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    Summary
    EudraCT Number:2016-001401-16
    Sponsor's Protocol Code Number:80-83600-98-40001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-001401-16
    A.3Full title of the trial
    The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy
    De SUGAR-DIP trial: Orale medicatie strategie versus insuline voor diabetes gravidarum
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The SUGAR-DIP trial: Oral medication versus insulin for diabetes in pregnancy
    De SUGAR-DIP trial: Orale medicatie versus insuline voor zwangerschapsdiabetes
    A.3.2Name or abbreviated title of the trial where available
    SUGAR-DIP
    A.4.1Sponsor's protocol code number80-83600-98-40001
    A.5.4Other Identifiers
    Name:ABR NumberNumber:57195.041.16
    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 SponsorAcademic Medical Center
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointDr R.C. Painter
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205669111
    B.5.6E-mailr.c.painter@amsterdamumc.nl
    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 Metformin
    D.2.1.1.2Name of the Marketing Authorisation holderActavis
    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.3.1Product nameMetformin
    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 INNMETFORMIN
    D.3.9.1CAS number 657-24-9
    D.3.9.4EV Substance CodeSUB08831MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 2000
    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.IMP: 2
    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.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V
    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.3.1Product nameGlibenclamide
    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.3.9.4EV Substance CodeSUB07916MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2,5 to 15
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Insulin: including - fast acting, analog: NovoRapid, Humalog, Apidra - short acting, human: Actrapid, Humuline Regular, Insuman Rapid - medium long acting, human: Insulatard, Humuline NPH, Insuman Basal - long acting analog: Lantus, Levemir
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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) Yes
    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
    The medical condition to be investigated in this trial is gestational diabetes with insufficient glycemic control by means of dietary adjustments and thus an indication for addiotional pharmacological treatment.
    In deze trial wordt het ziektebeeld diabetes gravidarum onderzocht, waarbij er met dieetaanpassingen onvoldoende glucosecontrole is bereikt en er dus indicatie is voor aanvullende farmacologische behandeling.
    E.1.1.1Medical condition in easily understood language
    Gestational diabetes, also known as gestational diabetes mellitus, is a condition in which women without previously diagnosed diabetes exhibit high blood glucose (blood sugar) levels during pregnancy.
    Zwangerschapssuikerziekte, ook wel zwangerschapsdiabetes, is een aandoening waarbij vrouwen waarbij niet al eerder suikerziekte is vastgesteld, tijdens de zwangerschap hoge bloedsuikerwaardes hebben.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018209
    E.1.2Term Gestational diabetes
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to conventional insulin (INS) treatment.
    Het evalueren van het effect van behandeling met orale antidiabetica op de incidentie van large-for-gestational-age (LGA) kinderen bij vrouwen met diabetes gravidarum met indicatie voor farmacologische behandeling, in vergelijking met de conventionele behandeling middels insuline.
    E.2.2Secondary objectives of the trial
    To study the effect of OHA treatment compared with INS treatment, on maternal and perinatal outcome, including maternal hypoglycemia, pregnancy related hypertensive disorders, premature delivery, birth injury, caesarean section, neonatal hypoglycemia and neonatal Medium Care / NICU admission.

    To evaluate the effect of OHA compared with INS treatment on cost-effectiveness, both from a societal perspective, and patient perspective (i.e. treatment satisfaction and health-related quality of life).
    Bestuderen van het effect van behandeling met orale antidiabetica, in vergelijking met insuline behandeling, op maternale en perinatale uitkomsten, waaronder maternale hypoglycaemie, zwangerschapsgerelateerde hypertensieve aandoeningen, partus prematurus, geboortetrauma, keizersnede, neonatale hypoglycaemie en neonatale Medium Care / NICU opname.

