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    The EU Clinical Trials Register currently displays   39183   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-004891-38
    Sponsor's Protocol Code Number:A7211005
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-19
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-004891-38
    A.3Full title of the trial
    A 12-week, phase 2A, radomized, subject and investigator blinded, placebo-controlled trial to evaluate the safety, tolerability and efficacy of CE-326,597 on glucose control and body weight in overweight adult subjects with Type 2 Diabetes Mellitus
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberA7211005
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Applicable
    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 nameCE-326,597
    D.3.2Product code CE-326,597
    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 4,5-Dihydro-
    D.3.9.2Current sponsor codeCE-326,597
    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.3.1Product nameCE-326,597
    D.3.2Product code CE-326,597
    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 4,5-Dihydro-
    D.3.9.2Current sponsor codeCE-326,597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Weight management/treatment of obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    1. To estimate the magnitude of change in HbA1C with a range of oral doses of CE-326,597 administered over 12 weeks in overweight and obese adult subjects with T2DM either treatment naïve or on stable, up to two, oral, anti-diabetic agents.

    2. To estimate the magnitude of weight loss with a range of oral doses of CE-326,597 administered over 12 weeks in overweight and obese adult subjects with T2DM either treatment naïve or on stable, up to two, oral, anti-diabetic agents.
    E.2.2Secondary objectives of the trial
    1. To estimate the magnitude of change in post-prandial glucose and insulin AUC following a MMTT with a range of oral doses of CE-326,597 in overweight and obese adult subjects with T2DM either treatment naïve or on stable, up to two, oral, anti-diabetic agents.
    2. To evaluate the safety and tolerability of a range of oral doses of CE-326,597
    administered over 12 weeks in overweight and obese adult subjects with T2DM either treatment naïve or on stable, up to two, oral, anti-diabetic agents – including use of a focused evaluation of GI-related AEs and episodes of hypoglycemia as well as assessment of cholelithiasis/cholecystolithiasis.
    3. To characterize the pharmacokinetics of CE-326,597 in overweight and obese adult subjects with T2DM either treatment naïve or on stable, up to two, oral, anti-diabetic agents.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Molecular profiling supplement
    Samples for Pfizer's exploratory research biobank
    A 12-week, phasa 2A, randomized, subject and investigator blinded, placebo-controlled trial to evaluate the safety, tolerability and efficacy of CE-326,597 on glucose control and body weight in overweight adult subjects with type 2 Diabetes Mellitus
    Final Protocol, 28-August-2007
    The primary objective of this additional research component is to collect, store, and use samples to investigate possible associations between genomic and metabonomic variation:
    - In relation to response to the study drugs, and
    - In relation to characteristics of the disease/condition under study in the associated clinical trial, and related conditions.
    In addition, samples may be used as controls in genomic and metabonomic investigations of the causes, natural history, and other aspects of important diseases and conditions for which Pfizer is researching now or improved drug therapies.
    Scientific information about these differences among groups of subjects can help researchers to better understand the response of subjects to investigational drugs and to learn more about diseases/conditions for which we are developing treatments.
    Samples collected will be stored in Pfizer's Exploratory Research Biobank in the USA.
    E.3Principal inclusion criteria
    Subjects must meet all the following inclusion criteria to be eligible for enrollment into the trial:
    1. Males and/or females of non-childbearing potential between the ages of 18 and 65 years, inclusive, at screening:
    • Women must be of non-childbearing potential as defined by one of the following:
    • Females who are amenorrheic for ≥2 years prior to screening PLUS a serum follicle stimulating hormone (FSH) within central laboratory’s reference range for
    postmenopausal women or
    • Documented bilateral oophorectomy or hysterectomy ≥6 months prior to
    screening.
    2. Subjects must have a diagnosis of T2DM in accordance with the ADA guidelines;
    subjects must have at least one of the following criteria previously documented:
    • Symptoms of diabetes in addition to casual plasma glucose concentration
    ≥ 200 mg/dL (ie, 11.10 mmol/L)
    • “Casual” is defined as plasma glucose concentration at any time of day without
    regard to time since last meal
    • Classic symptoms of diabetes include polyuria, polydipsia, and/or unexplained
    weight loss
    • Fasting plasma glucose (FPG) ≥126 mg/dL (ie, 6.99 mmol/L); term fasting is defined
    as no caloric intake for at least 8 hours
    • Two-hour post-load glucose ≥200 mg/dL (ie, 11.10 mmol/L) during an oral glucose
    tolerance test (OGTT) as performed per WHO (World Health Organization), using a
    glucose load containing the equivalent of 75 grams anhydrous glucose dissolved in
    ambient temperature water
    3. Subjects who have not previously received any pharmacological treatment for T2DM or are on stable doses of up to two, oral, anti-diabetic agents within at least 56 days prior to screening [Refer to Section 5.5 for acceptable anti-diabetic agents].
