RESUMEN
Resumen Objetivos. La hemoglobina glicada podría sub-representar las fluctuaciones diarias de la glucemia. Se han propuesto múltiples técnicas para estudiar la variabilidad glucémica con el fin de conocer más claramente el control metabólico de la enfermedad. El objetivo de este estudio es comparar la variabilidad glucémica medida por MAGE y CONGA en el grupo de intervención y control; Además, comparar los resultados de variabilidad glucémica obtenidos antes y 12 semanas después del inicio del tratamiento en ambos grupos. Métodos. Ensayo clínico aleatorizado, multicéntrico, de etiqueta abierta, fase IV. Cuarenta sujetos aleatorizados para recibir vildagliptina más metformina1 o glimepirida más metformina por un periodo de 12 semanas. Se realizaron monitoreos continuos de glicemia antes y después del periodo de tratamiento utilizando dispositivos iPro2. Se compararon los resultados de variabilidad glucémica medida por MAGE, CONGA y DET. Se comparó el perfil de seguridad y tolerabilidad de las intervenciones. Resultados. El uso de GalvusMet® o glimepirida más metformina por 12 semanas en pacientes diabéticos con mal control glucémico se asoció con una reducción estadísticamente significativa de la variabilidad glucémica (Valor p Wilcoxon
AbstractObjectives. Glycosylated hemoglobin could under-represent daily fluctuations in bloodglucose. Multiple techniques have been proposed to study glycemic variability in order to better understand the metabolic control of the disease. The objective of this study is to compare the glycemic variability measured by MAGE and CONGA in the intervention and control group; In addition, compare the glycemic variability results obtained before and 12 weeks after the start of treatment in both groups. Methods. Phase IV, randomized, multicenter, open-label clinical trial.Forty subjects were randomized to receive vildagliptine plus metformin1 or glimepiride plus metformin for a period of 12 weeks. Continuous blood glucose monitoring was performed before and after the treatment period using iPro2 devices. The results of glycemic variability measured by MAGE, CONGA and DET were compared. The safety and tolerability profile of the interventions was compared. Results. The use of GalvusMet®ï¸ or glimepiride plus metformin for 12 weeks in diabetic patients with poorglycemic control was associated with a statistically significant reduction in glycemic variability (Wilcoxon p-value <0.005) and HbA1c (Wilcoxon p-value <0.005) in both groups;however, insufficient evidence was found to determine the superiority of the treatments. No differences were detected in the safety or tolerability profile of the drugs. Conclusions.The results of the study suggest that the evaluated treatment regimens are equivalent. Additional studies are required to determine the clinical significance of the results.
Asunto(s)
Humanos , Diabetes Mellitus Tipo 2 , Enfermedad , Control Glucémico , GlucosaRESUMEN
Objetivo: evaluar el efecto de la combinación fija de vildagliptina o sitagliptina con metformina sobre la lipemia postprandial (PP) en pacientes con diabetes tipo 2 (DM2) previamente tratados solo con metformina. Métodos: cincuenta y siete pacientes con DM2 tratados con metformina y dieta, con valores de HbA1c entre 6,5-8,5% participaron en estudio aleatorizado, doble ciego de 8 semanas. Los participantes recibieron una carga oral de grasa antes y después de 8 semanas de la administración aleatorizada de combinación fija vildagliptina/metformina(grupo 1; n=29) o sitagliptina/metformina (grupo2; n = 28). Muestras de sangre se tomaron basalmente y a intervalos de 2 horas durante 8 horas después de la ingestión de la carga grasa. Resultados: la respuesta PP integrada de triglicéridos (AUC-TG) disminuyó en el 76% de los pacientes del grupo 1 y en el 64% del grupo 2. El perfil lipídico en ayunas no mostró cambios significativos post tratamiento. La glucosa en ayunas y 2h PP y la HbA1c disminuyeron significativamente en ambos grupos (p<0,01) acompañado de una disminución del IMC y la presión arterial (p<0,01). No se observaron efectos adversos. Conclusiones: además de mejorar el control glucémico, el tratamiento con combinación fija de vildagliptina/metformina o sitagliptina/metformina tiene un efecto beneficioso similar sobre la lipemia PP, lo cual es importante para mejorar el riesgo cardiometabólico de los pacientes con DM2.
