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    Summary
    EudraCT Number:2006-005192-18
    Sponsor's Protocol Code Number:A5351022
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-16
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2006-005192-18
    A.3Full title of the trial
    A 1-YEAR, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CP-945,598 IN THE TREATMENT OF OVERWEIGHT, ORAL AGENT-TREATED SUBJECTS WITH TYPE 2 DIABETES MELLITUS
    A.4.1Sponsor's protocol code numberA5351022
    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
    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.3.2Product code CP-945,598
    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 686347-12-6
    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 No
    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.3.2Product code CP-945,598
    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 686347-12-6
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine in overweight/obese subjects with type 2 diabetes mellitus whether body weight can be made significantly lower by treatment with CP 945,598 compared to treatment with placebo.
    E.2.2Secondary objectives of the trial
    Determine in overweight/obese subjects with type 2 diabetes mellitus treated with metformin or sulfonylurea monotherapy whether HbA1c can be made significantly lower by treatment with CP 945,598 compared to treatment with placebo;
    • Explore the effect of CP 945,598 at 1 year on:
    • Proportion of subjects who lose 5% and 10% body weight;
    • Proportion of subjects with HbA1c <6.5;
    • Proportion of subjects with HbA1c <7.0;
    • Change from baseline waist circumference;
    • Change from baseline fasting triglyceride and HDL concentrations;
    • Change from baseline fasting plasma glucose;
    • Change from baseline postprandial glucose determined from oral glucose
    tolerance tests (OGTT) in a subset of subjects;
    • Change from baseline in the following patient reported outcome subscales:
    Uncontrolled Eating/Hunger, Power of Food, Physical Functioning, and Self
    Esteem at 1 year.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and/or female subjects 18-70 years of age, inclusive, with BMI 27-45 kg/m2 inclusive, and with type 2 diabetes mellitus as defined by the American Diabetes Association for at least 4 months.
    2.Subjects on stable oral anti diabetes regimens (no changes in agents or doses for at least 4 months) consisting of sulfonylurea (SU), metformin (Met), or thiazolidinedione (TZD) monotherapy or any two of these drug classes used in combination. Doses of specific agents must be at least: glipizide 20 mg/d, glipizide XL (extended release) 10 mg/d, glyburide or glibenclamide 10 mg/d, micronized glyburide or glibenclamide 6 mg/day, gliclazide 160 mg/day, gliclazide modified release 60 mg/d, glimepiride 4 mg/d. Subjects on metformin, rosiglitazone, or pioglitazone must be on stable (at least 4 months), maximally allowable doses per package inserts or maximally tolerated doses of these agents.
    3.Screening HbA1c between 7.0% and 10%, inclusive.
    4.Week 1 fasting plasma glucose ≤ 270 mg/dl (15 mmol/L).
    5.Subjects must have documentation of an appropriate ophthalmologic exam (including dilated examination of the fundus) by a qualified health care professional, during the 12 months prior to randomization.
    6.For women of childbearing potential, a negative serum pregnancy test will be required prior to study inclusion. Female subjects must be surgically sterile or be postmenopausal or must agree to use effective contraception during the study. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate. Oral contraceptive use is permitted if used for at least 3 months before starting study medication.
    7.Male subjects must be surgically sterile or must use effective contraception during the study. The definition of effective contraception will be based on the judgment of the Investigator or a designated associate.
    8.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 trial.
    9.Subjects who are able to comply with scheduled visits, treatment plan (including diet and exercise program), home blood glucose monitoring, laboratory tests, and other trial procedures.
    E.4Principal exclusion criteria
    1.Women who are pregnant or lactating, or who are actively planning to become pregnant.
