E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type2-Diabetes |
Diabetes tipo 2 |
|
E.1.1.1 | Medical condition in easily understood language |
Type2-Diabetes |
Diabetes tipo 2 |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in patients with type 2 diabetes mellitus (T2DM) also using insulin glargine |
Demostrar la no inferioridad de SAR342434 frente a Humalog en el cambio de la HbA1c desde el momento basal hasta la Semana 26 en pacientes con diabetes mellitus tipo 2 que también utilizan insulina glargina. |
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E.2.2 | Secondary objectives of the trial |
-To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study; -To assess the relationship of anti-insulin antibodies with efficacy and safety. -To assess the efficacy of SAR342434 and Humalog on: proportion of patients reaching target HbA1c <7.0% and ?6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose. -To assess safety of SAR342434 and Humalog. |
Evaluar la inmunogenicidad de SAR342434 y Humalog en términos del estado positivo/negativo y títulos de anticuerpos en el momento basal y durante el transcurso del estudio. ? Evaluar la relación de los anticuerpos antiinsulina con la eficacia y la seguridad. ? Evaluar la eficacia de SAR342434 y Humalog en: la proporción de pacientes que alcanzan el objetivo de HbA1c (< 7,0 % y < 6,5 %), los perfiles de Glucosa Plasmática en Ayunas (GPA) y los perfiles de Autocontrol de la Glucosa Plasmática (Self-Monitored Plasma Glucose, SMPG), y la dosis de insulina. ? Evaluar la seguridad de SAR342434 y Humalog. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the last 6 months prior to the screening visit.
-Signed Written informed consent. |
? Pacientes con diabetes mellitus tipo 2 diagnosticados al menos hace 12 meses y que hayan recibido tratamiento con insulina glargina y Humalog o NovoLog®/NovoRapid® (como mínimo 3 veces al día antes de cada comida) en los 6 meses previos a la visita de selección. ? Consentimiento informado por escrito. |
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E.4 | Principal exclusion criteria |
-At screening visit, age under legal age of adulthood. -HbA1c <6.5% or >10.0% at screening. -Diabetes other than T2DM. -Pregnancy and lactation. -Women of childbearing potential not protected by highly effective contraceptive method of birth control. -Use of insulin pump in the 6 months before screening visit. -Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an EU approved insulin lispro and is allowed in those countries where it is marketed. -Use of Humalog or Novolog/NovoRapid less than 3 times daily, before each meal. -Use of non-injectable peptides (eg, GLP-1-receptor-agonists or other peptides) in the 6 months prior to screening visit. -Body mass index (BMI) ?40kg/m² at screening visit. -Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. -Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period. |
? En la visita de selección, no haber alcanzado la mayoría de edad. ? HbA1c < 6,5 % o > 10 % en la visita de selección. ? Diabetes que no sea diabetes mellitus tipo 2. ? Embarazo y lactancia. ? Mujeres en edad fértil no protegidas con un método anticonceptivo de control de natalidad altamente efectivo. ? Uso de bomba de insulina en los últimos 6 meses antes de la visita de selección. ? Uso de insulina que no sea insulina glargina y Humalog o Novolog/NovoRapid en los últimos 6 meses antes de la visita de selección; Liprolog® es una insulina lispro aprobada en la UE que está permitida en aquellos países en los que se comercializa. ? Uso de Humalog o NovoLog/NovoRapid menos de 3 veces al día antes de cada comida. ? Uso de péptidos inyectables no insulínicos (p. ej., agonistas del receptor GLP-1 u otros péptidos) en los últimos 6 meses antes de la visita de selección. ? Hospitalización por cetoacidosis diabética (CAD) en los últimos 6 meses antes de la visita de selección. ? Retinopatía diabética proliferativa inestable o cualquier otra retinopatía diabética de progresión rápida, o edema macular que probablemente requiera tratamiento (p. ej., láser, tratamiento quirúrgico o fármacos inyectables) durante el período del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Cambio en la HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to 26 weeks |
desde el momento basal hasta la Semana 26. |
|
E.5.2 | Secondary end point(s) |
1 - Percentage of patients with HbA1c <7.0% and ?6.5% 2 - Change in FPG 3 - Change in the mean 24-hour plasma glucose concentration, based on the 7-point Self Measured Plasma Glucose profile 4 - Change in postprandial plasma glucose excursions (difference between 2 hour postprandial and pre-prandial plasma glucose values at breakfast, lunch, and dinner) 5 - Number of patients with hypoglycemia event 6 - Number of hypoglycemia events per patient 7 - Number of patients with injection site reactions 8 - Number of patients with hypersensitivity reactions 9 - Number of patients with adverse events |
Inmunogenicidad: ? Estado positivo/negativo de los anticuerpos anti-SAR342434/Humalog y sus títulos Eficacia: ? El porcentaje de pacientes con HbA1c < 7,0 % y < 6,5 % ? Cambio en la GPA ? El cambio en la concentración media de glucosa plasmática tras 24 horas, según el perfil de SMPG de 7 puntos ? Cambio en las oscilaciones de la glucosa postprandial plasmática Seguridad: ? Los análisis de seguridad incluirán la evaluación de reacciones en el lugar de la inyección, reacciones de hipersensibilidad, hipoglucemias (según el Grupo de trabajo sobre Hipoglucemias de la Asociación Estadounidense de la Diabetes [American Diabetes Association, ADA], acontecimientos adversos, acontecimientos adversos graves, exploración física, constantes vitales, ECG y datos analíticos. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 : at 26 weeks 2, 3 and 4: from baseline to 26 weeks 5, 6, 7, 8 and 9: up to 26 weeks |
Inmunogenicidad: en cada visita en la que se extraigan muestras. Eficacia: en la Semana 26. Seguridad: hasta la semana 26 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Brazil |
Colombia |
Germany |
Hungary |
Italy |
Korea, Republic of |
Mexico |
Romania |
Russian Federation |
Spain |
Turkey |
United States |
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E.8.7 | Trial 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
|
LSLV |
Última visita del último paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 1 |