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    Summary
    EudraCT Number:2011-002931-25
    Sponsor's Protocol Code Number:GS-US-259-0131
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-30
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-002931-25
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ranolazine Monotherapy in Subjects with Type 2 Diabetes Mellitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate a new drug to treat Type 2 Diabetes
    A.4.1Sponsor's protocol code numberGS-US-259-0131
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd
    B.5.2Functional name of contact pointInternational Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington
    B.5.3.3Post codeCB216GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 2085872210
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.com
    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 Ranexa®
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg S.A
    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.3.4Pharmaceutical 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 INNRANOLAZINE
    D.3.9.1CAS number 95635-55-5
    D.3.9.4EV Substance CodeSUB10259MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated 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
    Type 2 Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    Diabetes
    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 16.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to:
    • Determine the effect of ranolazine monotherapy on HbA1c in subjects
    with T2DM who are inadequately controlled with diet and exercise alone
    and who are treatment naïve to antihyperglycemic therapy or have not
    received antihyperglycemic therapy in the 90 days (or TZDs in the 24
    weeks) prior to Screening
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to:
    • Determine the effect of ranolazine monotherapy on postprandial glucose (PPG)
    • Determine the effect of ranolazine monotherapy on fasting serum glucose (FSG)

    The additional objectives of the study are to:
    • Evaluate the effect of ranolazine monotherapy on each of the following endpoints: serum C-peptide, serum insulin, plasma glucagon
    • Evaluate the pharmacokinetics (PK) of ranolazine
    The safety objective of the study is to:
    • Evaluate the safety and tolerability of ranolazine monotherapy in
    subjects who are treatment naïve to antihyperglycemic therapy or have
    not received antihyperglycemic therapy in the 90 days (or TZDs in the 24
    weeks) prior to Screening
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
    1. Written informed consent

    2. Males and females, 18 to 75 years old, inclusive

    3. Documented history of T2DM

    4. Treatment naïve to antihyperglycemic therapy or having received no prior treatment with antihyperglycemic therapy for at least 90 days or TZDs (eg, rosiglitazone or pioglitazone) for at least 24 weeks prior to Screening

    5. Body mass index (BMI) 25kg/m2 to 45 kg/m2 inclusive at Screening

    6. HbA1c 7% - 10% inclusive, at Screening and at the end of Qualifying Period (Day 14 +2 days)

    7. FSG of ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of Qualifying Period (Day 14 +2 days). A onetime central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥125 mg/dL (6.9 mmol/L) and <130 mg/dL (7.2 mmol/L) who are otherwise eligible as determinedby the Investigator.

    8. Fasting serum C-peptide ≥ 0,8 ng/mL at Screening

    9. Ability and willingness to comply with all study procedures during the course of the study

    10. Females of child-bearing potential must have a negative pregnancy
    test at Screening and must agree to use highly effective contraception
    methods from Screening throughout the
    duration of the Treatment Period and for 14 days following the last dose
    of study drug
    11. At least 80% compliant with dosing during the Qualifying Period
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:

    - Diabetes- Specific Exclusions:
    1. History of or current diagnosis of Type 1 Diabetes Mellitus
    2. History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
    3. History of a severe episode of hypoglycemia (≥1 episode within 3 months prior to Screening or ≥2 episodes within 6 months prior to Screen.), defined as hypoglycemia requiring 3rd party assistance to actively administer carbohydrate, glucagon, or other
    resuscitative actions due to severe impairment in consciousness or behavior
    4. Clin. signif.complications of diabetes that, in the judgment of the investigator, would make subjects unsuitable to participate in this study
    - Medical Exclusions:
    5. History of any clin. signifi. cardiovascular or cerebrovascular
    event ≤ 3 months prior to Screen.
    6. Inadequately controlled or unstable hypertension as defined by systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and Randomization.
    7. Prolonged QTc interval > 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
    8. HistHistory of bariatric surgery at any time in the past or any other
    surgery <2 months before Screen.; or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the Medical Monitor.
    9. Any other hospitalization in the 14 days prior to Screen. or planned hospitalization at any time during the study.

    10. Significant weight change (± 5%) < 2 months prior to Screen. or on a weight-loss program and is not in the maintenance phase at Screen.

    11. Severe renal impairment, defined as an estimated glomerular
    filtration rate (eGFR) by the Modification of Diet in Renal Disease
    (MDRD) equation < 30 mL/min/1.73 m2 at Screening or undergoing any type of dialysis at Screening or planning to undergo any type of dialysis at any time during the course of the study
    12. History of liver cirrhosis (Child-Pugh Class A, B, or C).
    13. Active liver disease and/or significant abnormal liver function
    defined as AST> 3x ULN and/or ALT> 3x ULN and/or serum total bilirubin > 2.0 mg/dL
    14. History of cancer (except non-melanomic skin cancers or cervical in situ) within 5 years prior to Screening.
    15. History of alcohol or other drug abuse < 12 months prior to Screening
    16. Any other clin. signif. existing medical or psychiatric condition, inc. clin. signif. lab. abnormalities, or one requiring further evaluation that, in the opinion of the investigator, could interfere with conduct of the study or interpretation of the data
    - Medications Exclusions:
    17. Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine
    18. Treatment with strong or moderate CYP3A inhibitors or P-gp
    inhibitors within 14 days prior to Random.
    19. Treatment with CYP3A inducers or P-gp inducers within 14 days prior to Random.
    20. Treatment with CYP3A4 substrates with a narrow therapeutic range within 14 days prior to Random.
    21. Treatment with simvastatin at a daily dose of > 20 mg or lovastatin
    at a daily dose > 40 mg, within 14 days prior to Random.
    22. Weight-loss medication or anti-obesity medication (prescription or non-prescription) < 3 months prior to Screen.
    23. Treatment with niacin > 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 90 days prior to Screen. and for the duration of the study
    24. Expected or current treatment with systemic corticosteroids (oral or injectable) for a > 14 days from Screen. through the end of the Treat. Period. Topical or inhaled corticosteroid formulations are permitted at any time during the study

    25. If receiving thyroid replacement therapy, should be on stable doses for at least 6 weeks prior to Random.
    - Lab. Test Exclusions:
    26. Hemoglobin < 12 g/dL for males; or < 11 g/dL for females, at Screen.
    - Other Exclusions:
    27. Participation in another clinical study involving an investigational drug or device < 30 days prior to Screening; participation in another clinical study involving an
    antihyperglycemic therapy < 90 days prior to Screen.
    28. Donation of blood < 2 months prior to Screen. or plans to donate blood while participating in the study
    29. Females who are pregnant or breastfeeding
    30. Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or would compromise the quality of the clinical study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is:
    • Change from Baseline in HbA1c at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints of this study are:
    • Change from Baseline in incremental change of 2-hour PPG at Week 24
    • Change from Baseline in FSG at Week 24 or change from Baseline in 2-hour PPG at Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    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 Yes
    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) 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 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.8.2.4Number 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Czech Republic
    Hungary
    Israel
    Mexico
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Ukraine
    United States
    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
    Last patient Last Visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.1.1In 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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 400
    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)
    Long-term care for the participant will remain the responsibility of their primary treating physician
    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 Decision2012-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-21
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