AIM: The aim of this study was to compare the effect of continuation or discontinuation of glimepiride upon starting insulin therapy in type 2 diabetic patients poorly controlled with sub-maximalglimepiride. METHODS: This 48-week, randomized, observational, parallel-group study consisted of a 24-week screening period and a 24-week intervention period. During the screening period, we unified the sulfonylureas to glimepiride at 3mg/day for 8 weeks, and started biphasic insulin aspart 30 (Asp30Mix) once-daily injections for 16 weeks. At the start of the intervention period, we stepped up once- to twice-daily insulin injection and randomized the 26 patients into either continuation of glimepiride group (CONT, n=14) or discontinuation of glimepiride group (DISCON, n=12). The Asp30Mix dose-adjustment algorithm was used in both groups. HbA1C, plasma glucose, insulin daily dose, body weight, and number of hypoglycaemic episodes were evaluated. RESULTS: At the end of the study, HbA1C improved in CONT more than in DISCON (P<0.01), and daily dose of Asp30Mix was less in CONT than DISCON (P<0.05). Body weight and the numbers of hypoglycaemic episodes were similar between the two groups. CONCLUSION: Continuing glimepiride (sulfonylureas) allows a better glycaemic control with less insulin daily dose compared with discontinuing glimepride.
RCT Entities:
AIM: The aim of this study was to compare the effect of continuation or discontinuation of glimepiride upon starting insulin therapy in type 2 diabeticpatients poorly controlled with sub-maximal glimepiride. METHODS: This 48-week, randomized, observational, parallel-group study consisted of a 24-week screening period and a 24-week intervention period. During the screening period, we unified the sulfonylureas to glimepiride at 3mg/day for 8 weeks, and started biphasic insulin aspart 30 (Asp30Mix) once-daily injections for 16 weeks. At the start of the intervention period, we stepped up once- to twice-daily insulin injection and randomized the 26 patients into either continuation of glimepiride group (CONT, n=14) or discontinuation of glimepiride group (DISCON, n=12). The Asp30Mix dose-adjustment algorithm was used in both groups. HbA1C, plasma glucose, insulin daily dose, body weight, and number of hypoglycaemic episodes were evaluated. RESULTS: At the end of the study, HbA1C improved in CONT more than in DISCON (P<0.01), and daily dose of Asp30Mix was less in CONT than DISCON (P<0.05). Body weight and the numbers of hypoglycaemic episodes were similar between the two groups. CONCLUSION: Continuing glimepiride (sulfonylureas) allows a better glycaemic control with less insulin daily dose compared with discontinuing glimepride.