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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-000347-14
    Sponsor's Protocol Code Number:D6160C00028
    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:2004-10-06
    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 number2004-000347-14
    A.3Full title of the trial
    A 52-week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Glibenclamide) Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy when Administered to Patients with Type 2 Diabetes
    A.3.2Name or abbreviated title of the trial where available
    GALLANT 4
    A.4.1Sponsor's protocol code numberD6160C00028
    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 SponsorAstraZeneca Sverige
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameTesaglitazar Filmcoated Tablet
    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 INNTesaglitazar
    D.3.9.1CAS number 251565-85-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTesaglitazar
    D.3.9.1CAS number 251565-85-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Glibenclamide Tablets BP
    D.2.1.1.2Name of the Marketing Authorisation holderAPS Ltd
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 nameGlibenclamide
    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.3.8INN - Proposed INNGlibenclamide
    D.3.9.3Other descriptive nameCalabren
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5mg to 5mg
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Men or women who are >18 years of age or older at the enrolment visit (visit 1) diagnosed with type 2 diabetes and treated with diet alone or on treatment with a single oral anti diabetic agent or low doses of two agents.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is to assess whether tesaglitazar given as monotherapy is non-inferior to glibenclamide given as monotherapy during 52 weeks in improving glycaemic control in patients with type 2 diabetes as determined by the absolute change in glycosylated haemoglobin A1c (HbA1c), from baseline to the end of the randomized treatment period.
    E.2.2Secondary objectives of the trial
    To compare the effects of tesaglitazar monotherapy versus glibenclamide monotherapy by evaluation of:
    -the change in lipid and lipoprotein variables
    -responder rates as determined by the proportion of patients achieving a pre specified changed from baseline to the end of the randomized treatment period, TG, HDL-C, non-HDL-C and LDL-C
    -proportion of patients reaching pre-specified target levels for TG, HDL C, non HDL-C and LDL-C
    -the change in FPG, insulin, proinsulin and C peptide
    -insulin sensitivity by assessment of change in the calculated variable HOMA
    -the responder rates and proportion of patients achieving a pre-specified target levels for both HbA1c and FPG
    To compare the effects on the levels of risk markers for cardiovascular disease, on the levels of inflammatory markers, on a marker of thrombosis/coagulation (fibrinogen), on urinary albumin excretion, on the waist-hip ratio.
    To evaluate the pharmacokinetics, and safety and tolerability
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion criteria at enrolment (visit 1):
    1. Provision of a written informed consent at visit 1
    2. Men or women who are > or equal to 18 years of age at time of consenting upon visit 1
    3. Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control

    Post menopausal patients are defined as patients with:
    - natural or induced menopause with last menstruation >1 year ago, or
    - bilateral oophorectomy

    Reliable birth control is defined as barrier method (condoms with spermicide, diaphragm with spermicide), oral contraceptive, implant, long term injectable contraceptive, intrauterine device, or tubal ligation.
    4. Diagnosed with type 2 diabetes
    5. Treated with diet alone or treatment with a single oral agent or low doses of two agents. All anti-diabetic medications are to be discontinued at visit 1
    Inclusion criteria at placebo run-in (visit 2, lab values from visit 1):
    6. For patients < 30 years old C-peptide concentrations has to be >0.8 ng/mL, 0.3 nmol/L
    7. HbA1c > or equal to 7 % for patients not on any anti-diabetic drug for 12 weeks prior to visit 1
    8. HbA1c < or equal to 10%
    9. FPG < or equal to13.3 mmol/L, 240 mg/dL
    Inclusion criteria at randomization (visit 5, lab values from visit 3 and 4):
    10. HbA1c > or equal to 7 % for patients not on any anti-diabetic drug for 12 weeks prior to visit 1
    11. HbA1c < or equal to 10%
    12. Mean FPG from two measurements (lab values from visit 3 and 4) FPG < or equal to 13.3 mmol/L, 240 mg/dL.
    E.4Principal exclusion criteria
    1. Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes
    2. Active arterial disease such as unstable angina, myocardial infarction, transient ischaemic attack (TIA), cerebrovascular accident (CVA), myocardial or peripheral vascular disease (PVD) revascularization or angioplasty within 24 weeks prior to visit 1
    3. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. For definitions see Appendix F.
