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    Summary
    EudraCT Number:2013-002507-34
    Sponsor's Protocol Code Number:GSN000200
    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:2013-12-19
    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 number2013-002507-34
    A.3Full title of the trial
    A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients with Type 2 Diabetes and Albuminuria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in which patients with type 2 diabetes and who have been told they have a certain type of protein, albumin, in their urine, are given orally GKT137831 or placebo, no active, to determine whether GKT137831 has any effect in these patients and it is safe
    A.4.1Sponsor's protocol code numberGSN000200
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenkyotex Innovation SAS
    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 supportGenkyotex Innovation SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenkyotex Innovation SAS
    B.5.2Functional name of contact pointPhilippe Wiesel
    B.5.3 Address:
    B.5.3.1Street Address218 avenue Marie Curie
    B.5.3.2Town/ city74166 Saint-Julien-en-Genevois Cedex
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0) 4 56 44 81 12
    B.5.6E-mailphilippe.wiesel@genkyotex.com
    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 nameGKT137831
    D.3.2Product code GKT137831
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 applicable
    D.3.9.1CAS number 1218942-37-0
    D.3.9.2Current sponsor codeGKT137831
    D.3.9.3Other descriptive name2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H- pyrazolo[4,3 c]pyridine-3,6(2H,5H)-dione
    D.3.9.4EV Substance CodeSUB57852
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Patients with type 2 diabetes and albuminuria.
    E.1.1.1Medical condition in easily understood language
    Patients who have been told they have Type 2 diabetes that is they cannot metabolise sugar in the normal manner or the presence of a type of protein, albumin in their urine
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10061835
    E.1.2Term Diabetic nephropathy
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10001580
    E.1.2Term Albuminuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of oral GKT137831 in comparison with placebo, in patients with type 2 diabetes and albuminuria.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of oral GKT137831 in comparison with placebo, in patients with type 2 diabetes and albuminuria.

