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    Summary
    EudraCT Number:2004-002701-68
    Sponsor's Protocol Code Number:PSN9301CS01
    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:2004-10-06
    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 number2004-002701-68
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, multiple dose, time-lagged parallel groups trial, investigating the pharmacodynamics, the safety and tolerability and the pharmacokinetics of PSN9301 in type 2 diabetes patients
    A.3.2Name or abbreviated title of the trial where available
    Not available
    A.4.1Sponsor's protocol code numberPSN9301CS01
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot available
    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 Information not present in EudraCT
    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 nameNot applicable
    D.3.2Product code PSN9301
    D.3.4Pharmaceutical form Tablet
    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.3.8INN - Proposed INNNot available
    D.3.9.1CAS number N.a.
    D.3.9.2Current sponsor codePSN9301
    D.3.9.3Other descriptive nameP93/01
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.120
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 mellitus type 2
    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 investigate the pharmacodynamics of PSN9301 in patients with type 2 diabetes in relation to dosing regimen.
    E.2.2Secondary objectives of the trial
    1) To assess the safety and tolerability
    2) To investigate the dose linearity (dose proportionality) and PK of the ascending doses.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Patients must give their signed 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 patient.

    2. Patients diagnosed with type 2 diabetes according to WHO criteria.

    3. Diabetes treatment: Diet treatment only for at least 2 weeks prior to screening, or ongoing treatment with oral antidiabetics, which must be withdrawn for a minimum of 2 weeks before dosing.

    4. Males aged 30 <= age <= 74 years, or females aged 30 <= age <= 74 years if hysterectomised and therefore of no childbearing potential, or females aged 55 <= age <= 74 years of no childbearing potential as defined by amenorrhoea at least for the 12 months prior to inclusion.

    5. Body mass index (BMI) between 22 and 35 kg/m2 inclusive.

    6. 7.5 <= HbA1C <= 10.0%7. Plasma C-peptide within the normal reference range

    8. Fasting blood glucose (FBG) 7.2 mmol/L <= FBG <= 12.0 mmol/L measured in plasma
    E.4Principal exclusion criteria
    1. Pharmacological treatment with any of the following: Systemic steroids (within the last month), beta-blockers, and hormones (within the last month, hormone replacement therapy by female patients excluded).

    2. Any medication that the Investigator expects could interfere with blood glucose levels.

    3. Diabetic side complications

    4. History of severe pancreatitis interfering with blood glucose levels (as evaluated by the Investigator).

    5. History of, or current impaired hepatic function, ALAT or alkaline phosphatase >= 2 times upper normal level, and clinically increased liver size.

    6. Creatinine clearance (calculated according to the Cockcroft-Gault formula), that in the opinion of the investigaor does indicate renal impairment: Creatinine clearance (mL×min-1) = (140 – age) × body weight (kg) (× 0.85 for females) / 72 × serum creatinine (mg/dL)

    7. Hypertension (whether treated or not): systolic blood pressure > 160 mmHg blood pressure and/or >= 99 mmHg for diastolic blood pressure in the supine position.

    8. History of, or current cardiac problems, as angina pectoris, myocardial infarction, or symptoms of ischemic heart disease.

    9. Supine heart rate higher than 90 beats/min at each of 2 consecutive evaluations.

    10. Clinically significant abnormal 12-lead ECG (as evaluated by the Investigator).

    11. Positive urine pregnancy test (for female patients only).

    12. Any disease or condition which the Investigator feels will interfere with the trial.

    13. Patients who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for HIV antibodies.

    14. Patients with acute gastrointestinal symptoms at the time of entering the trial (e.g. nausea, vomiting, diarrhoea, or heartburn).

    15. Any clinically significant abnormal laboratory test results at screening.

    16. Patients who have received an investigational drug (new chemical entity or licensed product) in the month preceding the start of dosing, except antidiabetic medication.

    17. Patients who have a significant history of alcoholism or drug/chemical abuse, or who have a positive result in the urine drug/alcohol screen, or who consume more than 21 units of alcohol per week (one unit of alcohol equals about 250 mL of beer or lager, one glass of wine, or 20 mL spirits).

    18. Patients with a significant use of caffeine containing beverages (greater than 8 cups per day).

    19. Patients who smoke more than 10 cigarettes, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period.

    20. Patients with mental incapacity or language barriers which preclude adequate understanding or co-operation, who are unwilling to participate in the study, or who in the opinion of their general practitioner or the Investigator should not participate in the study.

    21. Patients who have taken part in strenuous exercise within 4 days prior to dosing in this trial. Whether strenuous exercise has been undertaken will be evaluated by the Investigator, and strenuous exercise is not allowed during the trial.

    22. Fasting blood glucose > 15 mmol/L more than 3 times during a 48-hour period during the period from screening to the run-in phase as measured in plasma.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacodynamic endpoints: DP IV, insulin, glucose (including OGTT results), food intake (% meal consumption) and satiety.
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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 Information not present in EudraCT
    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
    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 months11
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    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 Decision2004-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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