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    Summary
    EudraCT Number:2018-000003-16
    Sponsor's Protocol Code Number:UPBEAT-TIF
    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:2018-09-05
    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 number2018-000003-16
    A.3Full title of the trial
    Prevention of Gestational Diabetes in Obese Pregnant Women; a Proof of Principle Study Targeting Early Pregnancy Intervention to Women at Risk
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of Gestational Diabetes; a Study Targeting Early Pregnancy Intervention to Women at Risk
    A.3.2Name or abbreviated title of the trial where available
    UPBEAT-TIF
    A.4.1Sponsor's protocol code numberUPBEAT-TIF
    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 SponsorKing's 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 supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRosetrees Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Sara White
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Women and Children’s Health, Westminster Bridge Road, St Thomas’ Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402071883642
    B.5.6E-mailsara.white@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's and St Thomas' NHS Foundation Trust
    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 supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRosetrees Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointDr Sara White
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Women and Children’s Health, Westminster Bridge Road, St Thomas’ Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402071883642
    B.5.6E-mailsara.white@kcl.ac.uk
    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.2.1.2Country 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 nameMetformin 500mg 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 INNMetformin
    D.3.9.1CAS number 657-24-9
    D.3.9.3Other descriptive namemetformin hydrochloride
    D.3.9.4EV Substance CodeSUB08831MIG
    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
    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
    Diabetes that first presents in 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
    To assess in obese pregnant women at high risk of GDM the efficacy of a) dietary advice, b) metformin treatment plus dietary advice to improve maternal glycaemic control when compared with c) standard care.
    E.2.2Secondary objectives of the trial
    1) To assess feasibility of risk assessment for GDM using the new prediction tool in obese women.
    2) To determine the impact of each intervention on a targeted maternal metabolome (Nuclear Magnetic Resonance, NMR).
    3) To examine the effect of each intervention on dietary intake.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female, over 16 years
    BMI ≥30kg/m2
    High risk of GDM as identified by the risk assessment at screening
    Singleton pregnancy
    Gestation 21-14+6 weeks’ at the time of screening consent
    Willing and able to give written informed consent
    E.4Principal exclusion criteria
    Women identified as being low risk of GDM
    Pre-existing diabetes
    HbA1c ≥6.5mmol/l at screening in early pregnancy
    Hypertension requiring treatment pre-pregnancy/in pregnancy
    Thyroid disease
    Coeliac disease
    Systemic Lupus Erythematosus
    Antiphospholipid syndrome (APS)
    Thalassaemia
    Current psychosis
    Taking metformin
    Taking medications that affect insulin sensitivity
    Past bariatric surgery
    Sickle Cell
    Multiple pregnancy
    Insufficient understanding of the trial
    Participation in another IMP trial at the time of screening consent
    Contraindications to Metformin:
    • Hypersensitivity to metformin hydrochloride or to any of the excipients.
    • Diabetic ketoacidosis, diabetic pre-coma
    • Renal failure or renal dysfunction (creatinine clearance < 60 mL/min)
    • Acute conditions with the potential to alter renal function such as:
    - dehydration
    - severe infection
    - shock
    - intravascular administration of iodinated contrast agents
    • Acute or chronic disease which may cause tissue hypoxia such as:
    - cardiac or respiratory failure
    - recent myocardial infarction
    - shock
    • Hepatic insufficiency, acute alcohol intoxication, alcoholism
    • Lactation
    • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
    • Severe renal failure (GFR <30 mL/min)
    E.5 End points
    E.5.1Primary end point(s)
    A reduction in mean glucose/24hr of 0.5mmol/l after 8-week treatment, as assessed using continuous glucose monitoring.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary outcome will be evaluated at 22-25 weeks gestation.
    E.5.2Secondary end point(s)
    a) Other glycaemic parameters; mean daytime glucose 0.700-23.00h, mean nocturnal glucose 23.00-0.700h, percentage time in tight glucose control target 3.5- 6.7mmol/L, percentage time in NICE recommended glucose control target 3.5-7.8mmol/L, AUC <6.7mmol/L, AUC <7.8mmol/L, glucose variability measures (glucose SD, glucose CV standard deviation, correlation of coefficient), High Blood glucose index (HBGI), Low Blood glucose index after 8-week treatment and at 32-36 weeks gestation; GDM diagnosis at 24-28 weeks' (IADPSG and NICE criteria).
    b) metabolome at 14-17 weeks and 24-28 weeks gestation.
    c) dietary intake at 14-17 weeks, 22-25 weeks, and 32-36 weeks gestation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) Other glycaemic parametersÍž 22-25 weeks gestation and at 32-36 weeks gestationÍž GDM diagnosis at 24-28
    weeks' gestation.
    b) metabolome at 14-17 weeks and 24-28 weeks gestation
    c) dietary intake at 14-17 weeks, 22-25 weeks, and 32-36 weeks gestation
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    dietary advice or standard antenatal care
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    Database lock
    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 months0
    E.8.9.1In the Member State concerned days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 75
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    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 state75
    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)
    Patients will be managed as per standard of care. In the postnatal period, the women can decide as to whether or not to continue with the dietary component of the intervention. The recommended foods are widely available and accessible in the communities in which the research is being undertaken. However, there will be no input from the research team in the postnatal period. For future pregnancies, there is possibility that women will be prescribed metformin at the discretion of their doctor.
    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 Decision2018-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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