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    Summary
    EudraCT Number:2009-012597-13
    Sponsor's Protocol Code Number:DUT-MD-303
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-01
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-012597-13
    A.3Full title of the trial
    A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to
    Evaluate the Safety and Efficacy of Dutogliptin in Patients with Type 2 Diabetes
    Mellitus on Background Treatment with Glimepiride with or without Metformin
    A.4.1Sponsor's protocol code numberDUT-MD-303
    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 SponsorForest Research Institute, 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.3.1Product nameDutogliptin
    D.3.2Product code PHX1149T
    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 Tartrate
    D.3.9.1CAS number 890402-81-0
    D.3.9.2Current sponsor codePHX1149T
    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 2 diabetes mellitus (T2DM)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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 safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background therapy with glimepiride with or without metformin.
    E.2.2Secondary objectives of the trial
    There no secondary objectives in the trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in the study, patients must meet the following criteria:
    1. Be able to understand and provide written informed consent before the conduct of
    any study-related procedures
    2. Be male or female outpatients 18 to 85 years of age, inclusive, at the Screening Visit (Visit 1)
    3. Be diagnosed with T2DM according to the ADA (1997) and World Health Organization (1998) criteria at least 3 months before the Screening Visit (Visit 1)
    - FPG ≥ 126 mg/dL (7.0 mmol/L)
    - Plasma glucose ≥ 200 mg/dL (11.1 mmol/L) at 2 hours following the ingestion of
    75 g of anhydrous glucose in an oral glucose tolerance test
    - Random plasma glucose > 200 mg/dL (11.1 mmol/L) in a person with symptoms
    of diabetes
    4. Have a body mass index of 20 to 48 kg/m2 at the Screening Visit (Visit 1)
    5. Have received a stable dosage of glimepiride 4 to 6 mg/d alone or in combination
    with a stable dosage of metformin ≥ 1500 mg/d (or maximally tolerated dose) for at
    least 6 weeks before the Screening Visit (Visit 1). (Note: If the patient is taking
    < 1500 mg/d of metformin because of intolerance, the reason for intolerance must be
    documented. If the patient is taking > 6 mg/d of glimepiride, the dosage should be
    reduced to 6 mg/d at the Screening Visit [Visit 1])
    OR
    Be willing to switch to glimepiride if receiving a stable dose that is at least half the
    maximal labeled dose of another SU alone or in combination with a stable dosage of
    metformin ≥ 1500 mg/d (or maximally tolerated dose) for at least 6 weeks before the
    Screening Visit (Visit 1). See Appendix III and Section 9.4.7.1 for the recommended
    switch algorithm
    6. Have received a stable dosage of glimepiride 4 to 6 mg/d alone or in combination
    with a stable dosage of metformin ≥ 1500 mg/d (or maximally tolerated dose) for at
    least 2 weeks by Visit 2. (Note: If the patient is taking < 1500 mg/d of metformin
    because of intolerance, the reason for intolerance must be documented)
    7. Have an HbA1c value of ≥ 7% and ≤ 10% at the Screening Visit (Visit 1), except for (1) patients who have been taking glimepiride 4 mg/d alone or in combination with metformin and (2) patients who have been taking half the maximal dose of another SU alone or in combination with metformin, in which cases HbA1c can be
    ≥ 7% to ≤ 10.5%. These patients must be willing to switch to glimepiride and uptitrate the glimepiride dose if necessary. See Appendix III for further details on HbA1c levels and glimepiride dose modification
    8. Have an HbA1c value of ≥ 7% and ≤ 10% at Visit 4 (value taken at Visit 3)
    9. Have an FPG ≤ 270 mg/dL (15 mmol/L) before Visit 2 for patients whose dose of
    glimepiride is being modified, or who are being switched to glimepiride, during the
    Screening period. See Appendix III and Section 9.5.1.1 for further details
    10. Have a fasting plasma C-peptide > 0.26 nmol/L (> 0.8 ng/mL; > 260 pmol/L) at the Screening Visit (Visit 1)
    11. Have stable weight, with no more than a 7% gain or loss in the 3 months before the Screening Visit (Visit 1) (by history)
    12. If taking a medication(s), other than an antidiabetic, that might affect blood glucose, must have been receiving a stable dose for at least 4 weeks before the Screening Visit (Visit 1)
    13. Be willing at the Screening Visit (Visit 1) to discontinue for the duration of the study all herbal medication taken for the treatment of diabetes
    14. Have a thyroid-stimulating hormone level from the Screening Visit (Visit 1) that is
    within normal limits. If the patient is taking thyroid hormone, the dose must have
    been stable for at least 6 weeks before the Screening Visit (Visit 1)
    15. If taking a medication(s) for hypertension (including a diuretic), must have been
    taking a stable dose for at least 4 weeks before the Screening Visit (Visit 1)
    16. If female, must not be pregnant, not planning to become pregnant during the course of the study, and not lactating. Women of childbearing potential must have a negative serum β-hCG pregnancy test at the Screening Visit (Visit 1)
    17. If of childbearing potential, must be willing to use adequate contraception and not become pregnant (or have partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include and are not limited to oral
    contraceptives (stable use for 2 or more cycles before screening); intrauterine devices; Depo-Provera; Norplant System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence
    18. Be willing to return for all clinic visits and complete all study-related procedures,
    including self-monitoring of blood glucose
