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    Summary
    EudraCT Number:2016-001328-77
    Sponsor's Protocol Code Number:DRI13940
    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:2016-11-07
    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 number2016-001328-77
    A.3Full title of the trial
    A 26-Week Randomized, Double-blind, Placebo-controlled, Dose-ranging Phase 2 Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitus
    Estudio en Fase II, Aleatorizado, de Doble Ciego, Controlado con Placebo, de Escalada de Dosis, de 26 Semanas de Duración, para Evaluar la Seguridad y la Eficacia de SAR425899 en Pacientes con Diabetes Mellitus Tipo 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Safety and Efficacy of SAR425899 in Patients with Type 2 Diabetes Mellitus
    Estudio para Evaluar la Seguridad y la Eficacia de SAR425899 en Pacientes con Diabetes Mellitus Tipo 2
    A.4.1Sponsor's protocol code numberDRI13940
    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 Sponsorsanofi-aventis recherche & développement
    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 supportsanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationsanofi-aventis, s.a
    B.5.2Functional name of contact pointUnidad de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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.3.2Product code SAR425899
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.2Current sponsor codeSAR425899
    D.3.9.4EV Substance CodeSUB130900
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name VICTOZA
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLiraglutide
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIRAGLUTIDE
    D.3.9.1CAS number 204656-20-2
    D.3.9.4EV Substance CodeSUB25238
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nutritional and metabolic diseases
    Enfermedades nutricionales y metabólicas
    E.1.1.1Medical condition in easily understood language
    Type 2 diabetes mellitus
    Diabetes Mellitus tipo 2
    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 19.0
    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.1.3Condition 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 assess the dose-response relationship of SAR425899 versus placebo in terms of glycemic control as measured by the change in glycosylated hemoglobin (HbA1c).
    El objetivo principal de este estudio es evaluar la relación dosis-respuesta de SAR425899 frente a placebo en términos de control glucémico medido por el cambio en la hemoglobina glucosilada (HbA1c) desde el momento basal hasta la Semana 26
    E.2.2Secondary objectives of the trial
    -To assess the effect of SAR425899 on body weight.
    -To assess the safety and immunogenicity profile of SAR425899, including assessment of the heart rate (HR) change by electrocardiogram (ECG) and Holter
    monitor.
    -To assess the proportion of patients achieving predefined HbA1c targets of <7% and <6.5% as well as the proportion of patients achieving ≥5% and ≥10% body weight loss.
    -To assess the effect of once daily dosing of SAR425899 on additional parameters of glycemic control and lipid metabolism.
    -To assess the effect of once daily dosing of SAR425899 on additional pharmacodynamic (PD) biomarkers.
    -To assess the pharmacokinetic (PK) profile and parameters of SAR425899, interindividual and inter-occasion variability in PK parameters using a population PK
    approach.
    1. Evaluar el efecto de SAR425899 sobre el peso corporal
    2. Evaluar el perfil de seguridad e inmunogenicidad de SAR425899 al administrarlo como inyecciones subcutáneas (s. c.) diarias durante 26 semanas, incluida la evaluación del cambio en la frecuencia cardíaca (FC) mediante el uso de un electrocardiograma (ECG) y un monitor Holter.
    3. Evaluar la proporción de pacientes que logran los objetivos predefinidos de HbA1c <7 % y <6,5 %, así como la proporción de pacientes que logran una pérdida de peso corporal ≥5 % y ≥10 %
    4. Evaluar el efecto de la administración una vez al día de SAR425899 sobre parámetros adicionales de control glucémico y el metabolismo lipídico.
    5. Evaluar el efecto de la administración una vez al día de SAR425899 sobre biomarcadores farmacodinámicos (FD) adicionales.
    6. Evaluar el perfil farmacocinético (FC) y los parámetros de SAR425899, la variabilidad inter-individual e inter-ocasión en los parámetros FC, utilizando un enfoque FC poblacional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with type-2 diabetes mellitus (T2DM) for at least 3 months before the screening visit.
