Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial

Abstract

Objective: For many patients with type 2 diabetes, oral antidiabetic agents (OADs) do not provide optimal glycaemic control, necessitating insulin therapy. Fear of hypoglycaemia is a major barrier to initiating insulin therapy. The AT.LANTUS study investigated optimal methods to initiate and maintain insulin glargine (LANTUS Ò , glargine, Sanofi-aventis, Paris, France) therapy using two treatment algorithms. This subgroup analysis investigated the initi- ation of once-daily glargine therapy in patients suboptimally controlled on multiple OADs. Research Design and Methods: This study was a 24-week, multinational (59 countries), multicenter (611), random- ized study. Algorithm 1 was a clinic-driven titration and algorithm 2 was a patient-driven titration. Titration was based on target fasting blood glucose 100 mg/dl ( 5.5 mmol/l). Algorithms were compared for incidence of severe hypo- glycaemia [requiring assistance and blood glucose <50 mg/dl (<2.8 mmol/l)] and baseline to end-point change in haemoglobin A 1c (HbA 1c ). Results: Of the 4961 patients enrolled in the study, 865 were included in this subgroup analysis: 340 received glargine plus 1 OAD and 525 received glargine plus >1 OAD. Incidence of severe hypoglycaemia was <1%. HbA 1c decreased significantly between baseline and end-point for patients receiving glargine plus 1 OAD (1.4%, p < 0.001; algo- rithm 1 1.3% vs. algorithm 2 1.5%; p ¼ 0.03) and glargine plus >1 OAD (1.7%, p < 0.001; algorithm 1 1.5% vs. algorithm 2 1.8%; p ¼ 0.001). Conclusions: This study shows that initiation of once-daily glargine with OADs results in significant reduction of HbA 1c with a low risk of hypoglycaemia. The greater reduction in HbA 1c was seen in patients randomized to the patient-driven algorithm (algorithm 2) on 1 or >1 OAD. Keywords: basal insulin analogues, insulin glargine, oral antidiabetic agents, titration, type 2 diabetes, treatment algorithms Received 20 August 2007; accepted 8 February 2008