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    Summary
    EudraCT Number:2012-004045-33
    Sponsor's Protocol Code Number:PXL008-008
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-22
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2012-004045-33
    A.3Full title of the trial
    A dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the efficacy and safety of 4 doses of imeglimin after 24 weeks of treatment in subjects with type 2 diabetes mellitus
    Un studiu multicentric, controlat cu placebo, cu grup paralel, dublu-orb, randomizat, cu doze multiple pentru a evalua eficacitatea şi siguranţa a 4 doze de imeglimin după 24 de săptămâni de tratament la pacienţii cu diabet zaharat de tip 2.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study in patients with diabetes
    Studiu clinic al pacientilor cu diabet.
    A.4.1Sponsor's protocol code numberPXL008-008
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPoxel S.A.
    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 supportPOXEL S.A.
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINC Research
    B.5.2Functional name of contact pointIwona Chylak
    B.5.3 Address:
    B.5.3.1Street Address ul. Emaus 5
    B.5.3.2Town/ cityKrakov
    B.5.3.3Post code30-201
    B.5.3.4CountryPoland
    B.5.4Telephone number+4812646 25 09
    B.5.5Fax number+4812646 25 99
    B.5.6E-mailIwona.Chylak@INCResearch.com
    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 nameimeglimin
    D.3.2Product code PXL008
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNimeglimin
    D.3.9.2Current sponsor codePXL008
    D.3.9.3Other descriptive nameIMEGLIMIN
    D.3.9.4EV Substance CodeSUB31216
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Type 2 Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    adult-onset sugar diabetes
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10012607
    E.1.2Term Diabetes mellitus inadequate control
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the dose-response of imeglimin at 4 doses (500 mg, 1000 mg, 1500 mg and 2000 mg bid) compared to placebo in male and female subjects with type 2 diabetes mellitus after 24 weeks of treatment, using glycosylated hemoglobin (HbA1c) as the primary evaluation criterion.
    E.2.2Secondary objectives of the trial
    • To assess the optimal dose of imeglimin
    • To assess the activity of imeglimin compared to placebo on additional glycemic and non-glycemic parameters
    • To assess the tolerability and safety of imeglimin compared to placebo.
    • To investigate the pharmacokinetics (PK) / pharmacodynamics (PD) of imeglimin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject has given written informed consent before any study-related activities are carried out
    • Male and female type 2 diabetic subjects, who at the time of screening are either:
    - Naïve of anti-diabetic agents (no treatment for 12 weeks) or
    - Treated with an oral anti-diabetic monotherapy, including metformin, sulfonylurea, dipeptidyl peptidase 4 (DPP-4) inhibitors, glinide or alpha-glucosidase inhibitor,, stable for 12 weeks
    • Age: ≥ 18 to ≤ 75 years at screening
    • Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m² at screening
    • HbA1c criteria:
    - HbA1c ≥ 7% and ≤ 9.5% at Screening Visit 1 for subjects naïve of treatment
    - HbA1c ≥ 6.5% and ≤ 9% at Screening Visit 1 for subjects previously treated with an oral anti-diabetic monotherapy
    - HbA1c ≥ 7% and ≤ 9.5% at Visit 4 for both subjects naïve of treatment and previously treated with an oral anti-diabetic monotherapy
    • Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit 1 and ≥ 45 mL/[min*1.73 m2] at Visit 4, as estimated by the MDRD formula
    • Effective contraception for women of child bearing potential: females must have a negative pregnancy test and (if not surgically sterile or post-menopausal) practice acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception, sexual partner with non-reversed vasectomy [with azoospermia in 2 tests], 2 barrier methods [e.g., condom, diaphragm, or spermicide], or intrauterine device)
    E.4Principal exclusion criteria
    • Any disease which in the Investigator’s opinion would exclude the subject from the study
    • Treatment with TZD, GLP-1 analogs or insulin (except short use of insulin in the dedicated context of a concomitant disease or surgical procedure) within 12 weeks before screening
    • Acute cardiovascular event within 3 months before randomization
    • Uncontrolled high blood pressure (BP): diastolic ≥ 95 mm Hg or systolic ≥ 160 mm Hg with or without treatment
    • Impairment of hepatic function (alkaline phosphatase [AP], aspartate aminotransferase [AST] or alanine aminotransferase [ALT] ≥ 3 x the upper limit of normal)
    • History of drug-induced Torsades de Pointes (presence of a familial long QT syndrome, hypokalemia, heart failure…) or a marked baseline prolongation of the QTc interval (QTcF) greater than 450 ms on 2 different ECGs at either Screening Visit 1 or Laboratory Visit 4, or the use of at least 2 concomitant medications known to prolong the QTc interval. QTc will be calculated using the Fridericia’s formula.