    -On diet/exercise and/or treatment with metformin (stable dose of ≥1500 mg/day or maximal tolerated dose) for at least 3 months prior to screening.
    -Signed informed consent.
    • Pacientes con diabetes mellitus tipo 2 (DMT2) durante al menos 3 meses antes de la visita de selección.
    • Con dieta/ejercicio o tratamiento con metformina (dosis estable de ≥1500 mg/día o dosis máxima tolerada) durante al menos 3 meses antes de la selección.
    • Consentimiento informado firmado.
    E.4Principal exclusion criteria
    -At screening, patient’s age < legal age of adulthood and >80 years.
    -Glycated hemoglobin at screening visit <7.0% or >10.0%.
    -Body mass index (BMI) <25 kg/m^2 or >45.0 kg/m^2.
    -Pregnant or lactating women.
    -Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
    -Diagnosis of type 1 diabetes mellitus.
    -Fasting plasma glucose of >15 mmol/L (270 mg/dL) measured by the central laboratory at screening (Visit 1), and confirmed (>15 mmol/L [270 mg/dL]) by a repeat test before randomization.
    -Treatment with glucose-lowering agents(s) other than metformin, currently or within the 3 months prior to screening.
    -Previous insulin use, except for episode(s) of short-term treatment (≤15 consecutive days) for intercurrent illness or pregnancy, or use of insulin within the last 6 months.
    -Contraindication(s) to metformin use.
    -Contraindication(s) to liraglutide use.
    -Significant change in body weight in the 3 months before screening.
    -Poorly controlled hypertension (a resting systolic blood pressure [SBP] >160 mm Hg and/or diastolic blood pressure [DBP] >95 mm Hg at screening).
    -History of long QT syndrome and/or QTc more than 450 ms at screening visit.
    -History of pancreatitis or pancreatectomy.
    -History of weight loss surgery.
    -Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
    -Any prior exposure to drugs belonging to the class of glucagon-like peptide-1 (GLP-1) receptor agonists/GLP-1 analogs.
    -Contraindications or known hypersensitivity reaction to glucagon.
    • En la selección, no haber alcanzado la mayoría de edad o tener una edad superior a 80 años.
    • HbA1c en la visita de selección <7,0 % o >10,0 %.
    • IMC <25 kg/m2 o >45,0 kg/m2.
    • Mujeres embarazadas o en periodo de lactancia.
    • Mujeres con posibilidad de quedarse embarazadas que no estén protegidas por métodos anticonceptivos de gran eficacia o que no acepten o no se les puedan realizar pruebas de embarazo (véanse las directrices sobre anticoncepción en el Apéndice A).
    • Diagnóstico de diabetes mellitus tipo 1.
    • GPA >15 mmol/l (270 mg/dl) medida por el laboratorio central en la selección (Visita 1) y confirmada (>15 mmol/l [(270 mg/dl]) por la repetición de la prueba antes de la aleatorización.
    • Tratamiento con hipoglucemiante(s) que no sea metformina, actualmente o en los 3 meses anteriores a la selección.
    • Uso previo de insulina, excepto para episodio(s) de tratamiento a corto plazo (≤15 días consecutivos) debido a enfermedad intercurrente o embarazo, o uso de insulina en los últimos 6 meses.
    • Contraindicación(es) al uso de metformina.
    • Contraindicación(es) al uso de liraglutida.
    • Cambio significativo en el peso corporal en los 3 meses anteriores a la selección.
    • Hipertensión mal controlada (en reposo, presión arterial sistólica [PAS] >160 mmHg o presión arterial diastólica [PAD] >95 mmHg en la selección).
    • Antecedentes de síndrome de QT largo o QTc de más de 450 ms en la visita de selección.
    • Antecedentes de pancreatitis o pancreatectomía.
    • Antecedentes de cirugía de pérdida de peso.
    • Antecedentes personales o familiares inmediatos de cáncer medular tiroideo (CMT) o afecciones genéticas que predisponen al CMT.
