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    The EU Clinical Trials Register currently displays   44132   clinical trials with a EudraCT protocol, of which   7324   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:2004-004374-90
    Sponsor's Protocol Code Number:D6160C00055
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-25
    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 number2004-004374-90
    A.3Full title of the trial
    A 24-Week Randomized, Double-Blind, Parallel-Group, Multi-Centre, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy when Administered as Monotherapy to Drug-Naïve Patients with Type 2 Diabetes
    A.3.2Name or abbreviated title of the trial where available
    GALLANT 22
    A.4.1Sponsor's protocol code numberD6160C00055
    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 AB
    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
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.2.5The 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
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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.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
    Men or women who are 18 years of age or more at enrolment (visit 1). The patients should be drug-naïve with Type 2 diabetes and not on anti-diabetic treatment during the recent 24 weeks.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of tesaglitazar (0.5 and 1 mg) given as monotherapy for 24 weeks in improving glycaemic control in patients with type 2 diabetes with placebo 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 (0.5 and 1 mg) monotherapy versus placebo in modifying lipids and lipoproteins in patients with type 2 diabetes after a 24-week randomized treatment period by evaluation of:
    The change from baseline to the end of the randomized treatment period in lipid and lipoprotein variables
    Responder rates as determined by the proportion of patients achieving a pre-specified change from baseline to the end of the randomized treatment period, for 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
    To compare the effects of tesaglitazar (0.5 and 1 mg) monotheraphy versus placebo in modifying other markers of glycaemic control in patients with type 2 diabetes after a 24-week randomized treatment period by evaluation of:
    The change i FPG, insulin, proinsulin and C-peptide from baseline to the end of the randomized treatment period...
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Provision of a written informed consent at visit 1.
    Men or women who are 18 years of age or more at time of consenting upon visit 1.
    Female patients post menopausal, hysterectomized or if of childbearing potential using a reliable method of birth control...

    Diagnosed with type 2 diabetes.

    Drug-naïve (ie, no use of antidiabetic drug(s), for at least 24 weeks prior to visit 1). However, one temporary period of daily insulin injections no longer than 7 days during this period is allowed.

    For patients <30 years old C-peptide level has to be >0.8 ng/mL, 0.26 nmol/L.
    HbA1c 7% up to or equal of 10%. NB Enrolment will be stopped when the cohort of patients having HbA1c more or equal to 7% and less or equal to 7.4% is approximately 25% or the cohort of patients having HbA1c more or equal to 7.5% and less or equal to 10% is approximately 75%.

    FPG less than or equal to 13.3 mmol/L, 240 mg/dL.

    Inclusion criteria at randomization (visit 5, laboratory values from visit 3 and 4):
    HbA1c 7 % up to or equal of 10% (laboratory value from visit 4).

    Mean FPG of two measurements (laboratory values from visit 3 and 4) less or equal of 11.7 mmol/L, 210 mg/dL.
    E.4Principal exclusion criteria
    Type 1 diabetes, history of diabetic ketoacidosis, or corticosteroid-induced type 2 diabetes.
    Active arterial disease such as unstable angina...
    NYHA heart failure Class III or IV, or unstable Class I or II...
    History of thyroid ophthalmopathy.
    History of malignancy within the last 5 years...
    History of blood lipid induced eruptive xanthomas or hypertriglyceridemia induced pancreatitis.
    Pregnant or breastfeeding patients.
    Suspicion that the patient is infected according to WHO risk categories 2 to 4...
    Treatment with fibrates, within 4 weeks prior to visit 1.
    Treatment with glucocorticoids (equivalent to oral prednisolon >10 mg per day), within 4 weeks prior to visit 1.
    Treatment with probenecid that cannot be stopped at visit 1.
    History of hypersensitivity or intolerance to any PPAR-agonist.
    History of drug-induced myopathy or drug-induced CK elevation.
    History of drug-induced liver enzyme elevations.
    History of drug-induced neutropenia.
    History of alcohol or drug abuse within the last 5 years.
    Other serious or unstable medical or psychological condition...
    Receiving any investigational product within 12 weeks prior to visit 1.
    Previous enrolment in this study.
    Involvement in the planning and conduct of the Clinical Study (applies to both AstraZeneca staff and staff at the investigational site).
    Exclusion criteria at placebo run-in (visit 2, laboratory values from visit 1)
    Fasting TG >7.0 mmol/L, 620 mg/dL.
    Hb <90 g/L, 9 g/dL.
    ANC <1.0 x 1 000 000 000/L.
    Total bilirubin above the upper limit of normal unless exclusively caused by Gilbert’s syndrome.
    Creatinine >2 times the upper limit of normal.
    CK >3 times the upper limit of normal.
    High BP (mean diastolic BP >120 mm Hg) or malignant hypertension.
    Hb <90 g/L, 9 g/dL.
    ANC <1.0 x 1 000 000 000/L.
    Any of ALT, AST or ALP >2.5 times the upper limit of normal.
    E.5 End points
    E.5.1Primary end point(s)
    No primary end points.
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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, which is the time point after which no patient will patient will be exposed to study related activities. The study
    is expected to be completed in Q3 2006.
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-02-25. Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 415
    F.4.2.2In the whole clinical trial 475
    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 Decision2005-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-01
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