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    Summary
    EudraCT Number:2016-005031-32
    Sponsor's Protocol Code Number:Diabetes2017
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-29
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-005031-32
    A.3Full title of the trial
    Metformin use to improve pregnancy outcome in women with type 1 diabetes. A double-blind placebo-controlled multicenter study.
    Kaksoissokkoutettu ja lumekontrolloitu monikeskustutkimus metformiinin käytöstä raskauden ennusteen parantamiseksi tyypin 1 diabeteksessa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does metformin improve pregnancy outcome used by women with type 1 diabetes?
    Parantaako metformiini raskauden ennustetta tyypin 1 diabeetikoiden raskauksissa?
    A.4.1Sponsor's protocol code numberDiabetes2017
    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 SponsorPirkanmaan sairaanhoitopiiri
    B.1.3.4CountryFinland
    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 supportTakeda
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTampere University Hospital
    B.5.2Functional name of contact pointDep Obstetrics and gynecology
    B.5.3 Address:
    B.5.3.1Street AddressElämänaukio 2
    B.5.3.2Town/ cityTampere
    B.5.3.3Post code33520
    B.5.3.4CountryFinland
    B.5.6E-mailkati.tihtonen@pshp.fi
    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 Diformin retard
    D.2.1.1.2Name of the Marketing Authorisation holderOy Leiras Finland Ab
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.2Product code A10BA02
    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
    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
    Pregnancy of a women dealing with type 1 diabetes

    Tyypin 1 diabeetikon raskaus
    E.1.1.1Medical condition in easily understood language
    Pregnancy of a women dealing with type 1 diabetes
    Tyypin 1 diabeetikon raskaus
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012594
    E.1.2Term Diabetes
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to find out weather metformin ease insulin resistance during pregnancy in women deling with type 1 diabetes. The first endpoint of the study is the reduction of insulin requirement for more than 15% between the metformin and placebo group.

    Tutkimuksen tarkoituksena on selvittää voidaanko metformiinihoidolla helpottaa raskaudenaikaista insuliiniresistenssiä tyypin 1 diabeetikoilla. 1. päätetapahtuma on insuliinin tarpeen vähentyminen yli 15 %:lla metformiinihoidetussa ryhmässä.
    E.2.2Secondary objectives of the trial
    The secondary endpoints are to demonstrate if metformin improves pregnancy prognosis by reducing the number of macrosomic and frail newborns, and reduce the risk of pregnancy and delivery complications and whether it improves maternal blood glucose level.
    Pregnancy complications include pre-eclampsia, gestational hepatosis, worsening proteinuria, fetal macrosomia, fetal growth retardation, intrauterine fetal death and premature deliveries. To describe labor results and complications as the percentages of cesarean sections (elective and emergent), vacuum extractions, spontaneous deliveries, shoulder dystocias, lacerations of third and fourth degree and blood loss during labor are collected.
    Morbities of the newborns are described by birth weight, Apgar scores, umbilical artery pH, gestational weeks at birth, NICU transmissions, the incidence of hypoglycemia and other major problems of neonatal period.
    Tutkimuksen toissijaisena tavoitteena on selvittää parantaako metformiinihoito raskauden sokeritasapainoa, parantaako hoito raskauden ennustetta vähentämällä makrosomisten ja huonokuntoisten vastasyntyneiden määrää, sekä vähentääkö hoito raskaus- ja synnytyskomplikaatioita.
    Raskauskomplikaatioiden suhteen verrataan mm. liitännäispre-eklampsian, raskaushepatoosin, proteinurian, sikiön makrosomian, sikiön kasvunhidastuman, kohdunsisäisten sikiökuolemien ja ennenaikaisten synnytysten esiintymistä.
    Synnytysten osalta verrataan synnytystapaa ja raskauden kestoa.
    Vastasyntyneistä osalta verrataan syntymäpainoja, kuntoisuutta, teho-osastolle siirtyneiden määrää, hoitoa vaatineiden hypoglykemioiden ja muiden ongelmien esiintymistä.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The use of a new 3/4D ultrasound technology -fractional thigh volume- to detect fetal macrosomia in pregnancy complicated with type 1 diabetes.

    Courses of the inflammatory markers that reflect insulin resistance in diabetic pregnancy comparing placebo and metformin treated group.

    Uuden 3/4 ultraäänitekniikan -reiden volyymimittaus- käyttö sikiön makrosomian tunnistamisessa tyypin 1 diabeetikoiden raskauksissa.

    Insuliiniresistenssiä kuvaavien inflammatorisen markkereiden kulku tyypin 1 diabeetikoiden raskauksissa metformiini- ja placebohoidettujen ryhmissä.
    E.3Principal inclusion criteria
    A pregnancy of a women dealing with type 1 diabetes.

    Tyypin 1 diabeetikon raskaus.
    E.4Principal exclusion criteria
    Exclusion criteria for the study are a twin pregnancy, another significant underlying disease, severe complications of diabetes, substance abuse problems, smoking, underweight or strong early pregnancy nausea.


    Poissulkukriteerejä tutkimuksessa ovat monikkoraskaus, muu merkittävä perussairaus (sepelvaltimotauti, siirtomunuainen, krooniset maksasairaudet, IBD, SLE tai toistuvia oraalisia kortisonikuureja vaativa astma tai reumasairaus), vaikea diabeteksen lisäsairaus (nefropatia: cUAlb˃200µg/min, UAlbkre˃30/mmol tai GFR˂60 ml/min, proliferatiivinen retinopatia tai diabeettinen gastropareesi), päihdeongelma, tupakointi, alipaino (BMI <18) tai voimakas alkuraskauden pahoinvointi.
    E.5 End points
    E.5.1Primary end point(s)
    Ensisijaisena päätetapahtumana on insuliinin tarpeen väheneminen.
    E.5.2Secondary end point(s)
    Toissijaisena tavoitteena on selvittää parantaako metformiinihoito raskauden sokeritasapainoa ja veren lipidiprofiilia ja vaikuttaako hoito verenkierron inflammaatiomarkkereihin.
    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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    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: 200
    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 Information not present in EudraCT
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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
    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 Decision2017-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-28
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