Efficacy and safety of switching from basal insulin to once‐daily insulin degludec/insulin aspart in Japanese patients with inadequately controlled type 2 diabetes: A 4‐week, randomized, open‐label, treat‐to‐target study

Abstract

Aims/IntroductionA prospective, 4‐week, single‐center, randomized, open‐label, parallel‐group, treat‐to‐target study was carried out to develop an algorithm for safe and effective switching from basal insulin to once‐daily insulin degludec/insulin aspart (IDegAsp) in patients with inadequately controlled type 2 diabetes.Materials and MethodsPatients were randomly assigned to continue their current basal insulin therapy (n = 10) or to switch to IDegAsp on a 1:1 unit basis (n = 10). The insulin dose could be titrated once weekly, targeting a self‐measured blood glucose of 80–100 mg/dL before breakfast. A mixed meal test was carried out at baseline and after 4 weeks.ResultsAfter 4 weeks, the mean daily dose of insulin was similarly increased by 60% in both groups, and there was a significant decrease of mean plasma glucose and glucose area under the glucose concentration vs time curve for 2 h in the meal test. The mean estimated treatment difference (IDegAsp group − basal insulin group) of the mean plasma glucose level was −28 mg/dL (95% confidence interval −47 to −8, P = 0.008) after 4 weeks and that of the area under the glucose concentration vs time curve for 2 h was −2,800 mg/min/dL (95% confidence interval −5,300 to −350, P = 0.028), confirming the superiority of IDegAsp to basal insulin. In the IDegAsp group, the 2‐h postprandial plasma glucose level was significantly decreased to the fasting plasma glucose range. There were no confirmed hypoglycemic episodes in either group during the 4‐week study period.ConclusionsAfter switching from basal insulin, the IDegAsp dose can be uptitrated by 60% based on fasting plasma glucose data. However, monitoring of postprandial glucose should be considered before further uptitration of IDegAsp.

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

“…Posted online 2019 http://e-dmj.org ing from basal insulin to IDegAsp [17,18]. One of these reported that IDegAsp (n=10) was more effective than basal insulin at reducing postprandial plasma glucose, measured following a 2-hour meal test, after 4 weeks of administration [17]. Consistent with our findings, there was a significant improvement in post-meal plasma glucose concentration after switching from basal insulin analogues to IDegAsp.…”

“…Diabetes Metab J 2019 Forthcoming. Posted online 2019 http://e-dmj.org ing from basal insulin to IDegAsp [17,18]. One of these reported that IDegAsp (n=10) was more effective than basal insulin at reducing postprandial plasma glucose, measured following a 2-hour meal test, after 4 weeks of administration [17].…”

“…Although there have been several comparison studies regarding the use of IDegAsp and IGlr in insulin-naive participants for the initiation of once-daily insulin [ 13 15 16 ], there have only been two studies regarding the potential benefits of switching from basal insulin to IDegAsp [ 17 18 ]. One of these reported that IDegAsp ( n =10) was more effective than basal insulin at reducing postprandial plasma glucose, measured following a 2-hour meal test, after 4 weeks of administration [ 17 ]. Consistent with our findings, there was a significant improvement in post-meal plasma glucose concentration after switching from basal insulin analogues to IDegAsp.…”

Comparison of the efficacy and safety of once-daily insulin degludec/insulin aspart (IDegAsp) and long-acting second-generation basal insulin (insulin degludec and insulin glargine 300 units/mL) in insulin-naïve Japanese adults with type 2 diabetes: a pilot, randomized, controlled study

“…Several studies have reported the comparison of oncedaily IDegAsp and once-daily first-generation basal insulin (IGla-100) in patients with type 2 diabetes [11,[19][20][21][22]. However, there has been no comparative study between once-daily IDegAsp and once-daily secondgeneration basal insulin analogs, i.e.…”

“…As is well known, the relative contribution of the postprandial glucose increment to HbA1c level is larger than that of the fasting glucose increment at HbA1c level in the range below 8.5%, and IDegAsp vs. 2nd-generation basal insulin fasting hyperglycemia plays a major role as soon as the HbA1c level rises above 8.5% [17]. Nagai et al reported that IDegAsp was more effective than basal insulin in reducing postprandial glucose levels after test meal loading [22]. Although we did not evaluate postprandial glucose levels or 1,5-anhydroglucitol in the present study, this improvement in subjects with HbA1c less than 8.5% was likely due to reduction in postprandial glucose levels caused by IAsp, the bolus component of IDegAsp.…”