E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 1 Diabetes |
Diabete Mellito di Tipo 1 |
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E.1.1.1 | Medical condition in easily understood language |
Type 1 Diabetes |
Diabete Mellito di Tipo 1 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020639 |
E.1.2 | Term | Hyperglycemia |
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 test the hypothesis that LY900014 is noninferior to insulin lispro on glycemic control (non-inferiority margin [NIM]=0.4% for hemoglobin A1c [HbA1c]) in patients with T1D, when administered as prandial insulin (0 to 2 minutes prior to the meal), in combination with basal insulin glargine or insulin degludec for 26 weeks |
Analizzare l’ipotesi secondo la quale LY900014 è non inferiore a insulina lispro nel controllo glicemico (margine di non inferiorità [non-inferiority margin (NIM)]= 0,4% per emoglobina A1c [HbA1c]) nei pazienti con DM1, se somministrata come insulina prandiale (da 0 a 2 minuti prima del pasto) in combinazione con insulina glargine o insulina degludec basale per 26 settimane |
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E.2.2 | Secondary objectives of the trial |
To test the hypothesis that LY900014 is superior to insulin lispro in controlling 1-hour PPG excursions, when administered as prandial insulin. To test the hypothesis that LY900014 is superior to insulin lispro in controlling 2-hour PPG excursions, when administered as prandial insulin. To test the hypothesis that LY900014 is superior to insulin lispro on improving glycemic control (HbA1c) when administered as prandial insulin. To test the hypothesis that LY900014 administered as postprandial insulin immediately after completion of a meal or at 20 minutes after the start of a meal, whichever comes first (LY900014+20), is noninferior to insulin lispro, administered as prandial insulin, on glycemic control (NIM=0.4% for HbA1c). |
Analizzare l’ipotesi secondo la quale LY900014 è superiore a insulina lispro nel controllo delle escursioni glicemiche postprandiali di 1 ora, se somministrata come insulina prandiale. Analizzare l’ipotesi secondo la quale LY900014 è superiore a insulina lispro nel controllo delle escursioni glicemiche postprandiali di 2 ore, se somministrata come insulina prandiale. Analizzare l’ipotesi secondo la quale LY900014 è superiore a insulina lispro nel migliorare il controllo glicemico (HbA1c), se somministrata come insulina prandiale. Analizzare l’ipotesi secondo la quale LY900014 somministrata come insulina postprandiale subito dopo la fine di un pasto o 20 minuti dopo l’inizio del pasto, a seconda di quale si verifichi prima (LY900014+20), è non inferiore all’insulina lispro, se somministrata come insulina prandiale nel controllo glicemico (NIM= 0,4% per HbA1c). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• You were diagnosed with type 1 diabetes at least one year ago. • You are 18 years old or older. • You are already using a long-acting insulin and rapid-acting insulin analog. • Your blood glucose levels are within allowed limits for study participation |
• Le è stato diagnosticato il diabete di tipo 1 da almeno un anno. • Ha almeno 18 anni. • Sta già utilizzando insulina ad azione prolungata e analoghi dell’insulina ad azione rapida. • I livelli glicemici rientrano nei limiti consentiti per partecipare allo studio.
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E.4 | Principal exclusion criteria |
• You have had more than 1 emergency treatment for very low blood glucose in the last 6 months.
• You have had more than 1 emergency treatment for poor glucose control in the last 6 months.
• You are taking certain diabetes medications that are not allowed for study participation.
• You have major problems with your heart, kidneys, liver, or you have a blood disorder.
• You have had or are now being treated for certain types of cancer that prevents you from study participation. |
• Ha ricevuto più di 1 trattamento di emergenza a causa di ipoglicemia grave negli ultimi 6 mesi. • Ha ricevuto più di 1 trattamento di emergenza a causa di ipoglicemia estrema negli ultimi 6 mesi. • Assume determinati farmaci anti-diabetici non consentiti per partecipare allo studio. • Presenta gravi problemi cardiaci, renali, epatici o soffre di disturbi ematologici. • È stato trattato o è in corso di trattamento per determinati tipi di neoplasia che impediscono la partecipazione allo studio.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Variazione della HbA1c |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Difference between LY900014 and insulin lispro in the 1-hour PPG excursion (serum glucose measured 1 hour after the start of the meal minus fasting serum glucose) from a MMTT. 2. Difference between LY900014 and insulin lispro in the 2-hour PPG excursion (serum glucose measured 2 hours after the start of the meal minus fasting serum glucose) from an MMTT. 3. Difference between LY900014 and insulin lispro in change from baseline in HbA1c 4. Difference between LY900014+20 and insulin lispro in change from baseline in HbA1c |
1. Differenza fra LY900014 e insulina lispro nell’escursione glicemica postprandiale di 1 ora (glicemia misurata 1 ora dopo l’inizio del pasto meno la glicemia a digiuno) analizzata con un test MMTT. 2. Differenza fra LY900014 e insulina lispro nell’escursione glicemica postprandiale di 2 ore (glicemia misurata 2 ore dopo l’inizio del pasto meno la glicemia a digiuno) analizzata con un test MMTT. 3. Differenza fra LY900014 e insulina lispro nella variazione dell’HbA1c dal basale. Differenza fra LY900014+20 e insulina lispro nella variazione dell’HbA1c dal basale 4. Differenza fra LY900014+20 e insulina lispro nella variazione dell’HbA1c dal basale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 26 weeks 2. 26 weeks 3. 26 weeks 4. 26 weeks |
1. 26 settimane 2. 26 settimane 3. 26 settimane 4. 26 settimane |
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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 | Yes |
E.8.1.7.1 | Other trial design description |
un braccio è in aperto |
one arm is open label |
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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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 |
Argentina |
Australia |
Austria |
Brazil |
Germany |
Greece |
India |
Italy |
Japan |
Mexico |
New Zealand |
Poland |
Romania |
Russian Federation |
Slovakia |
Spain |
Switzerland |
Taiwan |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |