E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
Diabetes Mellitus tipo |
|
E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Diabetes 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 | 19.1 |
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. |
Comparar el efecto de semaglutida por vía subcutánea (SC), 1,0 mg una vez a la semana, con el de liraglutida SC, 1,2 mg una vez al día, sobre el control de la glucemia después de 30 semanas de tratamiento en pacientes con diabetes 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. |
Comparar los efectos de semaglutida SC, 1,0 mg una vez a la semana, con los de liraglutida SC, 1,2 mg una vez al día, después de 30 semanas de tratamiento sobre el peso corporal, parámetros de eficacia, la seguridad y la tolerabilidad en pacientes con diabetes 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). |
•Varón o mujer de edad ≥ 18 años en el momento de firmar el consentimiento informado. •Diagnóstico de diabetes mellitus tipo 2. •HbA1c de 7,0%-11,0% (53-97 mmol/mol) (ambos inclusive). •Dosis diarias estables de cualquiera de los siguientes antidiabéticos o regímenes de combinación en los 90 días previos al día de selección: a)Biguanidas (metformina ≥ 1500 mg o dosis máxima tolerada documentada en la historia clínica del paciente). b)Sulfonilureas (≥ mitad de la dosis máxima autorizada según la ficha técnica local o dosis máxima tolerada documentada en la historia clínica del paciente). c)Inhibidores del SGLT-2 (≥ mitad de la dosis máxima autorizada según la ficha técnica local o dosis máxima tolerada documentada en la historia clínica del paciente). |
|
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. |
•Antecedentes personales o familiares de síndrome de neoplasias endocrinas múltiples tipo 2 o carcinoma medular de tiroides. El término «familiares» se refiere a parientes de primer grado. •Antecedentes o presencia de pancreatitis (aguda o crónica). •Antecedente de cetoacidosis diabética. •Cualquiera de las circunstancias siguientes: infarto de miocardio, ictus, hospitalización por angina de pecho inestable o accidente isquémico transitorio en los 180 días previos al día de selección. •Pacientes en clase funcional IV según la New York Heart Association (NYHA). •Revascularización arterial coronaria, carotídea o periférica ya programada el día de la selección. •Disfunción renal medida como un valor de filtración glomerular estimada (FGe) < 30 ml/min/1,73 m2, definida según la clasificación de 2012 de la KDIGO1. •Disfunción hepática, definida como una ALT ≥ 2,5 veces el límite superior de la normalidad en la selección. •Retinopatía proliferativa o maculopatía con necesidad de tratamiento a corto plazo. Verificada mediante oftalmoscopia con dilatación o fotografía del fondo de ojo realizada en los 90 días previos a la aleatorización. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c. |
Variación de la HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to week 30 |
Entre el momento basal y la semana 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 |
Variación de los parámetros siguientes: 1.Peso corporal (kg). 2.Glucosa plasmática en ayunas (GPA). 3.Presión arterial sistólica y diastólica. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.-3. From baseline to week 30 |
1-3. Entre el momento basal y la semana 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 |
Tolerabilidad |
|
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 | 6 |
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 | No |
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 |