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




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).


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).


Mean numbers of hypoglycaemic events per year were 4.64 ± 11.4 (symptomatic < 60 mg/dl), 0.59 ± 2.28 (nocturnal) and 0.03 ± 0.22 (severe). A total of 44.5% of patients reached the composite endpoint of glycated haemoglobin (HbA1c) <7.0% plus no severe hypoglycaemia, and 26.7% reached the composite of HbA1c <7.0% plus no symptomatic hypoglycaemia. Predictors of nocturnal and symptomatic hypoglycaemia were female gender (OR 1.82; 95% CI 1.07–3.11 and OR 1.89; 95% CI 1.31–2.78), diabetes duration >10 versus <5 years (OR 2.61; 95% CI 1.03–6.59 and OR 2.01; 95% CI 1.15–3.51) and higher basal insulin dose (per unit of increase) (OR 1.01; 95% CI 1.00–1.03 and OR 1.01; 95% CI 1.00–1.02). Conversely, a higher body mass index (BMI) (27–30 vs. <27 kg/m2 and >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).


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.