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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   40995   clinical trials with a EudraCT protocol, of which   6701   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2009-016537-98
    Sponsor's Protocol Code Number:SRT-2104-011
    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:2009-11-04
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2009-016537-98
    A.3Full title of the trial
    A Phase IIa, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Assess the Safety, Tolerability and Activity of Oral SRT2104 Capsules Administered for 28 days to Subjects with Type 2 Diabetes Mellitus.
    A.4.1Sponsor's protocol code numberSRT-2104-011
    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.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 nameSRT2104
    D.3.2Product code SRT2104
    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.3.9.2Current sponsor codeSRT2104
    D.3.9.3Other descriptive nameAPI2104, API-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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 II Diabetes Mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    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
    1. To study the effects of SRT2104 vs. placebo on insulin sensitivity including hepatic and muscular insulin sensitivity.
    2. To determine the safety and tolerability of 28 days of dosing with 2.0 g SRT2104 in subjects with type 2 diabetes mellitus in a fed state.
    E.2.2Secondary objectives of the trial
    1. To determine the pharmacokinetics of 28 days of dosing with 2.0 g SRT2104 in subjects with type 2 diabetes mellitus in a fed state.
    2. To study the effects of SRT2104 vs. placebo on energy expenditure.
    3. To study the effects of SRT2104 vs. placebo on muscle histology and biomarkers of oxidative capacity.
    1. To study the effects of SRT2104 vs. placebo on biomarkers of glucose control and inflammation.
    2. To study the effects of SRT2104 vs. placebo on biological markers of bone turnover.
    3. To study the effects of SRT2104 vs. placebo on biomarkers of oxidative stress.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to provide written informed consent to participate in the study.
    2. Ambulatory male and female subjects (of any race) with T2D within the age range of 18–65 years (inclusive) at the time of screening.
    3. All female subjects must be of non-childbearing potential. For the purposes of this study, non-childbearing is defined as:
    • Amenorrheic for at least 12 consecutive months; menopausal status in amenorrheic females will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) >40–138 mIU/mL and estradiol < 30 pg/mL at entry. 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 estradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator with agreement of the independent medical monitor,
    • At least 6 weeks post-surgical bilateral oophorectomy (with or without hysterectomy) or post tubal ligation.
    4. The subject must be on stable metformin monotherapy for a minimum of 3 months prior to the Screening visit.
    5. HbA1c of < 8.5%.
    6. Body Mass Index (BMI) of 22–38 kg/m2 (inclusive).
    7. Resting supine blood pressure (BP) < 160/90 mmHg.
    8. Have a normal 12-lead electrocardiogram (ECG) or one with changes considered to be clinically insignificant on medical review and QTc intervals as defined below:
    • QTcB must be <450 msec for males and <470 msec for females (based on single or average QTc value of triplicate ECGs obtained over a brief period),
    • QTcB must be < 480 msec in subjects with Bundle Branch Block.
    9. Comprehension of the nature and purpose of the study and able to comply with the protocol requirements.
    10. Able to communicate in person and by telephone in a manner that allows all protocol procedures to be carried out safely and reliably in the opinion of the investigative site staff.
    E.4Principal exclusion criteria
    1. Any major illness in the 3 months prior to study entry or any significant ongoing chronic medical illness not related to diabetes (e.g., recent myocardial infarction, unstable angina, stroke, or transient ischemic attack) which in the opinion of the principal investigator or medical monitor could risk subject safety or interpretation of the results.
    2. Renal or liver impairment, defined as:
    • Serum creatinine level of ≥ 1.4 mg/dL for females and ≥ 1.5 mg/dL for males
    • Glomerular filtration rate < 80 mL.min/1.73 m2 (estimated according to Cockgroft-Gault),
    • AST and ALT ≥ 2xULN,
    • alkaline phosphatase and bilirubin > 1.5xULN (an isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
    3. Grade R2, M1 or higher diabetic retinopathy (according to the classification of the National Screening Committee) based on an ophthalmological examination or fundus photography performed within 3 months of the Screening Visit.
    4. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Screening.
    5. A positive test for HIV antibody.
    6. History of or current gastrointestinal diseases influencing drug absorption as judged by the investigator.
    7. History of known cardiovascular disorder including coronary artery disease or peripheral arterial disease.
    8. History of diabetic neuropathy, gastroparesis or diabetic foot.
    9. Significant history of alcoholism or drug/chemical abuse, or a positive result of the urine drug/alcohol screen at the Screening Visit, or consuming more than 28 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).
    10. Participation in any clinical trial within 3 months prior to the first dose of investigational product in the current study.
    11. History of difficulty in donating blood or accessibility of veins in left or right arm.
    12. Donation or loss of blood (more than 500 mL) within 3 months prior to receiving the first dose of investigational product.
    13. Use of any prescription drug therapy, with the 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 (see Appendix A for Glucophage® Summary of Product Characteristics). Subjects who are on chronic therapy with proton pump inhibitors must be able and willing to discontinue this therapy during the dosing interval of the study.
    14. Use of any anti-diabetic therapy other than metformin, within 3 months of the first dose of investigational product.
    15. Use of any dietary or herbal supplements within 3 weeks prior to the first dose of investigational product.
    16. History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
    17. Active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal cell carcinoma of the skin or carcinoma in situ).
    18. Increased risk of thrombosis, e.g., subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability:
    Incidence of AEs and clinically significant abnormal laboratory values will be recorded based upon investigator observation and subject reporting. Safety will be monitored by reports of AEs (at all visits and telephone contacts after the first dose has been administered through 30 days after the last dose), vital sign measurements (resting pulse rate, respiration rate, temperature, and blood pressure readings), physical examinations, laboratory parameters and electrocardiograms (ECG). Concomitant medications and AEs will be recorded at every visit. Additional visits will be permitted for safety follow-up as required.

    -HEGC procedures including indirect calorimetry (Days 0, 29, 43) to study the effects of SRT2104 vs. placebo on insulin sensitivity and energy expenditure.
    -OGTT will be used to assess the effects of SRT2104 on insulin sensitivity (Days -1, 28, 42). During the OGTT, blood samples will be obtained prior to the administration of 75g of oral glucose, at the time of oral glucose administration, and at 30, 60, 90, and 120 minutes following glucose administration.

    PK samples (Days 1, 28 at pre-dose and at 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, and 24 hours post-dose on Days 2, 29).

    -Serum/plasma sample(s) (Days 0, 29, 43) and will be used to measure biomarkers of glucose control and inflammation (including but not limited to HbA1c, 1,5-anhydroglucitol, glycated albumin, adiponectin, hsCRP, FGF21, IL-6, IL-1β, IL-1R antagonist, IL-8, TNF-α and TNF-β), biological markers of bone turnover (including but not limited to PINP and bAP, PTH, and 25-hydroxy vitamin D); and oxidative stress (including but not limited to malondialdehyde, 3’-nitrotyrosine, isoprostane, and 8-hydroxy-[desoxy] guanosine) (Days 0, 29, 43).
    - 24-hour urine samples (Days -1, 28, 42) to measure biological markers of bone turnover (urinary C-and N-telopeptide) and biomarkers of oxidative stress (3’-nitrotyrosine).
    - Muscle biopsies (Days -1, 28) used to analyze muscle histology and/or biomarkers of oxidative capacity and/or gene expression profiles.
    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 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
    measurement of biomarkers
    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. 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 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 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
    Last time data is collected from a subject ; Day 58 telephone call.
    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 months8
    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 state80
    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)
    Resume expected normal treatment.
    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 Decision2010-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-22
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