E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 diabetes mellitus |
Diabete Mellito di tipo 1 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 1 diabetes |
Diabete di tipo 1 |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I 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 |
To confirm the effect of treatment with meal-time faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec using a noninferiority approach in children and adolescents with type 1 diabetes |
Confermare l’efficacia nel controllo glicemico di insulina aspart ad azione ultra-rapida somministrata ai pasti in confronto con NovoRapid® entrambe in combinazione con insulina degludec, utilizzando un approccio di non inferiorità in bambini e adolescenti con diabete tipo 1. |
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E.2.2 | Secondary objectives of the trial |
1. To confirm the effect of treatment with post-meal faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec, using a noninferiority approach in children and adolescents with type 1 diabetes. 2. To confirm superiority of treatment with meal-time faster-acting insulin aspart in terms of glycaemic control by comparing it to meal-time NovoRapid®, both in combination with insulin degludec in children and adolescents with type 1 diabetes. 3. To compare the effect and safety of treatment with meal-time fasteracting insulin aspart vs. mealtime NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes. 4. To compare the effect and safety of treatment with post-meal fasteracting insulin aspart vs. mealtime NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes. |
1.Confermare l’efficacia nel controllo glicemico di insulina aspart ad azione ultrarapida somministrata dopo pasti in confronto con NovoRapid® ai pasti entrambe in combinazione con insulina degludec, utilizzando un approccio di non inferiorità in bambini e adolescenti con diabete tipo 2.Confermare la superiorità nel controllo glicemico di insulina aspart ad azione ultra rapida somministrata ai pasti in confronto con insulina NovoRapid® entrambi in combinazione con insulina degludec in bambini e adolescenti con diabete tipo 1. 3.Confrontare gli effetti e la sicurezza del trattamento con insulina aspart ad azione ultra rapida somministrata ai pasti in confronto con insulina NovoRapid® entrambe in combinazione con insulina degludec, in bambini e adolescenti con diabete tipo 1. 4.Confrontare gli effetti e la sicurezza del trattamento con insulina aspart ad azione più rapida somministrata dopo i pasti rispetto a NovoRapid® assunta ai pasti, entrambe in combinazione con insulina degludec, |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female, 1 = age < 18 years at the time of signing informed consent and < 18 years at the time of randomisation 2. Diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) 3. Ongoing daily treatment with a basal-bolus insulin regimen using basal insulin analogue or NPH insulin for at least 90 days prior to the screening visit 4. HbA1c = 9.5% (80 mmol/mol) analysed by the central laboratory at the screening visit |
1. Soggetti di sesso maschile o femminile, di età = 1 anno e < 18 anni al momento della firma del consenso informato e di età < 18 anni al momento della randomizzazione. 2. Diagnosi di diabete mellito tipo 1 (basata sul giudizio clinico e supportata da analisi di laboratorio in accordo alle linee guida vigenti). 3.Trattamento con regime insulinico basal-bolus giornaliero in corso da almeno 90 giorni prima della visita di screening, utilizzando un analogo dell’insulina basale o insulina NPH (Neutral Protamin Hagedorn) 4.Valore di HbA1c = 9,5% analizzato dal laboratorio centrale alla visita di screening |
|
E.4 | Principal exclusion criteria |
1. More than one episode of diabetic ketoacidosis requiring hospitalisation within the last 90 days prior to the screening visit 2. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening |
1. Più di un episodio di chetoacidosi diabetica che abbia richiesto il ricovero in ospedale entro gli ultimi 90 giorni precedenti lo screening.
2. Trattamento con qualsiasi farmaco indicato per il diabete o l’obesità, diverso da quelli stabiliti nei criteri di inclusione, in un periodo di 90 giorni precedenti lo screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c |
Variazione rispetto al valore iniziale dell’ HbA1c dopo 26 settimane di trattamento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
26 weeks after randomisation |
26 settimane dopo la randomizzazione |
|
E.5.2 | Secondary end point(s) |
1. Change from baseline in 8-point self-measured plasma glucose (SMPG) profile (8-point profile): - Mean postprandial glucose (PPG) and PPG increment over all three meals 2. Change from baseline in fasting plasma glucose (FPG) 3. Number of treatment emergent adverse events (AEs) |
1.Variazione rispetto al valore iniziale del profilo glicemico a 8 punti misurato dal paziente (Self-Measured Plasma Glucose, SMPG): 2. Variazione rispetto al valore iniziale dei valori glicemici plasmatici a digiuno (Fasting plasma glucose, FPG) 3. Numero degli eventi avversi (Adverse Event, AE) segnalati durante il trattamento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
26 weeks after randomisation |
26 settimane dopo la randomizzazione |
|
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 |
Parzialmente in doppio cieco parzialmente in aperto, treat to target. |
Partly double-blind, partly open, 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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 36 |
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 | Information not present in EudraCT |
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 |
India |
Israel |
Japan |
Russian Federation |
Serbia |
Turkey |
Ukraine |
United States |
European Union |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | 5 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 5 |