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

Abstract

To examine the efficacy and safety of once-daily insulin degludec/insulin aspart (IDegAsp) or once-daily secondgeneration basal insulin analogs (insulin degludec and insulin glargine 300 units/mL) in insulin-naïve Japanese adults with type 2 diabetes in routine clinical practice. A 12-week multicenter, open-label, randomized, pilot study was performed in 52 subjects with type 2 diabetes treated with oral antidiabetic drugs (OADs). Subjects were randomized to once-daily IDegAsp (n = 26) or basal insulin (n = 26). The primary endpoint was percent change in HbA1c from baseline to week 12. Furthermore, it was analyzed post hoc in subgroups stratified by baseline HbA1c. During a follow-up period, percent change in HbA1c was not significantly different between the two groups (p = 0.161). Daily insulin doses and frequency of overall hypoglycemia were also similar in the two groups. In post hoc analyses, once-daily basal insulin was more effective than IDegAsp in subjects with HbA1c more than or equal to 8.5% (p < 0.05); however, in subjects with HbA1c less than 8.5%, once-daily IDegAsp showed a significant improvement in percent change in HbA1c at week 12, compared with basal insulin (p < 0.01). Although there was no apparent difference in the HbA1c-lowering effects between two groups, when compared in subjects with HbA1c less than 8.5%, once-daily IDegAsp showed a significant effect in comparison with once-daily basal insulin. These findings suggest that the baseline HbA1c level might provide the important information for choosing IDegAsp or basal insulin in patients insufficiently controlled with OADs. This trial was registered with UMIN (no. UMIN000035431).

Fear of hypoglycemia in adults with diabetes mellitus switching to treatment with IDegAsp co-formulation to examine real-world setting: an observational study (The HATICE study)

“…IDegAsp serves as a simple and adaptive treatment option requiring only a single injection that can reveal a better alternative to achieve a higher standards of patients' lifestyle and QoL in comparison with more complex alternatives, with a lower frequency of daily injections (in comparison with the basal-bolus and premixed regimens), which is more likely to be perceived and recognized as less burdensome by patients [7,21,22]. By means of switching to IDegAsp in our study, the median of daily insulin administration frequency applied by the participants decreased from 4 to 2.…”

Outcomes of transition from premixed and intensive insulin therapies to insulin aspart/degludec co-formulation in type 2 diabetes mellitus: a real-world experience

“…Some physicians prefer not to use fixed-dose insulin preparations because of the belief that separation of basal and bolus components allows better adaptation of insulin dosages to patients' needs [22]. In a 12-week study comparing once-daily IDegAsp and basal in-sulin groups, HbA 1c change, daily insulin dose, and overall frequency of hypoglycaemia did not differ between the two groups [23]. Furthermore, Kawaguchi et al, in their recently published study using the flash glucose monitoring system, demonstrated that the IGlar U300/insulin glulisine (basal-bolus treatment) was superior to IDegAsp in terms of efficacy and safety [24].…”

Co-Formulations as the First Injectable in Type 2 Diabetes: A Review of Efficacy, Safety, and Implications in Clinical Practice

“…In a subgroup analysis of people stratified by baseline HbA1c, IDegAsp fared better than basal insulins in people with baseline HbA1c <69 mmol/mol (8.5%), whereas basal insulins fared better in people with HbA1c >69 mmol/mol (8.5%). These conclusions were limited by the small number of people enrolled and the less stringent targets for FPG and HbA1c [29].…”

“…When the comparator was basal insulin analogue, there was no significant benefit of IDegAsp on the reduction of overall or confirmed hypoglycaemia. However, fewer episodes of nocturnal hypoglycaemia were seen in people on IDegAsp in comparison to those on basal insulin [27-29]. However, in a trial comparing IDegAsp to BIAsp30, people randomised to the IDegAsp arm fared better in terms of overall confirmed hypoglycaemic episodes, nocturnal hypoglycaemic episodes, and number of people experiencing hypoglycaemia [30] (Table 3).…”

“…Although a possible effect of ethnic variations on insulin doses cannot be excluded, one of the trials used a conservative target of FPG (4.4–7.16 mmol/L) for titrations. In a trial where some of the people used IGlarU300, the doses of IGlarU300 were 26% more than those of IDegAsp [29]. In trials where IDegLira and IGlarLixi were compared to basal insulin, the doses of insulin used were significantly lower in the co-formulation group.…”