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    Summary
    EudraCT Number:2008-003640-11
    Sponsor's Protocol Code Number:MK0431C-102
    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:2008-07-11
    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 number2008-003640-11
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin
    and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate
    Glycemic Control.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberMK0431C-102
    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 &amp; 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 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 namesitagliptin/pioglitazone
    D.3.2Product code MK0431C
    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 codeMK0431C
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.8Extractive medicinal product No
    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 INNSITAGLIPTIN
    D.3.9.2Current sponsor codeMK0431
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.8Extractive medicinal product No
    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: 3
    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.3.1Product namePioglitazone
    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 No
    D.3.11.8Extractive medicinal product No
    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
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10049746
    E.1.2Term Insulin-requiring type II diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective: After 24 weeks, to assess the effect of the co-administration of sitagliptin and
    pioglitazone compared with pioglitazone monotherapy and sitagliptin monotherapy on
    HbA1c.
    Hypothesis: After 24 weeks, the co-administration of sitagliptin and pioglitazone
    provides greater reduction in HbA1c compared with pioglitazone monotherapy and
    sitagliptin monotherapy.
    Objective: After 24 and 54 weeks, to assess the safety and tolerability of the coadministration
    of sitagliptin and pioglitazone compared with pioglitazone monotherapy
    and sitagliptin monotherapy.
    Hypothesis: After 24 and 54 weeks, the co-administration of sitagliptin and pioglitazone is well tolerated.
    E.2.2Secondary objectives of the trial
    Objective: After 24 weeks, to assess the effect of the co-administration of sitagliptin and
    pioglitazone compared with pioglitazone monotherapy and sitagliptin monotherapy on
    fasting plasma glucose (FPG).
    Hypothesis: After 24 weeks, the co-administration of sitagliptin and pioglitazone
    provides greater reduction in FPG compared with pioglitazone monotherapy and
    sitagliptin monotherapy.
    Objective: After 24 weeks, to assess the effect of the co-administration of sitagliptin
    and pioglitazone compared with pioglitazone monotherapy and sitagliptin monotherapy
    on the 2-hour post meal glucose (PMG) following a standard meal challenge.
    Hypothesis: After 24 weeks, the co-administration of sitagliptin and pioglitazone
    provides greater reduction in 2-hour PMG following a standard meal challenge compared
    with pioglitazone monotherapy and sitagliptin monotherapy.
    Objective: After 54 weeks, to assess the effect of the co-administration of sitagliptin and pioglitazone compared with piogl
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1
    1. Patient has T2DM and is &#8805;18 and &#8804; 78 years of age on day of signing informed
    consent.
    2. Patient is highly unlikely to conceive, as indicated by at least one "yes" answer to the following questions:
    a. Patient is a male.
    b. Patient is a surgically sterilized female.
    Patient is not pregnant or breast feeding and is not intending to become pregnant
    or donate eggs within the projected duration of the study and post-study follow-up
    period.
    d. Patient is a postmenopausal female &#8805;45 years of age with >2 years since last
    menses.
    e. Patient is a non-sterilized, premenopausal female and agrees to use adequate
    contraception.
    3. Patient understands the study procedures, alternative treatments available, and risks
    involved with the study and voluntarily agrees to participate by giving informed
    written consent.
    Glycemic Entry Criteria
    4. Patient is in one of the following 3 categories.
    a. Patient is naïve to all AHA therapies (off all AHA therapies for at least 3 months
    and not on an AHA for more than 4 weeks cumulatively in the last 3 years prior to
    Visit 1) and has an HbA1c &#8805;7.5% and &#8804;11% on diet and exercise alone.
    Or

    Patient is in one of the following 2 non-naïve categories AND based upon review
    of the patient’s current diet, medical regimen, and Visit 1/Screening HbA1c,
    patient is considered likely to meet Visit 3 inclusion criterion of HbA1c &#8805;7.5% and
    &#8804;11.0%:
    b. Patient is currently not on an AHA (i.e., off therapy for &#8805;8 weeks) and has a Visit
    1/Screening Visit HbA1c &#8805;7.5% and &#8804;11.0% on diet and exercise alone.
    c. Patient is currently on either metformin monotherapy or sulfonylurea
    monotherapy and has a Visit 1/Screening Visit HbA1c &#8805;7% and &#8804;10.5%.
    At Visit 3
    5. HbA1c &#8805;7.5% and &#8804;11% at Visit 3 or measured within 2 weeks prior to Visit 3.
    At Visit 4
    6. Patient has &#8805;85% compliance with placebo treatment during the single-blind run-in,
    as measured by site performed tablet count (e.g., for a patient with a 14-day interval
    between Visit 3 and Visit 4, at least 12 tablets taken per bottle).
    b. Patient is a surgically sterilized female.
    E.4Principal exclusion criteria
    At Visit 1
    Glucose Metabolism and Therapy Criteria
    1. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis or patient
    has a C-peptide &#8804;0.8 ng/mL (0.26 nmol/L). Note: Only patients assessed by the
    investigator as possibly having type 1 diabetes should have C-peptide measured at
    Visit 1.
    2. Patient has previously been treated with insulin, a thiazolidinedione (rosiglitazone or
    pioglitazone), any DPP-4 inhibitor (sitagliptin, vildagliptin, saxagliptin or alogliptin),
    exenatide, or has previously been in a clinical study with any DPP-4 inhibitor or
    incretin mimetic.
    NOTE: A patient who has received only minimal therapy with an excluded AHA
    (e.g., <7 tablets of an oral AHA or brief insulin therapy during an acute illness) may
    be considered for study participation after approval from the Merck Clinical Monitor.
    Patients Requiring Specific Treatments
    3. Patient is on a weight loss program and is not in the maintenance phase or has started
    a weight loss medication (e.g. orlistat, phentermine, sibutramine or rimonabant)
    within the prior 8 weeks.
    4. Patient is on or is likely to require treatment with &#8805;14 consecutive days or repeated
    courses of pharmacologic doses of corticosteroids.
    Note: Inhaled, nasal, or topical corticosteroids are permitted.
    5. Patient has received treatment with an investigational drug within 12 weeks prior to
    Visit 1/Screening Visit or is currently participating in any other clinical study (drug
    or non-drug studies).
    6. Patient has undergone surgery within the prior 30 days or has major surgery planned during the study.
    7. Patient has any contraindication to sitagliptin or pioglitazone based upon the label of the country of the investigational site.
    E.5 End points
    E.5.1Primary end point(s)
    Safety parameters and adverse experiences of special interest that are identified a priori (i.e., hypoglycemia, edema, and body weight) constitute "Tier 1" safety endpoints.
    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 No
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    - same IMP used at different dosage
    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 concerned6
    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 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 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
    .
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-07-11. Yes
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 315
    F.4.2.2In the whole clinical trial 1295
    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 Decision2008-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-03-25
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