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    The EU Clinical Trials Register currently displays   36785   clinical trials with a EudraCT protocol, of which   6075   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2012-004303-12
    Sponsor's Protocol Code Number:MK-3102-028
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-08-05
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2012-004303-12
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-3102 in ≥18 and <45 Year-Old Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of the addition of a new drug (MK-3102) in patients with Type 2 Diabetes between the age of 18 and 44 years old, who are not taking any medications
    A.4.1Sponsor's protocol code numberMK-3102-028
    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+1 732 594 2622
    B.5.5Fax number+1 732-594-3560
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 17.0
    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
    1. To assess the effect of treatment with MK-3102 compared with placebo on A1C.

    2. To assess the safety and tolerability of MK-3102.
    E.2.2Secondary objectives of the trial
    1. To assess the effect of treatment with MK-3102 compared with placebo on 2-hour post-meal glucose (PMG).

    2. To assess the effect of treatment with MK-3102 compared with placebo on fasting plasma glucose (FPG).

    3. To assess the effect of treatment with MK-3102 on proportion of subjects achieving an A1C goal (<7.0%, <6.5%).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1/Screening:

    1. Have T2DM and be ≥18 and <45 years of age on the day of signing the informed consent form.

    2. Not be on AHA therapy (drug-naïve or off AHA therapy for at least 12 weeks) and have a Visit 1/Screening A1C ≥7.0% (53 mmol / mol) and ≤10.0% (86 mmol / mol). Note: A subject who has received a brief period of insulin treatment (such as few days during a hospitalization) and who no longer requires insulin treatment may participate.

    3. Meet one of the following criteria:
    a. Subject is a male.
    b. Subject is a female not of reproductive potential defined as one who has 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 review committees as the sole method of birth control). OR
    2. agrees to use (or their partner to use) acceptable contraception to prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of blinded trial medication. 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 contraceptive sponge and a 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 intrauterine device (IUD). Use of an IUD with one fo the following: condom;diaphragm with spermicide; contraceptive sponge; vasectomy; or hormonal contraception (see above).
    - Vasectomy with one of the following: diaphragm with spermicide; cervical cap; contraceptive sponge; condom; IUD;or hormonal contraception (see above).
    4. Understand the trial procedures, alternative treatments available, and risks involved with the trial, and voluntarily agrees to participate by giving written informed consent. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.

    At Visit 3/Randomization/Day 1:

    5. Be 100% compliant with MK-3102 placebo treatment during the single-blind run-in period (as determined by site-performed capsule count).
    E.4Principal exclusion criteria
    1. Has a history of type 1 diabetes mellitus or a history of ketoacidosis.
    2. Has a C-peptide <0.7 ng/mL (0.23 nmol/L).
    3. Has been treated with any AHA therapies within 12 weeks prior to signing informed consent or with MK-3102 at any time prior to signing informed consent.
    4. Has a history of hypersensitivity to a DPP-4 inhibitor.
    5. Is currently participating in, or has participated in, a trial in which the subject received an investigational compound or used an investigational device within the prior 12 weeks of signing the informed consent or is not willing to refrain from participating in any other trial.
    6. Is on a weight loss program and is not in the maintenance phase; has been on a weight loss medication in the past 6 months; or has undergone bariatric surgery within 12 months prior to signing the informed consent.
    7. Has undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial.
    8. Is on or likely to require treatment for ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
    9. Is currently being treated for hyperthyroidism or subject is on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks.
    10. Is currently on or likely to require treatment with a prohibited medication (see Section 5.5.2 for a list of prohibited medications).
    11. 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.
    12. Has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease.
    13. Has human immunodeficiency virus (HIV) as assessed by medical history.
    14. Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months, or has any of the following disorders within the past 3 months:
    a. Acute coronary syndrome (e.g., myocardial infarction or unstable angina),
    b. Coronary artery intervention (e.g., coronary artery bypass grafting or percutaneous transluminal coronary angioplasty),
    c. Stroke or transient ischemic neurological disorder.
    15. Has poorly controlled hypertension defined as systolic blood pressure of ≥160 mm Hg or diastolic blood pressure of ≥90 mm Hg and blood pressure is unlikely to be below these limits by Visit 2/Week -2 with an adjustment in antihypertensive medication.
    16. Has a 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.
    17. Has a clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia).
    18. Is pregnant or breast-feeding, or is expecting to conceive during the trial, including 21 days following the last dose of blinded study medication.
    19. Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug abuse. Routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per week, or engages in binge drinking.
    20. Has a history or current evidence of any condition, therapy, laboratory test abnormality or other circumstance that:
    a. makes participation not in the subject's best interest,
    b. might interfere with the subject’s participation for the full duration of the trial,
    c. might confound the results of the trial.
    21. Has a clinically significant ECG abnormality which in the opinion of the investigator exposes the subject to risk by enrolling in the trial.
    22. Has a fasting plasma glucose consistently (i.e., measurement repeated and confirmed within 7 days) >260 mg/dL (14.4 mmol/L).
    23. Has poorly controlled hypertension defined as systolic blood pressure of ≥160 mm Hg or diastolic blood pressure of ≥90 mmHg.
    24. Has a positive urine pregnancy test.
    25. Is on lipid-lowering medication or thyroid replacement therapy, and has not been on a stable regimen for the 4 weeks (lipid-lowering medication), or 6 weeks (thyroid replacement therapy) prior to Visit 3/Day 1. In this case the current visit can be changed to an Unscheduled Visit, and the subject should be rescheduled for a Visit 3/Day 1. Additional single-blind placebo run-in medication should be dispensed if needed.
    26. Has a positive urine pregnancy test.
    27. Has a site-fasting-fingerstick glucose (FFSG) <130 mg/dL (<7.2 mmol/L) or >260 mg/dL (>14.4 mmol/L).
    28. Has developed a new medical condition, suffered a change in status of an established medical condition, developed a laboratory or ECG abnormality, or required a new treatment or medication during the pre-randomization period meeting previously described trial exclusion criteria or which, exposes the subject to risk by enrolling in the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in A1C

    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 24
    E.5.2Secondary end point(s)
    1. Change from baseline in 2-hour PMG
    2. Change from baseline in FPG
    3. Proportion of subjects achieving an A1C goal <7.0% and < 6.5% after 24 weeks of treatment
    4. Time to rescue
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 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 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 Yes
    E.6.13.1Other scope of the trial description
    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. 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Russian Federation
    South Africa
    United States
    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
    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 months7
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days16
    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: 200
    F.1.3Elderly (>=65 years) No
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 73
    F.4.2.2In the whole clinical trial 200
    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 routine clinical care
    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 Decision2013-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-27
    P. End of Trial
    P.End of Trial StatusOngoing
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