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    Summary
    EudraCT Number:2009-011106-42
    Sponsor's Protocol Code Number:2008MZ09B
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-05-26
    Trial 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 number2009-011106-42
    A.3Full title of the trial
    Aditive effects of omega-3 polyunsaturated fatty acids and pioglitazone in the treatment of type 2 diabetes mellitus
    A.3.2Name or abbreviated title of the trial where available
    MEPIO
    A.4.1Sponsor's protocol code number2008MZ09B
    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 SponsorInstitute for Clinical and Experimental Medicine
    B.1.3.4CountryCzech Republic
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 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 Yes
    D.2.1.1.1Trade name ACTOS 15 MG POR TBL NOB 28X15MG
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Global Research and Development Centre (Europe) Ltd., London
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIOGLITAZONE
    D.3.9.1CAS number 111025468
    D.3.9.3Other descriptive nameACTOS 15 mg por. tbl. nob
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15 to 15
    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.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 Yes
    D.2.1.1.1Trade name Epax 1050TG
    D.2.1.1.2Name of the Marketing Authorisation holderEAPX AS
    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.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeFood suplement - Fish oil concentrate
    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 placeboCapsule*
    D.8.4Route of administration of the placeboGastroenteral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The project deals with hummoral and metabolic aspects of insulin resistance (IR), which is assumed to be the basic metabolic disorder which leads to the development of type 2 diabetes mellitus (T2D) and metabolic syndrome. Study population will be patients with T2D treated by metformin.
    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
    To reveal the effect of 24-week therapy with n-3 FA (3 g EPA + DHA/day) both alone and in combination pioglitazon (15mg/day) in comparison to i) pioglitazon and placebo and ii) placebo alone in type 2 diabetic patients on
    • blood glucose control, insulin secretion and insulin resistance
    • lipid metabolism
    • variety of serum biomarkers of oxidative stress and inflammation
    • liver and muscle (musculus tibialis) fat content, body fat distribution
    • fat quantity in different departments (subcutaneous, visceral)
    E.2.2Secondary objectives of the trial
    I) To find novel markers of the beneficial effects on lipid metabolism and glycemic control, with a special focus on gene expression in adipose tissue and fatty acid pattern of serum and adipose tissue lipids
    II) To explore whether the effect of combination therapy on glucose and lipid metabolism is more beneficial than pioglitazon therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by WHO, Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (American Diabetes Association, 2004) at least 3 months preceding screening

    2. Concurrent T2DM therapy:
    Taking metformin as a monotherapy at stable dose in at least 2 months preceding week 0 procedures
    Previous chronic diabetes therapy will be limited to: sulfonylureas, glitinides, biguanides,  glucosidase inhibitors such as acarbose, insulin.

    3. HbA1c (IFCC): < 8 % (equals to aprox. 10% by DCCT), Triglycerides 2-6 mmol/l

    4. Men and women who are 30 to 70 years of age

    5. Body Mass Index between 25 and 45 (kg/m2)

    6. Informed Consent: a signed and dated written consent obtained from the subject before any procedures are performed
    E.4Principal exclusion criteria
    1. Metabolic Disease including:
    Diagnosis of Type 1 diabetes mellitus
    Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 3 months prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the limits of normal may participate).
    2. Significant weight gain or loss (as defined as > 5% of total body weight) within the past 3 months prior to Screening.
    3. Regular use of insulin in previous 3 months
    4. History of clinically significant cardiovascular disease including:
    Documented myocardial infarction in the past year
    Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery in the previous year and no subsequent angina
    Unstable angina
    Congestive heart failure (CHF) classified as New York Heart Association (NYHA) Class II, III or IV heart failure
    5. Blood pressure > 150/100mmHg or HR > 100 beats/minute. Subjects using antihypertensives must be on stable doses during the 3 months prior to Screening and during the trial.
    6. If a subject is receiving lipid-lowering therapy, then they must have been on the same dose of therapy for the past 3 months, concomitant fenofibrate therapy is not allowed and must be withdrawn at least 1 month ahead of week 0 procedures.
    7. Is currently lactating, pregnant or actively trying to become pregnant.
    8. Has a significant renal impairment as defined by serum creatinine > 150umol/L.
    9. Has a documented history of chronic or advanced hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen, hepatitis B core antigen, and hepatitis C antibody) at Screening.
    Has clinically significant hepatic enzyme elevation greater than 2.5 times the upper limit of the reference range value /alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) /
    Has a total bilirubin level that is > 1.5 times the ULRR at Screening.
    10. Has a history of alcohol or substance abuse within the past year
    11. Is currently taking and will not stop prohibited concomitant medications, see concomitant therapy.
    12. Known allergy to any of the capsule excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation.
    13. Received treatment with an investigational drug or participated in any other clinical trial during the previous 3 months.
    14. Clinically significant anemia (i.e., hemoglobin < 120.0g/L for males and < 110.0g/L for females) or any other abnormal hematological profile that is considered by the investigator to be clinically significant.
    15. In the opinion of the Investigator has a risk of non-compliance with study procedures, or cannot read, understand, or complete study-related materials, particularly the informed consent.
    16. Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests, electrocardiogram, including pulmonary, neurological or inflammatory diseases, which, in the opinion of the Investigator, may affect the interpretation of efficacy and safety data, or which otherwise, contraindicates participation in a clinical trial with the chemical entity.
    E.5 End points
    E.5.1Primary end point(s)
    Differences between treatment by n-3 FA versus placebo vs. pioglitazon and placebo vs pioglitazon and n-3 FA.
    Change from baseline in above variables (see objective)
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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
    Double blind vs. n-3 FA, open vs. Pioglitazone
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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 Decision2009-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-13
    P. End of Trial
    P.End of Trial StatusOngoing
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