E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
atherosclerosis |
aterosclerosi |
|
E.1.1.1 | Medical condition in easily understood language |
atherosclerosis |
aterosclerosi |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
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 | 10003601 |
E.1.2 | Term | Atherosclerosis |
E.1.2 | System Organ Class | 100000004866 |
|
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 determine whether in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care increases insulin secretion and insulin sensitivity |
Lo scopo del presente sottostudio per lo studio CANTOS è di determinare se, nei pazienti affetti da diabete di tipo 2 (T2D) partecipanti allo studio principale, canakinumab, rispetto a placebo in aggiunta alla terapia standard, aumenta la secrezione di insulina e la sensibilità all’insulina. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable to substudy |
Non applicabile al sottostudio |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Written informed consent form 2. Meet main study eligibility criteria listed in Section 4.1 and 4.2 of protocol CACZ885M2301 and agreed to participate in CANTOS main study 3. T2D at baseline per CACZ885M2301 protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test 4. Willing to have the OGTT assessment started before 10 am |
I pazienti eleggibili per l’inclusione nel presente sottostudio devono soddisfare tutti i seguenti criteri: Consenso informato scritto per il sottostudio ottenuto prima dell’effettuazione di qualsiasi valutazione relativa al sottostudio. Pazienti che soddisfano tutti i criteri di eleggibilità elencati nella Sezione 4.1 e nella Sezione 4.2 del protocollo CACZ885M2301 e che hanno acconsentito alla partecipazione allo studio principale CANTOS. Pazienti con diagnosi di T2D al basale secondo i criteri del protocollo CACZ885M2301 (Sezione 5.3) e in trattamento con farmaco anti-iperglicemico a dose stabile da almeno 4 settimane prima del test OGTT al basale (Mese 0/Visita 2). Pazienti disposti ad iniziare la valutazione OGTT prima delle 10 del mattino. |
|
E.4 | Principal exclusion criteria |
• Pregnant or nursing (lactation) women • Women of child-bearing potential • Any of the following concomitent diseases: 1. Planned coronary revascularization 2. major non cardiac surgical or endoscopic procedure within past 6 months • Uncontrolled hypertension |
I pazienti che soddisfano uno qualsiasi dei criteri di esclusione per lo studio principale CANTOS non sono eleggibili per l’inclusione nel presente sottostudio sull’OGTT. Questo sottostudio non prevede alcun criterio di esclusione aggiuntivo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline of the insulin secretion rate (ISR) relative to glucose 0-30 min defined as Ф30 = AUCISR 0-30 / AUCGluc 0-30 averaged across the yearly visits. |
Cambiamenti rispetto al basale del tasso della secrezione dell'insulina (ISR) riguardante glucosio 0-30 min definito come Ф30 = AUCISR 0-30/AUCGluc 0-30 media attraverso le visite annuali. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Change from baseline in: • Insulin sensitivity index • OGTT stimulated area under curve (AUC) 0-120 min of glucose concentration, insulin concentration, pro insulin concentration and insulin concentration/glucose concentration ratio • fasting pro-insulin concentration /insulin concentration ratio • OGTT stimulated area under the curve (AUC) 0-120 min of C-peptide concentration |
Cambiamenti rispetto al basale in: • Indice di sensibilità all'insulina • OGTT area sotto la curva (AUC) 0-120 min della concentrazione di glucosio,concentrazione di insulina, pro insulina concentrazione e concentrazione insulina/glucosio concentrazione • concentrazione di insulina a digiuno/insulina concentrazione • OGTT area sotto la curva (AUC) 0-120 min C-peptide concentrazione |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
è un sub study, no farmaco - Stesso farmaco ad altro dosaggio |
it's a substudy, no drug - same IMP used at different dosage |
|
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 88 |
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 |
|
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 : 25/Sep/2016 |
LVLS : 25/09/2016 |
|
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 | 33 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
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 |