    • Cualquier exposición previa a fármacos pertenecientes a la clase de agonistas del receptor GLP-1 o análogos de GLP-1.
    • Contraindicaciones o reacción de hipersensibilidad conocida al glucagón.
    E.5 End points
    E.5.1Primary end point(s)
    Change in HbA1c
    Cambio en la HbA1c
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 26
    Desde el momento basal hasta la Semana 26.
    E.5.2Secondary end point(s)
    1- Change in body weight
    2- Percentage of patients achieving predefined HbA1c targets of <7%
    Percentage of patients achieving predefined HbA1c targets of <6.5%
    3- Percentage of patients achieving ≥5% body weight loss
    Percentage of patients achieving ≥10% body weight loss
    4- Change in FPG
    Change in postprandial plasma glucose (PPG) in response to a standardized meal test in up to 50% subset of all patients
    5- Percentage of patients requiring rescue therapy
    6- Change from baseline in postprandial insulin in response to a standardized meal test in up to 50% subset of all patients
    7- Change from baseline in proinsulin in response to a standardized meal test in up to 50% subset of all patients
    Change from baseline in C-peptide in response to a standardized meal test in up to 50% subset of all patients
    8- Change in fasting lipid profile
    9- Change in pharmacodynamic biomarkers
    10- Assessment of PK parameter: oral clearance(CL/F)
    Assessment of PK parameter: volume distribution after nonintravenous infusion (Vz/F)
    Assessment of PK parameter: terminal half-life (T1/2)
    1- Cambios en el peso corporal
    2- Porcentaje de pacientes que alcanzaron objetivos predefinidos de HbA1c <7% y Porcentaje de pacientes que alcanzaron objetivos predefinidos de HbA1c <6,5%
    3- Porcentaje de pacientes que alcanzan ≥5% de pérdida de peso corporal y Porcentaje de pacientes que alcanzan ≥ 10% de pérdida de peso corporal
    4- Cambio en FPG, Cambio en la glucosa plasmática postprandial (PPG) en respuesta a una prueba estandarizada de comida en un subconjunto de hasta el 50% de todos los pacientes
    5- Porcentaje de pacientes que requieren terapia de rescate
    6- Cambio de la línea de base de la insulina postprandial en respuesta a una prueba estandarizada de comida en un subconjunto de hasta el 50% de todos los pacientes
    7- Cambio de la línea de base de la proinsulina en respuesta a una prueba estandarizada de comida en un subconjunto de hasta el 50% de todos los pacientes y Cambio de la línea de base en el péptido C en respuesta a una prueba estandarizada de comida en un subconjunto de hasta el 50% de todos los pacientes
    8- Cambio en el perfil lipídico en ayunas
    9- Cambio en los biomarcadores farmacodinámicos
    10- Evaluación del parámetro PK: depuración oral (CL / F)
    Evaluación del parámetro PK: distribución del volumen después de la infusión no intravenosa (Vz / F) y Evaluación del parámetro PK: semivida terminal (T1 / 2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- From baseline to Week 26
    2- At Week 26
    3- At Week 26
    4- From baseline to Week 26
    5- During 26-week treatment period
    6- From baseline to Week 26
    7- From baseline to Week 26
    8- From baseline to Week 26
    9- From baseline to Week 26
    10- Week 26
    1- Desde el momento basal hasta la Semana 26.
    2- En la Semana 26
    3- En la Semana 26
    4- Desde el momento basal hasta la Semana 26.
    5- Durante el período de tratamiento de 26 semanas
    6- Desde el momento basal hasta la Semana 26.
    7- Desde el momento basal hasta la Semana 26.
    8- Desde el momento basal hasta la Semana 26.
    9- Desde el momento basal hasta la Semana 26.
    10- En la Semana 26
    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 Yes
    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) 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 trial7
    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 EEA28
    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
    Czech Republic
    Germany
    Hungary
    Mexico
    Russian Federation
    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
    Última visita del último paciente
    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 months1
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days16
    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: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state31
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 270
    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
    Ninguno
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-27
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