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    Summary
    EudraCT Number:2009-011589-27
    Sponsor's Protocol Code Number:S337.2.001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2009-011589-27
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients with Type 2 Diabetes on Metformin Monotherapy
    A.4.1Sponsor's protocol code numberS337.2.001
    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 SponsorLaboratoires Fournier S.A. A Solvay Pharmaceuticals company
    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 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 nameSLV337
    D.3.2Product code SLV337
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNone
    D.3.9.1CAS number 927961-18-0
    D.3.9.2Current sponsor codeSLV337
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule, hard
    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 (T2DM)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to explore the safety and tolerability of three oral doses of a new anti-diabetic agent, SLV337, in subjects with type 2 diabetes mellitus (T2DM) treated with metformin monotherapy, during four weeks of administration.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To investigate the pharmacokinetic (PK) profiles of these three oral doses of SLV337
    in subjects with T2DM.
    - To explore the effect of SLV337 on metformin plasma levels in subjects on stable
    treatment dose administered in the morning.
    - To explore the exposure-response relationships and preliminary efficacies of these
    three oral doses of SLV337 in subjects with T2DM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female of non-childbearing potential, aged 18 to 75 years inclusive.
    2. Diagnosed with T2DM defined by the American Diabetes Association criteria: FPG
    ≥7.0 mmol/L (126 mg/dL), or two hours postprandial glucose ≥11.1 mmol/L
    (200 mg/dL).
    3. Treated with life style modification and stable dose of metformin monotherapy, ≥850 mg daily dose, for at least three months; the dose of metformin, physical exercise and dietary recommendations will stay unchanged during the whole duration of the study.
    4. With inadequate glycemic control, defined by hemoglobin A1c (HbA1c) ≥7%, but <10%.
    5. With FPG <15 mmol/L (270 mg/dl).
    6. If female, the subject should be of non-childbearing potential, defined as being
    post-menopausal for at least 24 months prior to dosing (with confirmed estradiol
    ≤20 pg/mL [73 pmol/L] and follicle-stimulating hormone ≥40 mIU/mL) at Screening if
    less than 60 years old, or surgically sterilized (with negative pregnancy test at Screening in the absence of hysterectomy). If male, unless the subject has undergone a vasectomy, he must abstain from sexual contact with women who may become pregnant, or use a combination of a condom and spermicide as a contraception measure from the first dosing up to three months after the last intake of study drug.
    7. Subjects will have given their voluntary written informed consent to participate in the study in their own language and be willing to comply with the protocol. Consent will be documented by the subject’s name and dated signature prior to screening procedures.
    E.4Principal exclusion criteria
    1. Type 1 diabetes mellitus, maturity onset diabetes of the young.
    2. C-peptide <0.27 nmol/L (0.8 ng/mL).
    3. Currently treated or treated during the last three months with insulin therapy.
    4. Ongoing oral dual anti-diabetic therapy or treated during the last three months by oral anti-diabetic therapy other than metformin.
    5. Treatment with a fibrate, ezetimibe or with any lipid lowering agents other than statins.
    6. Treatment with warfarin and other coumarinic derivatives (i.e. acenocoumarol).
    7. Body mass index >40.0 kg/m2.
    8. Uncontrolled arterial hypertension defined by systolic blood pressure (SBP) ≥160 and/or diastolic blood pressure (DBP) ≥95 mmHg taken in a semi-recumbent position, after 5 minutes rest.
    9. Renal failure or renal dysfunction defined by creatinine clearance <60 mL/min as
    calculated with the Modification of Diet in Renal Disease formula as follows:eGFR (mL/min/1.73m2)= 175 x [SerumCreatinine(μmol/L) x 0.0113]-1.154
    x Age(years)-0.203 (x 0.742 if female). For African-Americans the value should be
    multiplied by 1.21.
    Note: values <60 mL/min are likely to deviate from the true value.
    10. History of proliferative retinopathy or maculopathy requiring, or previously treated with, laser therapy.
