E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
Diabetes Mellitus tipo 2 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 2 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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000072461 |
|
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 confirm the effect in terms of glycaemic control of treatment with fast-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen, using a non-inferiority approach. |
Confirmar el efecto del tratamiento con insulina aspart de acción rápida en términos de control glucémico comparado con NovoRapid® ambos en combinación con insulina degludec con o sin metformina en adultos con diabetes tipo 2 tratados en régimen bolo-basal utilizando una aproximación de no inferioridad. |
|
E.2.2 | Secondary objectives of the trial |
1. To confirm superiority of fast-acting insulin aspart compared to NovoRapid® both in combination
with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen in terms of:
- Postprandial glucose regulation
- Overall glycaemic control
- Postprandial glucose excursions
2. To compare the safety of fast-acting insulin aspart to NovoRapid® both in combination with insulin degludec with or without metformin in adults with type 2 diabetes treated with a basal-bolus regimen. |
1.Confirmar la superioridad de la insulina aspart de acción rápida sobre NovoRapid®, ambas en combinación con insulina degludec con o sin metformina en adultos con diabetes mellitus tipo 2 tratados con un régimen bolo-basal en cuanto a:
• Regulación de la glucosa posprandial
• Control global de la glucemia
• Oscilaciones de la glucosa posprandial
2.Comparar el efecto y la seguridad de la insulina aspart de acción rápida y de NovoRapid®, ambas en combinación con insulina degludec con o sin metformina en adultos con diabetes mellitus tipo 2 tratados con un régimen bolo-basal |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male or female, age ≥ 18 years at the time of signing informed consent.
•Diagnosed with type 2 diabetes mellitus≥ 10 years prior to screening (Visit 1).
•Treated with a basal-bolus insulin regimen ≥ 1 year prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen.
•Treated with or without oral antidiabetic drugs including extended release formulations. HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1)
Randomisation criterion:
- HbA1c ≤ 9.0% measured by the central laboratory at Visit 13 (week -1). |
•Hombre y mujeres de ≥ 18 años de edad en el momento de la firma del consentimiento informado.
•Diagnosticados de diabetes mellitus tipo 2 ≥ 10 años antes de la selección (visita 1).
•Tratados con un régimen de insulina bolo-basal ≥ 1 año antes del día de la selección (visita 1). El régimen de insulina bolo-basal se define como insulina basal una o dos veces al día y un análogo de la insulina en bolo administrado con las comidas al menos 3 veces al día. El tratamiento con una combinación de insulina premezclada o insulina soluble no se considera un régimen bolo-basal
•Tratados con o sin antidiabéticos orales, incluidas formulaciones de liberación prolongada. HbA1c del 7,0% al 10,0% (ambos inclusive) en el análisis del laboratorio central en la selección (visita 1).
Criterio de randomización
- HbA1c ≤ 9.0% medido en el laboratorio central en visita 13(week -1). |
|
E.4 | Principal exclusion criteria |
•Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1).
•Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1).
•Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1).
•Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
|
•Cualquiera de lo siguiente: infarto de miocardio, ictus u hospitalización por angina inestable o accidente isquémico transitorio en los 180 días previos al día de la selección (visita 1).
•Pacientes con una clase funcional IV según la New York Heart Association (NYHA).
•Revascularización arterial coronaria, carotídea o periférica programada el día de la selección (visita 1).
•Tratamiento con agonistas del receptor del GLP-1 inyectables en un período de 90 días antes de la selección (visita 1).
•Inicio o cambio previstos de medicamentos concomitantes (durante más de 14 días seguidos) con efectos conocidos sobre el peso o el metabolismo de la glucosa (p. ej., tratamiento con Orlistat, hormonas tiroideas o corticosteroides). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c |
Cambio en la HbA1c basal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
16 weeks after randomisation |
16 semanas después de la aleatorización |
|
E.5.2 | Secondary end point(s) |
1. Change from baseline in 1-hour postprandial glucose increment (meal test)
2. Change from baseline in 1,5-anhydroglucitol |
1.Variación con respecto al valor basal del incremento de la glucosa posprandial al cabo de 1 hora (prueba de ingesta de comida)
2.Variación con respecto al valor basal del 1,5-anhidroglucitol 16 semanas después de la aleatorización |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.2. 16 weeks after randomisation |
1.2.16 semanas después de la aleatorización |
|
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 |
Tratamiento al objetivo |
Treat-to-target |
|
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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 |
Canada |
European Union |
Korea, Republic of |
Russian Federation |
Serbia |
Ukraine |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 17 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 17 |