    2.Subjects with clinically significant abnormalities identified during the screening process. Specific exclusions include:
    a.Subjects with blood pressure systolic BP >155 mmHg and/or diastolic BP >95 mmHg or blood pressure requiring new pharmacologic treatment or change in current treatment according to local guidelines for diabetic patients;
    b.Subjects with clinically significant cardiovascular disease, defined as unstable coronary heart disease (CHD), cerebrovascular disease (CVD) or peripheral vascular disease (PVD) and/or an event/intervention during the past 6 months;
    Note: Clinically stable subjects with a history of CHD, CVD or PVD, provided that the level of exercise proposed in the trial is deemed safe and appropriate for the subject may be included.
    c.Subjects with dyslipidemia requiring new pharmacological treatment or a change in current treatment according to local guidelines for diabetic patients;
    d.Subjects with renal disease including:
    •Any history of nephrotic syndrome,
    •Chronic renal failure and/or serum creatinine above the upper limit of normal (ULN)
    for metformin-treated patients or >1.5 times the ULN for patients not treated with
    metformin.
    e.Subjects with abnormal screening TSH values;
    f.Subjects with significant hepatobiliary disease including:
    •History of hepatitis B or C infection and/or,
    •Aspartate aminotransferase or alanine aminotransferase ≥2 times the ULN.
    g.History of HIV infection or use of antiretroviral agents;
    h.Subjects with any prior history of malignancy except for:
    •Basal cell carcinoma of the skin curatively treated,
    •Other malignancies (regardless of site) that have been cancer-free for > 5 years
    prior to screening.
    i.Subjects with gastrointestinal disease, surgery limiting drug absorption or previous
    history of surgical procedure for weight loss;
    j.Clinical laboratory tests outside the pre-specified exclusionary limits;
    k.Subjects with a history of CNS disorder including:
    •A mood disturbance that meets the criteria for a Major Depressive Disorder within
    the last 10 years prior to screening, defined as requiring hospitalization, two or
    more episodes of a major depressive disorder or any previous suicide attempt.:
    •Use of antidepressants that are known to increase weight;
    Note: Subjects on a maintenance dose of other permitted antidepressants for a major depressive disorder, stable and in remission for at least 3 months prior to screening, and who plan to continue this treatment during the entire trial may be included.
    •Subjects with a score of ≥10 or who score positively on the item 9 addressing
    suicidal ideas on the PHQ-9;
    •Subjects with psychotic conditions or on antipsychotic pharmacotherapy;
    •Subjects with seizure disorders who:
    1.Are not controlled by current antiepileptic treatment, and/or
    2.Are taking antiepileptic drugs (AEDs) known to affect weight positively or
    negatively unless these medications have been taken at a stable dose for at
    least 6 months and the subject’s weight has been stable over the same time
    period, and/or
    •That may increase the risk of a drug-drug interaction.
    •Subjects with neurological disorders that are acute, chronic relapsing, progressive
    or have an unpredictable course.
    3.Subjects who use marijuana (determined by medical history).
    4.Subjects who frequently change smoking habits or have stopped smoking within 6
    months prior to screening.
    5.Subjects with known history of alcoholism or drug abuse or dependence within 1
    year prior to screening.
    6.Subjects with a history of anorexia, bulimia nervosa or binge eating disorder as
    per DSM-IV TR.
    7.Use of prescription drugs or over the counter agents/supplements known to alter
    body weight or appetite within 3 months prior to screening.
    8.Systemic therapy with strong CYP3A inhibitors.
    9.Systemic therapy with clinically significant CYP3A inducers or regular consumption
    of grapefruit/grapefruit juice.
    10.Treatment with any anti-diabetic agent within the last 4 months not allowed in
    inclusion criterion # 2.
    11.Treatment with an investigational drug during the 30 days prior to screening.
    12.Participation in any formal weight loss program within 3 months prior to screening.
    13.Fluctuation in body weight >5% within 3 months prior to screening.
    14.Failure to satisfactorily complete at least 5 of the 7-day food intake and/or
    physical activity records.
    15.Subjects with any other medical condition or laboratory abnormality prior to
    randomization, which in the opinion of the investigator or sponsor could affect
    subject safety, preclude evaluation of response, or render unlikely that the
    subject would complete the study.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change in body weight from baseline (Day 1) to 1 year
    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 Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 months4
    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 months4
    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 state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 337
    F.4.2.2In the whole clinical trial 900
    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 Decision2007-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-03
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