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    Summary
    EudraCT Number:2016-002580-34
    Sponsor's Protocol Code Number:THR-1442-C-448
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002580-34
    A.3Full title of the trial
    A double blind placebo controlled study to evaluate the effect of
    bexagliflozin tablets on hemoglobin A1c in patients with type 2
    diabetes mellitus and moderate renal impairment
    Estudio doble ciego, controlado con placebo para evaluar el efecto de los comprimidos de bexagliflozina sobre la hemoglobina A1c en pacientes con diabetes mellitus de tipo 2 e insuficiencia renal moderada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double blind placebo controlled study to evaluate the effect of
    bexagliflozin tablets on hemoglobin A1c in patients with type 2
    diabetes mellitus and moderate renal impairment
    Estudio doble ciego, controlado con placebo para evaluar el efecto de los comprimidos de bexagliflozina sobre la hemoglobina A1c en pacientes con diabetes mellitus de tipo 2 e insuficiencia renal moderada
    A.4.1Sponsor's protocol code numberTHR-1442-C-448
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02836873
    A.5.4Other Identifiers
    Name:EMANumber:UPI number 498543
    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 SponsorTheracos Sub, LLC
    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 supportTheracos Sub, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTranslational Medicine Group
    B.5.2Functional name of contact pointClinical Trial Project Management
    B.5.3 Address:
    B.5.3.1Street Address185 Cambridge Street
    B.5.3.2Town/ cityBoston, MA
    B.5.3.3Post codeMA 02114
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016176430699
    B.5.5Fax number0016176438203
    B.5.6E-mailinfo@theracos.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 nameBexagliflozina
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNBEXAGLIFLOZINA
    D.3.9.1CAS number 1118567-05-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 with renal imparement
    Diabetes Mellitus de Tipo 2 con insuficiencia renal moderada
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabetes
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10045250
    E.1.2Term Type II diabetes mellitus with renal manifestations
    E.1.2System Organ Class 100000004857
    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 determine the efficacy of bexagliflozin on lowering HbA1c in patients with type 2 diabetes mellitus and moderate renal impairment.
    El objetivo principal de este estudio es determinar la eficacia de bexagliflozina sobre la reducción de la HbA1c en pacientes con diabetes mellitus de tipo 2 e insuficiencia renal moderada.
    E.2.2Secondary objectives of the trial
    • To assess the effect of bexagliflozin on the change in body weight at week 24 in subjects
    with baseline BMI ≥ 25 kg/m2
    • To assess the effect of bexagliflozin on the change in systolic blood pressure (SBP) at week 24 in subjects with baseline SBP ≥ 130 mmHg
    • Change in HbA1c in subjects with eGFR 45 to 59 mL/min/1.73 m2 at week 24
    • Change in HbA1c in subjects with eGFR 30 to 44 mL/min/1.73 m2 at week 24
    • Evaluar el efecto de bexagliflozina sobre el cambio en el peso corporal a la semana 24 en sujetos con un IMC ≥25 kg/m2 al inicio del estudio.
    • Evaluar el efecto de bexagliflozina sobre el cambio en la presión arterial sistólica (PAS) a la semana 24 en sujetos con una PAS ≥130 mmHg al inicio del estudio.
    • Cambio, en la semana 24, en la HbA1c en sujetos con una TFGe entre 45 y 59 ml/min/1,73 m2.
    • Cambio, en la semana 24, en la HbA1c en sujetos con una TFGe entre 30 y 44 ml/min/1,73 m2.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Measurement of bexagliflozin plasma concentration over time (sparsely sampled) will also be conducted from approximately 144 study subjects as part of a bexagliflozin population pharmacokinetic (PK) study.
    También se llevará a cabo la medición de la concentración plasmática de bexagliflozina en el tiempo (escasamente muestreados) a partir de aproximadamente 144 sujetos de estudio como parte de un estudio farmacocinético (FC) de la población con bexagliflozina.
    E.3Principal inclusion criteria
    1. Men or non-pregnant women ≥ 20 years of age. Women of childbearing potential must agree to use contraception during the entire study to avoid any possible pregnancy.
    Females who are surgically sterile (hysterectomy, oophorectomy) or postmenopausal (absence of menses greater than 12 months and age > 45 years) are eligible if they test negative on the urine pregnancy test.
    2. Subjects with a diagnosis of T2DM with an HbA1c between 7.0 and 10.5% (inclusive) at the time of screening.
    3. Subjects who are treatment naïve or are treated with a stable regimen of anti-diabetic medications. At the time of screening, the doses and frequency of all anti-diabetic medications must have been stable for 8 weeks.
    4. Subjects who have an estimated glomerular filtration rate (eGFR) ≥ 30 and
    < 60 mL/min/1.73 m2 at 2 time points: screening (V1), and 1 additional time point between 1 and 12 monhs of screening (may be obtained from available medical records).
    The eGFR will be calculated by the MDRD equation.
