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    Summary
    EudraCT Number:2007-007588-26
    Sponsor's Protocol Code Number:A7941006
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-25
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-007588-26
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 12-WEEK ADMINISTRATION OF PF-00734200 TO SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON METFORMIN TREATMENT
    A.4.1Sponsor's protocol code numberA7941006
    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 Inc., 235 East 42nd Street, New York, NY 10017
    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 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.3.9.1CAS number 869490-23-3
    D.3.9.3Other descriptive namePyrrolidine,3,3-difluoro-1- [[(2S,4S)-4-[4-(2-pyrimidinyl)-1-piperazinyl] -2-pyrrolidinyl]carbonyl]-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 to mg
    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
    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 AND INSUFFICIENT GLYCEMIC CONTROL ON METFORMIN TREATMENT
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term 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
    To evaluate the effect of two oral doses of PF-00734200 on change from baseline to
    12 weeks in HbA1c levels in subjects with T2DM on metformin.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of two oral doses of PF-00734200 on change from baseline to
    12 weeks in fasting plasma glucose in subjects with T2DM on metformin.

    To compare the proportion of subjects who achieve the current ADA glycemic goal
    of HbA1c <7%.

    To provide 12-week safety and tolerability data of two oral doses of PF-00734200 in
    subjects with T2DM on metformin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women between the ages of >18 and <80 years of age at the time of
    Screening Visit 1 with a diagnosis of Type 2 diabetes mellitus in accordance with
    ADA guidelines.
    2. HbA1c at Screening Visit 1 based on the background diabetes medication of the
    subject:
    Diabetes Medication at Screening Visit 1 (S1)
    Metformin monotherapy = 7.0-11.0% HbA1c
    Metformin + Insulin secretagogue = 6.5-9.5%, inclusive HbA1c
    Metformin + TZD = 6.5-9.5%, inclusive HbA1c
    3. Body mass index (BMI) >22.0 kg/m2 and <45.0 kg/m2 at Screening Visit S1
    4. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    5. Subjects who are willing and able to comply with scheduled visits, treatment plan,
    laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1. History of Type 1 diabetes mellitus or secondary forms of diabetes.
    2. History of myocardial infarction, unstable angina, coronary revascularization, stroke
    or transient ischemic attack within 6 months of Screening.
    3. Uncontrolled hypertension as determined by the Principal Investigator
    4. Screening 12-lead ECG demonstrating a QTc >470 msec, confirmed by a single
    repeat if deemed necessary.
    5. Any prior history of malignancy with the exception of:
    a. Basal cell carcinoma of the skin; or
    b. Squamous cell carcinoma of the skin that has been cancer free for >5 years; or
    c. Other malignancies (regardless of site) that have been cancer free for >10 years
    6. History of major depressive disorder within 2 years from Screening.
    7. History of abuse of alcohol and/or any other illicit drug use or dependence within
    6 months of Screening. As a general rule alcohol intake should not exceed 21 drinks
    per week for men and 14 drinks a week for women. (1 drink = 5 ounces of wine
    (150 mL) or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor).
    8. Any medical condition possible affecting study drug absorption (ex, gastrectomy).
    9. Women who are pregnant, planning to become pregnant or nursing
    10. Subjects with a known hypersensitivity or intolerance to any DPP-4 inhibitor
    11. Subjects who have previously been enrolled in a trial with PF-00734200.
    12. Screening C-peptide <0.8 ng/mL.
    13. Screening fasting plasma glucose >270 mg/dL, confirmed by a single repeat
    following counseling on exercise and diet.
    14. Fasting serum triglyceride >500 mg/dL at Screening, confirmed by a single repeat if deemed necessary.
    15. Subjects with uncontrolled thyroid disease at Screening
    16. Serum creatinine or creatinine clearance at Screening which would be a
    contraindication to metformin treatment according to the country product label. For
    example, in the United States, a serum creatinine >1.5 mg/dL for men and >1.4
    mg/dL for women.
    17. Active hepatobiliary disease or an AST or ALT >2-x the upper limit of the reference
    range (ULRR) at Screening, or a TBili >1.5-x the ULRR at Screening.
    18. Unexplained creatine kinase >3-x ULRR at Screening (eg, not due to recent trauma, heavy exercise, intramuscular injection, etc). Subjects with a reason for the creatine kinase elevation may have the value repeated once during Screening. A repeat creatine kinase >3-x ULRR is exclusionary.
    19. The following therapeutic agents are prohibited for the duration of the study. These medications are not to be used from the time of the start of the placebo run-in period to the completion of the study.
    • Chronic oral or parenteral prednisone, dexamethasone, methylprednisolone or
    hydrocortisone at any dose. Intercurrent steroid treatment may be administered if
    treatment does not exceed one week. Note that inhaled and topical corticosteroids
    are permitted.
    • Orlistat, sibutramine, rimonabant, or other medications approved for weight loss
    • Anti-psychotic medication including olanzapine, risperidone
    20. The following therapeutic agents are prohibited for the duration of the study. These medications are not to be used from the time of Screening Visit S1 through the
    completion of the study.
    • Insulin
    • Exenatide or any GLP-1 analogue
    • Bromocriptine
    • Any other anti-hyperglycemic therapy with the exception of the protocol approved agents (includes the agents that subjects are allowed to wash-off from)
    21. Participation in other studies within 30 days before the current study begins and/or during study participation.
    22. Subjects who have donated blood or blood products within six weeks of screening Visit 1 or who plan to donate blood or blood products at any time during the trial.
    23. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. This includes any contraindication to metformin therapy according to the country specific product label
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the change in HbA1c from baseline to Week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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) 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA2
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 225
    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 Decision2008-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-26
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