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    Summary
    EudraCT Number:2009-010720-26
    Sponsor's Protocol Code Number:SRT-2104-005
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-08
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-010720-26
    A.3Full title of the trial
    A Phase II, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
    A.4.1Sponsor's protocol code numberSRT-2104-005
    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 SponsorSirtris Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 nameSRT-2104
    D.3.2Product code SRT-2104
    D.3.4Pharmaceutical form Capsule*
    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 codeSRT-2104
    D.3.9.3Other descriptive nameSRT-2104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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*
    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 2
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II 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
    The primary objectives of this study are:
    Safety: To determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0
    g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive
    days.
    Pharmacokinetics: To characterize the pharmacokinetic profile of SRT2104 (0.25,
    0.5, 1.0, and 2.0 g/day) after a single dose and multiple administrations in type 2
    diabetic subjects.
    E.2.2Secondary objectives of the trial
    Activity: To determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) on
    fasting blood glucose and insulin and post-prandial glucose and insulin in type 2
    diabetic subjects when administered once daily for 28 consecutive days.

    Exploratory biomarker/research endpoints will be analysed (e.g. FGF-21)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects of any race and gender within the age range of 30 to 70 years.
    2. All female subjects must be of non-child-bearing potential. For the purposes of this
    study, this is defined as the subject being amenorrheic for at least 12 consecutive
    months or at least 6 weeks post-surgical bilateral oophorectomy with or without
    hysterectomy or women who underwent tubal ligation. Menopausal status will be
    confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 – 138
    mIU/ml and oestradiol < 20 pg/ml at entry, unless this information is available in the
    subject’s medical record. In the event a subject's menopause status has been clearly
    established (for example, the subject indicates she has been amenorrheic for 10
    years), but FSH and/or oestradiol levels are not consistent with a post-menopausal
    condition, determination of subject eligibility will be at the discretion of the principal
    investigator following consultation with the sponsor and independent medical
    monitor.
    3. All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug.
    4. Willingness to provide written informed consent to participate in the study
    5. HbA1c ≥ 8.0 and ≤ 10.5
    6. Fasting glucose ≥ 160 and ≤ 240 mg/dL
    7. Body Mass Index (BMI) ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2
    8. On stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to
    Screening
    9. No prior history of HIV 1 or 2
    10. Absence of disease markers for hepatitis B & C virus
    11. Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the
    screening; normal end organ function
    12. Have a normal 12-lead ECG or one with abnormality considered to be clinically
    insignificant
    13. Have a normal chest X-ray (P. A. View) or one with abnormality considered to be
    clinically insignificant
    14. Comprehension of the nature and purpose of the study and compliance with the
    requirement of the entire protocol.
    E.4Principal exclusion criteria
    1. Any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
    2. Renal or liver impairment, defined as serum creatinine level of ≥ 1.4 mg/dL for
    females and ≥ 1.5 mg/dL for males, and greater than two times the upper limit of
    normal for liver enzymes, respectively.
    3. History of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
    4. History, within 3 years, of drug abuse (including Benzodiazepines, opioids,
    amphetamine, cocaine, and THC)
    5. History of alcoholism (more than two years), moderate drinkers (more than three
    drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink
    is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)]
    6. Participation in any clinical trial within the past three months
    7. History of difficulty in donating blood or accessibility of veins in left or right arm
    8. Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
    9. Use of any prescription drug therapy, with exception of any prescription medication
    administered at a stable dose for at least 6 weeks prior to Screening, provided the
    medication is not contraindicated by the metformin label
    10. Use of any alternate anti-diabetic therapy, except metformin, within one month of
    enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    1) Pharmacokinetics (assessed at Day 1 and Day 28)
    2) Safety (assessed throughout the study)
    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 Yes
    E.6.13.1Other scope of the trial description
    Effect of SRT2104 on fasting and post-prandial blood glucose and insulin levels
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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 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 188
    F.4.2.2In the whole clinical trial 225
    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 Decision2009-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
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