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

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 (HbA1c) concentration ≥7.5 to ≤10.5 % and fasting plasma glucose ≤121 mg/dL. The primary efficacy end point was change in HbA1c from baseline to 24 weeks of treatment. Secondary efficacy end points included change in HbA1c 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 HbA1c 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.