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    Summary
    EudraCT Number:2011-004245-41
    Sponsor's Protocol Code Number:Nill
    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:2012-08-20
    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 number2011-004245-41
    A.3Full title of the trial
    Safety, Tolerability and Effectiveness of Glocophage®SR in patients with type-2 Diabetes and Chronic Kidney Disease (eGFR 30 to 45mL/minute/1.73m2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of effects of Glucophage SR (a slow relaese metformin) tablet in patients with type-2 (adult onset) Diabetes and mild kidney dysfunction.
    A.3.2Name or abbreviated title of the trial where available
    GlucophageSR in patients with type-2 Diabetes & CKD (eGFR 30 to 45)
    A.4.1Sponsor's protocol code numberNill
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN54219044
    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 SponsorHywel Dda Health Board
    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 organisationHywel Dda Health Board
    B.5.2Functional name of contact pointDr Atir Khan
    B.5.3 Address:
    B.5.3.1Street AddressDolgwili Road, Glangwili Hospital
    B.5.3.2Town/ cityCarmarthen
    B.5.3.3Post codeSA31 2AF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01267227869
    B.5.5Fax number01267231339
    B.5.6E-mailatirsultanali.khan@wales.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 (Merck Serono)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code Not Applicable
    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
    D.3.9.1CAS number 1115-70-4
    D.3.9.2Current sponsor codeLA 6023
    D.3.9.3Other descriptive nameMetformin Hydrochloride
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500 to MG
    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
    Type-2 Diabetes with chronic kidney disease (eGFR 30 to 45)
    E.1.1.1Medical condition in easily understood language
    Adult onset Diabetes patients who have developed kidney problem.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives in this study are: to evaluate change in eGFR from baseline, incidence of lactic acidosis and tolerability (measured by number patients completed the study) in the Glucophage® SR group of the study; compared to placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age > 18 years. Male or Female. In addition, patients should fulfill all the following criteria at the randomization visit:
    1. Patients with Type – 2 Diabetes.
    2. Suboptimal glycaemic control {HbA1c ≥ 7.5% (IFCC equivalent ≥ 58mmol/mol)} at the screening visit.
    3. Chronic kidney disease with eGFR ≥ 30mL/minute/1.73m2 to ≤ 45mL/minute/1.73m2 (calculated by MDRD equation) at the screening visit.
    4. Stable renal function (eGFR) in the last three months.
    5. Willing and able to comply with the study protocol.
    E.4Principal exclusion criteria
    1. Previous H/O: M.I. (in last 6 months),
    2. Previous history of Congestive Cardiac Failure (NYHA class III or IV),
    3. Previous history of Chronic obstructive pulmonary disease (COPD).
    4. Chronic kidney disease with eGFR < 30mL/minute/1.73m2.
    5. Abnormal ALT (> 3fold at baseline).
    6. Hypoglycaemia symptoms unawareness
    7. History of hypoglycemic episodes requiring 3rd party assistance for reversal in last 12 months.
    8. Uncontrolled Hypertension (BP > 180/100mmHg).
    9. Pregnant OR likelihood of pregnancy during the study.
    10. Females who are breast feeding.
    11. Proliferative Diabetic retinopathy and / or laser treatment in last 6 months.
    12. History of Diabetic ketoacidosis, lactic acidosis and gasteroparesis.
    13. Current treatment with metformin / Glucophage® SR.
    14. Treatment with metformin / Glucophage® SR in last 3 months prior to screening visit.
    15. History of irritable bowel syndrome.
    16. Previous intolerance to metformin or Glucophage® SR.
    17. Patients currently on DPPIV inhibitors and GLP analogues.
    18. History of significant (more than one stone) weight loss in last 6 months.
    19. History of allergic or hypersensitivity reaction to metformin, Glucophage® SR or any insulin.
    20. Patients unable to tolerate minimum 1000mg daily divided dose of Glucophage® SR.
    21. Excessive alcohol intake where precipitation of lactic acidosis is suspected.
    22. Any other condition excluded in Summary of Product Characteristics (SPC).
    E.5 End points
    E.5.1Primary end point(s)
    1% Change in HbA1c at the end of study from baseline in the Glucophage® SR group of the study, compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome will be evaluated at the end of the study.
    E.5.2Secondary end point(s)
    The secondary objectives in this study are: to evaluate change in eGFR from baseline, incidence of lactic acidosis and tolerability (measured by number of patients completed the study) in the Glucophage® SR group of the study; compared to placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary end points will be evaluated at the end of the study.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned3
    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
    Every effort will be made to end the study with the last patient visit. If a scenario is encountered as in this question (A-70), we will seek extension from MHRA and will inform ethics committee and local R&D office.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    If the results are favourable for the intervention arm of the study then the patients can opt for this treatment at the end of the study. This combination treatment will be available to patients in the control group as well. We will share the results of the study with patients after complete analysis is done.
    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 Not Applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-06-24
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