Improving metabolic control in sub-optimally controlled subjects with Type 1 diabetes: Comparison of two treatment algorithms using insulin glargine

This study assessed the incidence of severe hypoglycaemia with two insulin glargine titration algorithms: Algorithm 1 (increments of at least 10%, but not exceeding 4 U) versus Algorithm 2 (1–6 U increments). In this multicenter (n = 409), multinational (n = 54), open-label, 24-week randomized trial in 2442 subjects with sub-optimally controlled Type 1 diabetes (T1DM), mean prior insulin therapy duration was 14.6 ± 10.3 years. The incidence of severe hypoglycaemia was similar with Algorithms 1 and 2 (16.6 events/100 patient–years versus 14.4 events/100 patient–years). There were similar rates of both symptomatic and nocturnal hypoglycaemia. HbA1c and fasting blood glucose (FBG) decreased significantly (baseline to endpoint; p < 0.001), and comparably with Algorithms 1 and 2 (HbA1c: −0.64% versus −0.72%; FBG: −57 mg/dL versus −59 mg/dL). Mean basal insulin dose increased with both algorithms (+5.7 U versus +5.9 U). In a diverse population with longstanding T1DM, transfer from any insulin regimen, including basal–bolus or premixed insulin to an insulin glargine-based regimen resulted in significant improvements in glycaemic control, with low rates of severe hypoglycaemia, irrespective of the titration algorithm used.