    4. HbA1C ≥6.5% and ≤10% at screening (as assessed by trial-specific central laboratory).
    5. Fasting plasma glucose levels < 270 mg/dL (ie, 15.04 mmol/L), at screening, (as assessed by trial-specific central laboratory) confirmed by a single repeat, if deemed necessary.
    6. BMI of ≥27 kg/m2 and ≤ 45 kg/m2, at screening.
    7. 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.
    8. Subjects who are willing and able to comply with the scheduled visits, treatment regimen, laboratory tests and other trial procedures.
    9. Subjects willing and able to perform self-test of blood sugars at least once daily for the duration of the trial.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. Recent (within 12 months prior to screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including severe gastroparesis), cardiovascular, hepatic, psychiatric, neurologic, or clinically significant allergic disease (including any drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
    2. History of cholecystitis or previously diagnosed biliary colic; subjects with documented cholecystectomy are eligible for the trial.
    3. History of documented cholelithiasis/cholecystolithiasis or evidence of this on screening gallbladder transabdominal ultrasonography.
    4. Any condition possibly affecting drug absorption (eg, gastrectomy or any area of
    intestinal resection, active inflammatory bowel disease or pancreatic insufficiency).
    5. Diagnosis of Type 1 diabetes mellitus.
    6. Presence of positive glutamic acid decarboxylase (GAD) antibody titer at screening, as assessed by trial-specific central laboratory.
    7. Treatment with any thiazolidinediones (TZDs), insulin, Byetta® (exenatide) or Symlin® (pramlintide) within 56 days prior to Day 1.
    8. Subjects on concomitant agents known to be PgP substrates with narrow therapeutic margin such as digoxin within 7 days prior to Day 1.
    9. History of evidence of diabetic complications with significant end-organ damage such as:
    • Proliferative retinopathy and/or macular edema, or
    • Diabetic neuropathy complicated by neuropathic ulcers, or
    • Creatinine clearance ≤60 mL/min based on Cockcroft-Gault equation using serum
    creatinine measured at screening [See below],
    • Males -> [(140 - age in years) x total body weight (in kg)] divided by
    [72 x serum creatinine (in mg/dL)]
    • Females -> 0.85 x calculation for males
    10. Clinically significant peripheral vascular disease such as that manifested by claudication.
    11. History of stroke or transient ischemic attack.
    12. Current medical history of unstable angina.
    13. History of myocardial infarction within 1 year prior to screening.
    14. History of repeated or frequent documented hypoglycemia within 6 months prior to screening.
    15. Participation in any formal weight loss program, or fluctuation of >5% in body weight, within 3 months prior to screening.
    16. History of human immunodeficiency virus (HIV) infection or treatment with
    antiretroviral agents.
    17. Subjects with ANY of the following abnormalities in clinical chemistry at screening as assessed by trial-specific central laboratory:
    • Fasting serum triglycerides ≥500 mg/dL (ie, 5.65 mmol/L)
    • AST/SGOT or ALT/SGPT ≥2x ULN
    • Total bilirubin ≥1.5x ULN
    • Direct bilirubin > ULN
    • Serum lipase or amylase > ULN
    18. At screening, 12-lead electrocardiogram (ECG) demonstrating QTc interval >450 msec, confirmed by a single repeat, if deemed necessary.
    19. Persistent severe, uncontrolled hypertension; for example: supine systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥105 mm Hg on at least 2 consecutive measurements following at least 10 minutes of rest between measurements.
    20. Any medical history or clinical evidence of congestive heart failure, NYHA (New York Heart Association) Functional Classification, Classes III-IV.
    21. A positive urine drug test for illicit drugs, at screening.
    22. Alcohol dependency: a subject will not be permitted to consume alcohol in a quantity exceeding 7 drinks per week for females or 14 drinks per week for males.
    • 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces
    (45 mL) of hard liquor
    23. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1 and/or during trial participation.
    24. Pregnant, nursing, or females of childbearing potential.
    25. Use of herbal supplements (including herbal weight-loss or “metabolism booster”
    therapies), over the counter appetite or weight modifying medications or hormone
    replacement therapy within 28 days prior to Day 1.
    26. History of sensitivity or intolerance to CE-326,597.
    27. History of sensitivity to heparin or heparin-induced thrombocytopenia (if heparin is used to flush intravenous catheters).
    28. Blood donation of approximately 1 pint (500 mL) within 56 days prior to Day 1.
    29. Unwilling or unable to comply with the Life Style Guidelines as presented in Section 4.4.
    30. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary comparisons of interest following 12 weeks of dosing with a range of oral doses of CE-326,597 (Day 84 minus baseline [ie, Day 1]) are,
    1. Placebo-adjusted, change from baseline in HbA1C (%)
    2. Placebo-adjusted, percent change from baseline in body-weight
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    As per protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 45
    F.4.2.2In the whole clinical trial 200
    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 Decision2008-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-25
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