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    Summary
    EudraCT Number:2010-023182-22
    Sponsor's Protocol Code Number:PSN821-203
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-26
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-023182-22
    A.3Full title of the trial
    A Phase 2, Double-Blind, Placebo-Controlled, Randomised, Single Dose, Crossover Study to Investigate the Glucose Lowering of PSN821 in Patients with Type 2 Diabetes (T2DM) after an Ensure Plus challenge
    A.4.1Sponsor's protocol code numberPSN821-203
    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 SponsorProsidion Ltd
    B.1.3.4CountryUnited Kingdom
    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 namePSN821AA
    D.3.2Product code PSN821AA
    D.3.4Pharmaceutical form Oral suspension
    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.3.9.2Current sponsor codePSN821AA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 placeboOral suspension
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 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 compare the pharmacodynamic response of single oral doses of PSN821 following a
    MMTT (based on the area under the glucose concentration-time curve from 1-6 hours
    post-dose, i.e. from 0-5 hours after a MMTT)
    • To establish the dose response relationship for the glucose lowering effect of PSN821
    using reactive glucose area under the curve (AUC)
    E.2.2Secondary objectives of the trial
    • To compare other pharmacodynamic properties (based on glucose, insulin and C-peptide
    measurements) of single oral doses of PSN821 before and following a MMTT
    • To compare the pharmacokinetic (PK) exposure and properties of each single oral dose
    for 12h post-dosing
    • To assess the PK/PD relationship (based on AUC PSN821 and AUC glucose)
    • To assess the short-term safety after single oral dosing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent obtained before any study-related activities
    2. Male and female patients with a diagnosis of type 2 diabetes mellitus according to ADA
    criteria at least 4 months prior to screening
    3. Medical history without major pathology (with the exception of type 2 diabetes)
    4. On a stable regimen of metformin monotherapy (minimum of 850 mg/day) prior to
    screening (medication type and dose unchanged for the last 3 months)
    5. Aged between 18 and 65 years of age, both inclusive
    6. Body mass index (BMI) between 25 and 40kg/m2, both inclusive
    7. HbA1c between 6.8 and 9.5 %, both inclusive
    8. Fasting plasma glucose (FPG) between 126 and 270 mg/dL (7-15 mmol/L), both inclusive
    9. A female patient is eligible to participate if she is of:
    Non-childbearing potential defined as pre-menopausal females with a documented tubal
    ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous
    amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating
    hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/mL (<140 pmol/L) is confirmatory].
    Females on stable hormone replacement therapy are allowed to participate in the study at
    the discretion of the Investigator. All female patients must have a negative pregnancy test
    results at screening.
    10. A male patient who is sexually active and not surgically sterilised, must agree to use
    adequate contraceptive methods as described in Section 4.3.2.1 from the time of first
    study drug administration until 90 days after last dosing.
    11. Ability and willingness to abstain from grapefruit juice (and all grapefruit containing
    products) throughout the study and from alcohol, methylxanthine-containing beverages or
    food (coffee, tea, Coke, chocolate, “power drinks”), tobacco products and from engaging
    in strenuous physical activity from 24 hours prior to each admission until discharge from
    the unit
    E.4Principal exclusion criteria
    1. Patients with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary
    forms of diabetes such as due to pancreatitis
    2. Current or previous treatment with insulin therapy
    3. Treatment with any hypoglycaemic medication other than metformin within the three
    months prior to screening
    4. Patients with any severe medical or surgical history of conditions likely to confound study
    assessments or study endpoints20. Participation in another clinical trial within the 3 months preceding screening or 5-halflives
    5. Serious respiratory, serious and/or unstable coronary heart disease
    6. History of arrhythmia
    7. Marked diabetic complications
    8. Clinically significant vital signs or 12-lead ECG findings including pre-treatment QTcF >
    450msec
    9. Clinically significant abnormal haematology, biochemistry, lipids, or urinalysis or
    coagulation screening tests
    10. Moderate or severe renal dysfunction
    11. Clinical or laboratory evidence of hepatic dysfunction or disease
    12. Uncontrolled high blood pressure (DBP > 95 mmHg and/or SBP > 160 mmHg)
    13. History of any psychiatric condition that might impair the patient’s ability to understand
    or to comply with the requirements of the study or to provide informed consent
    14. History of relevant drug and/or food allergies or a history of severe anaphylactic reaction
    15. Smoking more than 5 cigarettes/cigars/pipes daily
    16. Currently active or history of alcohol abuse
    17. Positive screen for drugs of abuse or alcohol test at screening
    18. Use of concomitant medication which would confound study conduct
    19. Use of drugs that have a known risk of causing Torsades de Pointes are prohibited within
    14 days prior to randomisation.
    20. Participation in another clinical trial within the 3 months preceding screening or 5-halflives
    of drug studied, whichever is longer, prior to study medication administration
    21. Participation in more than three other clinical trials in the ten months preceding screening
    22. Malignancy within 5 years of study start, except for successfully treated local basal cell
    carcinomas
    23. Patients known to be positive for Hepatitis B surface antigen or Hepatitis C antibodies (or
    diagnosed with active hepatitis according to local practice)
    24. Positive result to the screening test for HIV-1 antibodies, HIV-2 antibodies or HIV-1
    antigen according to locally used diagnostic testing
    25. Patients in whom metformin is contraindicated according to the local SPC
    26. Use of concomitant medication which would be likely to interact with metformin
    (according to the Patient information leaflet)
    27. Patient who has donated or lost more than 500 mL blood within 3 months prior to
    screening
    28. Significant illness within five days prior to the first administration of study medication
    29. History of hypersensitivity to the study medication or any of the excipients or to medicinal
    products with similar chemical structures
    30. Veins unsuitable for repeat venipuncture
    E.5 End points
    E.5.1Primary end point(s)
    The primary (PD) endpoint of the study is:
    - AUCPG(5h) area under the plasma glucose concentration-time profile from 1-6 hours postdose (i.e. from 0-5 hours after a MMTT)
    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 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 No
    E.8.1.6Cross over Yes
    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 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
    refer to section 8.8 protocol --> End of trial = LPLV
    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
    E.8.9.2In all countries concerned by the trial years0
    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 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) 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 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
    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 Decision2011-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-04
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