    5. Subjects who have a body mass index (BMI) ≤ 45 kg/m2 (inclusive)
    6. Subjects who taking stable doses of medications for hypertension or hyperlipidemia for at least 30 days prior to randomization
    7. Subjects who have stable eGFR between the historic value and day of screening (no more than 20% change in eGFR).
    1. Varones o mujeres no embarazadas ≥20 años de edad. Las mujeres en edad fértil deben aceptar utilizar un método anticonceptivo durante todo el estudio para evitar cualquier posible embarazo. Las mujeres esterilizadas quirúrgicamente (histerectomía, ovariectomía) o posmenopáusicas (ausencia de menstruación durante más de 12 meses y edad >45 años) son elegibles si tienen un resultado negativo en la prueba de embarazo en orina.
    2. Sujetos con un diagnóstico de DMT2 y un nivel de HbA1c de entre 7,0 y 10,5 % (ambos inclusive) en el momento de la selección.
    3. Sujetos que no han sido tratados previamente o que reciben un tratamiento estable con medicación antidiabética. En el momento de la selección, las dosis y la frecuencia de todos los medicamentos antidiabéticos deben haber permanecido estables durante 8 semanas.
    4. Sujetos que tienen una tasa de filtración glomerular estimada (TFGe) ≥30 y
    <60 ml/min/1,73 m2 en dos puntos temporales: visita de selección (V1) y en un punto temporal adicional entre 1 y 12 meses de la visita de selección (puede obtenerse de la historia clínica disponible). La TFGe se calculará mediante “modification of diet in renal disease study equation (MDRD).
    5. Sujetos que tengan un índice de masa corporal (IMC) ≤45 kg/m2 (inclusive).
    6. Sujetos que toman dosis estables de medicamentos para la hipertensión o la hiperlipidemia durante al menos 30 días antes de la aleatorización.
    7. Sujetos que tienen una TFGe estable entre el valor histórico y el día de la visita de selección (con un cambio no superior al 20 % en la TFGe).
    E.4Principal exclusion criteria
    1. Diagnosis of type 1 diabetes mellitus or maturity–onset diabetes of the young (MODY)
    2. Hemoglobinopathy that affects HbA1c measurement
    3. Frequent symptomatic hypoglycemia (greater than one episode per week on average)
    4. Genitourinary tract infection within 6 weeks of screening or history of ≥ 3 genitourinary infections requiring treatment within the last 6 months
    5. Cancer, active or in remission for < 3 years (Non-melanoma skin cancer or basal cell carcinoma or carcinoma in situ of the cervix will not be grounds for exclusion)
    6. History of alcohol or illicit drug abuse in the past 2 years
    7. Evidence of abnormal liver function tests (total bilirubin or alkaline phosphatase > 1.5 x upper limit of normal (ULN) with the exception of isolated Gilbert's syndrome); or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x ULN
    8. History of MI, stroke or hospitalization for heart failure, or hospitalization for unstable angina in the prior 3 months
    9. Evidence of NYHA class IV heart failure at screening or randomization
    10. Currently or within 3 months of taking an SGLT2 inhibitor from screening (Appendix 5)
    11. Any condition, disease, disorder, or clinically relevant laboratory abnormality that, in the opinion of the PI, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment
    12. Women who are pregnant or breastfeeding
    13. Patients who are receiving renal replacement therapy (peritoneal or hemodialysis) or who have undergone renal transplantation
    14. Corrected serum calcium < 8 mg/dL (Appendix 4) at screening (V1) or randomization (V3)
    15. Uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressure> 110)
    16. Currently participating in another interventional trial or receiving treatment with an investigational drug within 30 days or 7 half-lives of screening, whichever is longer
    17. Previous treatment with bexagliflozin or EGT0001474
    18. Missing 1 or more doses of the study drug during the run-in period
    19. Fasting blood glucose value during the run-in period ≥ 250 mg/dL (13.9 mmol/L) associated with severe clinical signs or symptoms of hyperglycemia
    20. Any episode of symptomatic hypoglycemia during the run-in period in which symptoms are severe
    21. Subjects who are unable to read and write in their native language
    22. Subjects who are unable to comprehend and willing to provide written informed consent in accordance with institutional and regulatory guidelines
    1. Diagnóstico de diabetes mellitus tipo 1 o diabetes de inicio en la madurez de los jóvenes (MODY)
    2. Hemoglobinopatía que afecta a la medición de la HbA1c
    3. Hipoglucemia sintomática frecuente (más de un episodio por semana en promedio)
    4. Infección del tracto genitourinario en las 6 semanas desde la selección o antecedentes de ≥ 3 infecciones genitourinarias que requieran tratamiento dentro de los últimos 6 meses
    5. Cáncer, activo o en remisión, por < 3 años (el cáncer de piel no melanoma o el carcinoma de células basales o el carcinoma in situ del cuello del útero no serán motivo de exclusión)
    6. Antecedentes de abuso de alcohol o de drogas ilícitas en los últimos 2 años
    7. Evidencia de pruebas anormales de función hepática (bilirrubina o fosfatasa alcalina total> 1,5 veces el límite superior de la normalidad (LSN), con la excepción del síndrome de Gilbert aislado); o la alanina aminotransferasa (ALT) o la aspartato aminotransferasa (AST)> 2,5 x LSN
