E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes mellitus |
Diabete mellito tipo 2 |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes mellitus |
Diabete mellito 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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 demonstrate non-inferiority of Toujeo versus "standard of care" basal insulin therapy as measured by glycated hemoglobin (HbA1c) change. |
Dimostrare la non inferiorit¿ di Toujeo rispetto alla terapia standard con insulina basale misurata attraverso la variazione della HbAlc. |
|
E.2.2 | Secondary objectives of the trial |
1) To demonstrate superiority of Toujeo versus "standard of care" basal insulin if non-inferiority criterion is met, measured by HbA1c change 2) To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification 3) Risk of hypoglycemia including documented, symptomatic hypoglycemia (=70 mg/dL) or severe (according to ADA Working Group). 4) Change in fasting plasma glucose (FPG) 5) Change in body weight 6) Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change versions (DTSQs and DTSQc) 7) Change in hypoglycemia control subscale of Treatment Satisfaction Questionnaire (TSQ) 8) Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs |
1) Dimostrare la superiorit¿ di Toujeo rispetto alla terapia standard con insulina basale se il criterio di non inferiorit¿, misurato attraverso la variazione della HbA1c, sar¿ stato soddisfatto Confrontare Toujeo ad altri trattamenti standard con insulina basale in termini di persistenza paziente con la terapia insulinica basale assegnata con o senza intensificazione 3) Rischio di ipoglicemia ivi compresa ipoglicemia sintomatica documentata (=70 mg / dL) o grave (secondo gruppo di lavoro ADA) 4) Variazione della glicemia a digiuno (FPG) 5) Variazione del peso corporeo 6) Differenze nei risultati riferiti dal paziente misurati mediante il Diabetes Treatment Satisfaction Questionnaire, versioni Status e Change (DTSQs e DTSQc) 7) Variazione della sottoscala di controllo dell'ipoglicemia nel Treatment Satisfaction Questionnaire (TSQ) 8) Utilizzo di strutture sanitarie ivi compresi ricoveri e visite in pronto soccorso o presso altri operatori sanitari e costi dell'assistenza sanitaria |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patients with type 2 diabetes insufficiently controlled (HbA1c >7%) with current (= 6 months) "standard of care" basal insulin therapy (including Lantus insulin glargine U100, Levemir, NPH or Tresiba or new basal insulin products including biosimilar) with or without oral agents (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinides) and with or without use of a GLP-1 receptor agonist 2) Fasting plasma glucose (FPG) >130 mg/dL (7.2 mmol/L) 3) Adult patients who have signed an Informed Consent Form (ICF) and privacy form(s) |
1) Pazienti con diabete di tipo 2 non sufficientemente controllato (HbAlc >7%) attualmente in terapia (=6 mesi) con insulina basale standard (ivi compresa insulina glargine Lantus U100, Levemir, NPH, Tresiba o altri nuovi prodotti insulinici compresi biosimilari) con o senza farmaci orali (metformina, sulfoniluree, tiazolidinedione, inibitori della DPP-4, inibitori del SGLT-2, glinidi) e con o senza l'uso degli agonisti del recettore del GLP-1 2) Glicemia a digiuno (FPG) >130 mg/dl (7,2 mmol/l) 3) Pazienti adulti che hanno firmato un consenso informato e l'autorizzazione al trattamento dei dati personali |
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E.4 | Principal exclusion criteria |
1) HbA1c =7%, no upper bound 2) Age <18 years 3) Type 1 diabetes mellitus 4) Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient's successful participation for the duration of the study 5) Use of any product containing short or rapid acting insulin since the time of diagnosis with type 2 diabetes mellitus other than temporary use during a pregnancy or hospitalization, (such as Humulin®-R, Humalog®, Novolog®, Apidra®, Afrezza®, pre-mix insulin and including biosimilar preparation of these products, or other rapid acting insulins which may become available.) 6) Use of any product containing short or rapid acting insulin occurring within 3 months prior to the time of screening, such as Humulin-R, Humalog, Novolog, Apidra, Afrezza, pre-mix insulin and including biosimilar preparations of these products, or other rapid acting insulins which may become available) 7) Use of oral hypoglycemic agents other than those noted in the inclusion criteria, GLP-1 receptor agonists not approved for use with insulin, or any investigational agent (drug, biologic, device) within 3 months prior to the time of screening 8) All contraindications to "standard of care" insulin therapy or warnings/precautions of use as displayed in the respective National Product labeling for these products 9) Pregnancy or lactation 10) Women of childbearing potential with no effective contraceptive method |
