E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type1-Diabetes |
Diabetes Mellitus Tipo 1 |
|
E.1.1.1 | Medical condition in easily understood language |
Type1-Diabetes |
Diabetes Mellitus Tipo 1 |
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 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 HbA1c change in patients with type 1 diabetes mellitus (T1DM) also using insulin glargine |
Demostrar la no inferioridad de SAR342434 frente a Humalog en el cambio de la HbA1c en pacientes con diabetes mellitus tipo 1 que también utilizan insulina glargina. |
|
E.2.2 | Secondary objectives of the trial |
- To assess the immunogenicity of SAR342434 and Humalog in terms of change in anti-insulin antibodies. - To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. - To assess the efficacy of SAR342434 and Humalog on: fasting plasma glucose (FPG) and self measured plasma glucose (SMPG) profiles. - To assess safety of SAR342434 and Humalog. |
- Evaluar la inmunogenicidad de SAR342434 y Humalog en términos del cambio en los anticuerpos antiinsulina desde el momento basal hasta la Semana 26. - Evaluar la relación de los anticuerpos antiinsulina con la eficacia y la seguridad, incluyendo el periodo de extensión de seguridad (Semana 52). - Evaluar la eficacia de SAR342434 y Humalog en: la Glucosa Plasmática en Ayunas (GPA) y los Perfiles de Autocontrol de la Glucosa Plasmática (self-measured plasma glucose, SMPG). - 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 T1DM diagnosed for at least 12 months, and have been on basal bolus therapy using insulin glargine and Humalog or Novolog®/Novo Rapid® for at least 6 months. Written informed consent. |
- Pacientes con diabetes mellitus tipo 1 diagnosticados al menos hace 12 meses, y que hayan recibido un tratamiento basal bolus con insulina glargina y Humalog o Novolog®/Novo Rapid® durante al menos 6 meses - Consentimiento informado por escrito |
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E.4 | Principal exclusion criteria |
At screening visit, age under legal age of adulthood. HbA1c <7.0% or >10% at screening. Diabetes other than T1DM. Status post pancreatectomy. Status post pancreas and/or islet cell transplantation. Pregnancy and lactation. Women of childbearing potential not protected by highly effective contraceptive method of birth control. Less than 1 year on continuous insulin treatment. Use of insulin pump in the last 6 months before screening visit. Use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit. Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before 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 < 7,0 % o > 10 % en la selección; - Diabetes que no sea diabetes mellitus tipo 1; - Estado de postpancreatectomía; - Estado postrasplante de páncreas y/o de células islote; - Embarazo y lactancia; - Mujeres en edad fértil no protegidas con un método anticonceptivo de control de natalidad altamente efectivo; - Menos de 1 año de tratamiento continuo con insulina; - Uso de bomba de insulina en los últimos 6 meses antes de la visita de selección; - Uso de tratamientos hipoglucemiantes que no sean insulina incluidos péptidos inyectables que no sean insulina en los últimos 6 meses antes de la visita de selección; - Uso de insulina que no sea insulina glargina y Humalog o Novo log/Novo Rapid como parte de un régimen de inyecciones múltiples (de 3 a 4 inyecciones al día) en los últimos 6 meses antes de la visita de selección; - Hospitalización por cetoacidosis diabética 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 from baseline |
Cambio en la HbA1c desde el momento basal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline, 26 weeks |
Desde el momento basal hasta la Semana 26 |
|
E.5.2 | Secondary end point(s) |
1 - Percentage of patients with HbA1c <7% 2 - Change in FPG from baseline 3 - Change in the mean 24-hour plasma glucose concentration, based on the 7-point self measured plasma glucose profile from baseline 4 - Change in postprandial plasma glucose excursions (difference between 2 hour postprandial and pre-prandial plasma glucose values at breakfast, lunch, and dinner) from baseline 5 - Number of patients with hypoglycemia event 6 - Number of hypoglycemia events per patient |
1. El porcentaje de pacientes con HbA1c < 7 % 2. Cambio en la GPA 3. El cambio en la concentración media de glucosa plasmática tras 24 horas, basándose en el perfil de autocontrol de la glucosa plasmática con 7 puntos 4. Cambio en las oscilaciones de la glucosa plasmática postprandial desde el momento basal hasta la semana 26 (diferencia entre los valores de la glucosa plasmática preprandial y postprandial a las 2 horas en el desayuno, la comida y la cena); Seguridad: 5. Número de paciente con un acontecimineton de hipoglucemia 6. Número de hipoglicemias por paciente |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 5 and 6 : 26 weeks 2, 3 and 4: baseline, 26 weeks |
1,5 y 6: Semana 26 2,3 y 4: desde el momento basal hasta la Semana 26 |
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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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
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 |
France |
Germany |
Hungary |
Japan |
Mexico |
Poland |
Russian Federation |
Spain |
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
|
LVLS |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 1 |