    To characterize the Pharmacodynamics of GKT137831 in this patient population, along with GKT137831 plasma concentrations, and any Pharmacokinetic/Pharmacodynamic relationship.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged 18 to 80 years, inclusive.
    2. Willing and able to give written informed consent and to comply with the requirements of the study.
    3. History of type 2 diabetes, defined as fasting plasma glucose > or equal to 7.0 mmol/L (126 mg/dL) or a glycated
    hemoglobin (HbA1c) >6.5% (48 mmol/mol) on at least 2 occasions prior to screening. If the diagnosis of type 2 diabetes has been made before 30 years of age, an optional fasting C-peptide level will be obtained during the second screening visit (Visit 2) and must be > or equal to 0.1 ng/mL to confirm type 2 diabetes.
    4. Albuminuria defined as a urinary albumin to creatinine ratio (UACR) of:
    - (a) 300 to 3500 mg/g (33.9 to 395.5 mg/mmol) during the screening period to be eligible to enter the run-in period, determined as described in the Methodology section.
    - (b) 200 to 3500 mg/g ( 22.6 to 395.5 mg/mmol) by Week-2 (Visit 4) of the run-in period to be eligible to enter the double-blind treatment period, determined as described in the Methodology section.
    5. An eGFR > or equal to 30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.
    6. Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening visit (Visit 1) and during the screening period. The dose must have been stable for at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy associating an ACEI and an ARB is not permitted.
    7. Willing to practice highly effective methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during the screening period and the run-in period, while taking investigational product and for at least 90 days since the last dose of investigational product is ingested. Women of childbearing potential are female patients who are not surgically sterile (no history of bilateral tubal ligation, hysterectomy, or bilateral salpingo-oophorectomy), and are not postmenopausal for at least 1 year. Furthermore, male study patients must also not donate sperm from Day 1/Baseline (Visit 5) until 90 days after the last dose of investigational product. In the German territory, women of childbearing potential are not eligible to enter the study.
    E.4Principal exclusion criteria
    1. A positive pregnancy test or breast-feeding for female patients.
    2. History of type 1 diabetes.
    3. Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable.
    4. Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (Visit 1) or planned during the study.
    5. History of renal transplant or planned renal transplant during the study.
    6. A history of acute renal dialysis or acute kidney injury (defined according to the Kidney Disease: Improving Global Outcomes [KDIGO] definition) within 12 weeks of the first screening visit (Visit 1)
    7. A body mass index (BMI) <18.5 kg/m2.
    8. Elevated liver enzymes (alkaline phosphatase or alanine aminotransferase [ALT]) >3 x the upper limit of normal (ULN), or bilirubin >1.5 x the ULN) during the screening period (to enter the run-in period) and during the run-in period (to enter the double-blind treatment period).
    9. HA1c level >11% (97 mmol/mol).
    10. Inadequately controlled arterial blood pressure, defined as:
    a) SBP >180 mmHg and <110 mmHg at the screening visits to be eligible to enter the run-in period, determined as described in Section 9.1.1.
    b) SBP >160 mmHg and <110 mmHg at Visit 5 to enter the double-blind treatment period, determined as described in Section 9.1.1.
    11. History of hypothyroidism requiring hormone replacement therapy unless the dose of thyroid hormone(s) has been stable at least 4 weeks prior to the Visit 1 and the TSH value is not greater then upper limit of the normal range at Visit 1.
    12. History of active cardiovascular disease defined as the occurrence of the following events or conditions within the 12 weeks preceding the first screening visit (Visit 1): acute myocardial infarction; unstable angina pectoris; stroke, including a transient ischemic attack; a coronary revascularization procedure; congestive heart failure New York Health Association (NYHA) Class III or IV.
    13. A personal or family history of long QT syndrome.
    14. Evidence of any of the following cardiac conduction abnormalities during the screening period (to enter the run-in period) and during the run-in period (to enter the double-blind treatment period):
    - A QTc Fredericia interval >450 milliseconds for males and >470 milliseconds for females.
    - A second or third degree atrioventricular block not successfully treated with a pacemaker.
    15. History of cancer in the preceding 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, in situ prostate cancer, in situ breast ductal carcinoma, or superficial bladder cancer (stage 0).
    16. Current history of drug or alcohol abuse, as assessed by the Investigator.
    17. The occurrence of any acute infection requiring systemic antibiotic therapy within the 2 weeks prior to the first day of the run-in period, Week -4 (Visit 3), or infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
    18. A history of bone marrow disorder including aplastic anemia, or marked anemia defined as hemoglobin <10.0 g/dL (or 6.2 mmol/L) during screening.
    19. Administration of any investigational product within 30 days or within 5 half-lives of the investigational agent (whichever is longer) of the first day of the run-in period, Week -4 (Visit 3).
    20. Any condition which, in the opinion of the Investigator, constitute a risk or contraindication for the participation of the patient in the study, or that could interfere with the study objectives, conduct, or evaluation.
    21. Use of the following medications within 4 weeks of the first screening visit: direct renin inhibitors, mineralocorticoid receptor antagonists, EPO, endothelin receptor antagonists and or a history of systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to the first screening visit or anticipated need for immunosuppression during the study.
    22. Major protocol deviation during the run-in period, subject to an evaluation by the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable for the evaluation of therapeutic efficacy will be albuminuria. Albuminuria will be characterized as the geometric mean of 2 consecutive early morning urine albumin/creatinine ratios (UACRs) collected twice during the baseline period (Visits 4 and 5), and then during the double-blind treatment period (Visits 6, 7, 8, 9, 10, 11, and 12). The primary efficacy endpoint will be defined as the change from baseline to the log-transformed geometric mean of the UACR measurements during Visits 9, 10, and 11. Baseline UACR will be defined as the geometric mean of UACR measurements at Visit 4 and Visit 5.
    If there is at least 1 UACR value available at Visits 9, 10 or 11 the primary endpoint will be computed using all the available values. If all UACR measurements are missing at Visits 9, 10 and 11 the last non-missing value from Visit 8 will be used.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint will be defined as the change from baseline to the log-transformed geometric mean of the urine albumin/creatinine ratios (UACR) measurements during Visits 9, 10, and 11 (study weeks 8, 10 and 12).
    E.5.2Secondary end point(s)
    Efficacy end points:
    24-hour albumin excretion will be determined at Baseline (Visit 5) and end of treatment (Visit 11).
    eGFR will be analyzed on an exploratory basis to verify that changes in UACR are not due to changes in eGFR.
    Glucose metabolism:
    - In patients not receiving insulin or secretagogues, homeostasis model assessment-estimated insulin resistance (HOMA-IR) and HOMA-estimated B-cell function (HOMA-B) determined at Day 1/Baseline (Visit 5) and Weeks 6 and 12 (Visits 8 and 11).
    - Glycemic control, as determined from HbA1c at second screening visit (Visit 2), Day 1/Baseline (Visit 5) and at Weeks 6 and 12 (Visits 8 and 11).
    - Diabetic peripheral neuropathy assessed using a 100 mm visual analogue scale (VAS) at Day 1/Baseline (Visit 5) and Week 12 (Visit 11).
    - Erectile dysfunction assessed using the International Index of Erectile Function (IIEF) questionnaire at Day 1/Baseline (Visit 5) and Week 12 (Visit 11).

