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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-005570-56
    Sponsor's Protocol Code Number:GLINT
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-11-14
    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 number2012-005570-56
    A.3Full title of the trial
    Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT) - a randomised controlled trial to establish the effectiveness and cost-effectiveness of metformin in preventing cardiovascular events over five years in people with non-diabetic hyperglycaemia at high cardiovascular risk.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glucose lowering for prevention of heart attack and stroke in participants at risk of developing diabetes
    A.3.2Name or abbreviated title of the trial where available
    Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT)
    A.4.1Sponsor's protocol code numberGLINT
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number34875079
    A.5.4Other Identifiers
    Name:EudraCTNumber:2012-005570-56
    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 SponsorCambridge University Hospitals NHS Foundation Trust and the University of Cambridge
    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 supportMerck Serono
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointCarrie Bayliss
    B.5.3 Address:
    B.5.3.1Street AddressCambridge Clinicals Trials Unit, Addenbrooke's Hospital, Level 6, Coton House, Box 401, Hills Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01223348158
    B.5.5Fax number01223596471
    B.5.6E-mailcctu@addenbrookes.nhs.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.2.1.1.1Trade name Glucophage SR (Metformin)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono
    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 nameGlucophage SR
    D.3.4Pharmaceutical form Prolonged-release 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 1115-70-4
    D.3.9.3Other descriptive nameGlucophage SR
    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 placeboProlonged-release tablet
    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
    Non-diabetic hyperglycaemia (elevated blood glucose levels below the diagnostic threshold for diabetes) and high risk of cardiovascular disease (>20% risk over 10 years)
    E.1.1.1Medical condition in easily understood language
    Participants have higher than normal blood glucose levels below the diagnostic threshold for diabetes. They are also at increased risk of developing cardiovascular disease.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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
    People who do not have diabetes but who have higher than normal blood sugar levels are at an increased risk of cardiovascular disease (e.g. heart attack or stroke). This study will test whether early treatment with a well-established, safe and cheap drug (metformin) reduces the risk of developing cardiovascular disease in people who do not have diabetes but have high blood sugar levels and above-average risk of heart attacks and strokes.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of metformin treatment on:
    • Time to event for each component of the primary composite endpoint
    • All cause mortality
    • Time to non-melanoma cancer
    • Death due to non-melanoma cancer cause
    • Time to incident physician-diagnosed Type 2 diabetes
    • Patient satisfaction with treatment
    • Functional status (SF-8)
    • Health utility (EuroQol EQ-5D)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must meet all of the following criteria to participate in the study:
    • Age ≥ 40 years
    • HbA1c ≥36.6mmol/mol but <47.5mmol/mol, measured within 12 months prior to enrolment
    • Estimated 10-year CVD risk ≥20% as assessed by the Framingham or QRISK2 scores, measured within 12 months prior to involvement (laboratory values used for the risk calculators should be collected no more than one year prior enrolment)
    • Estimated glomerular filtration rate (eGFR) ≥45ml/min as determined by the MDRD-4 method and measured within 6 months prior to enrollment
    • Participant understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent
    • Participant agrees to allow study staff to contact his or her General Practitioner and/or consultant to notify them of study participation and to obtain all medical records necessary for complete data ascertainment during the follow-up period (including recording of NHS number and access to Health Episode Statistics (HES))
    • Participant agrees to be tagged for mortality with the Office for National Statistics and to be tagged for:
    • time to first non-melanoma cancer diagnosis (supplied by the National Cancer Registry
    • death due to a non-melanoma cancer cause according to primary/underlying cause of death on death certificate (supplied by the Office of National Statistics)
    E.4Principal exclusion criteria
    The participant may not enter the study if ANY of the following apply:
    • Unable to provide written consent
    • Prior history of physician-diagnosed Type 2 diabetes.
    NOTE: Participants with a history of gestational diabetes which resolved after pregnancy are permitted to enrol.
    • Prior history of CVD, defined as:
    o myocardial infarction, surgical or percutaneous coronary revascularization procedure
    o Stroke (hemorrhagic or ischemic)
    NOTE: Participants with prior transient ischemic attack or unstable angina are NOT excluded and may be enrolled
    • Participant has a planned or anticipated revascularization procedure within 6 months following enrolment
    NOTE: Participants with previous peripheral revascularisation procedure are NOT excluded and may be enrolled
    • Participant is pregnant
    • Participant is breastfeeding
    • Participant is currently taking metformin (for any reason) or they have taken metformin in the last 3 months
    • History of cirrhosis of the liver or other significant hepatic impairment, as assessed by medical history
    • End-stage renal disease (CKD stage 3b, eGFR <45ml/min)
    • In the investigator’s opinion, participant has a medical history that indicates a life expectancy of <2 years or might limit the individual’s ability to take the trial treatments for the duration of the study
    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
    • Participant is enrolled in or has participated within 12 weeks prior to enrolment in another experimental protocol involving the use of an investigational drug or device or an intervention that would interfere with the conduct of the trial
    E.5 End points
    E.5.1Primary end point(s)
    Time from randomisation to the first confirmed CV event in the primary composite endpoint (CV mortality, nonfatal myocardial infarction or nonfatal stroke).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to first confirmed event in the primary composite macrovascular endpoint (cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke).
    E.5.2Secondary end point(s)
    To evaluate the effect of adding metformin to the usual care of participants with non-diabetic hyperglycaemia on:
    - Each of the components of the primary composite endpoint
    - All-cause mortality
    - Incidence of non-melanoma cancer
    - Death due to a non-melanoma cancer cause
    - Incidence of physician-diagnosed Type 2 diabetes
    - Patient satisfaction with treatment
    - Functional status
    - Health utility
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from randomisation to the first confirmed event of the individual components of the primary composite endpoint i.e. CV mortality, nonfatal myocardial infarction or nonfatal stroke.
    All-cause mortality (supplied by Office of National Statistics)
    Time to first non-melanoma cancer (supplied by the National Cancer Registry)
    Death due to non-melanoma cancer cause according to primary/underlying cause of death on death certificate (supplied by the Office of National Statistics)
    Incident Type 2 Diabetes (physician diagnosed)
    Patient satisfaction with treatment (annual questionnaire)
    Functional status (annual questionnaire)
    Health utility (annual questionnaire)
    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 No
    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 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 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 Yes
    E.8.2.3Other No
    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 concerned6
    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 end of the full trial will be the date when the final participant and GP questionnaires have been received for data entry. The date of the last point of contact will be the date of censor for participants who do not return a questionnaire.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days29
    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: 6449
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6449
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state12898
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12898
    F.4.2.2In the whole clinical trial 12898
    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)
    Provision of the study medication will not be continued beyond the study period. After the study ends participants should speak with their GP to determine appropriate future treatment. GPs are able to prescribe metformin to participants as per the NICE guidelines but the drug is not currently licensed for this indication.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Research Network: Eastern
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-11-05
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