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    Summary
    EudraCT Number:2006-005101-64
    Sponsor's Protocol Code Number:059
    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:2007-07-04
    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 number2006-005101-64
    A.3Full title of the trial
    A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK-0431/Sitagliptin 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 number059
    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 namesitagliptin
    D.3.2Product code MK-0431
    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.3.10 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 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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    type 2 diabetes
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012613
    E.1.2Term Diabetes mellitus non-insulin-dependent
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients who are 8805;30 and 8804;65 years of age with type 2 diabetes mellitus T2DM who have inadequate glycemic control FPG 8805;130 7.2mmol/l and 8804;260 mg/dL 14.4 mmol/L 2.1.1 Primary Objective After 6 weeks, to assess the effect of treatment of sitagliptin compared with placebo on incremental glucose area under the curve. Hypothesis After 6 weeks, treatment with sitagliptin compared with placebo provides greater improvement in incremental glucose area under the curve. Objective To assess the safety and tolerability of sitagliptin. Hypothesis Sitagliptin is well tolerated
    E.2.2Secondary objectives of the trial
    Objective After 6 weeks, to examine the effect of treatment with sitagliptin compared with placebo on 1. Parameters of model assessment of 946;-cell function a. 946;-cell glucose sensitivity b. Rate sensitivity c. Potentiation factor 2. Incretin response for insulin. 3. Plasma glucagon response after a meal challenge. 4. Endogenous glucose production. 5. Incretin response for glucagon. 6. Glucose clearance. 7. Appearance of exogenous glucose. 8. The post-meal triglyceride excursion. 9. The post-meal Non-esterified Free Fatty Acids.Objective To examine incretin function in T2DM compared with normal glucose tolerant subjects under physiological conditions by quantifying the incretin contribution to overall 946;-cell function.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patient has type 2 diabetes mellitus T2DM diagnosed within the past 5 years. Exception This criterion is not applicable to the cohort of NFG subjects. 2. Patient is 8805;30 and 8804;65 years of age on day of signing informed consent. 3. Patient has a BMI this is 8805;20 and 8804;40 kg/m2. 4. Patient meets one of the following criteria as indicated by a yes answer to one of the following a Patient is currently not on an AHA and has a Screening/Visit 1 HbA1c 8805;7 and 8804;10 . OR b Patient is currently on AHA monotherapy or low dose i.e. 8804;50 maximum labeled dose of each agent oral combination therapy and has a Screening/Visit 1 HbA1c 8805;6.5 and 8804;10 . Exception This criterion is not applicable to the cohort of NFG subjects. 5. Subjects who are screening for the cohort of NFG subjects has an FPG 100 mg/dL 5.5 mmol/L . Exception This criterion is not applicable to the cohort of T2DM patients. 6. Patient is a male, or a female who is 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. c Patient is a postmenopausal female 8805;45 years of age with 2 years since last menses. d Patient is a non-sterilized premenopausal female and agrees to 1 use 2 adequate methods of contraception to prevent pregnancy either 2 barrier methods or a barrier method plus a hormonal contraceptive method or 2 abstain from heterosexual activity throughout the study starting with Visit 1 and for 14 days after the last dose of study medication. 7. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 8. Patient is able to read, understand, and complete study questionnaires and diaries. At Visit 3 9 Patient has an FPG 8805;130 mg/dL 7.2 mmol/L and 8804;260 mg/dl 14.4 mmol/L measured at Visit 3. NOTE If the Visit 3 FPG does not meet this criterion, a single repeat measurement may be performed at the discretion of the investigator. If repeat value meets FPG inclusion criterion, patient may continue in the study. Exception This criterion is not applicable to the cohort of NFG subjects. 10. Patient is compliant with diet, exercise and other run-in treatments during the run-in period. 2.3 SUBJECT/PATIENT EXCLUSION CRITERIA Patients are excluded from participation in the study if they meet any of the following criteria. Note NFG subjects are also excluded from participation if they meet any of the Visit 1 exclusion criteria. 0431, Protocol 059-00 16
    E.4Principal exclusion criteria
    1. Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis. 2. Patient is not weight stable. Patient has gained or lost more than 3 kg during the 3 months prior to Visit 1. 3. Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history within the last year of drug or alcohol abuse or dependence. Note Alcohol abuse includes heavy alcohol intake as defined by 2 drinks per day or 14 drinks per week, or binge drinking. 4. Patient has evidence of a significant cardiovascular disorder within 6 months of signing informed consent e.g. acute coronary syndrome e.g. MI or unstable angina ; coronary artery intervention e.g., CABG or PTCA ; stroke or transient ischemic neurological disorder; congestive heart failure treated with pharmacologic therapy. Note NYHA Class III or IV CHF patients are excluded from participation. 5. Patient has a systolic blood pressure of 8805;160 mm Hg or diastolic blood pressure of 8805;95 mm Hg. Note Patients may have their antihypertensive regimen adjusted and be randomized if they meet the blood pressure criteria at Visit 3. 6. Patient has a recent within 6 months prior to signing informed consent diagnosis/episode/recurrence of stroke, TIA or neurological disorder, including but not limited to seizures, blackouts, or a recent within 3 months prior to signing informed consent change in the dose or class of medications used to treat these conditions. 7. Patient has a history of malignancy 8804;5 years prior to signing informed consent, or 5 years without documentation of remission/cure. Exception Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Patients with melanoma, leukemia, lymphoma and myeloproliferative disorders of any duration are excluded. 8. Patient has undergone a surgical procedure within 1 month prior to signing informed consent. Exception Patient with a history of minor surgery i.e. using local anesthesia within 1 month of signing informed consent and is fully recovered may participate. 0431, Protocol 059-00 17 Product MK-0431 11 Protocol/Amendment No. 059-00 0431 059-00 ProtCore VERSION 11.1 APPROVED 22-Sep-2006 Non-U.S. IND, Ex-U.S. Study Restricted Confidential Limited Access 9. Patient has undergone surgical treatment for obesity. Exception Patient s procedure occurred at least 5 years prior to signing informed consent and there is no clinical evidence of complications including, but not limited to malabsorption. 10. Patient is pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 11. Patient is expecting to donate eggs within the projected duration of the study. 12. Patient has been diagnosed with HIV. 13. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient s participation for the full duration of the study, such that it is not in the best interest of the patient to participate. 14. Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 15. Patient is lactose intolerant. 16. Patient is allergic to egg and/or products. Specific Treatments 17. Patient currently uses, has used within 3 months prior to signing informed consent or plans to use any prescription or nonprescription drugs, including over-the-counter or herbal supplements that can alter body weight see Section 3.2.1 . 18. Patient is on or likely to require treatment with 8805;14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. Exception Topical or inhaled corticosteroids are permitted in the study. 19. Patient is currently participating or has participated in a study with an investigational
    E.5 End points
    E.5.1Primary end point(s)
    beta cells function
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years0
    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 years0
    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) No
    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 Information not present in EudraCT
    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 2007-07-04. Yes
    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 state57
    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 Decision2007-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-28
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