    Safety End points:
    Adverse events (AEs). Monitoring for AEs at all visits.
    Laboratory tests:
    - Clinical safety tests at the second screening visit (Visit 2), Weeks -2 to 16 (Visits 4 to 12):
    - Hematology: hematocrit, hemoglobin, reticulocyte count, red blood cell (RBC) count, white blood cell (WBC) count, differential WBC count, and platelet count.
    - A plasma sample for the determination of erythropoietin will be taken from all patients at Day 1/Baseline (Visit 5), Week 6 (Visit 8) and Week 12 (Visit 11). In case a retest is necessary due to a reduction in reticulocyte count the retest sample will be used to measure the standard hematology parameters and eythropoietin.
    - Biochemistry: fasting glucose, creatinine, urea, sodium, potassium, chloride, aspartate aminotransferase (AST), ALT, total bilirubin, alkaline phosphatase, and gamma-glutamyl transferase (GGT), and total bile acids.
    - Urinalysis: quantitative test for pH and protein; qualitative tests for glucose, ketones, bilirubin, blood; microscopic examination of the sediment. Additional dipstick test at the first screening visit (Visit 1).
    - Viral serology performed at Visit 2: HIV antibodies (1 and 2), hepatitis B surface antigen and hepatitis C virus antibodies.
    - Tests for thyroid stimulating hormone (TSH) performed at Day 1/Baseline (Visit 5) and Weeks 6, 12 and 16 (Visits 8, 11 and 12): free thyroxine (FT4) and thyroglobulin will be tested if TSH is abnormal.
    - Blood lipid tests performed at Day 1/Baseline (Visit 5) and Weeks 6 and 12 (Visits 8 and 11): total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides.
    Vital signs: oral temperature, at the first screening visit (Visit 1) and Week 16 follow-up (Visit 12); pulse rate, SBP and DBP at all visits.
    - 12-lead electrocardiogram (ECG) at the second screening visit (Visit 2), Day 1/Baseline (Visit 5) and Weeks 2, 4, 6, 8, 10, 12 and 16 (Visits 6, 7, 8, 9, 10, 11, and 12, respectively).
    - Complete physical examination at the first screening visit (Visit 1) and Week 16 follow-up (Visit 12); symptom-directed physical examination (associated with occurrence of AEs) at all other visits.

    Pharmacodynamics:
    The PD markers will be assessed in serum and/or plasma, or urine (samples taken at Day 1/Baseline, Weeks 6, 12 and Follow-up [Visits 5, 8, 11 and 12]) include:
    - Metabolic and inflammatory biomarkers: adiponectin, high sensitivity C-reactive protein (hs-CRP), leptin, monocyte chemotactic protein-1 (MCP-1), serum plasminogen activator inhibitor-1 (PAI-1), resistin, soluble tumor necrosis factor type 1 receptor (sTNFR1), and vascular cell adhesion molecule-1 (VCAM-1).
    - Renal oxidative stress: urinary MCP-1,transforming growth factor- beta1 (TGF-beta1) and aldosterone.
    - Optionally, additional biomarkers of interest will be measured. The identity of these exploratory markers will be defined in response to findings described in the literature or obtained in this study. These markers will not have diagnostic or prognostic value and will not have an established normal range according to the World Health Organization (WHO).

    Pharmacokinetics:
    Venous blood samples will be collected at Weeks 2, 6, 8 and 12 (Visits 6, 8, 9 and 11) in order to determine plasma drug
    concentrations and investigation of any PK/PD relationship with PD and/or efficacy endpoints, and optionally for the relationships between PK parameters and pharmacogenomics data.

    Pharmacogenetics:
    Genetic and pharmacogenetic research may be conducted on the DNA samples collected at Day 1/Baseline (Visit 5) from patients who sign an optional, additional informed consent.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy end points:
    24-hour albumin excretion - Day 1/ Baseline, end of treatment
    eGFR - Day 1/Baseline, Week 2, 4, 6, 8, 10, 12.
    Glucose metabolism and Glycemic control - Day 1/Baseline, Weeks 6 and 12.
    Diabetic peripheral neuropathy and Erectile dysfunction - Day 1/Baseline, and Week 12.

    Safety End points:
    Adverse events (AEs)- assessed at all visits.
    Clinical safety tests at the second screening visit (Visit 2), and Weeks -2 to 16.

    Pharmacodynamic markers - samples taken at Day 1/Baseline, Weeks 6, 12 and Follow-up.
    Pharmacokinetic markers - samples taken at Weeks 2, 6, 8 and 12.
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.2.1Number of subjects for this age range: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 200
    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)
    After study participation the patients will be treated with the current standard therapy on the discretion of their treating doctor
    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 Decision2014-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-30
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