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    Summary
    EudraCT Number:2007-001922-28
    Sponsor's Protocol Code Number:A7941005
    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:2008-03-12
    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 number2007-001922-28
    A.3Full title of the trial
    A PHASE 2A, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTIPLE-DOSE STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF 12-WEEK ORAL ADMINISTRATION OF PF-00734200 TABLETS TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS ON STABLE TREATMENT WITH METFORMIN
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberA7941005
    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 SponsorPFIZER
    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 namePF-00734200
    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 codePF-00734200
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    D.IMP: 2
    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 namePF-00734200
    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 codePF-00734200
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PF-00734200 is indicated for the treatment of T2DM.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10012601
    E.1.2Term 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
    To compare the effect of multiple oral doses of PF-00734200 tablet versus placebo on change from baseline to 12 weeks of Hb A1c levels and evaluate dose response in subjects with T2DM on a stable dose of metformin. The term ‘stable dose of metformin’ is defined as the same dose of metformin for at least 2 months prior to randomization.
    E.2.2Secondary objectives of the trial
    1. To evaluate the effect of multiple oral doses of PF-00734200 tablet on change from baseline to 12 weeks of insulin AUC following mixed meal tolerance test (MMTT) in subjects with T2DM. 2. To evaluate the proportion of subjects achieving the current ADA glycemic goal of Hb A1c <7%. 3. To evaluate the safety and tolerability of multiple oral doses of PF-00734200 tablet administered to subjects with T2DM.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FARMACOGENETICA
    E.3Principal inclusion criteria
    Diagnosis of Type 2 Diabetes Mellitus per ADA Subjects must be diagnosed with type 2 diabetes mellitus in accordance with the ADA guidelines. Diagnosis may have occurred in the recent past (documented patient medical history). Guidelines for diagnosis include at least one of the following criteria: Symptoms of diabetes in addition to casual plasma glucose concentration >/=200 mg/dl. Term ‘casual’ is defined as plasma glucose concentration at any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and/or unexplained weight loss. OR: FPG (fasting plasma glucose) >/=126 mg/dL. Term ‘fasting’ is defined as no caloric intake for at least 8 hours. OR: Two-hour post-load glucose >/=200 mg/dL during an OGTT (oral glucose tolerance test). The test should be performed as described by WHO (World Health Organization), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in ambient water. Inclusion Criteria 1. Male and/or female subjects (non-childbearing potential) between the ages of 18 and 70 years, inclusive. 2. Subjects currently taking a stable dose of metformin for treatment of their diabetes within past 2 months or longer before enrollment. 3. HbA1c >7% - 11% inclusive. 4. Fasting blood glucose levels in a range of >/=140 mg/dl to <270 mg /dL. 5. BMI >/=25 and </=40 kg/m2, and a total body weight >/=50 kg (110 Lbs). 6. Documented evidence of obtained written and witnessed informed consent - a subject (or their legal representative) signed and dated informed consent document in the presence of a witness. 7. Subjects are willing and able to comply with all study required procedures, including scheduled visits, assigned treatment, clinical laboratory tests. 8. Subjects are willing and able to perform self-test of blood sugars twice daily.
    Female Subjects of Non-Childbearing Potential Inclusion Criteria Female subjects of non-childbearing potential must meet at least one of the following criteria: Natural or surgically postmenopausal females, defined as: Natural postmenopausal - females over the age of 60 years, (FSH >40mIU/mL) Natural postmenopausal - females who are 45 to 60 years of age must be amenorrheic for at least 2 years and have a serum FSH (follicle-stimulating hormone) level within the regional standard laboratory reference range for postmenopausal women and/or FSH >40mIU/mL. Surgically postmenopausal - females who have undergone a total hysterectomy and/or total bilateral oophorectomy 6 months or earlier before the enrollment. All other female subjects (including women who have undergone tubal ligations) will be considered as women of childbearing potential and will be excluded from participation in this study.
    E.4Principal exclusion criteria
    1. Recent (within 12 months of enrollment) evidence or medical history of unstable concurrent disease. For example, documented evidence or history of clinically significant hematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding clinically insignificant drug allergies and untreated, asymptomatic, seasonal allergies). 2. Any medical condition possibly affecting study drug absorption (eg, gastrectomy). 3. A positive urine screen test for illegitimate/non-prescribed use of commonly abused drugs. 4. Treatment with any class of investigational drug within 30 days preceding the screening. 5. Fasting serum triglycerides result >/=500 mg/dL. 6. Treatment with any oral hypoglycemic agent within 2 months before enrollment. The exception to these criteria is a stable dose of metformin for treatment of T2DM within the past 2 months or longer of enrollment. 7. History of repeated or frequent documented hypoglycemia over the last 6 months prior to enrollment. 8. Screening fasting blood glucose level <140 or >270 mg/dL. 9. Diagnosis of Type 1 diabetes mellitus. 10. Presence of positive glutamic acid decarboxylase (GAD) antibody titer. 11. Women of childbearing potential, pregnant or nursing. 12. The following therapeutic agents use is specifically not permitted: Anticonvulsants, opioids, antiarrhythmics, coumarin-type anticoagulants, antipsychotics, tricyclic and related antidepressants, and paroxetine. Corticosteroids, sympathomimetic agents, and over the counter omega-3 fatty acids are not permitted. Herbal supplements must be discontinued at least 28 days before the first double-blind dose of study drug. Acetaminophen (paracetamol [EU]) allowed to be used at doses of </=2 g per day. 13. Blood donation of approximately 1 pint (500 mL) within 56 days of enrollment. 14. History of sensitivity to heparin or heparin-induced thrombocytopenia (including heparin use to flush intravenous catheters). 15. Evidence of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance </=60 mL/min based on the Cockcroft-Gault equation (listed below), diabetic neuropathy complicated by neuropathic ulcers. Males: (140 – age in years) x total body weight (kg)/ 72 x serum creatinine (mg/dL) Females: (0.85) x (Calculation for males) 16. Clinically significant peripheral vascular disease (eg, manifested by claudication). 17. History of stroke or transient ischemic attack. 18. Current medical history of unstable angina. 19. History of myocardial infarction within one year of enrollment. 20. 12-lead ECG at screening demonstrating QTc >450 msec. 21. Persistent severe uncontrolled hypertension, eg, supine systolic blood pressure (BP) >/=180 mm Hg and/or diastolic BP >/=105 mm Hg on at least 2 consecutive measurements following at least 10 minutes of rest between the measurements. 22. Any medical history or clinical evidence of congestive heart failure, NYHA (New York Heart Association) Functional Classification, Classes III-IV.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of Safety and Tolerability Safety and tolerability will be assessed by physical examinations, adverse event monitoring, clinical safety laboratory tests, blood glucose level measured by glucometer, vital sign measurements, and 12-lead ECGs Assessment of PF-00734200 Pharmacokinetics On Days 14, 56 and 84 fasting levels (0 hour) of PF-00734200. On Day 84 fasting (0 hour) and 0.75, 1.75 and 3.25 hours post-dose levels of PF-00734200.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned3
    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 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 years0
    E.8.9.1In the Member State concerned months12
    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 months12
    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 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 2008-03-12. 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 320
    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 Decision2008-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-26
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