    4. History of thyroid ophthalmopathy
    5. History of malignancy within the last 5 years, excluding successful treatment of basal or squamous cell skin carcinoma
    6. History of blood lipid induced eruptive xanthomas or hypertriglyceridaemia induced pancreatitis
    7. Pregnant or breastfeeding patients
    8. Suspicion that the patient is infected according to world health organisation (WHO) risk categories 2 to 4
    9. Treatment with chronic insulin, within 24 weeks prior to visit 1 (however, one temporary period of daily insulin injections no longer than 7 days is allowed)
    10. Treatment with combination therapy (i.e. two anti diabetic agents, except low doses of two agents, see Section 3.4.4) within 12 weeks prior to visit 1
    11. Treatment with a thiazolidinedione within 4 weeks prior to visit 1
    12. Treatment with fibrates, within 4 weeks prior to visit 1
    13. Treatment with glucocorticoids (equivalent to oral prednisolon >10 mg per day), within 4 weeks prior to visit 1
    14. Treatment with probenecid that cannot be stopped at visit 1
    15. History of hypersensitivity or intolerance to any PPAR agonist
    16. Intolerance to glibenclamide at any time in the past, or preexisting medical conditions that is contraindicated for the use of glibenclamide
    17. History of drug-induced myopathy or drug-induced CK elevation
    18. History of drug-induced liver enzyme elevations
    19. History of drug-induced neutropenia
    20. History of alcohol or drug abuse within the last 5 years
    21. Other serious or unstable medical or psychological condition identified in the patient’s medical history that, in the judgement of the investigator, would compromise the patients’ safety or successful participation in the Clinical Study
    22. Receiving any investigational product within 12 weeks prior to visit 1
    23. Previous enrolment in this study.
    Exclusion criteria at placebo run-in (visit 2, lab values from visit 1)
    24. Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients´ safety or successful participation in the study.
    25. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. For definitions see Appendix F.
    26. Fasting TG >7.0 mmol/L, 620 mg/dL
    27. Hb < 90 g/L, 9 g/dL
    28. ANC < 1.0 x 109/L
    29. Any of alanine aminotransferase (ALT), aspartate transaminase (AST) or alkaline phosphatase (ALP) >2.5 times the upper limit of normal
    30. Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert’s syndrome
    31. Creatinine >2 times the upper limit of normal
    32. CK >3 times the upper limit of normal
    Exclusion criteria at randomization (visit 5, lab values from visit 4)
    33. Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgement of the investigator would compromise the patients´ safety or successful participation in the Clinical Study
    34. NYHA heart failure Class III or IV, or unstable Class I or II as judged by the investigator. For definitions see Appendix F
    35. Other serious or unstable medical or psychological condition identified on medical history that, in the judgement of the investigator, would compromise the patients’ safety or successful participation in the Clinical Study
    36. High blood pressure (mean diastolic BP >120 mmHg) or malignant hypertension
    37. Hb <90 g/L, 9 g/dL
    38. ANC < 1.0 x 109/L
    39. Any of ALT, AST or ALP >2.5 times the upper limit of normal
    40. Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert’s syndrome
    41. Creatinine >2 times the upper limit of normal
    42. CK >3 times the upper limit of normal
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in glycosylated haemoglobin A1c (HbA1c), from baseline to the end of the randomized treatment period.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    End of study is defined as date of database lock. The study is expected to start in June 2004, and to be completed in July 2006
    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 months25
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months25
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 580
    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 Decision2004-11-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-02
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