Insulina degludec en pacientes diabéticos tipo 1: observación a 18 meses / Degludec insulin in type 1 diabetic patients: 18 months of observation

Antecedentes: En el tratamiento de la diabetes se buscan insulinas de acción más prolongada y con menores tasas de hipoglicemias. Objetivo. Uso del análogo de insulina de acción ultralenta degludec en diabéticos tipo 1 (DM1) tratados previamente con glargina. Pacientes y método: Se observaron 230 DM1 durante 18 meses, promedio de edad 34 años y de diagnóstico 14 años, registrándose parámetros clínicos, bioquímicos, hipoglicemias y requerimientos de insulina (U/kg/peso), en régimen basal/bolo, con degludec y ultra-rápida precomidas. Degludec se ajustó quincenalmente. Resultados: A los 3 meses, la glicemia de ayunas disminuyó de 253mg/dl (243-270) a 180 mg/dl (172- 240), (p< 0,05); a los 6 meses a 156 mg/dl (137-180) (p< 0,05), a los 12 meses a 151 mg/dl (50-328) (p< 0,001) y a los 18 meses 150 (50-321) (p<0,001). La HbA1c, inicialmente de 10,6% (10,3-12,2) bajó a los 3 meses a 8,7% (8,2-11,1) (p< 0,05), a 6 meses a 8,3% (8,0-9,6) (p<0,05), a los 12 meses subió 9,0% (5,9-14,5) (p<0,001) y a los 18 meses 9,0% (5,9-14,6) (p<0,001). La dosis de degludec fue 0,5 U/kg/peso a los 18 meses. Hubo reducción de hipoglicemias: a los 3 meses 14 leves, 4 moderados 1 grave; a los 6 meses 8 leves, 2 moderados y ninguna grave; a los 12 meses 1 leve, y a los 18 meses 2 leves, 1 moderado y ninguna grave. Un 7,8% no presentó hipoglicemias. Conclusión: Degludec en DM1 mostró reducir las glicemias de ayunas y HbA1c, y menor número de hipoglicemias.

Background: In the treatment of diabetes, longer-acting insulins with lower rates of hypoglycaemia are sought. Objective. Use of ultralow-acting insulin analog degludec in type 1 diabetic patients (T1D) previously treated with glargine. Patients and method: 230 T1D patients were observed during 18 months, average of age 34 years and of diagnosis 14 years, registering clinical, biochemical, hypoglycemia and insulin requirements (U / kg / weight), in basal / bolus regimen, with degludec and ultra-fast pre-meals. Degludec adjusted himself fortnightly. Results: At 3 months, the fasting glycemia decreased from 253 mg / dl (243-270) to 180 mg / dl (172 - 240), (p <0.05); at 6 months at 156 mg / dl (137-180) (p <0.05), at 12 months at 151 mg / dl (50-328) (p <0.001) and at 18 months 150 (50-321) ;(p <0.001). HbA1c, initially of 10.6% (10.3-12.2), decreased after 3 months to 8.7% (8.2 - 11.1) (p <0.05), to 6 months to 8 months, 3% (8.0-9.6) (p <0.05), at 12 months it rose 9.0% (5.9-14.5) (p <0.001) and at 18 months 9.0 % (5.9-14.6) (p <0.001). The dose of degludec was 0.5 U / kg / weight at 18 months. There was reduction of hypoglycemia: at 3 months, 14 mild, 4 moderate, 1 severe; at 6 months 8 mild, 2 moderate and none serious; at 12 months 1 mild, and at 18 months 2 mild, 1 moderate and none serious. 7.8% did not present hypoglycemia. Conclusion: Degludec in T1D patients showed to reduce fasting glycemia and HbA1c, and lower number of hypoglycemia.