    • Retinopathy of severity above mild non proliferative diabetic retinopathy assessed within 12 months before randomization (see classification in Appendix II of Protocol). In case no examination has been performed within the last 12 months, an ophthalmological examination is to be conducted prior to visit 2 (start of run-in)
    • Pregnancy or lactation
    • Mental handicap, legal incapacity, or any history of clinically important emotional and/or psychiatric illness
    • Known hypersensitivity to any of the constituents or excipients of the study drug, or history of relevant drug and/or food allergies (e.g. anaphylactic, anaphylactoid reactions)
    • Use of any non-permitted medication (described in Section 6.5.2 Non-Permitted Medicines of Protocol) starting from the signature of the informed consent. As far as possible concomitant medication should be stable
    • Positive screen for hepatitis B surface antigen (HbsAg), antibody to the hepatitis A virus (anti- HAV; immunoglobulin M [IgM]), antibody to hepatitis C virus (anti-HCV) in the context of positive circulating RNA or antibodies to human immunodeficiency virus (anti-HIV) 1 and 2 at screening
    • Any current history of alcohol abuse or drug addiction
    • Participation in a clinical study within 30 days before screening
    • Participation in a previous clinical study from the same Sponsor POXEL (PXL008-002 or PXL008-004)
    • Donation of blood or blood transfusion within 30 days before screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy objective of this study is to demonstrate a dose-dependent response on HbA1c in subjects with type 2 diabetes mellitus after 24 weeks of imeglimin at 4 doses versus placebo, as evaluated by the mean change between Baseline (Visit 5) and week 24 (Visit 10) HbA1c. HbA1c will be measured from fasting blood samples collected at these time points. This parameter will be assessed both using the ITT and the PP populations and by LOCF and observed cases (OC).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24 (compared with Baseline value at Visit 5)
    E.5.2Secondary end point(s)
    Efficacy will be further assessed based on the following secondary variables:
    • Percentage of HbA1c responder (Yes/No): defined as HbA1c ≤ 7.0% at Week 24
    • Change from baseline to Week 24 in fasting plasma glucose, insulin and C-peptide
    • Change from baseline to Week 24 in homeostasis model of insulin resistance (HOMA-IR) and beta-cell function (HOMA-B)
    • Change from baseline to Week 24 in pro-insulin/insulin ratio
    • Change from baseline to Week 24 in total cholesterol, HDL-C and LDL-C
    • Change from baseline to Week 24 in triglycerides
    • Change from baseline to Week 24 in hsCRP
    • Percentage of subjects requiring rescue therapy any time between receiving first dose and Week 24.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For all secondary endpoints the timepoint of evaluation is week 24 when the change to Baseline (Visit 5) is assessed; Exception is the secondary endpoint assessing percentage of subjects requiring rescue therapy - this may occur any time between receiving first dose and Week 24.
    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 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.8.2.4Number of treatment arms in the trial5
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Estonia
    Hungary
    Latvia
    Ukraine
    United States
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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.1.2.1Number of subjects for this age range: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 800
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After a subject has completed the study or has withdrawn prematurely, he/she will be referred to his/her physician with an appropriate anti-diabetic treatment, in accordance with the study site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs.
    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 Decision2013-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-10
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