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    Summary
    EudraCT Number:2009-012598-37
    Sponsor's Protocol Code Number:DUT-MD-304
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-09-15
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2009-012598-37
    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 PIOGLITAZONE
    A.4.1Sponsor's protocol code numberDUT-MD-304
    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 pioglitazone.
    E.2.2Secondary objectives of the trial
    There are 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:
    At the Screening Visit (Visit 1):
    1. Be able to understand and provide written informed consent before participating in any study-related procedures
    2. Be male or female outpatients 18 to 85 years of age, inclusive
    3. Be willing to return for all clinic visits and complete all study-related procedures, including self-monitoring of blood glucose
    4. Have a body mass index of 20 to 48 kg/m2
    5. Have stable weight, with no more than a 7% gain or loss in the previous 3 months
    6. Be diagnosed with T2DM at least 3 months before the Screening Visit (Visit 1). Verification of diagnosis should be made by obtaining documentation or written confirmation from the physician treating the patient’s diabetes
    7. If taking a medication(s) for hypertension (including a diuretic), be taking a stable dose for at least 4 weeks before study start
    8. If taking a medication(s) other than an antidiabetic that might affect blood glucose level, be taking a stable dose for at least 4 weeks before study start
    9. Have a thyroid-stimulating hormone level on laboratory testing at screening that is within the reference range provided by the central laboratory. If the patient is taking thyroid hormone, the dose must have been stable for at least 6 weeks before study start
    10. Be willing to discontinue, for the duration of the study, all herbal medication taken for the treatment of diabetes
    11. Have a fasting serum C-peptide > 0.26 nmol/L (> 0.8 ng/mL; > 260 pmol/L) on laboratory testing at screening
    12. Female patients 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-human chorionic gonadotropin (β-hCG) pregnancy test on laboratory testing at screening
    13. If of childbearing potential (or having partner[s] of childbearing potential), must be willing to use an adequate method of contraception and not become pregnant (or have partner[s] become pregnant) for the duration of the study. Adequate contraceptive methods include, but 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
    14. Have an HbA1c level ≥ 7.0% and ≤ 10.0%
    15. Be drug-treatment naïve, or treated with a stable dose of pioglitazone or rosiglitazone, or treated with a stable dose of any other oral hypoglycemic agent (OHA) as monotherapy at the time of the Screening Visit (Visit 1): - Drug-treatment naïve means never having received an OHA or parenteral medication (insulin or GLP-1 analogue) or, if having received an OHA or parenteral medication, been off said OHA or parenteral medication for a minimum of 6 weeks (12 weeks for pioglitazone or rosiglitazone) before Visit 1 - Stable dose of pioglitazone or rosiglitazone means a minimum of 12 weeks - Stable dose of any other OHA as monotherapy means a minimum of 6 weeks
    16. Be willing to refrain from donating blood during the study and for up to 1 month after completing the study Between Visits 1 and 2:
    17. Patients who switch to pioglitazone or whose dosage of pioglitazone is increased during the screening period must have an FPG level ≤ 270 mg/dL (15 mmol/L) before Visit 2
    At Visit 2:
    18. Have been on a stable dosage of pioglitazone, 30 to 45 mg/d, as monotherapy for 8 or 12 weeks, depending on OHA therapy leading up to Visit 1 (Screening) At the Randomization Visit (Visit 4):
    19. Have an HbA1c level ≥ 7.0% and ≤ 10.0% (measured at Visit 3)
    20. Have an FPG level ≤ 270 mg/dL (15 mmol/L) (measured at Visit 3). The test can be repeated once if the initial result is felt to be inaccurate or not representative 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 one OHA
    2. Have been treated as an outpatient with insulin, a GLP-1 analogue, or a DPP4 inhibitor 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 levels owing to medical treatment or to a concurrent medical condition other than T2DM
    5. Have skin lesions (eg, discoloration, swelling, atrophy, ulceration), edema states, or diabetic foot ulcers considered medically important by the Investigator
    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 the 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 class III or class IV congestive heart failure (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 value
    12. Have had gastrointestinal surgery for obesity (including bypass, gastroplasty, and banding procedures) within 1 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. Currently taking an antipsychotic medication (except prochlorperazine as needed for nausea), have taken systemic glucocorticoids at a dose > 5 mg of prednisone or equivalent daily within the 2 weeks before the Screening Visit (Visit 1), or 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. (Note: Patients with a history of cancer are allowed to participate provided that the malignancy has been in complete remission for at least 5 years before the Screening Visit [Visit 1]. Complete remission is defined as the disappearance of all signs of cancer in response to treatment)
    16. Have been infected with or have serologic evidence of previous infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus (as determined by the central laboratory)
    17. Have a history of alcohol or substance abuse in the prior 2 years or an eating disorder diagnosed in the prior 5 years
    18. Have total bilirubin concentration above the upper limit of normal (ULN) (unless associated with an elevated indirect bilirubin concentration 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 level < 11 g/dL (< 110 g/L) from the Screening Visit (Visit 1) clinical laboratory results
    20. Have an estimated glomerular filtration rate (GFR) < 50 mL/min/1.73 m2 per the Modification of Diet in Renal Disease (MDRD) equation at Screening Visit (Visit 1), as provided by the central laboratory
    21. Have received treatment with any investigational product or participated in any investigational study within 30 days or 5 half-lives of the investigational product, 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 pioglitazone, rosiglitazone, glimepiride, 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 level
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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 months4
    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 months11
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 400
    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 investigational product. A follow-up visit, if one should be necessary, will take place within 30 days of study 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 Decision2009-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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