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 | 16.1 |
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 | 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 |
The primary objective is to confirm the cardiovascular safety of insulin degludec compared to that of insulin glargine. |
El objetivo principal es confirmar la seguridad cardiovascular de la insulina degludec en comparación con la insulina glargina. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess efficacy of insulin degludec on markers of glycaemic control and to assess safety on other parameters in subjects with type 2 diabetes at high risk of cardiovascular events. |
Los objetivos secundarios son evaluar la eficacia de la insulina degludec respecto a los marcadores del control de la glucemia y evaluar la seguridad respecto a otros parámetros en pacientes con diabetes de tipo 2 y alto riesgo de padecer episodios cardiovasculares. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Type 2 diabetes - Age ? 50 years with predefined previous cardiovascular disease(s) or renal disease or age ? 60 years with predefined cardiovascular risk factors - HbA1c ? 7.0% or HbA1c < 7.0% and current insulin treatment corresponding to ? 20 U of basal insulin per day. - One or more oral or injectable antidiabetic agent(s) |
?Diabetes de tipo 2 ?Edad ? 50 años con enfermedades cardiovasculares predefinidas o insuficiencia renal, o edad ? 60 años con factores de riesgo cardiovascular predefinidos. ?HbA1c ? 7,0 % o HbA1c < 7,0 % e insulinoterapia actual correspondiente como mínimo a 20 U de insulina basal al día. ?Uno o más antidiabéticos orales o inyectables. |
|
E.4 | Principal exclusion criteria |
- An acute coronary or cerebrovascular event in the previous 60 days - Planned coronary, carotid or peripheral artery revascularisation - Chronic heart failure NYHA class IV - Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) |
?Episodio coronario o cerebrovascular agudo en los 60 días previos. ?Revascularización arterial coronaria, carotídea o periférica programada. ?Insuficiencia cardíaca crónica con clase funcional IV de la NYHA. ?Neoplasias malignas presentes o pasadas (en los 5 últimos años) (excepto carcinoma basocelular y carcinoma espinocelular de la piel). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke |
El tiempo transcurrido desde la aleatorización hasta la aparición del primer acontecimiento adverso cardiovascular importante (AACI): muerte de origen cardiovascular, infarto de miocardio no mortal o ictus no mortal. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From randomisation to 60 months |
Desde la aleatorización hasta 60 meses |
|
E.5.2 | Secondary end point(s) |
1. Number of severe hypoglycaemic episodes 2. Change in Glycosylated haemoglobin (HbA1c) |
1. Número de episodios de hipoglucemia intensagrave. 2. Cambio en la Hemoglobina glucosilada (HbA1c) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 0 to the last assessment (60 months) 2. Week 0 to the last assessment (59 months) |
1. Desde la semana 0 hasta la última evaluación (60 meses) 2. Desde la semana 0 hasta la última evaluación (59 meses) |
|
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 63 |
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 |
Canada |
Japan |
European Union |
Algeria |
Argentina |
Brazil |
India |
Korea, Republic of |
Malaysia |
Thailand |
Mexico |
Russian Federation |
South Africa |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |