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    Summary
    EudraCT Number:2012-002414-39
    Sponsor's Protocol Code Number:MK-3102-018
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-26
    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 ConcernedFrance - ANSM
    A.2EudraCT number2012-002414-39
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 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 Phase 3 study in Patients with Type 2 Diabetes Mellitus
    A.4.1Sponsor's protocol code numberMK-3102-018
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1732 594 2622
    B.5.5Fax number+1732-594-3560
    B.5.6E-mailira_gantz@merck.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 No
    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 nameMK-3102
    D.3.2Product code MK-3102
    D.3.4Pharmaceutical form Capsule
    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 INNOmarigliptin
    D.3.9.2Current sponsor codeMK-3102
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboCapsule
    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
    Type 2 Diabetes Mellitus is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency
    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 14.1
    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
    To assess the impact of MK-3102 25 mg q.w. on time to confirmed CV outcomes across the MK-3102 program

    To assess the safety and tolerability of MK-3102 25 mg q.w.
    E.2.2Secondary objectives of the trial
    To assess the impact of MK-3102 25 mg q.w. on:
    a. the key secondary composite confirmed CV endpoint of CV-related death, nonfatal MI, and nonfatal stroke;
    b. each of the components of the primary composite endpoint (i.e., confirmed CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring
    hospitalization);
    c. all-cause mortality

    To assess the impact of MK-3102 25 mg q.w. on:
    a. change from baseline in A1C over time;
    b. in subjects not receiving insulin at baseline, time to initiation of long-term insulin therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Having T2DM and is ≥40 years of age.
    2. Receiving one of the following diabetes treatment regimens and has A1C of ≥7.0% and ≤10.0%:
    (a) treated by diet and exercise alone (not on AHA for ≥12 weeks)
    (b) on metformin, a sulfonylurea, a meglitinide, pioglitazone, or an alpha-glucosidase, or an SGLT2 inhibitor as mono- or dual combination therapy continuously for at least 12 weeks (except for pioglitazone for at least 16 weeks) without dose alterations.
    (c) on a stable insulin regimen with any one of the following insulins, alone or in combination with or without metformin: intermediate-acting insulin (e.g., NPH); pre-mixed insulin (e.g., Novolog 70/30®, Novolin 70/30®, Humalog 75/25®, or Humulin 70/30®); or long-acting insulin (e.g., glargine, detemir, degludec)
    3. Having following preexisting vascular disease:
    (a) History of a major clinical manifestation of coronary artery disease (i.e., myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥50% in a major epicardial artery or branch vessel);
    (b)Ischemic cerebrovascular disease, including:
    - History of ischemic stroke
    - History of carotid arterial disease as documented by ≥50% stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit.
    (c) Atherosclerotic peripheral arterial disease, as documented by objective - amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or less than 0.9 or a toe-brachial pressure index less than 0.7 or history of surgical or percutaneous revascularization procedure.
    4.Meets one of the following criteria:
    a. Subject is a male
    b. Subject is a female not of reproductive potential defined as one who has either:
    (1) reached natural menopause (defined as ≥12 months of spontaneous amenorrhea in women >45 years of age, or ≥6 months of spontaneous amenorrhea with serum follicular stimulating hormone [FSH] levels in the postmenopausal range as determined by the laboratory), or
    (2)had a hysterectomy and/or bilateral oophorectomy, or had bilateral tubal ligation or occlusion at least 6 weeks prior to screening
    c. Subject is a female of reproductive potential and:
    1. agrees to remain abstinent from heterosexual activity (if this form of birth control is accepted by local regulatory agencies and ethics review committees as the sole method of birth control) or
    2. agrees to use (or have their partner use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded study medication. Two methods of contraception will be used to avoid pregnancy. Acceptable combinations of methods include:
    •Use of one of the following double-barrier methods:diaphragm with spermicide and a condom; cervical cap and a condom; or a contraceptive sponge and condom.
    •Use of hormonal contraception (any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent [including oral, subcutaneous, intrauterine and intramuscular agents, and cutaneous patch]) with one of the following:diaphragm with spermicide; cervical cap; contraceptive sponge; condom; vasectomy; or IUD.
    •Use of an IUD with one of the following: condom; diaphragm with spermicide; contraceptive sponge, vasectomy; or hormonal contraception (see above).
    • Vasectomy with one of the following:diphragm with spermicide; cervical cap; contraceptive sponge; condom; IUD; or hormonal contraception (see above).
    5. Understanding the trial procedures, alternative treatments available, providing the providing written informed consent, consent for Future Biomedical Research can be provided (not obligatory).
    E.4Principal exclusion criteria
    1. History of type 1 diabetes mellitus or a history of ketoacidosis or possibly having type 1 diabetes
    2. Beeing treated with rosiglitazone, a DPP-4 inhibitor or a GLP-1 receptor agonist within the prior 12 weeks of Visit 1/Screening.
    3. Having a history of hypersensitivity to a DPP-4 inhibitor
    4. Participation in trial with investigational compound prior 12 weeks of signing the informed consent or is not willing to refrain from participating in another trial.
    5. Beeing in weight loss program, not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to signing the informed consent.
    6. Surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial.
    7. Treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
    8. Treatement for hyperthyroidism or thyroid replacement therapy and has not been on a stable dose for at least 6 weeks.
    9. Medical history of active liver disease
    10. Human immunodeficiency virus (HIV) as assessed by medical history.
    11. Worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months.
    12. Poorly-controlled hypertension
    13. History of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
    14. Clinically important hematological disorder
    15. Exclusionary laboratory values
    16. Positive urine pregnancy test.
    17. Subject is pregnant or breast-feeding, or is expecting to conceive during the trial, including 21 days following the last dose of blinded study medication. OR is expecting to undergo hormonal therapy in preparation to donate eggs during the period of the trial, including 21 days following the last dose of blinded study medication.
    18. At the time of signing informed consent using recreational or illicit drugs or has had a recent history of drug abuse.
    19. Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per
    week, or engages in binge drinking.
    20. History or current evidence of condition, therapy, lab abnormality or other circumstance that
    makes participation not in the subject’s best interest.
    21. Donating blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intending to donate blood products within the projected duration of the trial OR receiving blood products within 12 weeks of signing informed consent or within the projected duration of the trial.
    22. Subject is unlikely to adhere to the trial procedures, keep appointments.
    E.5 End points
    E.5.1Primary end point(s)
    CV endpoints:
    a. the key secondary composite confirmed CV endpoint of CV-related death, nonfatal MI, nonfatal stroke;
    b. each of the components of the primary composite endpoint (i.e., confirmed CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization);
    c. all-cause mortality.

    E.5.1.1Timepoint(s) of evaluation of this end point
    156 weeks + 21 days
    E.5.2Secondary end point(s)
    - change from baseline in A1C over time
    - in subjects not receiving insulin at baseline, time to initiation of long-term insulin therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    156 weeks + 21 days
    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) 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA188
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Georgia
    Germany
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Jordan
    Korea, Republic of
    Lebanon
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Norway
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Saudi Arabia
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    Croatia
    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
    LVLS
    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 months11
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In 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: 3800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1440
    F.4.2.2In the whole clinical trial 4000
    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)
    Subjects will return to their normal standard of care therapy
    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 Decision2013-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-04-08
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