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    Summary
    EudraCT Number:2018-001880-22
    Sponsor's Protocol Code Number:PP-CT02
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-16
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2018-001880-22
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes type 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes
    A.4.1Sponsor's protocol code numberPP-CT02
    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 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 supportPILA PHARMA AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPILA PHARMA AB
    B.5.2Functional name of contact pointDorte X. Gram
    B.5.3 Address:
    B.5.3.1Street AddressVästergatan 1
    B.5.3.2Town/ cityMalmö
    B.5.3.3Post code211 21
    B.5.3.4CountrySweden
    B.5.4Telephone number+4673903 6969
    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.3.8INN - Proposed INNXEN-D0501
    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
    Diabetes Type II
    E.1.1.1Medical condition in easily understood language
    Diabetes Type II
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    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 investigate the effects of four weeks of bi-daily dosing of XEN-D0501 (4 mg BID) as add-on to metformin on fasting blood glucose in patients with diabetes mellitus type 2
    E.2.2Secondary objectives of the trial
    • To investigate the effects of bi-daily doses of XEN-D0501 on self-monitored blood glucose (SMBG) concentrations during an 8-point profile in patients with diabetes mellitus type 2
    • To investigate the effects of bi-daily doses of XEN-D0501 on plasma HbA1c in patients with diabetes mellitus type 2
    • To investigate the effects of bi-daily doses of XEN-D0501 on the glucose tolerance of patients with diabetes mellitus type 2 during a 2 h oral glucose tolerance test (OGTT) in patients with diabetes mellitus type 2
    • To investigate the effects of bi-daily doses of XEN-D0501 (4 mg) on insulin secretion during a 2 h oral glucose tolerance test (OGTT) in patients with diabetes mellitus type 2
    • To investigate the effects of bi-daily doses of XEN-D0501 on beta-cell function during a 2 h oral glucose tolerance test (OGTT) in patients with diabetes mellitus type 2
    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 a stable metformin dose during the last three months, but no other anti-diabetic drugs
    4. HbA1C (glycosylated haemoglobin A1C): 6.5-10 %
    5. Age above 25
    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 clinically significant abnormal ECG at screening, as judged by the investigator
    3. A subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
    4. A subject who has donated any blood or plasma in the past month or in excess of 500 mL within 1 month preceding screening
    5. A subject who has a significant history of alcoholism or drug/chemical abuse as per investigator’s judgement
    6. 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
    7. Surgery or trauma with significant blood loss within the last 2 months prior to dosing
    8. A subject with a clinically significant abnormal haematology or biochemistry tests at screening visit, as judged by the Investigator considering the underlying disease
    9. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticoids and monoamine oxidase inhibitors (MAO) inhibitors
    10. Haemoglobin < 6.2 mmol/l (<99.8 g/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, alanine aminotransferase > 2 x the upper limit of normal (ULN), alkaline phosphatase > 2 x ULN, one re-test within a week is permitted
    11. Previous participation (randomisation) in this trial
    12. Any condition that would interfere with trial participation or evaluation of results, as judged by the investigator and/or sponsor
    13. Recurrent major hypoglycaemia or hypoglycaemic unawareness, as judged by the Investigator
    14. Females of childbearing potential (i. e. not post-menopausal ≥ 12 months or surgically sterilised) 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
    E.5 End points
    E.5.1Primary end point(s)
    • Fasting blood glucose after four weeks of bi-daily dosing of XEN-D0501
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation for 4 weeks after bi-daily oral use
    E.5.2Secondary end point(s)
    • Self-monitored blood glucose (SMBG) concentrations during an 8-point profile after two and four weeks of bi-daily doses of XEN-D0501
    • Plasma HbA1c after four weeks of bi-daily doses of XEN-D0501
    • Glucose tolerance during a 2 h oral glucose tolerance test (OGTT) after four weeks of bi-daily doses of XEN-D0501
    • Insulin secretion during a 2 h oral glucose tolerance test (OGTT) after four weeks of bi-daily doses of XEN-D0501
    • Beta-cell function during a 2 h oral glucose tolerance test (OGTT) after four weeks of bi-daily doses of XEN-D0501
    • Insulin sensitivity during a 2 h OGTT after four weeks of bi-daily doses of XEN-D0501
    • Fasting plasma insulin after four weeks of bi-daily doses of XEN-D0501
    • HOMA estimate of insulin resistance and -cell function after four weeks of bi-daily doses of XEN-D0501
    • Plasma glucagon after four weeks of bi-daily doses of XEN-D0501
    • Body weight after four weeks of bi-daily doses of XEN-D0501
    • Waist circumference after four weeks of bi-daily doses of XEN-D0501
    • Waist-hip ratio after four weeks of bi-daily doses of XEN-D0501
    • Fasting blood lipids (LDL cholesterol, HDL cholesterol and TAG) after four weeks of bi-daily doses of XEN-D0501
    • Plasma C-reactive protein (CRP) after four weeks of bi-daily doses of XEN-D0501
    • Plasma NTpro-BNP after four weeks of bi-daily doses of XEN-D0501
    • Plasma ANP after four weeks of bi-daily doses of XEN-D0501
    • Adverse events (AEs) / Severe adverse events (SAEs)
    • Hyperthermia events
    • Hypoglycemic events
    • Physical examinations
    • Electrocardiogram (ECG)
    • Vital signs (body temperature, blood pressure and heart rate)
    • Laboratory safety variables
    • Self-monitored body temperature
    • Self-monitored blood pressure
    • Plasma concentration of XEN-D0501 after four weeks of bi-daily dosing of XEN-D0501
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation for 4 weeks after bi-daily oral use
    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 Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Yes
    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
    Last Patient Last Visit
    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 months3
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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)
    If patients experience abnormalities following the bi-daily dose of XEN-D0501 for 4 weeks, they must contact the Principal Investigator
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Quay Pharmaceuticals Ltd
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-19
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