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    Summary
    EudraCT Number:2016-003843-12
    Sponsor's Protocol Code Number:PP-CT01
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-16
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2016-003843-12
    A.3Full title of the trial
    A Single-dose dose escalation trial in a randomised, single-blind, placebo-controlled group-comparison design to investigate the safety and tolerability of XEN-D0501 in 24 patients with diabetes mellitus type 2
    Et enkeltdosis-, dosiseskaleringsstudie i et randomiseret, enkeltblindet,
    placebokontrolleret, gruppesammenligningsdesign for at undersøge sikkerheden og tolerabiliteten af XEN-D0501 i 24 patienter med diabetes mellitus type 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigation to investigate whether a single dose of XEN-D0501 is tolerable by type 2 diabetic patients prior to multiple dose trials (to investigate if the compound can effectively regulate diabetes)
    En undersøgelse af om en enkelt dosis af XEN-D0501 tåles af type 2 diabetikere inden man tester substansen i længere varende studier for at måle dets eventuelle effekt på at behandle sukkersyge
    A.4.1Sponsor's protocol code numberPP-CT01
    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 SponsorPILA PHARMA
    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 supportPILA PHARMA
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPILA PHARMA
    B.5.2Functional name of contact pointDorte X. Gram
    B.5.3 Address:
    B.5.3.1Street AddressPer Albin Hanssons vag
    B.5.3.2Town/ cityMalmo
    B.5.3.3Post code205 12
    B.5.3.4CountrySweden
    B.5.4Telephone number460739036969
    B.5.6E-mailinfo@pilapharma.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.3.2Product code XEN-D0501
    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.3.9.3Other descriptive nameXEN-D0501
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameXEN-D0501
    D.3.9.4EV Substance CodeSUB30611
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameXEN-D0501
    D.3.9.4EV Substance CodeSUB30611
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Type 2 sukkersyge
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes
    Type 2 sukkersyge
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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 evaluate the safety and tolerability of single ascending oral doses of XEN-D0501, (1, 2 and 4 mg) versus placebo in type 2 diabetic patients in treatment with metformin.
    Det primære formål med studiet er at undersøge sikkerheden og tolerabiliteten (bivirkningsprofilen) af en enkelt oral dosis af XEN-D0501 i tre forskellige styrker (tabletter à 1, 2 og 4 mg) i forhold til en ikke-aktiv kontrol (placebo) i patienter med type 2 sukkersyge, der i forvejen er i behandling med metformin uden god nok effekt på blodsukkeret.
    E.2.2Secondary objectives of the trial
    Besides it is the purpose of this trial to identify the optimal dose for later clinical trials to study the efficacy of XEN-D0501 in patients with type 2 diabetes with the aim of developing a novel type of type 2 diabetes.
    Det er desuden hensigten med dette studie at finde den optimale dosis til senere kliniske studier, hvor vi gerne vil undersøge effekten af XEN-D0501 i patienter med type 2 diabetes med henblik på at udvikle XEN-D0501 til behandling af type 2 diabetes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject must give his/her signed and dated informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject.
    2. Diagnosis of type 2 diabetes mellitus
    3. In treatment with metformin, but no other anti-diabetic drugs
    4. In treatment with an ACE-inhibitor but no other anti-hypertensive drugs
    5. HbA1C (glycosylated haemoglobin A1C) 7-9 %
    6. Age between 30 and 70 years (both inclusive).
    7. Body mass index (BMI) 27 to 35 kg/m2
    8. Fasting C-peptide > 600 pmol/l
    9. Abdominal adiposity, defined waist circumference > 102 cm for male and > 88 cm for
    female subjects
    1. Patienten skal give underskrevet og dateret samtykke inden deltagelse i forsøgsrelaterede aktiviteter.
    Forsøgsrelaterede aktiviteter er alle procedurer, der ikke ville blive udført som en del af den
    almindelige behandling af patienten.
    2. Diagnosticeret med type 2 diabetes mellitus (sukkersyge)
    3. I behandling med metformin, men ikke med andre anti-sukkersyge lægemidler
    4. I behandling med en ACE-hæmmer, men ikke med andre blodtrykssænkende lægemidler
    5. HbA1C (glykosyleret hæmoglobin A1C) 7-9 %
    6. Alder mellem 30 og 70 år (begge inklusive).
    7. Body mass index (BMI) mellem 27 og 35 kg/m2 (begge inklusive).
    8. Fastende C-peptid > 600 pmol/l
    9. Abdominal fedme, defineret taljemål > 102 cm for mandlige og > 88 cm for kvindelige deltagere


    E.4Principal exclusion criteria
    1. A subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trial product, as judged by the Investigator.
    2. A subject who has a supine blood pressure at screening (including those on antihypertensives),
    after resting for 5 min, outside the range of 90-140 mmHg systolic or
    50-90 mmHg diastolic (excluding white-coat hypertension; therefore, if a repeated
    measurement on a second screening visit shows values within the range, the subject
    can be included in the trial).
