E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 1 |
Diabetes mellitus de tipo 1. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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 test the hypothesis that LY900014 is noninferior to Fiasp on glycemic control (NIM=0.4% for HbA1c) in patients with T1D, when administered as prandial insulin (0 to 2 minutes prior to the meal), in combination with basal insulin for 20 weeks |
• Contrastar la hipótesis de que LY900014 no es inferior a Fiasp para controlar la glucemia (MNI = 0,4 % para la HbA1c) en pacientes con DT1, cuando se administra como insulina prandial (de 0 a 2 minutos antes de las comidas) en combinación con una insulina basal durante 20 semanas. |
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E.2.2 | Secondary objectives of the trial |
• To test the hypothesis that LY900014 is superior to Fiasp on improving glycemic control (HbA1c) when administered as prandial insulin • To compare LY900014 and Fiasp with respect to the rate of severe hypoglycemic events • To compare LY900014 and Fiasp with respect to the rate of documented symptomatic hypoglycemia • To compare LY900014 and Fiasp with respect to total, basal, and prandial insulin doses • To compare LY900014 and Fiasp with respect to 7-point SMBG profiles • To compare LY900014 and Fiasp with respect to glycemic variability • To compare LY900014 and Fiasp with respect to the proportion of patients achieving HbA1c targets • To compare LY900014 and Fiasp with respect to diabetes treatment satisfaction as measured by the ITSQ |
Contrastar la hipótesis de que LY900014 es superior a Fiasp para mejorar el control de la glucemia (HbA1c) cuando se administra como insulina prandial. • Comparar LY900014 y Fiasp en cuanto a la tasa de episodios de hipoglucemia grave. • Comparar LY900014 y Fiasp en cuanto a la tasa de hipoglucemia sintomática documentada. • Comparar LY900014 y Fiasp en cuanto a las dosis de insulina total, basal y prandial. • Comparar LY900014 y Fiasp en cuanto a los perfiles de SMBG de 7 puntos. • Comparar LY900014 y Fiasp en cuanto a la variabilidad de la glucemia. • Comparar LY900014 y Fiasp en cuanto a la proporción de pacientes que alcanzan los objetivos de HbA1c. • Comparar LY900014 y Fiasp en cuanto a la satisfacción con el tratamiento de la diabetes medida con el ITSQ. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• You are diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months • You are 18 years of age or older • You are already being treated with insulin allowed for study participation. • Your blood glucose levels are within allowed limits for study participation |
• Le han diagnosticado de diabetes de tipo 1 y ha estado utilizando insulina de forma continua durante al menos 12 meses. • Tiene 18 años o más. • Ya está recibiendo un tratamiento con insulina que le permite participar en el estudio. • Su glucemia está dentro de los límites permitidos para participar en el estudio. |
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E.4 | Principal exclusion criteria |
• You have had more than 1 emergency treatment for very low blood glucose or poor blood glucose control in the last 6 months. • You are taking certain diabetes medications that are not allowed for study participation. • You have major problems with your heart, kidneys, liver, or you have a blood disorder. • You have had, or are now being treated for, certain types of cancer. |
• Ha recibido más de un tratamiento de urgencia para la hipoglucemia (nivel muy bajo de glucosa en sangre) o por un control deficiente de la glucemia en los últimos 6 meses. • Está tomando determinados medicamentos para la diabetes que no están permitidos en el estudio. • Tiene problemas importantes de corazón, riñones o hígado o una enfermedad de la sangre. • Ha tenido ciertos tipos de cáncer o está recibiendo tratamiento por ese motivo. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Difference between LY900014 and Fiasp in change from baseline to Week 20 in HbA1c |
• Diferencia entre LY900014 y Fiasp en cuanto a la variación de la HbA1c entre el momento basal y la semana 20. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Difference between LY900014 and Fiasp in change from baseline to Week 20 in HbA1c 2. Rate (events/patient/100 years) of severe hypoglycemic events from baseline to Week 20 3. Rate (events/patient/year) of documented symptomatic hypoglycemic events from baseline to Week 20 4. Change from baseline in total, basal, and prandial insulin doses and prandial/total insulin dose ratios at Week 20 5. Change from baseline in 7-point SMBG postprandial glucose excursions at Week 20 6. Within-day and between-day glycemic variability measured by the standard deviation and the coefficient of variation of 7-point SMBG profiles 7. The proportion of patients with HbA1c <7% and ≤6.5% at Week 20 8. Change from baseline ITSQ regimen inconvenience and lifestyle flexibility domain scores at Week 20 |
1. Diferencia entre LY900014 y Fiasp en cuanto a la variación de la HbA1c entre el momento basal y la semana 20. 2. Tasa (episodios/paciente/100 años) de episodios de hipoglucemia grave entre el momento basal y la semana 20. 3. Tasa (episodios/paciente/año) de episodios de hipoglucemia sintomática documentada entre el momento basal y la semana 20. 4. Variación de las dosis de insulina total, basal y prandial y de los cocientes entre las dosis de insulina prandial y total entre el momento basal y la semana 20. 5. Variación de las oscilaciones de la glucemia posprandial en el SMBG de 7 puntos entre el momento basal la semana 20. 6. Variabilidad intradiaria e interdiaria de la glucemia determinada por la desviación estándar y el coeficiente de variación de los perfiles de SMBG de 7 puntos. 7. Proporción de pacientes con una HbA1c < 7 % y ≤ 6,5 % en la semana 20. 8. Variación de la puntuación de los dominios del ITSQ de incomodidad del tratamiento y flexibilidad del modo de vida entre el momento basal y la semana 20. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 20 for all secondary endpoints 1,2,3,4,5,7 and 8. For secondary point 6 timepoint is within-day/between-day. |
Semana 20 para los criterios de valoración secundarios 1, 2, 3, 4, 5, 7 y 8. La evaluación del criterio de valoración secundario 6 se realiza con carácter intradiario/interdiario. |
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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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
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 |
Austria |
Canada |
Czech Republic |
Germany |
Romania |
Spain |
United Kingdom |
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
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End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient. |
El final del estudio es la fecha de la última visita o del último procedimiento programado en el calendario de actividades 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 | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 17 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 17 |