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    Summary
    EudraCT Number:2008-008974-30
    Sponsor's Protocol Code Number:PHX1149-PROT302
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-05-12
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-008974-30
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin
    A.4.1Sponsor's protocol code numberPHX1149-PROT302
    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 SponsorPhenomix Corporation
    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 namedutogliptin
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNdutogliptin
    D.3.9.1CAS number 890402-81-0
    D.3.9.2Current sponsor codePHX1149 tartrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboFilm-coated tablet
    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 II Diabetes Mellitus
    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 demonstrate the efficacy of dutogliptin over 26 weeks, as evidenced by placebo-corrected changes in HbA1c
    E.2.2Secondary objectives of the trial
    To demonstrate safety and tolerability of dutogliptin and the changes in fasting plasma glucose over 26 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1).
    2. Male and female subjects with a BMI of 20 to 48 kg/m2, inclusive. Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥2000 mg (or the highest tolerated dose; reason for intolerance must be documented) used in accordance with product labeling for at least 6 weeks prior to Screening (Visit 1).
    3. Fasting plasma C-peptide greater than 0.26 nmol/L (> 0.8ng/mL; > 281 pmol/L) at Screening (Visit 1).
    4. HbA1c 7.0% – 10.0%, inclusive, at Screening (Visit 1) and Visit 4 (lab results from Visit 3).
    5. Stable weight, with no more than a 5 kg weight gain or loss in the 3 months prior to Screening (Visit 1) (by history).
    6. Age 18 to 85 years, inclusive.
    7. Subjects receiving medication(s) other than anti-diabetic medication that might affect the maintenance or measurement of plasma glucose must be on a stable dose for 4 weeks prior to Screening (Visit 1). All herbal medication taken for the treatment of diabetes must be discontinued for the duration of the study.
    8. TSH results must be within normal limits. If taking thyroid hormone, the dose must have been stable for at least 6 weeks prior to Screening (Visit 1).
    9. If taking medication(s) for hypertension (including diuretics), the dose(s) must have been stable for at least 4 weeks prior to Screening (Visit 1).
    10. Male and non-pregnant, non-lactating (and not planning to become pregnant during the course of the study) female subjects. For men and women of childbearing potential, willingness to use adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to Screening\Visit 1); IUD; Depo Provera; Norplant System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence.
    11. Willing to return for all clinic visits and complete all study-related procedures, including self-monitoring of blood glucose.
    12. Able to understand and provide informed consent.
    E.4Principal exclusion criteria
    1. Currently on anti-diabetic drugs other than metformin.
    2. Type 1 diabetes mellitus, mature onset diabetes of the young (MODY), insulin requiring Type 2 diabetes mellitus, or other unusual or rare forms of diabetes mellitus.
    3. Elevated blood glucose due to medical treatment or due to a concurrent medical condition other than Type 2 diabetes mellitus.
    4. Skin lesions, edema states, diabetic foot, or epilepsy.
    5. History of diabetic coma or hypoglycemic episode requiring help in the form of glucose, glucagon, orange juice, etc, from a second person during the 6 months prior to Screening (Visit 1).
    6. History of stroke, myocardial infarction, symptomatic coronary artery disease, angina, or arrhythmia within 4 weeks prior to Screening (Visit 1) or any history of congestive heart failure Class III or IV according to the New York Heart Association functional classification system (NYHA, The Stages of Heart Failure).
    7. History of or risk for acute pancreatitis or exacerbation of pancreatitis.
    8. Inadequately controlled hypertension: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Visit 1 or Visit 2. The measurement at Visit 1 or 2 may be repeated if the initial read-out is felt to be inaccurate.
    9. Gastrointestinal surgery for obesity (including bypass, gastroplasty, and banding procedures) within the last year prior to Screening (Visit 1) or plans to have such surgery or procedures for removal of excess fatty tissue (e.g., liposuction, breast reduction or augmentation) during the course of the study.
    10. Current efforts to lose weight either by participation in a commercial behavior modification/diet program (e.g., Jenny Craig, Weight Watchers) or attempting to lose weight outside of such a program with or without drugs.
    11. Current administration of antipsychotic medications (except for PRN use of prochlorperazine for nausea), administration within the past 2 weeks of systemic glucocorticoids at a dose greater than 5 mg of prednisone or equivalent daily, or current administration of products intended to stimulate appetite (e.g., Megace).
    12. Except for Type 2 diabetes mellitus, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat.
    13. History or presence of malignancy within the past year. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
    14. HIV, Hepatitis B, or Hepatitis C virus positive (by history only).
    15. History of alcohol or substance abuse in the past 2 years or eating disorder diagnosed in the past 5 years.
    16. Use of any investigational drug or participation in any investigational study within 30 days prior to Screening (Visit 1).
    17. Total bilirubin above the upper limit of normal; creatinine ≥ 1.5 mg/dL (≥ 142 µmol/L) (for males) or creatinine ≥ 1.4 mg/dL (≥ 133 µmol/L) (for females); AST (SGOT) or ALT (SGPT) > 2.5 × the upper limit of normal; alkaline phosphatase > 1.5 × the upper limit of normal; or hemoglobin < 11 g/dL (< 110 g/L).
    18. Any condition, disease, disorder or clinically significant laboratory abnormality which, in the opinion of the Investigator, would jeopardize the subject’s appropriate participation in this study or obscure the effects of treatment.
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c, fasting plasma glucose, % to achieve target HbA1c < 7%. PK and PD (DPP4 inhibition).
    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 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) 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 No
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 Information not present in EudraCT
    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 state175
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 385
    F.4.2.2In the whole clinical trial 1400
    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 Decision2009-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-06-25
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