E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Diabetes type 2. |
Pacientes con Diabetes tipo 2. |
|
E.1.1.1 | Medical condition in easily understood language |
Diabetes type 2 |
Diabetes tipo 2. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
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 |
The aim of this trial is to assess the effect pf a GLP1 agonist on clinically relevant measures of myocardial function. |
El objetivo de este ensayo es evaluar el efecto de un agonista de GLP1 spnre medidas clínicamente relevantes de función miocárdica. |
|
E.2.2 | Secondary objectives of the trial |
Distance covered during a 6 minute walk test. Left ventricular function parameters (ecocardiography). Diastolic function (ecocardiography) Total number of steps in 24 hours, registered by Holter. Quality of life questionnaires. HbA1c amd total daily insulin dose. Lipids nd apoB CRP ProBNP Fasting C peptide Daily medication Body weight, waist circumference and BMI |
Distancia recorrida durante una prueba de marcha de 6 minutos. Fracción de eyección y otras medidas de función ventricular sistólica evaluadas por ecocardiografía. Función ventricular diastólica evaluada por ecocardiografía. Pro-BNP, PCR. HbA1c, perfil lipídico, apolipoproteína B, CRP, peso corporal, perímetro de cintura. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Type 2 diabetes treated with oral agents (including metformin if tolerated and not contraindicated), a maximum of 2 intermediate-long acting insulin injections per day or a combination of both. -HbA1c between 7 and 10 %. |
-Diabetes tipo 2 tratada con agentes orales (incluyendo metformina, en ausencia de intolerancia o contraindicación a la misma), un máximo de 2 inyecciones de insulina de acción intermedia o lenta o la combinación de ambos tipos de tratamiento. - HbA1c 7-10%. |
|
E.4 | Principal exclusion criteria |
Severe renal failure (estimated CFR<30ml/min) Liver failure (child-pugh score > 6 points) Present or planned pregnancy/breastfeeding or inadequate contraception intolerance/allergy to liraglutide Familiar/personal history of medullary thyroid cancer or multiple endocrine neoplasia 2 personal history of pancreatitis triglyceride concentrations above 500mg/dl or alcohol intake>40 grams/day known active malignancy tratment with GLP1 agonist or DPP4 inhibitors in the previous 3 months factors potentially interfering with adherence to treatment or follow-up (investigator´s criteria) known coronary artery disease with exercise-induced ischaemia planned revascularisations in the following 6 months severe symptoms of heart failure (NYHA class IV) |
Fallo renal severo (estimado CFR<30ml/min). Fallo hepático (child-pugh marcador >6 puntos) Embarazo actual o planeado/lactancia maternal o metodos anticonceptivos inapropiados Intolerancia/alergia a liraglutide Familiar/personal historial de cancer medular de tiroides o neoplasia 2 endocrina múltiple Historial personal de pancreatitis Concentraciones de triglicéridos por encima de 500mg/dl o ingesta de alcohol > 40 gramos/día Maligno activo conocido Tratamiento con agonista GLP1 o inhibidores de DPP4 en los tres meses anteriores. Factores potenciales que interfieran en la adherencia y seguimiento del tratamiento (criterio del investigador) Enfermedad arterial coronaria conocida con isquemia producida por ejercicio. Revascularización planeada en los siguientes 6 meses. Sintomas severos de fallo cardíaco (NYHA casificación IV) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Fitness, assessed as maximum oxygen comsumption (VO2 max) on a cycle ergometer test. |
Consumo máximo de oxígeno durante una prueba de esfuerzo con cicloergómetro. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Distance covered during a 6 minute walk test. left ventricular function parameters. Diastolic function. Total number of steps in 24 hours, registered by Holter. Quality of life questionnaires. HbA1c amd total daily insulin dose. Lipids nd apoB CRP ProBNP Fasting C peptide Daily medication Body weight, waist circumference and BMI |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and 26 weeks and 12 weeks for some measurementes |
|
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 | Yes |
E.6.4 | Safety | No |
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 | 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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |