Basal insulin or premix analogue therapy in type 2 diabetes patients.

BACKGROUND: We sought to compare the safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) given twice daily with once-daily insulin glargine in patients with type 2 diabetes beginning insulin therapy and who did not use thiazolidinediones, which are contraindicated with insulin in the European Union, in a subpopulation (N=157) of the INITIATE study. METHODS: At baseline, HbA(1c) was >/=8.0% on >/=1000 mg/day metformin alone or in combination with other oral antidiabetic drugs (OADs; e.g. sulphonylurea or alpha-glucosidase inhibitors). Metformin was adjusted up to 2550 mg/day and other OADs were discontinued. Starting insulin doses were subsequently adjusted weekly for 26 weeks by algorithm-directed titration. RESULTS: The proportion of patients achieving a HbA(1c) below 7.0% at 28 weeks was greater with BIAsp 30 than with insulin glargine (65% vs 41%, P=0.003). The mean reduction in HbA(1c) was greater for BIAsp 30 than for insulin glargine: -2.89+/-1.6% vs -2.46+/-1.6%, respectively (P=0.035). Postprandial glucose increments were lower for the BIAsp 30 group after breakfast (P=0.003) and dinner (P=0.033); post-lunch values were not significantly different. No major hypoglycemic episodes were recorded. Nocturnal hypoglycemia was reported by 25% of subjects in the BIAsp 30 group and by 10% in the insulin glargine group (P=0.021). Weight gain was 5.6+/-4.6 and 3.0+/-4.3 kg (P=0.0004) for BIAsp 30 and insulin glargine, respectively. CONCLUSIONS: BIAsp 30, given twice daily in combination with metformin, was more effective than insulin glargine, given once daily in combination with metformin, at controlling blood glucose in insulin-naïve patients with type 2 diabetes, but was associated with increased weight gain and minor hypoglycemic events.