Efficacy and Safety of Insulin Glulisine in Intensive Insulin Therapy: Bolus Insulin Adjust Nice Control by apiDRA Study (BANDRA Study)

Abstract

Background: Treatment for postprandial glycemia using rapid-acting insulin analogues sometimes resulted in preprandial hypoglycemia or weight gain. Objective: This study evaluated the efficacy and safety of switching bolus insulin from insulin lispro (Lis) to insulin glulisine (Glu) in patients with inadequately controlled diabetes on intensive insulin therapy with Lis and glargine (Gla). Methods: Seventy-two outpatients with inadequate glycemic control (glycated hemoglobin [HbA1c] ≥ 7.0%, glycated albumin [GA] ≥ 20%) on intensive insulin therapy comprising Lis and Gla for ≥ 24 weeks were enrolled. We switched treatment from Lis to Glu with a stepwise increase in the dose by 1 unit per meal to obtain a GA level of ≤ 20% for 24 weeks, and the efficacy and safety were evaluated. Patients’ treatment satisfaction was also evaluated using the Diabetes Treatment Satisfaction Questionnaire (DTSQ) after the treatment. Results: After switching from Lis to Glu, both HbA1c and GA levels significantly lowered from 8.26% ± 0.13% to 7.71% ± 0.13% (P < 0.01) and from 23.9% ± 1.8% to 21.4% ± 1.9% (P < 0.01), respectively. Furthermore, switching from Lis to Glu improved patients’ treatment satisfaction; scores for 7 of the 8 items, such as “satisfaction” and “convenience” were significantly improved (P < 0.001), with no significant change in the scores for “improvement of hypoglycemia” (P = 0.91). Conclusions: Our present study suggests that switching bolus insulin from Lis to Glu by the addition of 1 unit of Glu per meal may be a useful treatment option for patients with inadequate glycemic control receiving intensive insulin therapy with Lis and Gla.