Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the PREDICTIVE™ study

Abstract

The aim of the PREDICTIVE study, a large, multinational observational trial, was to evaluate the efficacy and safety of insulin detemir (IDet) in routine clinical practice. Twelve-week follow-up data from patients with type 1 (T1D) or type 2 (T2D) diabetes in the European cohort switched from once (qd) or twice (bid) daily insulin glargine (IGlarg) (+/-oral antidiabetic therapy) to qd IDet in a basal-bolus regimen. End-points, assessed from patient recall/diaries, included incidence of serious adverse drug reactions, glycaemic parameters, hypoglycaemia and weight change. The analysis included 1285 patients with T1D (n = 508) or T2D (n = 777). At 12 weeks, glycosylated haemoglobin (HbA1c) was significantly reduced (qd IGlarg to qd IDet: T1D, -0.47%; T2D, -0.51%; p < 0.0001 for both; bid IGlarg to qd IDet: T1D, -0.31%; T2D, -0.89%, p < 0.05 for both). Fasting blood glucose (FBG) and FBG variability were also reduced. Reductions in overall, major and nocturnal hypoglycaemic events were observed after switching from qd IGlarg to qd IDet (overall, T1D, 39.7-18.85 episodes/patient-year; overall, T2D, 11.57-2.99 episodes/patient-year, p < 0.0001 for both). Similar reductions were observed in bid IGlarg to qd IDet patients. Mean weight change was -0.3 to -0.4 kg across patient groups. Switching from IGlarg to qd IDet was associated with improvements in glycaemic parameters with no associated increase in hypoglycaemic episodes or weight gain. Patients with T1D and T2D may be switched from IGlarg to qd IDet as part of a basal-bolus regimen.