    3. A subject who is in pharmacological treatment of hypertension if the current treatment
    includes other than an ACE-inhibitor
    4. A subject who has a clinically significant abnormal ECG at screening, as judged by
    the investigator.
    5. A subject who has participated in any other trials involving investigational products
    within the 3 months preceding the start of dosing.
    6. A subject who has donated any blood or plasma in the past month or in excess of 500
    mL within the 3 months preceding screening.
    7. A subject who has a significant history of alcoholism or drug/chemical abuse as per
    investigator’s judgement, or who has a positive result in the urine drug/alcohol screen
    at screening visit.
    8. A subject who smokes more than 5 cigarettes, or the equivalent, per day and is unable
    to refrain from smoking during the in-house periods as determined by the Investigator.
    9. A subject with mental incapacity or language barriers which preclude adequate
    understanding or cooperation, who is unwilling to participate in the trial, or who in the
    opinion of their general practitioner or the Investigator should not participate in the
    trial.
    10. Surgery or trauma with significant blood loss within the last 2 months prior to dosing.
    11. A subject with a history of or presence of cancer, or any clinically significant,
    respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the
    exception of diabetes mellitus type 2 and euthyroid struma), haematological,
    dermatological, venereal, neurological, psychiatric diseases or other major disorders.
    12. Cardiac problems defined as: decompensated heart failure (New York Heart Association (NYHA) class III and IV) at any time and/or angina pectoris and/or acute myocardial infarction within the last 12 months.
    13. A subject with a clinically significant abnormal haematology or biochemistry tests at
    screening visit, as judged by the Investigator considering the underlying disease.
    14. Current treatment with drugs known to interfere with glucose metabolism such as
    systemic corticoids and monoamine oxidase inhibitors (MAO) inhibitors.
    15. A subject who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
    16. Haemoglobin < 6.2 mmol/l, total leukocyte count < 3.0 x 109/l, thrombocytes <100 x 109/l, serum creatinine levels ≥ 126 μmol/l (male) or ≥ 111 μmol/l (female), bilirubin > 3 x ULN, alkaline phosphatase > 2 x ULN, one re-test within a week is permitted.
    17. Previous participation (randomisation) in this trial.
    18. Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator and/or sponsor
    19. Recurrent major hypoglycaemia or hypoglycaemic unawareness, as judged by the Investigator.
    20. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (Adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral hormonal contraceptives (p-pills), implantants, transdermal patches, p-ring or depot injection, sexual abstinence or vasectomised partner). A male subject who is sexually active and has not been surgically sterilised must be informed that he must ensure that his partner practices effective contraception, as stated above, or he must refrain from sexual intercourse during the trial and until 90 days after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication.
    1. En person med en historie med signifikant multipel lægemiddelallergi eller med kendt eller mistanke om allergi overfor forsøgslægemidlet eller lægemidler, der er kemisk relaterede til forsøgslægemidlet, efter vurdering af den forsøgsansvarlige.
    2. En person, som har et blodtryk (ved liggende) ved screeningsbesøg efter 5 min hvile udenfor området 90-140 mmHg systolisk eller 50-90 mmHg diastolisk. Hvis en gentaget måling ved et andet screeningsbesøg viser værdier indenfor området, kan personen blive inkluderet i forsøget.
    3. En person, der er i farmakologisk behandling for hypertension, hvis denne behandling inkluderer enten 1) betablokkere eller 2) mere end to forskelllige blodtrykssænkende lægemidler.
    4. En person, der har et klinisk abnormt EKG ved screening, efter vurdering af den forsøgsansvarlige.
    5. En person, der har deltaget i andre kliniske studier, der involverer forsøgslægemidler, indenfor de sidste tre måneder inden doseringsstart.
    6. En person, der har doneret blod eller plasma i den seneste måned, eller over 500 ml indenfor de seneste tre måneder inden screeningsbesøget.
    7. En person, der har en signifikant historie med alkoholisme eller stof-/lægemiddelmisbrug, efter vurdering af den forsøgsansvarlige, eller der har et positivt resultat i urinanalysen for
    stof/alkohol ved screeningsbesøget.
    8. En person, der ryger mere end 5 cigaretter eller tilsvarende pr. dag og ikke er i stand til at holde sig fra rygning i den periode, personen skal opholde sig på forsøgsstedet, efter vurdering af den forsøgsansvarlige.
    9. En person, der er mentalt inkapabel eller har sprogbarrierer, der udelukker tilstrækkelig forståelse for eller samarbejde om forsøget, eller der er uvillig i at deltage i forsøget, eller der ifølge vurdering fra deres praktiserende læge eller den forsøgsansvarlige, ikke skal deltage i forsøget.
