A study to assess the unmet medical needs associated with the use of basal insulin in patients with type 2 diabetes.

Aim: To describe in a real-world setting, the proportion of patients with a symptomatic hypoglycaemic event and the proportion of individuals with type 2 diabetes, who newly or recently initiated with basal insulin, achieving individual or general HbA1c target. Materials and Method: DINAS-AR was a national prospective observational study to assess the unmet needs in patients with type 2 diabetes treated with basal insulin with or without oral antihyperglycaemic drugs and/or GLP-1 receptor agonist. The study was conducted at 19 hospitals. Results: A total of 385 uncontrolled patients (≥18 years) who recently initiated basal insulin or who initiated treatment within a year prior to study enrolment entered the study. Outcomes were follow-up incidence of hypoglycaemic events, change of HbA1C and achievement of HBA1c <7% or individual target. A total of 44 patients (11.9%) reported the occurrence of ≥1 symptomatic hypoglycaemia event(s). HbA1c reductions were greater in patients who had recently initiated treatment with basal insulin (between 15 and 90 days prior to study entry) vs patients who initiated treatment within 1 year. A total of 80 patients (31.6%) achieved individual HbA1c target (or target <7.0%) at Week 24. Furthermore, the proportion of patients achieving this target without symptomatic hypoglycaemia was 26.1% (n = 66). A lower percentage of glycemia target achievement was observed in patients reporting hypoglycaemia (n = 14), 20.6% of all patients reporting hypoglycaemia event(s) vs (n = 66) 35.7% of all patients without hypoglycaemia event reported. Conclusion: In this real-world study, although the hypoglycaemia rate was not high in adults with type 2 diabetes treated with insulin, there was a lower percentage of patients that achieved glycemic target among those reporting hypoglycaemia events vs patients who did not report them.

[New generation of insulins: glargine U300. Summary of clinical evidence]. / Nueva generación de insulinas: glargina U300. Resumen de evidencia clínica.

Type 2 diabetes is a chronic, progressive disease with increasing prevalence and still late diagnostic. This leads to an increase in the incidence of chronic complications, with signifi cantly increasing health costs. There is also a delay in the onset of insulin therapy in patients with type 2 diabetes for causes related to both patients and physicians. Despite advances in treatment, a low proportion of patients achieve adequate glycemic control. The high hypoglycemia prevalence, consequence of insulin, has led to the development of a new generation long-acting basal insulins to achieve a more stable and prolonged action profile, reducing the variability and risk of hypoglycemia. The EDITION program evaluated the efficacy and safety of glargine U300 compared to glargine U100 in patients with type 1 and 2 diabetes at different stages of the disease. Gla-300 is a new formulation of insulin glargine which has a more stable and prolonged pharmacokinetic and pharmacodynamic profile. Gla-300 demonstrated efficacy and tolerability comparable to glargine U100, with a significant decrease in the risk of hypoglycemia, at night and in 24 hours, providing greater flexibility in the injection schedule, with a window of 6 hours. No increase in weight was observed compared to glargine U100. Bright study (2018) compared glargine U300 vs. degludec U100, demonstrating greater benefit in relation to the risk of hypoglycemia with Gla-300 during titration period. Gla-300 is a last-generation basal insulin, available to improve metabolic control, with a lower risk of hypoglycemia.