    19. Have a fasting plasma glucose ≤ 270 mg/dL (15 mmol/L) at Visit 4 (value taken at Visit 3). A test may be repeated once if the initial value is felt to be inaccurate or
    unrepresentative of the patient’s usual value
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will not be eligible to participate in the study:
    1. Currently taking more than two oral hypoglycemic agents (OHA)
    2. Have been treated with insulin or a GLP-1 analogue as an outpatient within 6 weeks of the Screening Visit (Visit 1)
    3. Have type 1 diabetes mellitus, maturity-onset diabetes of the young, insulin-requiring T2DM, other unusual or rare forms of diabetes mellitus, or history of diabetic
    ketoacidosis
    4. Have elevated blood glucose due to medical treatment or to a concurrent medical
    condition other than T2DM
    5. Have skin lesions, edema states, diabetic foot ulcers
    6. Have a history of epilepsy, not including childhood febrile seizures
    7. Have a history of hypoglycemic episode requiring glucose, glucagon, orange juice,
    etc administered by a second person during the 6 months before the Screening Visit
    (Visit 1)
    8. Have a history of hyperosmolar, hyperglycemic, or nonketotic syndrome during the
    6 months before Screening Visit (Visit 1)
    9. Have had a stroke, myocardial infarction, symptomatic coronary artery disease,
    angina, or arrhythmia within 4 weeks before the Screening Visit (Visit 1) or a history
    of congestive heart failure class III or class IV (according to the New York Heart
    Association functional classification system)
    10. Have a history of or risk factors for acute pancreatitis or exacerbation of chronic pancreatitis
    11. Have a systolic blood pressure (SBP) ≥ 160 mm Hg or < 90 mm Hg and/or diastolic blood pressure (DBP) ≥ 100 mm Hg or < 50 mm Hg at the Screening Visit (Visit 1). The measurement at the Screening Visit (Visit 1) can be repeated if the initial reading is felt to be inaccurate or unrepresentative of the patient’s usual blood pressure
    12. Have had gastrointestinal surgery for obesity (including bypass, gastroplasty, and banding procedures) within the year before the Screening Visit (Visit 1) or have plans to have such surgery or procedures for the removal of excess fatty tissue during the course of the study
    13. Have started a weight-loss regimen within 4 weeks of the Screening Visit (Visit 1)
    either on one’s own or by participating in a commercial behavior modification/diet
    program or by taking a medication for weight reduction
    14. Be currently taking an antipsychotic medication (except prochlorperazine as needed for nausea), have taken systemic glucocorticoids at a dose greater than 5 mg of prednisone or equivalent daily within the 2 weeks before the Screening Visit (Visit 1), or be currently taking products intended to stimulate appetite. See the Study Reference Manual for prednisone equivalence of other glucocorticoids
    15. Have a history of cancer other than treated basal-cell or squamous-cell carcinoma of the skin
    16. Have been infected with or have serologic evidence of previous infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (by history only)
    17. Have a history of alcohol or substance abuse in the past 2 years or an eating disorder diagnosed in the past 5 years
    18. Have total bilirubin above the upper limit of normal (ULN) (unless associated with an elevated indirect bilirubin typical of Gilbert syndrome), aspartate aminotransferase
    (AST) or alanine aminotransferase (ALT) > 2.5 times the ULN, or alkaline phosphatase > 1.5 times the ULN from the Screening Visit (Visit 1) clinical laboratory results
    19. Have hemoglobin of < 11 g/dL (< 110 g/L) from the Screening Visit (Visit 1) clinical
    laboratory results
    20. Have serum creatinine of ≥ 1.5 mg/dL (≥ 133 μmol/L) for men or ≥ 1.4 mg/dL
    (≥ 124 μmol/L) for women from the Screening Visit (Visit 1) clinical laboratory
    results, unless the calculated creatinine clearance using the Modification for Diet in
    Renal Disease (MDRD) method is > 50 mL/min
    21. Have received treatment with any investigational product (IP) or participated in
    any investigational study within 30 days or 5 half-lives of the IP, whichever is longer,
    before the Screening Visit (Visit 1)
    22. Have been randomized in a previous investigational study of dutogliptin
    23. Be an employee or a relative of an employee of the study center
    24. Have a history of hypersensitivity reaction to glimepiride, other SU agents,
    metformin, pioglitazone, or DPP4 inhibitors
    25. Have any condition, disease, disorder, or clinically significant laboratory abnormality that, in the opinion of the PI, would jeopardize the patient’s appropriate participation in this study or obscure the effects of treatment
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c
    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 Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Multicenter, fixed-dose trial.
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    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 years1
    E.8.9.1In the Member State concerned months3
    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 months7
    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 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 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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 155
    F.4.2.2In the whole clinical trial 650
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Any clinical findings of significance noted during the final examination or at premature
    discontinuation for any reason, including clinically significant laboratory abnormalities,
    will be followed until the condition returns to prestudy status, has resolved or stabilized, or can be explained as being unrelated to the IP. A follow-up visit, if one should be necessary, will take place within 30 days of termination.
    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 Decision2010-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-24
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