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    Summary
    EudraCT Number:2007-002218-21
    Sponsor's Protocol Code Number:MK0431-068
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-002218-21
    A.3Full title of the trial
    A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to
    Study the Efficacy and Safety of Sitagliptin and MK-0431A (A Fixed-Dose Combination
    Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberMK0431-068
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERCK SHARP DOHME
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 namemetformina e sitagliptin
    D.3.2Product code MK0431A
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMK0431A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Information not present in EudraCT
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPioglitazone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients With Type 2 Diabetes Mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 6.1
    E.1.2Level PT
    E.1.2Classification code 10049746
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) Objective: To assess the effect of the fixed-dose combination sitagliptin/metformin
    (MK-0431A) 50/1000 mg b.i.d. compared with the effect of pioglitazone 45 mg q.d.
    on HbA1c at Week 40.
    Hypothesis: The fixed-dose combination sitagliptin/metformin (MK-0431A)
    50/1000 mg b.i.d. will lower HbA1c (mean change from baseline) more than
    pioglitazone 45 mg q.d. at Week 40.
    (2) Objective: After 12 weeks, to assess the HbA1c-lowering efficacy of treatment with
    sitagliptin.
    Hypothesis: After 12 weeks of treatment, sitagliptin results in a significant reduction
    of HbA1c from baseline.
    (3) Objective: To assess the safety and tolerability of sitagliptin and the fixed-dose
    combination sitagliptin/metformin (MK-0431A).
    Hypothesis: Sitagliptin and the fixed-dose combination sitagliptin/metformin
    (MK-0431A) are well-tolerated.
    E.2.2Secondary objectives of the trial
    (1) Objective: To assess the effect of the fixed-dose combination sitagliptin/metformin
    (MK-0431A) 50/1000 mg b.i.d. compared with the effect of pioglitazone 45 mg q.d.
    on the proportion of patients achieving glycemic goals (HbA1c <7.0%, <6.5%) at
    Week 40.
    Hypothesis: The fixed-dose combination sitagliptin/metformin (MK-0431A)
    50/1000 mg b.i.d. will result in a higher proportion of patients who achieve the
    glycemic goal of HbA1c <7.0% than pioglitazone 45 mg q.d. at Week 40.
    (2) Objective: To assess the effect of the fixed-dose combination sitagliptin/metformin
    (MK-0431A) 50/1000 mg b.i.d. compared with the effect of pioglitazone 45 mg q.d.
    on 2-hour post prandial glucose (PPG) as determined by MTT at Week 40.
    Hypothesis: The fixed-dose combination of sitagliptin/metformin (MK-0431A)
    50/1000 mg b.i.d. will result in a greater reduction of the 2-hour PPG after standard
    meal challenge from baseline than pioglitazone 45 mg q.d. at Week 40.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At Visit 1
    a. Patient has T2DM.
    b. Patient is &#8805;18 and &#8804;78 years of age on day of signing informed consent.
    c. Patient has an HbA1c of 7.5% and &#8804;12% at Visit 1.
    d. Patient is drug-naïve (off antihyperglycemic agent [AHA] therapy for at least
    3 months prior to the Screening Visit/Visit 1, and no more than 4 weeks cumulative
    AHA therapy over the previous 3 years).
    e. Patient is a male, or a female who is unlikely to conceive, as indicated by at least one
    “yes” answer to the following questions:
    1) Patient is a male.
    2) Patient is a surgically sterilized female.
    3) Patient is a postmenopausal female &#8805;45 years of age with >2 years since last
    menses.
    4) Patient is a non-sterilized, premenopausal female and agrees to abstain from
    heterosexual activity or to use an adequate method of contraception:
    Note: Acceptable methods of birth control are: hormonal contraceptive,
    intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge,
    condom, or vasectomy.
    f. Patient understands the study procedures, alternative treatments available, and risks
    involved with the study and voluntarily agrees to participate by giving informed
    written consent.
    At Visit 3/Day 1/Randomization
    Patient has &#8805;85% compliance with placebo treatment during the single-blind run-in as
    measured by site performed tablet count.
    E.4Principal exclusion criteria
    At Visit 1
    Glucose Metabolism and Therapy Criteria
    a. Patient has a history of type 1 diabetes mellitus or a history of Ketoacidosis.
    OR
    Patient is assessed by the investigator as possibly having type 1 diabetes confirmed
    with a C-peptide <0.7 ng/mL (0.23 nmol/L). Note: Only patients assessed by the
    investigator as possibly having type 1 diabetes should have C-peptide measured at
    Visit 1.
    b. Patient has symptomatic hyperglycemia requiring immediate initiation of
    antihyperglycemic therapy.
    Patients Requiring Specific Treatments
    c. Hypersensitivity or contraindication to biguanide medication (i.e., metformin),
    pioglitazone hydrochloride (i.e., ACTOS™), or thiazolidinedione medication.
    d. Patient is on a weight loss program and is not in the maintenance phase, or patient
    started on a weight loss medication (e.g., orlistat, sibutramine, or rimonabant) within
    8 weeks of Visit 1.
    e. Patient has received treatment with an investigational drug within the prior 3 months
    or is otherwise participating in another clinical trial.
    f. Patient has previously been treated clinically with sitagliptin, vildagliptin, or
    exenatide or has previously been in clinical study with any DPP-4 inhibitor or
    incretin mimetic.
    g. Patient is on lipid-modifying medications (or requires initiation of lipid-modifying
    medications) and will not be on a stable dose for at least 4 weeks prior to Visit 3.
    h. Patient is on or likely to require treatment with immunosuppressive/
    immunomodulating agents (e.g., cyclosporine, methotrexate, etanercept) or patient
    is on or likely to require treatment &#8805;14 consecutive days or repeated courses of
    pharmacologic doses of corticosteroids.
    Note: inhaled, nasal, and topical corticosteroids are permitted.
    i. Patient is on or likely to require treatment with CYP2C8 inhibitors (such as
    gemfibrozil) or CYP2C8 inducers (such as rifampicin).
    j. Patient has undergone surgery within 30 days prior to Visit 1 or has planned major
    surgery.
    Note: Patients who have undergone minor surgery within the prior 30 days or have
    planned minor surgery may be enrolled upon approval by the Merck Medical
    Monitor.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the effect of the fixed-dose combination sitagliptin/metformin
    (MK-0431A) 50/1000 mg b.i.d. compared with the effect of pioglitazone 45 mg q.d.
    on HbA1c at Week 40.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months10
    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 months10
    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.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 178
    F.4.2.2In the whole clinical trial 498
    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 Decision2007-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-16
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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