1) HbAlc =7%, nessun limite superiore 2) Età <18 anni 3) Diabete mellito di tipo 1 4) Qualsiasi alterazione clinicamente significativa identificata in sede di esame obiettivo, test di laboratorio o segni vitali al momento dello screening o qualsiasi importante malattia sistemica risultante in una aspettativa di vita breve che, secondo l'opinione dello sperimentatore, potrebbe restringere o limitare la partecipazione del paziente per tutta la durata dello studio 5) Uso di un qualsiasi prodotto contenente insulina ad azione breve o rapida dal momento della diagnosi di T2DM (quali Humulin®-R, Humalog®, Novolog®, Apidra®, Afrezza®, insulina premiscelata, inclusi prodotti biosimilari o altre insuline ad azione rapida che potrebbero essere disponibili in commercio) eccezion fatta per un uso temporaneo durante la gravidanza o un ricovero 6) Uso di un qualsiasi prodotto contenente insulina ad azione breve o rapida nei 3 mesi precedenti lo screening, come Humulin®-R, Humalog®, Novolog®, Apidra®, Afrezza®, insuline premiscelate, incluse preparazioni biosimilari di questi prodotti, o altre insuline ad azione rapida che potrebbero essere disponibili in commercio 7) Uso di agenti ipoglicemizzanti orali diversi da quelli indicati nei criteri di inclusione, agonisti del recettore del GLP-1 non approvati per l'uso con insulina o qualsiasi prodotto sperimentale (farmaco, biologico, dispositivo) nei 3 mesi precedenti lo screening 8) Tutte le controindicazioni alla terapia con insulina standard o le avvertenze/precauzioni d'uso indicate nella relativa etichettatura nazionale di questi prodotti 9) Gravidanza o allattamento 10) Donne in età fertile che non utilizzano alcun metodo contraccettivo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent change in HbA1c |
Variazione percentuale della HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to 6 months |
dal basale al mese 6 |
|
E.5.2 | Secondary end point(s) |
Percent change in HbA1c; Percentage of patients whose HbA1c decreased at least 0.5%; Percentage of patients whose HbA1c decreased at least 0.5%; Percentage of patients requiring intensification and time to intensification; Change in fasting plasma glucose; 1- Proportion of patients who remain on assigned basal insulin therapy before intensification (persistent with assigned therapy) 2- Proportion of patients who remain on assigned basal insulin therapy whether intensification occurred or not 3- Proportion of patients who achieve target HbA1c (<6.5%, <7%, <7.5%,<8.0%) 4- Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (blood glucose [BG] = 70 mg/dl, [3.9 mmol/L]) symptomatic or severe 5- Proportion of patients with HbA1c target (thresholds listed above) (attainment of metabolic benefit) without documented (BG <54 mg/dl, [3.0 mmol/L]) symptomatic or severe hypoglycemia |
Variazione percentuale della HbA1c; Percentuale di pazienti la cui HbA1c ¿ diminuita di almeno lo 0,5%; Percentuale di pazienti la cui HbA1c ¿ diminuita di almeno lo 0,5%; Percentuale di pazienti che necessita di intensificazione e tempo all'intensificazione; Variazione della glicemia a digiuno; 1- Proporzione di pazienti che continua ad assumere la terapia con insulina basale assegnata prima dell'intensificazione (persistenti alla terapia assegnata) 2- Proporzione di pazienti che continua ad assumere la terapia con insulina basale indipendentemente che l'intensificazione sia avvenuta o meno 3- Proporzione di pazienti che raggiunge il livello target di HbA1c (<6,5%, <7%, <7,5%,<8,0%) 4- Proporzione di pazienti con HbA1c target (soglie limite summenzionate) (raggiungimento del vantaggio metabolico) senza ipoglicemia documentata (BG =70 mg/dl, [3,9 mmol/l]) sintomatica o grave 5- Proporzione di pazienti con HbA1c target (soglie limite summenzionate) (raggiungimento del vantaggio metabolico) senza ipoglicemia documentata (BG <54 mg/dl, [3.0 mmol/l]) sintomatica o grave |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
From baseline to Month 12; at Month 6 and Month 12; at Month 6 and maintained at Month 12; at Month 6 and Month 12; From baseline to Month 6 and Month 12; at Month 6 and Month 12 |
dal basale al mese 12; al mese 6 e al mese 12; al mese 6 e si ¿ mantenuta costante al mese 12; al mese 6 e al mese 12; dal basale al mese 6 e al mese 12; al mese 6 e al mese 12 |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 25 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 122 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 6 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 6 |