Randomized, Open-Label, Parallel-Group Evaluations of Basal-Bolus Therapy Versus Insulin Lispro Premixed Therapy in Patients With Type 2 Diabetes Mellitus Failing to Achieve Control With Starter Insulin Treatment and Continuing Oral Antihyperglycemic Drugs: A Noninferiority Intensification Substudy of the DURABLE Trial*

摘要

Background: Insulin glargine and lispro mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection [LM75/25]) represent 2 common starter insulin regimen classes: basal and premixed. After initiation of starter insulin therapy, if patients with type 2 diabetes mellitus (DM) are unable to achieve a glycosylated hemoglobin (HbAlc) level <7.0%, insulin intensification may be indicated. The DURABLE (Assessing Durability of Basal Versus Lispro Mix 75/25 Insulin Efficacy) trial was designed to compare initiating insulin therapy with analogue basal insulin versus premixed analogue insulin in patients unable to achieve good glycemic control while taking multiple oral antihyperglycemic drugs (OADs).