La diabetes mellitus tipo 2 tiene evolución crónica y progresiva, prevalencia creciente y aún es diagnosticada tardíamente. Esto conlleva mayor incidencia de complicaciones crónicas, con incremento de costos en salud. Existe retraso en el inicio de insulinoterapia por causas relacionadas tanto al paciente como al médico. A pesar de los avances en su tratamiento, una baja proporción de enfermos logra control glucémico adecuado. La alta prevalencia de hipoglucemia en pacientes insulino-tratados, impulsó el desarrollo de una nueva generación de insulinas basales de acción prolongada, mayor estabilidad con menor variabilidad y riesgo de hipoglucemias. El programa EDITION evaluó la eficacia y seguridad de glargina U300 vs. glargina U100 en pacientes con diabetes tipo 1 y 2, en distintas etapas de la enfermedad. Glargina U300 es una nueva formulación de insulina glargina con perfil farmacocinético y farmacodinámico más estable y prolongado que glargina U100. Glargina U300 demostró eficacia y tolerabilidad comparable a glargina U100, con descenso significativo del riesgo de hipoglucemias nocturnas y en 24 horas, aportando mayor flexibilidad en el horario de inyección, con una ventana de 6 horas. Además, no se observó mayor aumento de peso que con glargina U100. El estudio Bright (2018) comparó glargina U300 vs. degludec U100, demostrando mayor beneficio en relación al riesgo de hipoglucemia con Gla-300 durante el período de titulación. Gla-300 es una insulina basal de última generación, disponible para mejorar el control metabólico, con menor riesgo de hipoglucemia.

Nueva generación de insulinas: glargina U300: Resumen de evidencia clínica / New generation of insulins: glargine U300. Summary of clinical evidence

La diabetes mellitus tipo 2 tiene evolución crónica y progresiva, prevalencia creciente y aún es diagnosticada tardíamente. Esto conlleva mayor incidencia de complicaciones crónicas, con incremento de costos en salud. Existe retraso en el inicio de insulinoterapia por causas relacionadas tanto al paciente como al médico. A pesar de los avances en su tratamiento, una baja proporción de enfermos logra control glucémico adecuado. La alta prevalencia de hipoglucemia en pacientes insulino-tratados, impulsó el desarrollo de una nueva generación de insulinas basales de acción prolongada, mayor estabilidad con menor variabilidad y riesgo de hipoglucemias. El programa EDITION evaluó la eficacia y seguridad de glargina U300 vs. glargina U100 en pacientes con diabetes tipo 1 y 2, en distintas etapas de la enfermedad. Glargina U300 es una nueva formulación de insulina glargina con perfil farmacocinético y farmacodinámico más estable y prolongado que glargina U100. Glargina U300 demostró eficacia y tolerabilidad comparable a glargina U100, con descenso significativo del riesgo de hipoglucemias nocturnas y en 24 horas, aportando mayor flexibilidad en el horario de inyección, con una ventana de 6 horas. Además, no se observó mayor aumento de peso que con glargina U100. El estudio Bright (2018) comparó glargina U300 vs. degludec U100, demostrando mayor beneficio en relación al riesgo de hipoglucemia con Gla-300 durante el período de titulación. Gla-300 es una insulina basal de última generación, disponible para mejorar el control metabólico, con menor riesgo de hipoglucemia.

Type 2 diabetes is a chronic, progressive disease with increasing prevalence and still late diagnostic. This leads to an increase in the incidence of chronic complications, with signifi cantly increasing health costs. There is also a delay in the onset of insulin therapy in patients with type 2 diabetes for causes related to both patients and physicians. Despite advances in treatment, a low proportion of patients achieve adequate glycemic control. The high hypoglycemia prevalence, consequence of insulin, has led to the development of a new generation long-acting basal insulins to achieve a more stable and prolonged action profile, reducing the variability and risk of hypoglycemia. The EDITION program evaluated the efficacy and safety of glargine U300 compared to glargine U100 in patients with type 1 and 2 diabetes at different stages of the disease. Gla-300 is a new formulation of insulin glargine which has a more stable and prolonged pharmacokinetic and pharmacodynamic profile. Gla-300 demonstrated efficacy and tolerability comparable to glargine U100, with a significant decrease in the risk of hypoglycemia, at night and in 24 hours, providing greater flexibility in the injection schedule, with a window of 6 hours. No increase in weight was observed compared to glargine U100. Bright study (2018) compared glargine U300 vs. degludec U100, demonstrating greater benefit in relation to the risk of hypoglycemia with Gla-300 during titration period. Gla-300 is a last-generation basal insulin, available to improve metabolic control, with a lower risk of hypoglycemia.

Treat-to-target HbA1c and lipid profile to prolong ß-cell mass/function and optimize treatment goal attainment.

