.5 mmol/l
    • Number and percentage of excursions in blood glucose above or equal to 7.0 mmol/l at post-prandial test and above or equal to 5.5mmol/l at fasting test.
    • Proportion of women in the glibenclamide group who need insulin to maintain normoglycaemia.
    Patient satisfaction
    • Patient satisfaction assessed by visual analogue scale
    Clinical outcomes
    • Change in maternal weight between booking and 36 weeks
    • Mode and gestation of delivery.
    • Birthweight centile (adjusted for sex and gestation at birth)
    • Incidence of neonatal hypoglycaemia (defined as any of the following: blood glucose <2.6 mmol/l) in first 48hrs age, or given intravenous glucose or any other drug to increase blood glucose)
    Other components of the primary outcome in the MIG study (6)
    • Apgar less than 7
    • Need for phototherapy
    • Respiratory distress syndrome (need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or intermittent positive-pressure ventilation during the first 24 hours after delivery)
    • Birth trauma (injury to the baby at delivery, defined as mild if bruises or abrasions were present at birth but resolved before 6 weeks post partum; or moderate or serious for other injuries including fractures, Erb’s palsy and brachial plexus injuries)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Glycaemic control will be assess at each consultation with the patient either in person or on occasional telephone consultations.
    - Patient satisfaction will be assessed between 36 and 40 weeks gestation for each patient through a visual analogue scale questionaire.
    - clinical outcomes will be collected in clinic appointments and deliery details and neonatal outcomes will be taken from patient's clinic notes at that point in time

    All of these end points will be collected at different times for the different patients depending on their gestation for recruitment into the trial and when they deliver. Their involvement in the trial will end at the point that they deliver.
    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 Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    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 Information not present in EudraCT
    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
    48 hours after delivery
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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: 50
    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 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 state50
    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)
    Participants will stop the intervention once they have delivered their baby at which point all treatment of gestational diabetes always stops as the condition resolves with delivery.
    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 Decision2014-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-01
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