E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
Diabete Mellito di tipo 2 |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Diabete Mellito di tipo 2 |
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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 | 14.1 |
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 |
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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 |
The primary objective is to confirm the cardiovascular safety of insulin degludec compared to that of insulin glargine. |
L’obiettivo primario dello studio è confermare la sicurezza cardiovascolare dell’insulina degludec rispetto a quella dell’insulina glargine. |
|
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. |
Gli obiettivi secondari consistono nel valutare l’efficacia dell’insulina degludec sul controllo glicemico e la sicurezza degli altri parametri nei soggetti ad alto rischio cardiovascolare affetti da diabete di tipo 2. |
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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) |
-Diabete di tipo 2
-Età ≥ 50 anni allo screening con predefinite malattie cardiovascolari o età≥ 60 anni con fattori di rischio cardiovascolare.
-HbA1c ≥ 7,0 % o HbA1c < 7,0 % in terapia con ≥ 20 U/giorno di insulina basale
-Qualsiasi trattamento antidiabetico orale o iniettabile
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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) |
-Un evento cerebro-vascolare o coronarico acuto insorto nei 60 giorni precedenti alla visita 1 (screening).
-Pianificazione di una rivascolarizzazione arteriosa periferica, carotidea o coronarica.
-Insufficienza cardiaca cronica di classe IV NYHA (New York Heart Association).
-Neoplasia maligna che richiede chemioterapia, intervento chirurgico, radioterapia o terapia palliativa nei 5 anni precedenti.
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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
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L’endpoint primario è definito come il tempo trascorso dalla randomizzazione al primo evento MACE, definito come decesso cardiovascolare, infarto del miocardio non fatale o ictus non fatale. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From randomisation to 60 months
|
Dalla randomizzazione a 60 mesi. |
|
E.5.2 | Secondary end point(s) |
1. Number of severe hypoglycaemic episodes
2. Change in Glycosylated haemoglobin (HbA1c)
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1. Numero di ipoglicemie gravi
2. Variazioni nel livello di emoglobina glicosilata (HbA1c) |
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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)
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1. Settimana 0 all'ultima analisi (60 mesi)
2. Settimana 0 all'ultima analisi (59 mesi)
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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 | 14 |
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 |
Algeria |
Argentina |
Brazil |
Canada |
India |
Japan |
Malaysia |
Mexico |
Russian Federation |
Korea, Republic of |
South Africa |
Thailand |
United States |
European Union |
|
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
|
LVLS |
Ultima visita ultimo soggetto |
|
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 |