Eficacia y seguridad de IdegLira para la intensificación del tratamiento en la diabetes tipo 2 / Efficacy and safety of IdegLira for the intensification of type 2 diabetes treatment

La diabetes mellitus es una verdadera pandemia; la diabetes tipo 2 en particular, con su carácter progresivo, constituye un grave problema de salud. A pesar de los avances e innovaciones en el tratamiento, continúa generando una alta morbimortalidad, debido a que muchos pacientes no logran los objetivos de control metabólicos, entre otras causas por la inercia clínica, el temor a la hipoglucemia, el aumento de peso, la complejidad del tratamiento y la falta de adherencia al mismo. En el último tiempo, se ha evaluado con éxito los resultados clínicos del uso combinado de insulina basal y agonistas del receptor del péptido similar al glucagón tipo 1 (AR-GLP1). Se propone, por lo tanto, el uso combinado de una insulina basal (insulina degludec) con un AR-GLP1 (liraglutida), en un único dispositivo (IdegLira), como una alternativa terapéutica eficaz y segura para la intensificación del tratamiento de las personas con diabetes tipo 2. IdegLira ha demostrado mayores reducciones de HbA1c comparado con sus componentes individuales, con un bajo riesgo de hipoglucemia y pérdida de peso, tanto en pacientes naive de insulina como en aquellos previamente insulinizados. En esta revisión se describe la farmacología, el racional de la combinación y la evidencia clínica relevante de la seguridad y eficacia de IdegLira.

Diabetes mellitus is a true pandemic; type 2 diabetes in particular, with its progressive nature, constitutes a serious health problem. Despite advances and innovations in treatment, it continues to generate high morbidity and mortality.Many patients do not achieve their metabolic control objectives, due to clinical inertia, fear of hypoglycaemia, weight gain, the complexity of the treatment and the lack of adherence to it. Recently, the clinical results of the combined use of basal insulin and agonist receptor of the glucagon-like peptide type 1 (AR-GLP1) have been successfully evaluated. Therefore, the combined use of a basal insulin (insulin degludec) with an AR-GLP1 (liraglutide), in a single device (IdegLira), is proposed as an effective and safe therapeutic alternative for the treatment intensification in people with type 2 diabetes. IdegLira has shown greater reductions in HbA1c compared to its individual components, with a low risk of hypoglycaemia and weight loss, both in insulin naïve patients and in those previously insulinized. In this review we describe the pharmacology, the rational of the combination and the most relevant clinical evidence on IdegLira safety and efficacy.

Insulinización en la diabetes mellitus tipo 2: Alternativas de intensificación / Insulinization in type 2 diabetes mellitus. Intensification options

La diabetes mellitus se asocia con complicaciones vasculares y elevadas tasas de morbimortalidad. La terapia oportuna con insulina y su intensificación cuando es necesaria, representan estrategias apropiadas para evitar o retardar la aparición de dichas complicaciones. Sin embargo, la incidencia de hipoglucemia y las dificultades en la adherencia al tratamiento representan barreras para alcanzar el éxito terapéutico. Las nuevas combinaciones de análogos de insulina constituyen tratamientos que presentarían ventajas farmacocinéticas y farmacodinámicas, logrando beneficios clínicos tales como un mejor control metabólico, la disminución de eventos hipoglucémicos y, por su simplicidad, potencialmente una mayor adherencia al tratamiento.

Diabetes mellitus is associated with vascular complications and high rates of morbidity and mortality. Timely insulin therapy, intensified when necessary, represent appropriate measures to prevent or delay the onset of complications. However, the incidence of hypoglycemia and difficulties in treatment adherence represent barriers to achieve therapeutic success. Premixes analogs and, specially, combinations of insulin analogues are associated with pharmacokinetic and pharmacodynamic advantages, that translate into clinical benefits such as improved metabolic control, decreased hypoglycemic events and, for their simplicity, potentially greater adherence.

[New insulin types in type 1 diabetes mellitus]. / Nuevas insulinas en la diabetes tipo 1.

Since its discovery almost a century ago, insulin remains the mainstay of treatment of patients with type 1 diabetes mellitus. Although progress in the synthesis of new formulations has been remarkable, the physiological profile of insulin is still different from that observed with preparations available nowadays. In the last decade, the introduction into clinical practice of insulin analogues has allowed significantly improvement in glycemic control and has facilitated the spread of basal/bolus patterns, the most physiological ones until now. Despite the benefits of basal analogues, glycemia often varies considerably when used as a single daily injection and this is why new molecules have been further investigated. Improvement has been achieved especially in terms of duration and rate of hypoglycemia, the main limiting factor of intensive therapy. This article reviews the available data concerning the new basal insulin analogues, degludec, pegylated lispro and glargine U300, and new formulations currently under development.