| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Pacients receiving enteral nutrition and who present hyperglycemia. |
| Pacientes tratados con nutrición enteral y que presenten hiperglicemia. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Patients receiving artificial tube feeding who present high blood glucose levels. |
| Pacientes que reciban nutrición artificial por sonda que presenten niveles elevados de glucosa en sangre. |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
| MedDRA Classification |
| 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 compare in terms of safety the use of insulin analogues versus human insulin in stable patients hospitalized outside intensive care units who require enteral nutrition, based on the development of hypoglycemia.
To compare the efficacy of insulin analogues versus human insulin in this group of patients in glycemic control of patients. |
Comparar en términos de seguridad el uso de análogos de insulina frente a insulinas humanas en pacientes estables hospitalizados fuera de unidades de cuidados intensivos que precisen nutrición enteral, en base al desarrollo de hipoglicemias.
Comparar la eficacia de los análogos de insulina versus insulinas humanas en este grupo de pacientes en el control glicémico de los pacientes |
|
| E.2.2 | Secondary objectives of the trial |
1.To compare the efficacy and safety of insulin analogues vs. human insulin in the first 72 hours after the first dose of insulin received after randomization.
2.To evaluate the differentiating characteristics for efficacy and safety between the following subgroups:
-Obese patients (BMI> 30 kg/m2) versus non-obese (BMI <30 kg/m2).
-Patients with previous known diabetes mellitus with respect to patients with undiagnosed diabetes
-Patients on concomitant treatment with glucocorticoid vs patients without glucocorticoids.
3.To compare nutritional evolution of patients in both study groups, in patients receiving insulin treatment after randomization for a period equal to or greater than one week.
4.To compare glycemic variability in patients with insulin analogues compared with patients receiving human insulins.
5.To compare the frequency of metabolic complications in both groups. |
1.Comparar la eficacia y seguridad de los análogos de insulina vs. insulinas humanas en las primeras 72 horas desde la primera dosis de insulina recibida tras la aleatorización.
2.Evaluar las características diferenciales entre cuanto a eficacia y seguridad entre los siguientes subgrupos:
–pacientes obesos (IMC > 30 kg/m2) frente a no obesos (IMC < 30 kg/m2).
–pacientes con diabetes mellitus previamente conocida respecto a pacientes con diabetes no conocida
–Pacientes con toma concomitante de glucocorticoides vs pacientes sin glucocorticoides.
3.Comparar la evolución nutricional de los pacientes en ambos grupos de estudio, dentro de los pacientes que reciban tratamiento insulínico tras la aleatorización por un periodo igual o mayor a una semana.
4.Comparar la variabilidad glicémica en los pacientes con análogos de insulina frente a los pacientes que reciben insulinas humanas.
5.Comparar la frecuencia de complicaciones no metabólicas en ambos grupos.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
-Patients who receive tube feeding as the only way of nutrition.
-Patients presenting hyperglycemia (> 140 mg / dl) on two consecutive occasions and in less than or equal to 48 hours.
-Patients aged over 18 years.
-Signing of informed consent by the patient and, if not possible, by the family and/or legal representative. |
-Pacientes que reciban nutrición enteral por sonda como única vía de nutrición.
-Pacientes que presenten hiperglicemia (>140 mg/dl) en dos ocasiones consecutivas y en un tiempo inferior o igual a 48 horas.
-Edad superior a 18 años.
-Firma de consentimiento informado por parte del paciente y, si no es posible, del familiar y/o representante legal.
|
|
| E.4 | Principal exclusion criteria |
-Patients in critical phase (admitted to the ICU, recovery unit, coronary care unit or stroke unit)
-Patients who present creatinine over 200 mcmol/L
-Patients with comorbidities that determine the use of a specific enteral formula (eg, cirrhosis, malabsorption syndrome)
-Patients with type 1 diabetes mellitus.
-Pregnancy or breastfeeding. |
-Pacientes en fase crítica del proceso (ingresados en UCI, Unidad de Reanimación, Unidad Coronaria o en Unidad de Ictus)
-Pacientes con cretinina superior a 200 mcmol/l
-Pacientes con comorbilidades que condicionen el uso de una fórmula de nutrición enteral específica (ej: cirrosis, sd de malabsorción)
-Pacientes con diabetes mellitus tipo 1.
-Embarazo o lactancia. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The main assessment of safety is measured by the percentage of patients in both groups with at least one hypoglycemia (<70mg/dl) during the intervention period and by the rate of hypoglycemias/day of each group, defined as the addition of the number of hypoglycemia (<70mg/dl) of the patients divided by the number of days of monitoring.
The main efficacy assessment will be measured by the proportion of glycemic control, defined for each patient as the ratio between the number of measurements of glucose within the desired range and the total number of measurements taken during the intervention period of the patient. The desired range is defined as:
- Intermittent enteral nutrition (NEI):
- Prior to the administration of NE: 70-140 mg/dl
- 2 hours after starting the administration of NE: 70-180 mg/dl
- Continuous Enteral Nutrition (NEC):
- At any time: 70-140 mg / dl |
La valoración principal de seguridad se medirá mediante el porcentaje de pacientes en ambos grupos que presentan al menos una hipoglicemia (<70mg/dL) durante el periodo de intervención y la tasa de hipoglicemias/día de cada grupo, definida como el sumatorio del número de hipoglicemias (<70mg/dl) de los pacientes dividido por el numero de días de seguimiento.
La evaluación principal de eficacia se medirá mediante la proporción de control glicémico, definida para cada paciente como el cociente entre el número de mediciones de glicemia dentro del rango deseado entre el número de mediciones totales tomadas durante el periodo de intervención del paciente. El rango deseado se define como:
–Nutrición enteral intermitente (NEI):
–Previa administración de NE: 70-140 mg/dl
–2 horas tras inicio de administración de NE: 70-180 mg/dl
–Nutrición enteral continua (NEC):
–En cualquier momento 70-140 mg/dl
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|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Last visit. |
| Última visita. |
|
| E.5.2 | Secondary end point(s) |
Safety:
-Percentage of patients with severe hypoglycemia (<40 mg/dl).
-Total number of hypoglycemia (<70mg/dl) per group and per patient.
-Number of severe hypoglycemia (<40mg/dl) per group and per patient.
-Severe hypoglycemia rate, defined as the number of severe hypoglycemia (<40mg/dl) of the patient divided by the number of days of monitoring.
-Presence of metabolic complications: Infectious, Gastrointestinal, Cardiovascular, Other, death.
Efficacy:
-Total number of capillary blood glucose within the desired range by group and patient.
- Rate of glycemic control/day, defined as the number of patient blood glucose within the range divided by the number of days of monitoring.
-Mean daily glucose.
-Glycemic variability (MAGE)
-Insulin dose during admission
-Nutritional assessment of the patient: malnutrition will be classified in caloric, proteic or mixed and in each one there will be three categories: mild, moderate or severe.
-Time to stabilization of glycemic control.
-Percentage of patients in both groups who are discharged within 14 days after randomization. |
Seguridad:
-Porcentaje de pacientes con hipoglicemias severas (<40 mg/dl).
-Número total de hipoglicemias (<70mg/dl) por grupo y por paciente.
-Número de hipoglicemias severas (<40mg/dl) por grupo y por paciente.
-Tasa de hipoglicemias severas, definida como el número de hipoglicemias severas (<40mg/dl) del paciente dividido por el numero de días de seguimiento.
-Presencia de complicaciones no metabólicas: Infecciosas, Gastrointestinales, Cardiovasculares, Otras, Éxitus.
Eficacia:
-Número total de glicemias capilares dentro del rango deseado por grupo y por paciente.
-Tasa de control glicémico/día, definida como el número de glicemias del paciente dentro del rango dividido por el numero de días de seguimiento.
-Glicemia diaria media.
-Variabilidad de la glicemia (MAGE)
-Dosis de insulina durante el ingreso
-Valoración nutricional del paciente: la desnutrición será clasificada en calórica, proteica o mixta y en cada una de ellas habrá tres categorías: leve, moderada o grave.
-Tiempo hasta estabilización del control glicémico.
-Porcentaje de pacientes en ambos grupos que son dados de alta en los primeros 14 días tras la aleatorización.
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|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Last visit. |
| Última visita. |
|
| 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) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| 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
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| 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
|
| Last visit of the last subject. |
| 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 | 0 |
| E.8.9.1 | In the Member State concerned months | 12 |
| E.8.9.1 | In the Member State concerned days | 0 |
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