Composite efficacy parameters and predictors of hypoglycaemia in basal-plus insulin therapy—a combined analysis of 713 type 2 diabetic patients

Aims We aimed to identify predictors of hypoglycaemia in patients with poorly controlled type 2 diabetes treated with a single daily bolus of insulin glulisine on top of insulin glargine and oral antidiabetic drugs (basal-plus regimen). Methods We retrospectively analysed four large basal-plus trials including 713 patients (47% female) with type 2 diabetes, mean age of 59.9 ± 9.5 years and diabetes duration of 11 ± 7.0 years. Predictors for symptomatic, severe and nocturnal hypoglycaemia were identified by multivariate logistic regression analyses, calculation of odds ratios (ORs) and Wald 95% confidence intervals (CIs). Results Mean numbers of hypoglycaemic events per year were 4.64 ± 11.4 (symptomatic  10 versus 30 vs. <27 kg/m2) conferred a reduced risk of symptomatic hypoglycaemia with an OR of 0.53 (95% CI 0.31–0.90) and an OR of 0.61 (95% CI 0.39–0.97). Conclusions Female gender, a long diabetes duration and higher basal insulin dose were predictors of hypoglycaemia, while protection was provided by BMI > 30. These results may help to successfully establish basal-plus insulin regimen in individual patients on their transition from basal-only to basal-bolus treatment.