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 use-* Corresponding author. Y. Bando et al. 29ful treatment option for patients with inadequate glycemic control receiving intensive insulin therapy with Lis and Gla.

Effectiveness and Safety of Switching Rapid-Acting Insulins to Insulin Glulisine in Patients with Diabetes: The Observational IGLU-S Study

“…An improved glycaemic control after switching from insulin lispro to insulin glulisine has also been reported by a study performed in Japan (BANDRA) [ 6 ], where patients with different diabetes types experienced a reduction of the HbA1c from 8.26 to 7.71% (66.8–60.8 mmol/mol; p < 0.01) using a glulisine titration algorithm. Furthermore, Yanagisawa et al [ 7 ] reported on the outcomes of a study in 49 T1DM and 10 T2DM patients whose treatment was switched from basal insulin in combination with aspart, lispro or regular human insulin to a combination of basal insulin and insulin glulisine.…”

“…This was likely due to the lower number of patients with T1DM ( n = 40) compared to T2DM ( n = 304). Both the introduction of insulin glulisine [ 6 , 7 ] and its up-titration upon a switch [ 6 ], as well as the performance of a 7-point blood glucose profile [ 11 , 12 ], have been demonstrated to improve glycaemic control in patients with diabetes. As such, these two changes to patient care likely contributed to the observed effects on glycaemic control and potentially should be implemented in parallel in practice.…”

“…In patients with T2DM, switching mealtime insulin to rapid-acting analogues as part of a supplementary insulin therapy (SIT), basal-insulin supported oral therapy with a single prandial dose of rapid-acting insulin (BOT Plus) or ICT may be considered after failure of previous insulin treatment [ 5 ]. Recent studies provide evidence that switching from another rapid-acting insulin analogue, e.g., insulin lispro, to insulin glulisine may improve glycosylated haemoglobin A1c (HbA1c) and patient satisfaction [ 6 , 7 ]. There is insufficient longer term data, however, in both T1DM and T2DM, on the performance of insulin glulisine in patients who are switched to insulin glulisine under real-world conditions.…”