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    Summary
    EudraCT Number:2010-021986-60
    Sponsor's Protocol Code Number:GFT505-210-5
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-11
    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 ConcernedLatvia - SAM
    A.2EudraCT number2010-021986-60
    A.3Full title of the trial
    A Pilot study to evaluate the Efficacy and Safety of GFT505 (80mg) orally administered once daily for 12 weeks in patients with Type 2 Diabetes mellitus.
    A Multicentre, Randomised, Double Blind, Placebo-Controlled study.
    A.4.1Sponsor's protocol code numberGFT505-210-5
    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 SponsorGENFIT
    B.1.3.4CountryFrance
    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 nameGFT505 20mg lactose - magnesium stearate
    D.3.2Product code GFT505
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 824932-88-9
    D.3.9.2Current sponsor codeGFT505
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboCapsule, hard
    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
    Patients with Type 2 Diabetes Mellitus.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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 after 12 weeks of oral administrated treatment the change from baseline in HbA1c level achieved with GFT505 80mg versus placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the changes in glucose homeostasis
    To evaluate the changes in lipid metabolism
    To evaluate the changes in liver enzyme levels
    To evaluate the changes in inflammatory markers and other parameters
    To evaluate the variation in body weight
    To assess the safety of once-a-day administrations of oral doses of GFT505 80mg during 12 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
    1. Provide written informed consent prior to enrolment.
    2. Male or post-menopausal female (defined as >12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening.
    3. Aged from 18 to 75 years.
    4. BMI ≥27 and ≤45 kg/m².
    5. Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study.
    6. Non-hypertensive or patient taking antihypertensive medication (except non-permitted medication) maintained at a stable dosage at least for 2 months prior to screening (and the stable dosage can be maintained throughout the study).
    7. Patient agrees to come to following visits inside the protocol specified range.

    In addition to the above criteria, these following inclusion criteria must be fulfilled according to B1 lab results:
    8. HbA1c ≥ 7.0% and <9.5%.
    9. Anti-GAD negative for patients aged less than 40 years.
    E.4Principal exclusion criteria
    Patients presenting with any of the following exclusion criteria will not be included in the trial:
    1. Type I Diabetes Mellitus.
    2. Patients who have one or more of the following: symptoms of poorly controlled diabetes (drastic weight loss, polyuria-polydypsia) according to the investigator’s opinion, a history of diabetic ketoacidosis or hyperosmolar nonketosic coma.
    3. Severe macular oedema requiring photocoagulation or specific treatment.
    4. Known Heart Failure (Grade I to IV of NYHA classification).
    5. Patients who had an acute cardiovascular episode within the 6 months previous to the start of the trial, or with a history of coronary angioplasty, history of stroke, TIA (Transient Ischemic Attack)], Coronary Heart Disease (Angina pectoris, history of myocardial infarction, revascularisation procedures)
    6. Blood Pressure > 160 / 95 mmHg.
    7. Evidence of any other unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease.
    8. Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
    9. Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 3 alcoholic beverages per day is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer.
    10. Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study.
    11. The Patient is a female of childbearing potential, is pregnant or lactating.
    12. Known intolerance or contra-indication to the list of excipients of GFT505 (Gelatin, Lactose monohydrate, Titanium dioxide, Red Iron Oxide, Magnesium Stearate).
    13. Patient not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force.
    14. Patient who cannot be contacted in case of emergency.
    15. Any medication that may interfere with study medication absorption, distribution, metabolism or excretion or could lead to induction or inhibition of microsomial enzymes within 3 months prior to screening
    16. Insulin or other anti-diabetic medication. Patients treated for less than 4 weeks
    with insulin may be included in the study.
    17. Lipid-lowering drugs such as fibrates.
    18. Currently taking other investigational drugs or who have taken part in a clinical trial within the previous month prior to screening.

    In addition to the above criteria, patient should not present any of the following exclusion criteria according to B1 lab results:
    19. Fasting Plasma Glucose (FPG) ≥ 240 mg/dL
    20. TG > 400 mg/dL
    21. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and Gamma glutamyltransferase (GGT) >3 X the upper limit of normal (ULN).
    22. Positive screening for HBsAg or HCV
    23. Uncontrolled hypothyroidism defined as TSH > 2X the upper limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to screening is permitted.
    24. Significant renal disease, including nephritic syndrome, chronic renal failure (defined as creatinine clearance < 60mL/mn according to MDRD formula and serum creatinine >180Wmol/L).
    25. Unexplained serum creatine phosphokinase (CPK) > 3X the upper limit of normal (ULN). Patients with a reason for CPK elevation may continue in screening and have the measurement repeated prior to randomisation; a repeat CPK > 3X ULN is exclusionary.
    26. Positive ketonuria
    E.5 End points
    E.5.1Primary end point(s)
    After 12 weeks of daily administration of GFT505 80mg, compare changes vs baseline with those observed in the placebo group.

    Primary Endpoint:
    - Changes in HbA1c

    Secondary Endpoints:
    - Changes in fasting plasma Glucose
    - Changes in insulin resistance index (fasting insulin and HOMA-IR).
    - Changes in OGTT parameters (glucose, insulin and FFA at each timepoint, oral disposition index, insulin AUC, glucose AUC and FFA AUC)
    - Changes in Proinsulin and in Pro-insulin/insulin ratio.
    - Changes in Fructosamine level.
    - Proportion of patients that reach the target of HbA1c<6.5% and HbA1c<7%.
    - Changes in lipids (LDL-C, non-HDL-C,TG, HDL-C, Total Cholesterol, calculated VLDL-C, apolipoproteins).
    - Changes in Aminotransferases level (ALT and AST) and GGT levels.
    - Changes in inflammatory markers (hsCRP, haptoglobin, fibrinogen) and others parameters.
    - Variations in body weight.
    - Description of SAE, AE, physical examination, vital signs, medical history, ECG.
    - Description of haematological parameters, biochemical markers and urinalysis.
    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) 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 end of the trial corresponds to the last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 120
    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 Decision2010-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
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