E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 Diabetes |
Diabetes tipo 1 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 1 Diabetes |
Diabetes tipo 1 |
|
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 | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020639 |
E.1.2 | Term | Hyperglycemia |
E.1.2 | System Organ Class | 100000004861 |
|
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 insulin lispro on glycemic control (non-inferiority margin [NIM]=0.4% for hemoglobin A1c [HbA1c]) in patients with T1D, when administered as prandial insulin (0 to 2 minutes prior to the meal), in combination with basal insulin glargine or insulin degludec for 26 weeks |
Contrastar la hipótesis según la cual LY900014 no es inferior a la insulina lispro, desde el punto de vista del control glucémico (margen de no inferioridad [MNI] = 0,4 % para la hemoglobina A1c [HbA1c]), en pacientes con DT1, cuando se administra como insulina prandial (en los 2 minutos anteriores a la comida), en combinación con una insulina basal (insulina glargina o insulina degludec), durante 26 semanas. |
|
E.2.2 | Secondary objectives of the trial |
To test the hypothesis that LY900014 is superior to insulin lispro in controlling 1-hour PPG excursions, when administered as prandial insulin. To test the hypothesis that LY900014 is superior to insulin lispro in controlling 2-hour PPG excursions, when administered as prandial insulin. To test the hypothesis that LY900014 is superior to insulin lispro on improving glycemic control (HbA1c) when administered as prandial insulin. To test the hypothesis that LY900014 administered as postprandial insulin immediately after completion of a meal or at 20 minutes after the start of a meal, whichever comes first (LY900014+20), is noninferior to insulin lispro, administered as prandial insulin, on glycemic control (NIM=0.4% for HbA1c). |
Contrastar la hipótesis según la cual LY900014 es superior a la insulina lispro desde el punto de vista del control de las fluctuaciones de la glucosa posprandial (GPP) al cabo de 1 hora, cuando se administra como insulina prandial. Contrastar la hipótesis según la cual LY900014 es superior a la insulina lispro desde el punto de vista del control de las fluctuaciones de la GPP al cabo de 2 horas, cuando se administra como insulina prandial. Contrastar la hipótesis según la cual LY900014 es superior a la insulina lispro desde el punto de vista de la mejoría del control glucémico (HbA1c), cuando se administra como insulina prandial. Contrastar la hipótesis según la cual LY900014, administrado como insulina posprandial inmediatamente después del final de una comida o 20 minutos después del inicio de esta, lo que acontezca antes (LY900014+20) no es inferior a la insulina lispro, administrada como insulina prandial,desde el punto de vista del control glucémico (MNI para la HbA1c = 0,4 %) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• You were diagnosed with type 1 diabetes at least one year ago. • You are 18 years old or older. • You are already using a long-acting insulin and rapid-acting insulin analog. • Your blood glucose levels are within allowed limits for study participation |
•Le han diagnosticado diabetes de tipo 1 al menos hace un año. •Tiene al menos 18 años. •Ya recibe una insulina de acción prolongada y un análogo de insulina de acción rápida. •Sus valores de glucemia se encuentran dentro de los límites aceptables para participar en el estudio. |
|
E.4 | Principal exclusion criteria |
• You have had more than 1 emergency treatment for very low blood glucose in the last 6 months. • You have had more than 1 emergency treatment for poor 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 that prevents you from study participation. |
•Ha recibido tratamiento de urgencia por presentar valores de glucemia muy bajos o mal control glucémico en los últimos 6 meses. •Toma ciertos medicamentos para la diabetes que no están permitidos para participar en el estudio. •Tiene algún trastorno cardiaco, renal o hepático importante o padece algún trastorno hematológico. •Ha recibido tratamiento para ciertos tipos de cáncer, o lo recibe en la actualidad. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Cambio en HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Difference between LY900014 and insulin lispro in the 1-hour PPG excursion (serum glucose measured 1 hour after the start of the meal minus fasting serum glucose) from a MMTT. 2. Difference between LY900014 and insulin lispro in the 2-hour PPG excursion (serum glucose measured 2 hours after the start of the meal minus fasting serum glucose) from an MMTT. 3. Difference between LY900014 and insulin lispro in change from baseline in HbA1c 4. Difference between LY900014+20 and insulin lispro in change from baseline in HbA1c |
-Diferencia entre LY900014 y la insulina lispro en las fluctuaciones de la GPP al cabo de 1 hora (concentración sérica de glucosa determinada 1 hora después del inicio de la comida menos la concentración sérica de glucosa en ayunas), de acuerdo con una PTCM -Diferencia entre LY900014 y la insulina lispro en las fluctuaciones de la GPP al cabo de 2 horas (concentración sérica de glucosa determinada 2 horas después del inicio de la comida menos la concentración sérica de glucosa en ayunas), de acuerdo con una PTCM -Diferencia entre LY900014 y la insulina lispro en la variación de la concentración de HbA1c desde el período basal -Diferencia entre LY900014+20 y la insulina lispro en la variación de la concentración de HbA1c desde el período basal |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 26 weeks 2. 26 weeks 3. 26 weeks 4. 26 weeks |
1. 26 semanas 2. 26 semanas 3. 26 semanas 4. 26 semanas |
|
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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 |
Australia |
Austria |
Brazil |
Germany |
Greece |
India |
Italy |
Japan |
Mexico |
New Zealand |
Poland |
Romania |
Russian Federation |
Slovakia |
Spain |
Sweden |
Taiwan |
United States |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 | 5 |