    8. Antecedentes de IM, infarto cerebral u hospitalización por insuficiencia cardíaca, u hospitalización por angina inestable en los 3 meses anteriores
    9. Evidencia de insuficiencia cardiaca clase IV de la NYHA en la selección o la aleatorización
    10. Que esté tomando en la actualidad o en los 3 meses desde la selección, un inhibidor de SGLT2 (Apéndice 5)
    11. Cualquier condición, enfermedad, trastorno o anormalidad de laboratorio clínicamente relevante que, en opinión del investigador principal, pondría poner en peligro la adecuada participación del sujeto en este estudio u ocultar los efectos del tratamiento
    12. Mujeres que están embarazadas o en periodo en lactancia
    13. Pacientes que están recibiendo terapia de reemplazo renal (peritoneal o hemodiálisis) o que han sido sometidos a trasplante renal
    14. Calcio sérico corregido <8 mg/dL (Apéndice 4) en la selección (V1) o en la aleatorización (V3)
    15. Hipertensión no controlada (presión arterial sistólica >170 o presión arterial diastólica > 110)
    16. Que esté participando actualmente en otro ensayo intervencionista o recibiendo tratamiento con un fármaco en investigación dentro de los 30 días o dentro de 7 vidas medias del fármaco desde la selección, lo que sea mayor
    17. Tratamiento previo con bexagliflozina o EGT0001474
    18. Que haya dejado de tomar 1 o más dosis de la medicación del estudio durante el período de pre-inclusión
    19. Valor de glucosa en sangre en ayunas durante el periodo de pre-inclusión ≥ 250 mg/dL (13,9 mmol/L) asociado con signos clínicos graves o síntomas de la hiperglucemia
    20. Cualquier episodio de hipoglucemia sintomática durante el período de pre-inclusión en el que los síntomas sean graves
    21. Sujetos que no sea capaces de leer y escribir en su lengua materna
    22. Sujetos que no sean capaces de comprender y estén dispuestos a otorgar el consentimiento informado por escrito de conformidad con las directrices institucionales y regulatorias
    E.5 End points
    E.5.1Primary end point(s)
    Change of HbA1c from baseline to week 24
    Cambio en la HbA1c desde el inicio del estudio a la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Change of HbA1c from baseline over 24 weeks of treatment
    Cambio en la HbA1c desde el inicio a lo largo de 24 semanas de tratamiento
    E.5.2Secondary end point(s)
    • Change in body weight in subjects with baseline body mass index (BMI) ≥25 kg/m
    • Changes in systolic blood pressure (SBP) over time in subjects with baseline SBP ≥130 mmHg
    • Change in HbA1c over time in subjects with eGFR 45 to 59 mL/min/1.73 m2
    • Change in HbA1c over time in subjects with eGFR 30 to 44 mL/min/1.73 m2
    • Cambio en el peso corporal en sujetos con un índice de masa corporal (IMC) ≥25 kg/m al inicio del estudio.
    • Cambios en la presión arterial sistólica (PAS) a lo largo del tiempo en sujetos con una PAS ≥130 mmHg al inicio del estudio.
    • Cambio en la HbA1c a lo largo del tiempo en sujetos con una TFGe entre 45 y 59 ml/min/1,73 m2.
    • Cambio en la HbA1c a lo largo del tiempo en sujetos con una TFGe entre 30 y 44 ml/min/1,73 m2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    To assess the treatment effect on the change of body weight in subjects with baseline BMI ≥25 kg/m2 at week 24, an analysis of covariance model (ANCOVA) will be implemented using all available data at week 24.
    The change in systolic blood pressure (SBP) in subjects with baseline SBP ≥ 130 mmHg in the bexagliflozin group compared with placebo at week 24 will be analyzed using the similar
    method with baseline SBP measure as a covariate. The same analysis method applies for the testing of changes in HbA1c at week 24 for subjects with baseline eGFR 45- 59 mL/min/1.73m2, and for subjects with baseline eGFR 30-44 mL/min/1.73m2
    Para evaluar el efecto del tratamiento sobre el cambio de peso corporal en sujetos con IMC al inicio del estudio ≥25 kg/m2 en la semana 24, se llevará a cabo un análisis del modelo de covarianza (ANCOVA) utilizando todos los datos disponibles en la semana 24.
    Se analizará el cambio en la presión arterial sistólica (PAS) en sujetos con PAS al inicio del estudio ≥ 130 mmHg en el grupo bexagliflozina en comparación con placebo en la semana 24 utilizando el método similar con la medida PAS al inicio de estudio como covariable. El mismo método de análisis se aplica para la comprobación de los cambios en la HbA1c en la semana 24 para los sujetos con FGe al inicio del estudio de 45- 59 mL/min/1.73m2, y para los sujetos con FGe al inicio del estudio de 30-44 mL/min/1.73m2
    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 Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    Croatia
    France
    Japan
    Spain
    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
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 300
    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)
    None, only safety FUP when the Patient is still in the Trial but has ended Treatment Phase.
    Ninguno, solo Seguimiento de seguridad mientras el Paciente permanece en el Ensayo pero ha finalizado la Fase de Tratamiento.
    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 Decision2016-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-11
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