Superior glycaemic control with once‐daily insulin degludec/insulin aspart versus insulin glargine in Japanese adults with type 2 diabetes inadequately controlled with oral drugs: a randomized, controlled phase 3 trial

Abstract

Aims: This phase 3, 26-week, open-label, treat-to-target trial investigated the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) in insulin-naïve Japanese adults with type 2 diabetes. Methods:Subjects were randomized to once-daily injections of IDegAsp (n = 147) or insulin glargine (IGlar) (n = 149), both ±≤2 oral antidiabetic treatments. IDegAsp was given before the largest meal at the discretion of each subject (and maintained throughout the trial); IGlar was dosed according to label. Both insulins were titrated to a target prebreakfast self-measured plasma glucose of 3.9 to <5.0 mmol/l. Conclusions: IDegAsp provided superior long-term glycaemic control compared to IGlar, with similar FPG and doses and numerically lower rates of overall and nocturnal hypoglycaemia (p = NS).

IDegAsp (insulin degludec + insulin aspart) for the management of type 2 diabetes: current status

“…The strategy of using a limited number of mealtime injections with basal insulin in T2DM has been well investigated in recent years [52][53][54]. In the current study series, once-daily IDegAsp gave, as expected, superior performance to IGlar alone in insulin-naïve people, without detriment in terms of hypoglycemia despite the improved postmain-meal glucose control [44]. Here, the finding by continuous glucose monitoring of lower glycemic excursions during the night appears to be consistent with the clamp findings of low within-day variability compared with IGlar [42].…”

“…In this trial, despite identical mean insulin doses, IDegAsp was superior to IGlar in lowering HbA 1c , having a clinically relevant treatment difference of −0.28 (95% CI −0.46, −0.10), with similar FPG (Table 2). Central estimates for any-time and nocturnal hypoglycemia were lower but not statistically significantly different (Table 2) [44]. Bodyweight change and adverse-event profiles were similar.…”

“…No severe hypoglycemic event was recorded in the IDegAsp versus IGlar trial [44]. The previously insulin-naïve trial against BIAsp 30 recorded low rates of severe hypoglycemia in the IDegAsp and comparator arms [45].…”

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

“…Thus, better glycemic control could have been achieved in the IDegAsp group if this study had been extended until fasting blood glucose reached the target value. Another phase 3 treat‐to‐target trial of once‐daily IDegAsp therapy for 26 weeks in insulin‐naïve Japanese patients showed that IDegAsp provided superior long‐term glycemic control compared with IGlar, with a similar fasting plasma glucose level and insulin dose16. However, postprandial hypoglycemia would be expected to occur if we continued to titrate the dose of IDegAsp based on SMBG data before breakfast alone, because the postprandial plasma glucose level was decreased to the fasting plasma glucose range in the IDegAsp group (Figure 3b).…”

“…It was calculated that a sample size of 20 patients was required to detect a decrease of prandial glucose corresponding to that reported in a phase 3 trial16 with a 5% level of significance (two‐sided) and a power of 80%.…”