Switching to Once-Daily Insulin Degludec/Insulin Aspart from Basal Insulin Improves Postprandial Glycemia in Patients with Type 2 Diabetes Mellitus: Randomized Controlled Trial

Abstract

Background: To explore the efficacy and safety of switching from once-daily basal insulin therapy to once-daily pre-meal injection insulin degludec/insulin aspart (IDegAsp) with respect to the glycemic control of participants with type 2 diabetes mellitus (T2DM). Methods: In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, participants on basal insulin therapy were switched to IDegAsp (IDegAsp group; n=30) or continued basal insulin (Basal group; n=29). The primary endpoint was the superiority of IDegAsp in causing changes in the daily blood glucose profile, especially post-prandial blood glucose concentration after 12 weeks. Results: Blood glucose concentrations after dinner and before bedtime were lower in the IDegAsp group, and the improvement in blood glucose before bedtime was significantly greater in the IDegAsp group than in the Basal group at 12 weeks (−1.7±3.0 mmol/L vs. 0.3±2.1 mmol/L, P<0.05). Intriguingly, glycemic control after breakfast was not improved by IDegAsp injection before breakfast, in contrast to the favorable effect of injection before dinner on blood glucose after dinner. Glycosylated hemoglobin significantly decreased only in the IDegAsp group (58 to 55 mmol/mol, P<0.05). Changes in daily insulin dose, body mass, and recorded adverse effects, including hypoglycemia, were comparable between groups. Conclusion: IDegAsp was more effective than basal insulin at reducing blood glucose after dinner and before bedtime, but did not increase the incidence of hypoglycemia. Switching from basal insulin to IDegAsp does not increase the burden on the patient and positively impacts glycemic control in patients with T2DM.

Use of Insulin Degludec/Insulin Aspart in the Management of Diabetes Mellitus: Expert Panel Recommendations on Appropriate Practice Patterns

“…At the end of the 12 weeks, HbA1c level was significantly decreased (7.5% to 7.3%) only in the IDegAsp group. IDegAsp was more effective in controlling blood glucose after dinner and before bedtime without causing any increase in hypoglycemia (64).…”

“…Recently, Cho et al evaluated 59 Japanese patients (aged 20-80 years) with T2D who were on basal insulin (insulin degludec or glargine) at least for 12 weeks before enrollment. A 12 week, multicenter, open-label, randomized, prospective, parallel-group comparison, treat to target study was conducted (64). Patients were randomly assigned to continue basal insulin (n = 29) or to switch to IDegAsp (n = 30).…”

Clinical research of insulin glargine U300 basal‐bolus therapy and insulin degludec/aspart co‐formulation in type 2 diabetes mellitus: A real world experience

“…In the IDegAsp group, in a similar way to the IGlarU300 group, both FPG and HbA1c levels decreased significantly both in all patients and in the patients that were followed up until month 12 ( P < .001 for all). IDegAsp has been reported to be more effective than basal insulin in the regulation of PPG 16 . However, Ozcelik et al found no significant change in FPG and HbA1c levels after switching from intensive insulin to IDegAsp 9 .…”

Indirect comparison of efficacy and safety of insulin glargine/lixisenatide and insulin degludec/insulin aspart in type 2 diabetes patients not controlled on basal insulin

“…Importantly, IGlarLixi follows a once-daily subcutaneous injection regimen [15], while IDegAsp might require a twice-daily administration for optimal glycaemic control [21,22], though a recent study suggested higher efficacy of a once-daily injection of IDegAsp compared to basal insulin [23]. The advantage of once-daily injection cannot be underestimated given the prevalence of fear of injection and social discomfort among patients with diabetes on injectable therapy [24,25].…”