E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
(ES): Diabetes mellitus tipo 2 (EN): Type 2 diabetes mellitus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
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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 |
(ES): Evaluar el efecto del tratamiento con liraglutida en comparación con un placebo durante un mínimo de 3,5 años y un máximo de 5 años sobre la incidencia de episodios cardiovasculares, según lo definido por los siguientes criterios de valoración principales y secundarios, en adultos con diabetes tipo 2 que tienen un riesgo elevado de sufrir episodios cardiovasculares. (EN): To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 year and up to 5 years on the incidence of cardiovascular events, as defined by the below primary and secondary endpoints, in adults with type 2 diabetes that are at high risk for cardiovascular events |
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E.2.2 | Secondary objectives of the trial |
(ES): Evaluar la eficacia y la seguridad con respecto a acontecimientos clínicamente importantes u otros parámetros sustitutivos del tratamiento con liraglutida en comparación con un placebo en adultos con diabetes tipo 2 que tienen un riesgo elevado de sufrir episodios cardiovasculares. (EN): To assess the efficacy and safety with regard to clinically important events or other surrogate parameters of treatment with liraglutide compared to placebo in adults with type 2 diabetes that are at high risk for cardiovascular events |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(ES): Varones o mujeres con diabetes de tipo 2. Edad mayor o igual a 50 años en el momento de la selección y enfermedad cardiovascular, enfermedad cerebrovascular, vasculopatía periférica, insuficiencia renal crónica o insuficiencia cardiaca crónica o edad mayor o igual a 60 años en el momento de la selección y otros factores de riesgo especificados de vasculopatía. HbA1c mayor o igual a 7,0% en el momento de la selección. (EN): - Men or women with type 2 diabetes - Age major or equal to 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age major o equal to 60 years at screening and other specified risk factors of vascular disease - HbA1c major or equal to 7.0% at screening |
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E.4 | Principal exclusion criteria |
(ES): Diabetes tipo 1. Uso de un agonista de los receptores del GLP-1 (exenatida, liraglutida u otro) o pramlintida o cualquier inhibidor de la dipeptidil-peptidasa 4 (DPP-4) en los 3 meses previos a la selección. Uso de insulina distinta de la insulina de tipo protamina neutra de Hagedorn (NPH) humana o de un análogo de la insulina de acción prolongada en los 3 meses previos a la selección. Se permite, a discreción del investigador, el uso a corto plazo durante ese periodo de otro tipo de insulina por una enfermedad intercurrente. Descompensación aguda del control de la glucemia que requiere una intensificación inmediata del tratamiento para prevenir complicaciones agudas de la diabetes (por ejemplo, cetoacidosis diabética) en los 3 meses previos. Episodio coronario o cerebrovascular agudo en los 14 días previos. Terapia de reemplazo renal continuo Hepatopatía terminal. Insuficiencia cardiaca en clase funcional IV de la NYHA. Trasplante de órgano sólido previo o a la espera de un trasplante de órgano sólido. Familia o antecedentes personales de neoplasia endocrina múltiple de tipo 2 (MEN2) o carcinoma medular de tiroides familiar (CMTF). Antecedentes personales de carcinoma medular de tiroides no familiar. Neoplasia maligna que requería quimioterapia, cirugía, radioterapia o tratamiento paliativo en los 5 años anteriores. Se permitirá participar en el estudio a sujetos con carcinoma epidermoide intraepitelial de la piel (enfermedad de Bowen) tratados con 5-fluorouracilo (5FU) tópico y a sujetos con cáncer de piel basocelular. (EN): - Type 1 diabetes - Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any (dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening - Use of insulin other than human neutral protamine hagedorn (NPH) insulin or long-acting insulin analogue within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed at Investigator's discretion - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months - An acute coronary or cerebrovascular event in the previous 14 days - Current continuous renal replacement therapy - End-stage liver disease - Chronic heart failure NYHA IV - A prior solid organ transplant or awaiting solid organ transplant - Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) - Personal history of non-familial medullary thyroid carcinoma - Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen's disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial |
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E.5 End points |
E.5.1 | Primary end point(s) |
(ES): Tiempo desde la aleatorización hasta la primera aparición de muerte de origen cardiovascular, infarto de miocardio no mortal o ictus no mortal (un criterio de valoración cardiovascular compuesto). (EN): Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 |
Run-in period is open label |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 133 |
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 |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 19 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 19 |