Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes

Aims To examine whether insulin glargine can lead to better control of glycated haemoglobin (HbA1c) than that achieved by neutral protamine Hagedorn (NPH) insulin, using a protocol designed to limit nocturnal hypoglycaemia. Methods The present study, the Least One Oral Antidiabetic Drug Treatment (LANCELOT) Study, was a 36‐week, randomized, open‐label, parallel‐arm study conducted in Europe, Asia, the Middle East and South America. Participants were randomized (1 : 1) to begin glargine or NPH, on background of metformin with glimepiride. Weekly insulin titration aimed to achieve median prebreakfast and nocturnal plasma glucose levels ≤5.5 mmol/l, while limiting values ≤4.4 mmol/l. Results The efficacy population (n = 701) had a mean age of 57 years, a mean body mass index of 29.8 kg/m2, a mean duration of diabetes of 9.2 years and a mean HbA1c level of 8.2% (66 mmol/mol). At treatment end, HbA1c values and the proportion of participants with HbA1c