    10. Operation eller traume med signifikant blodtab indenfor de seneste to måneder inden dosering.
    11. En person med en historie med eller tilstedeværelse af kræft eller andre klinisk signifikante lunge-, metaboliske, nyre-, mavetarm-, endokrinologiske- (med undtagelse af type 2 sukkersyge og euthyroid struma), hæmatologiske, hud-, køns-, neurologiske, psykiatriske sygdomme eller andre betydelige sygdomme.
    12. Hjerteproblemer defineret ved dekompenseret hjertesvigt og/eller angina pectoris og/eller akut myokardi infarkt indenfor de seneste 12 måneder.
    13. En person med en klinisk signifikant abnorm hæmatologi- eller biokemitest ved screeningsbesøget, efter vurdering af den forsøgsansvarlige i forhold til den underliggende sygdom.
    14. Behandling med lægemidler, der påvirker glukosemetabolisme som systemiske kortikoider og monoaminoxidasehæmmere.
    15. En person som har proliferativ retinopati eller maculopati og/eller alvorlig neuropati, særligt autonomisk neuropati, efter vurdering af den forsøgsansvarlige.
    16. Hæmoglobin < 6.2 mmol/l, total leukocyttal < 3.0 x 109/l, thrombocytter <100 x 109/l, serum creatininekoncentration ≥ 126 μmol/l (mænd) or ≥ 111 μmol/l (kvinder), bilirubin > 3 x ULN, alkalinphosphatase > 2 x ULN, en retest indenfor en uge er tilladt.
    17. Tidligere deltagelse i dette forsøg.
    18. Forhold, der kan påvirke forsøgsdeltagelse eller vurdering af resultaterne, efter vurdering af den forsøgsansvarlige eller af sponsor.
    19. Tilbagevendende betydelig hygoglykæmi eller manglende evne til at føle hypoglykæmi, efter vurdering af den forsøgsansvarlige.
    20. Kvinder i den fødedygtige alder, der er gravide, ammer, prøver at blive gravide eller ikke bruger en effektiv præventionsmetode. Flg. præventionsmetoder anses for sikre: spiral eller hormonel antikonception (p-piller, implantat, transdermal depotplastre, vaginalring eller depotinjektion) eller steriliseret partner. Seksuelt aktive mænd, der ikke er steriliserede, skal sikre sig, at deres partner anvender en effektiv præventiosnmetode som nævnt ovenfor, ellers skal de afholde sig fra seksuel aktivitet i min. 90 dage efter, at forsøge er afsluttet.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of XEN-D0501 in patients with type 2 diabetes
    Sikkerhed og tolerabilitet af XEN-D0501 i patienter med type 2 diabetes
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation for 8 h after single oral dose
    Evaluerering i 8 timer efter enkelt tablet dosering
    E.5.2Secondary end point(s)
    • Adverse events (AEs) / Severe adverse events (SAEs)
    • Hyperthermia events
    • Hypoglycemic events
    • Physical examinations
    • Electrocardiogram (ECG)
    • Vital signs
    • Laboratory safety variables
    • Uventede hændelser/ alvorlige uventede hændelser
    • Episoder med forhøjet temperatur
    • Episoder med for lavt blodsukker (hypoglykæmi)
    • Alm. helbredsundersøgelse
    • Elektrokardiogram (ECG)
    • Tegn på sundhed
    • Laboratorie sikkerheds variable
    E.5.2.1Timepoint(s) of evaluation of this end point
    For 8 h after single oral dose
    I 8 timer efter enkelt oral dosering
    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 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 Yes
    E.8.1.4Double blind No
    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.8.2.4Number of treatment arms in the trial4
    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 No
    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 trial may be terminated prematurely if:
    • The Principal Investigator and the Sponsor feel that the number and/or severity of AEs justify discontinuation of the trial.
    • New data become available, which raise concern about the safety of the trial drug so that continuation would pose potential risks to the subjects.
    Forsøget kan blive afsluttet før tid, hvis:
    - Hvis den forsøgsansvarlige og sponsoren mere at antallet og/eller alvorligheden af uventede hændelser godtgør at forsøget afsluttes
    - Hvis nye data fremkommer som sår tvivl om forsøgs substansens sikkerhed hvormed en fortsættelse af forsøget ville udsætte forsøgsdeltagerne for en potentiel risiko/fare.
    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 months4
    E.8.9.1In the Member State concerned 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: 24
    F.1.3Elderly (>=65 years) No
    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 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 state24
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 24
    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)
    No - if patients experience abnormalities following the 8 hours in-house after the single dose of XEN-D0501 they must contact the principal investigator
    Nej - hvis patienterne oplever noget unormalt efter de 8 timers 'in-house' efter den enkelte dosis skal de kontakte den forsøgs ansvarlige
    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 Decision2017-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-08
    P. End of Trial
    P.End of Trial StatusOngoing
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