Objective: to assess the effect of fixed combination of vildagiptin/metformin and sitagliptina/ metformin on postprandiallipemia (PP) in patients with type 2 diabetes mellitus (DM2). Methods: fifty-seven patients with DM2 previously treated with metformin and diet and HbA1c between 6,5-8,5% participated in a 8 weeks randomized, double blind study. An oral fat load was performed at baseline and 8 weeks after treatment with fixed combination of vildagliptin/metformin (grupo 1; n=29) or sitagliptin/metformin (group 2; n=28) twice a day. Blood samples were taken at baseline and at 2 hours interval during 8 hours after oral fat load. Results: integrated postprandial triglyceride response (AUC-TG) decreased in 76% of patients of group 1 and 64% of group 2. Fasting lipoprotein profile did not show significant changes post treatment. Both fasting and 2h postprandial glucose and HbA1c showed a significant decrease in both groups, in association with a decrease of body mass index and blood pressure (p<0,001). No adverse effects were observed. Conclusions: besides improving glucose control, fixed combination of vildagliptin/metformina or sitagliptina/metformin treatment has a beneficial effect postprandial lipemia which is important to improve the cardiometabolic risk of type 2 patients.
RESUMEN
OBJECTIVE: To evaluate the effectiveness of adding vildagliptin to the treatment of patients with inadequately controlled type 2 diabetes mellitus (T2DM) treated with a combination of metformin and a sulphonylurea. SUBJECTS AND METHODS: 37 T2DM patients with HbA1c ranging from 7.7 percent to 12.4 percent (mean of 9.30 ± 1.38), despite the use of metformin in combination with a sulphonylurea, were additionally treated with vildagliptin (100 mg/day) for at least 6 months. RESULTS: During triple oral therapy (TOT) HbA1c levels < 7 percent were achieved in 11 patients (29.7 percent), whereas levels of fasting plasma glucose (FPG) < 120 mg/dL were observed in 12 patients (32.4 percent). Both findings were observed in 10 patients (27.0 percent). Compared to nonresponsive subjects, lower mean baseline HbA1c and FPG levels were seen in responsive patients, but the difference was only statistically significant for fasting plasma glucose (FPG). Moreover, there was considerable overlap between the two groups. CONLUSION: Our preliminary results suggest that TOT with metformin, a sulphonylurea and vildagliptin may be useful for some T2DM patients nonresponsive to combination therapy with metformin and sulphonylurea.
OBJETIVO: Avaliar a eficácia da adição de vildagliptina ao tratamento de pacientes com diabetes melito tipo 2 (DM2) inadequadamente controlados com a terapia de combinação com metformina e sulfonilureia. SUJEITOS E MÉTODOS: 37 pacientes com DM2 e HbA1c variando entre 7,7 por cento e 12,4 por cento (média, 9,30 ± 1,38), apesar do uso de metformina associada a uma sulfonilureia, foram adicionalmente tratados com vildagliptina (100 mg/dia) durante, pelo menos, 6 meses. RESULTADOS: Durante a terapia oral tripla TOT), níveis de HbA1c < 7 por cento foram alcançados em 11 pacientes (27,9 por cento), enquanto a glicemia de jejum (GJ) < 120 mg/dL foi observada em 12 pacientes (32,4.1 por cento). Ambos os resultados foram descritos em 10 pacientes (27,0 por cento). Em comparação com indivíduos não responsivos, os pacientes responsivos tinham níveis basais mais baixos de HbA1c e GJ, mas a diferença foi estatisticamente significativa somente para glicemia de jejum. Além disso, houve grande sobre-posição entre os dois grupos. CONSLUSÃO: Nossos resultados preliminares sugerem que a TOT com metformina, uma sulfonilureia e vildagliptina pode ser útil para alguns pacientes com DM2 não responsivos à combinação com metformina e uma sulfonilureia.