    11. Evidence of unstable cardiovascular diseases: 1) coronary bypass surgery, or angioplasty within three months of the screening visit; 2) myocardial infarction, unstable angina pectoris or other significant cardiac event (including history of cardiac arrhythmias or conduction delays on electrocardiogram [ECG]) or cerebral stroke within three months of the screening visit; 3) severe peripheral artery disease as evidenced by intermittent claudication within three months of the screening visit; 4) peripheral artery surgery within three months of the screening visit.
    12. Heart failure New York Heart Association class I to IV.
    13. History of pancreatitis or gall bladder disease, with the exception of subjects with gall bladder disease who have previously undergone a cholecystectomy.
    14. History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
    15. History of gastric or duodenal ulcer within three months of the screening visit.
    16. History of diagnosis of hepatitis B or hepatitis C.
    17. History of solid organ transplant.
    18. History of diagnosed hereditary or acquired myopathy.
    19. History of mental instability, drug or alcohol abuse or subject who was treated for severe psychiatric illness, which, in the opinion of the Investigator, may interfere with optimal participation in the study.
    20. History of cancer (except basal cell carcinoma or squamous cell skin cancer).
    21. Evidence of other relevant diseases not related to T2DM as revealed by history, physical examination and laboratory assessments which are deemed to limit study evaluation or participation in the judgment of the Investigator.
    22. Alanine aminotransferase (ALT) ≥ two times upper limit of normal.
    23. Known to be positive to the human immunodeficiency virus (HIV)1 or HIV2 virus.
    24. Known hypersensitivity to the excipients of SLV337 capsules (lactose monohydrate, sucrose, hydroxypropyl methylcellulose, sodium lauryl sulfate, sodium docusate, purified water, sodium starch glycolate and magnesium stearate).
    25. Has taken one single dose of an investigational drug within 30 days or multiple doses of an investigational drug within 60 days prior to dosing.
    26. Has an acute infection at the time of Screening and/or admission.
    27. Has acute gastrointestinal symptoms at the time of Screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
    28. Unlikely to comply with the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetics:
    For the calculation of the PK parameters the following rules will be applied:
    - Non-compartmental modeling will be applied.
    - Actual sampling times will be used.
    - At time points in the lag-time between time zero and the first concentration equal or above lower limit of quantification (LLOQ), concentrations below LLOQ will be set
    to zero.
    - Concentrations below LLOQ between two concentrations equal or above LLOQ will
    be set to half the LLOQ.
    - Trailing concentrations below LLOQ will not be used.
    - The AUC parameters will be calculated according to the lin-up log-down trapezoidal
    rule.
    The values of Cmax and tmax will be taken directly from the individual concentration versus time data.

    Pharmacodynamics:
    The following PD endpoints will be calculated:
    - HMW/total adiponectin ratio.
    - HOMA-IR, calculated as fasting insulin [μU/L] × FPG [mmol/L] / 22.5
    - ApoB/apoA1 ratio.
    - Mean of the seven blood glucose values (glucometer) on Days -1 and 28.
    - Mean of the three post-prandial measures of blood glucose values (glucometer); one hour post breakfast and two hours post lunch and two hours post dinner on
    Days -1 and 28

    The relationship between SLV337 plasma parameters (AUC0-t, AUC0-τ and Cmax) and change from baseline PD measurements on Day 28 will be graphically presented for selected PD endpoints. This evaluation will be limited to those PD endpoints that exhibited a significant dose-response relationship.

    An independent cardiovascular endpoints committee will be appointed to prospectively collect and review before adjudication, in a blinded fashion, cardiovascular events during the study.
    The safety sample will be used for the analysis of the safety and tolerability data. Safety variables will be summarized by descriptive statistics.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of Study is defined as Last Subject Last Visit + 30 days
    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 months9
    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 months9
    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) 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 56
    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)
    According to the protocol
    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 Decision2009-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-02
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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