BACKGROUND: To evaluate the relation between different serum lipid fractions and other known barriers to attain the HbA1c  ≤ 7.0% (53 mmol/mol) target. METHODS: Data on 2719 patients with type 2 diabetes were collected from the five waves of the International Diabetes Mellitus Practice Study implemented in Argentina (2006 to 2012) including demographic/socioeconomic profile, clinical, metabolic (HbA1c and serum lipids) data, and treatment type and also, percentage of treatment goal attainment. Descriptive statistical analyses included ANOVA, χ2 test, and Fisher exact test and univariate and multivariate logistic regression analyses, which identified predictive factors for HbA1c  ≤ 7% (53 mmol/mol). RESULTS: The average age was 63 years, primary/secondary education, health insurance, 10-year type 2 diabetes duration, most associated with cardiovascular risk factors and some microvascular/macrovascular complications; 94.5% received antihyperglycaemic drugs. Percentage of people on target: HbA1c 51.2%, blood pressure 23.5%, total cholesterol 62.6%, low-density lipoprotein (LDL) cholesterol 38.9%, and triglycerides 61.1%. HbA1c on target depended markedly on treatment type: more of those treated with lifestyle changes and significantly fewer of those receiving insulin. Only 4.1% had all parameters simultaneously on target. Multivariate logistic regression analyses showed that achieving HbA1c  ≤ 7.0% (53 mmol/mol) was associated with higher educational level, shorter diabetes duration, and having reached goals for LDL cholesterol and triglycerides, whereas opposite results were obtained with insulin treatment and longer diabetes duration. CONCLUSIONS: High LDL cholesterol and triglyceride levels simultaneously potentiate development/progression of chronic complications, exerting this effect in the long term by decreasing ß-cell mass/function, thereby making it more difficult to reach HbA1c values able to prevent complications.

[Update on the diagnosis of diabetes]. / Actualización en el diagnóstico de la diabetes.

Diabetes mellitus is a chronic metabolic disease characterized by the presence of hyperglycemia. This condition must be detected early in order to establish a proper treatment and prevent its micro and macro vascular complications. The diagnosis of diabetes mellitus is based on the detection of abnormally high levels of glycemia. This task may appear to be simple but should not be underestimated. Misclassifying an individual as a diabetic can expose him/her not only to emotional damage but also to unnecessary diagnostic tests and potentially harmful treatments. Many different clinical situations such as pregnancy or acute critical illness may hamper the interpretation of laboratory findings. In this article, we present an updated review on the main aspects related to diagnosis of diabetes mellitus.

Actualización en el diagnóstico de la diabetes / [Update on the diagnosis of diabetes].

Diabetes mellitus is a chronic metabolic disease characterized by the presence of hyperglycemia. This condition must be detected early in order to establish a proper treatment and prevent its micro and macro vascular complications. The diagnosis of diabetes mellitus is based on the detection of abnormally high levels of glycemia. This task may appear to be simple but should not be underestimated. Misclassifying an individual as a diabetic can expose him/her not only to emotional damage but also to unnecessary diagnostic tests and potentially harmful treatments. Many different clinical situations such as pregnancy or acute critical illness may hamper the interpretation of laboratory findings. In this article, we present an updated review on the main aspects related to diagnosis of diabetes mellitus.

Actualización en el diagnóstico de la diabetes. / [Update on the diagnosis of diabetes].

Diabetes mellitus is a chronic metabolic disease characterized by the presence of hyperglycemia. This condition must be detected early in order to establish a proper treatment and prevent its micro and macro vascular complications. The diagnosis of diabetes mellitus is based on the detection of abnormally high levels of glycemia. This task may appear to be simple but should not be underestimated. Misclassifying an individual as a diabetic can expose him/her not only to emotional damage but also to unnecessary diagnostic tests and potentially harmful treatments. Many different clinical situations such as pregnancy or acute critical illness may hamper the interpretation of laboratory findings. In this article, we present an updated review on the main aspects related to diagnosis of diabetes mellitus.