Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride (GLOBE)
Excursiones de glucosa en pacientes con diabetes mellitus tipo 2 tratados con vildagliptina más metformina1 versus glimepirida más metformina –GLOBE–: Ensayo clínico aleatorizado
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Objectives: Glycosylated hemoglobin could under-represent daily fluctuations in blood glucose. 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®️ or glimepiride plus metformin for 12 weeks in diabetic patients with poor glycemic 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.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.
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