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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2004-000350-24
    Sponsor's Protocol Code Number:D6160C09999
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-05-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-000350-24
    A.3Full title of the trial
    A 16-Week Randomized, Double-blind, Parallel-group, Multicentre, Placebo- and Active- (Metformin) Controlled Study to Evaluate the Effect on Whole Body Insulin Sensitivity of Tesaglitazar Therapy when Administered to Patients with Type 2 Diabetes
    A.3.2Name or abbreviated title of the trial where available
    ARAMIS
    A.4.1Sponsor's protocol code numberD6160C09999
    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.3.2Product code AZ242
    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.3.9.3Other descriptive nameAz242
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Metformin 500 Heumann
    D.2.1.1.2Name of the Marketing Authorisation holderHeumann
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMetformin 500 Heumann
    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 INNMetformin
    D.3.9.1CAS number 657-24-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    D.8 Placebo: 2
    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
    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
    The primary objective of this study is to determine the efficacy of tesaglitazar given as monotherapy as compared to placebo in patients with type 2 diabetes in improving whole body insulin sensitivity by assessing the M value during high (80mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
    E.2.2Secondary objectives of the trial
    1To determine the efficacy of tesaglitazar given as monotherapy as compared to metformin in type 2 diabetic patients in improving whole body insulin sensitivity
    2To determine the efficacy of tesaglitazar given as monotherapy as compared to placebo/metformin in type 2 diabetic patients in improving hepatic and peripheral insulin sensitivity
    3To assess the effects of tesaglitazar given as monotherapy as compared to
    placebo/metformin in type 2 diabetic patients on: basal hepatic glucose output;the plasma profile of glucose, insulin and lipids after a mixed meal;calculated insulin secretion;energy expenditure and substrate metabolism by indirect calorimetry;body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy;laboratory efficacy variables
    4Exploratory assess the plasma levels of amino acids
    5To determine the safety and tolerability of tesaglitazar in type 2 diabetic patients
    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 the enrolment visit
    2. Male or female, 30–70 years old. Females must be post menopausal or hysterectomized. Post menopausal patients are defined as patients with:
    -Natural or induced menopaus with last menstruation more than 12 months ago, or
    -Bilateral oophorectomy
    3. Diagnosed with type 2 diabetes >12 weeks ago
    4. Treated with diet alone or treatment with a single oral agent or low doses of two agents. All antidiabetic medications are required to be discontinued at enrolment visit.

    Inclusion criteria at placebo run-in (visit 2, lab values from visit 1):
    5. HbA1c >6.5% for patients not on any anti-diabetic drug for 12 weeks
    prior to visit 1
    6. HbA1c <8,5% if previously drug-naïve and <7,5% if previously treated with a single oral agent or low doses of two agents
    7. FPG <13.3 mmol/L, 240 mg/dL

    Inclusion criteria at randomization (visit 5, lab values from visit 3 and 4):
    8. HbA1c >6.5 % for patients not on any anti-diabetic drug for 12 weeks
    prior to visit 1 (lab value from visit 4)
    9. HbA1c <8,5% if previously drug-naïve and <7,5% if previously treated with a single oral agent or low doses of two agents (lab value from visit 4)
    10. Mean FPG from two measurements (lab values from visit 3 and 4) FPG <13.3 mmol/L, 240 mg/dL.
    E.4Principal exclusion criteria
    Exclusion criteria at enrolment (visit 1):
    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 ischemic attack (TIA), cerebrovascular accident (CVA), myocardial or peripheral vascular disease (PVD) revascularization or angioplasty within 24 weeks prior to enrolment visit
    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 hypertriglyceridemia induced pancreatitis.
    7. Suspicion that the patient is infected according to world health organisation (WHO) risk categories 2 to 4 (see Appendix G).
    8. 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)
    9. Treatment with combination therapy (i.e. two anti diabetic agents, except low doses of two agents, see Section 3.4.5) within 12 weeks prior to visit 1
    10. Treatment with a PPARgamma or PPARalpha/gamma agonists within 24 weeks prior to visit 1
    11. Treatment with fibrates (PPARalpha agonist), within 4 weeks prior to visit 1
    12. Treatment with systemic corticosteroids , within 4 weeks prior to visit 1.
    13. Treatment with probenecid that cannot be stopped at visit 1
    14. History of hypersensitivity or intolerance to any PPAR agonist
    15. Intolerance to metformin at any time in the past or preexisting medical conditions that is contraindicated for the use of metformin.
    16. History of drug-induced myopathy or drug-induced CK elevation.
    17. History of drug-induced liver enzyme elevations.
    18. History of drug-induced neutropenia.
    19. History of alcohol or drug abuse within the last 5 years.
    20. 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 study.
    21. Receiving any investigational product within 12 weeks (90 days) prior to visit 1.
    22. Previous enrolment in this study.
    23. Body weight >120 kg

    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. Absolute neutrophile count (ANC) <1.0x 109/L.
    29. Any of ALT, AST or 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 > the upper limit of normal.
    32. CK >3 times the upper limit of normal.

    Exclusion criteria at randomization (visit 5, lab values from visit 3 and4)
    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 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 study.
    36. High blood pressure (mean diastolic BP >120 mm Hg) or malignant hypertension.
    37. Hb <90 g/L, 9 g/dL.
    38. ANC <1.0x 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 > the upper limit of normal.
    42. CK >3 times the upper limit of normal.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the M value during the last 40 minutes (140-180 minutes) of the second clamp step adjusted for lean body mass (mg/min/kg).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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.
    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 months6
    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 months6
    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 2005-05-04. 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 state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 105
    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 Decision2005-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-03-14
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