Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes mellitus requiring insulin intensification—a randomized phase IV trial: Indian subpopulation analyses

Abstract

The aim of this study was to describe the efficacy and safety of two insulin intensification strategies in patients recruited in India with type 2 diabetes mellitus inadequately controlled on basal insulin glargine with metformin and/or pioglitazone. This multinational, open-label, randomized, parallel-arm, noninferiority, phase IV clinical trial evaluated insulin lispro low mixture (LM25) and basal insulin glargine administered with prandial insulin lispro (IGL) for 24 weeks. Patients were male and female, aged ≥18 to ≤75 years, with screening glycosylated hemoglobin (HbA_1c) concentration ≥7.5 to ≤10.5 % and fasting plasma glucose ≤121 mg/dL. The primary efficacy end point was change in HbA_1c from baseline to 24 weeks of treatment. Secondary efficacy end points included change in HbA_1c from baseline to 12 weeks and change in fasting blood glucose (FBG) from baseline to 12 and 24 weeks. Safety and tolerability were measured by treatment-emergent adverse events and the incidence, rate, and severity of hypoglycemic episodes. Of 81 patients randomized to LM25 (n = 40) or IGL (n = 41), 80 patients completed the trial and one patient discontinued due to subject decision. Mean (SD) change in HbA_1c from baseline to week 24 was −1.2 % (1.11) for the LM25 group and −1.0 % (1.18) for the IGL group. Safety profile, mean (FBG), glycemic variability, hypoglycemic episodes per patient-year, and health outcome measures were numerically similar between the two groups. The results of this post hoc analysis in an Indian subpopulation were consistent with results reported for the trial-level population and provide information to the consideration of LM25 as treatment option for intensification.