Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride.

Aim: To compare the efficacy and safety of two analog insulins as starting regimens in insulin-naive Type 2 diabetes patients. Methods: In this randomized, open-label parallel study, twice-daily biphasic insulin aspart 30 (30% soluble and 70% protaminated insulin aspart; BIAsp 30) plus metformin (met) was compared with once-daily insulin glargine (glarg) plus glimepiride (glim) in 255 insulin-naive patients (131 male; mean±SD age, 61.2 ± 9.1 years). Mean baseline HbA 1c ( ± SD) was 9.2 ± 1.4% and 8.9±1.3% for BIAsp 30 plus met (n =128) and glarg plus glim (n=127), respectively (P= 0.0747). Primary endpoint was the difference in absolute change in HbA 1c between groups after 26 weeks of treatment. Results: HbA 1c change was significantly greater in the BIAsp 30 plus met group than the glarg plus glim group (between-group difference: -0.5% (95% Cl: -0.8; -0.2); P= 0.0002). Mean prandial plasma glucose increment was significantly lower for BIAsp 30 plus met compared with glarg plus glim: 1.4 ± 1.4 mmol/l vs. 2.2 ± 1.8 mmol/l; P = 0.0002. During the maintenance phase (weeks 6-26), one major hypoglycemic episode occurred in each group; 20.3 % and 9% of patients experienced minor hypoglycemic episodes in the BlAsp 30 plus met and glarg plus glim groups, respectively (P=0.0124). At end-of-trial, mean daily insulin doses were 0.40 U/kg BlAsp 30 and 0.39 U/kg glarg. Glarg plus glim-treated patients experienced significant weight gain of 1.5 kg (95% CI: 0.84; 2.19; P <0.0001). Weight change with BlAsp 30 plus met of +0.7kg was not statistically significant (95% CI: -0.07; 1.42; P= 0.0762). Conclusions: Starting insulin in Type 2 diabetes patients with twice-daily BlAsp 30 plus met can reduce HbA 1c and mean prandial plasma glucose increment to a greater extent than once-daily glarg plus glim.