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 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Diabete di tipo 2 |
|
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 | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
|
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 compare the effect of semaglutide subcutaneous (s.c.) 1.0 mg once-weekly versus liraglutide s.c. 1.2 mg once-daily on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. |
Confrontare l¿effetto di semaglutide in somministrazione sottocutanea (s.c.) 1,0mg una volta alla settimana in confronto a liraglutide s.c. 1,2mg una volta al giorno sul controllo glicemico dopo 30 settimane di trattamento in soggetti con diabete tipo 2. |
|
E.2.2 | Secondary objectives of the trial |
To compare the effects of semaglutide s.c. 1.0 mg once-weekly versus liraglutide s.c. 1.2 mg once-daily after 30 weeks of treatment on body weight, efficacy parameters, safety and tolerability in subjects with type 2 diabetes. |
Confrontare gli effetti di semaglutide s.c. 1,0mg una volta alla settimana in confronto a liraglutide s.c. 1,2mg una volta al giorno dopo 30 settimane di trattamento su peso corporeo, parametri di efficacia, sicurezza e tollerabilit¿ in soggetti con diabete tipo 2. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus. - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive). - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin equal to or above 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (equal to or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). c) SGLT-2 inhibitors (equal to or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record). |
-Sesso maschile o femminile, = 18 anni di età al momento della firma del modulo di consenso informato. -Diagnosi di diabete mellito tipo 2. -HbA1c compresa tra 7 e 11% (53 - 97 mmol/mol)(entrambi inclusi). -Dose/i giornaliera/e stabile/i di uno dei seguenti farmaci antidiabetici o regimi di combinazione nei 90 giorni precedenti lo screening: a) Biguanidi (metformina = 1500 mg o dose massima tollerata documentata nella cartella clinica del soggetto). b) Sulfaniluree (= metà della dose massima approvata in accordo al folgietto illustrativo locale o dose massima tollerata documentata nella cartella clinica del soggetto). c) Inibitori di SGLT-2 (= metà della dose massima approvata in accordo al folgietto illustrativo locale o dose massima tollerata documentata nella cartella clinica del soggetto). |
|
E.4 | Principal exclusion criteria |
- Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative. - History or presence of pancreatitis (acute or chronic). - History of diabetic ketoacidosis. - Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening. - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 ml/min/1.73 m^2 as defined by KDIGO 2012 classification. - Impaired liver function, defined as ALT equal to or above 2.5 times upper normal limit at screening. - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation. |
-Storia familiare o personale di neoplasia endocrina multipla di tipo 2 o di carcinoma midollare della tiroide. Per familiare si intende un parente di primo grado. -Storia o presenza di pancreatite (acuta o cronica). -Storia di chetoacidosi diabetica. -Uno qualsiasi dei seguenti eventi: infarto del miocardio, ictus, ricovero in ospedale per angina instabile o attacco ischemico transitorio nei 180 giorni precedenti al giorno dello screening. -Soggetti attualmente classificati nella Classe IV della New York Heart Association (NYHA). -Rivascolarizzazione arteriosa periferica, carotidea o coronarica pianificata nota il giorno dello screening. -Insufficienza renale misurata in termini di velocità di filtrazione glomerulare stimata (estimated Glomerular Filtration Rate, eGFR) con un valore <30 ml/min/1,73 m2 definito secondo la classificazione KDIGO 2012. -Funzionalità epatica ridotta, definita come alanina aminotransferasi (ALT) = 2,5 volte il limite superiore allo screening. -Retinopatia proliferativa o maculopatia che necessita di trattamento acuto, verificata per mezzo di fotografia del fondo oculare o fondoscopia in condizioni di dilatazione eseguita entro i 90 giorni precedenti la randomizzazione. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Variazione dell'HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to week 30 |
Dal valore basale alla settimana 30 |
|
E.5.2 | Secondary end point(s) |
1. Change in body weight (kg) 2. Change in fasting plasma glucose (FPG) 3. Change in systolic and diastolic blood pressure |
1. Variazione del peso corporeo (kg) 2. Variazione della glicemia a digiuno (Fasting Plasma Glucose, FPG) 3. Variazione della pressione arteriosa sistolica e diastolica
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.-3. From baseline to week 30 |
1.-3. Dal valore basale alla settimana 30 |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tollerabilit¿ |
|
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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 79 |
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
|
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | 18 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 18 |