    Evalueren van het effect van behandeling met orale antidiabetica, in vergelijking met insuline, op de kosteneffectiviteit, zowel vanuit een maatschappelijk perspectief als patientperspectief (tevredenheid behandeling en gezondheidsgerelateerde kwaliteit van leven).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Aged 18 years or over
    - Singleton pregnancy
    - Diagnosis of GDM as per national guidelines
    - Indication for pharmacological treatment of GDM
    - Gestational age between 16 and 34 weeks
    - Ability to understand Dutch or English
    - Ability to provide written informed consent
    Om in aanmerking te komen voor deelname aan deze studie, dient een proefpersoon te voldoen aan alle onderstaande criteria:
    - Leeftijd van 18 jaar of ouder
    - Eenlingzwangerschap
    - Diabetes gravidarum gediagnosticeerd volgens nationale richtlijnen
    - Indicatie voor farmacologische behandeling van de diabetes gravidarum
    - Zwangerschapsduur tussen de 16 en 34 weken
    - In staat zijn Nederlands of Engels te begrijpen
    - In staat zijn schriftelijk informed consent te geven
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from the study:
    - Known pre-existent type 1 or type 2 diabetes mellitus
    - Severe medical or psychiatric comorbidities
    - Serious liver disease or kidney failure, or any other condition with contraindications for the use of either metformin or glibenclamide
    - Pregnancy with a fetus affected by major congenital birth defects and/or chromosomal abnormalities
    Patienten die voldoen aan een of meedere van de onderstaande criteria worden uitgesloten van deelname:
    - Bekende preexistente diabetes mellitus type 1 of 2
    - Ernstige medische of psychiatrische comorbiditeit
    - Ernstig leveraandoeningen of nierfalen, of een andere aandoening met een contra-indicatie voor het gebruik van metformine of glibenclamide
    - Een zwangerschap van een foetus aangedaan door een ernstige congenitale afwijking en/of chromosomale afwijking
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the RCT will be the rate of large for gestational age (neonatal birth weight >90th percentile, LGA).
    De primaire uitkomst van de RCT is de mate van large-for-gestational-age kinderen (neonataal geboortegewicht >90e percentiel).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After delivery
    Na de bevalling
    E.5.2Secondary end point(s)
    1) Maternal hypoglycemia (biochemical hypoglycemia <3.9 mmol/l, symptomatic hypoglycemia and severe hypoglycemia prompting the need for help by another person, hospital admission for hypoglycaemia)
    2) Primary / secondary caesarean section
    3) Pregnancy related hypertensive disorders: pregnancy induced hypertension, preeclampsia
    4) Preterm delivery (<37 weeks of gestation)
    5) Neonatal hypoglycemia: moderate (serum glucose <2.6 mmol/l), severe (serum glucose <2.0 mmol/l)
    6) Neonatal hyperbilirubinemia requiring phototherapy
    7) Neonatal Medium care / NICU admission
    - Maternale hypoglycaemie (biochemische hypoglycaemie <3.9 mmol/l, symptomatische hypoglycaemie, ernstige hypoglycaemie waarbij hulp van een ander persoon noodzakelijk is en ziekenhuisopname in verband met hypoglycaemie)
    - Primaire / secundaire keizersnede
    - Zwangerschapsgerelateerde hypertensieve aandoeningen: pregnancy induced hypertension, preeclampsie
    - Partus prematurus (<37 weken amenorroe)
    - Neonatale hypoglycaemie: matig (serum glucose <2.6mmol/l), ernstig (serum glucose <2.0 mmol/l)
    - Neonatale hyperbilirubinemie met fototherapie
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) during pregnancy and delivery
    2) during and after delivery
    3) during pregnancy and delivery
    4) during pregnancy and delivery
    5) postpartum until discharge or 6 weeks postpartum
    6) postpartum until discharge or 6 weeks postpartum
    7) postpartum until discharge or 6 weeks postpartum
    1) gedurende de zwangerschap en bevalling
    2) gedurende en na de bevalling
    3) gedurende de zwangerschap en bevalling
    4) gedurende de zwangerschap en bevalling
    5) postpartum tot ontslag of 6 weken postpartum
    6) postpartum tot ontslag of 6 weken postpartum
    7) postpartum tot ontslag of tot 6 weken postpartum
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned20
    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
    Laatste bezoek van laatste proefpersoon
    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 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: 810
    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 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 state810
    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)
    Treatment or care after the subject has ended the participation in the trial is not different from normal treatment of that condition. All medication is stopped at time of the delivery.
    Behandeling of zorg nadat de proefpersoon zijn deelname aan de studie heeft doorlopen is niet anders dan de standaardzorg voor deze aandoening. Alle medicatie wordt gestopt ten tijden van de bevalling.
    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 Decision
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-09
    P. End of Trial
    P.End of Trial StatusOngoing
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