Comparison of the efficacy and safety of insulin degludec/aspart (twice‐daily injections), insulin glargine 300 U/mL, and insulin glulisine (basal–bolus therapy)

Abstract

Aims/IntroductionWe compared the efficacy and safety of insulin degludec/aspart (IDegAsp) twice‐daily injections with insulin glargine 300 U/mL and insulin glulisine basal–bolus therapy (Gla300/Glu) using insulin glargine 300 U/mL (Gla300) and insulin glulisine (Glu).Materials and MethodsA total of 20 patients with type 2 diabetes mellitus were treated with IDegAsp twice‐daily injections; achievement of target preprandial glucose concentration of 100–130 mg/dL at breakfast and supper was determined using a wearable flash glucose monitoring system. Patients were later switched to Gla300/Glu basal–bolus therapy before breakfast and before supper. Data were collected on days 2–4 and days 12–14 for each treatment period. The study's primary efficacy end‐point was the mean percentage of time with a target glucose range of 70–180 mg/dL, and safety end‐points were the mean percentage of time with hypoglycemia having glucose levels <70 mg/dL, clinically important hypoglycemia with glucose levels <54 mg/dL and nocturnal (00.00–06.00) hypoglycemia.ResultsConsidering efficacy, the mean percentage of time for the target glucose range of IDegAsp was significantly lower than that of Gla300/Glu (73.1 [69.4–81.1] vs 84.2 [80.2–93.1], P = 0.001). Considering safety, the mean percentages of hypoglycemia (<70 mg/dL; 2.1 [0.0–9.4] vs 14.4 [4.4–22.3]), clinically important hypoglycemia (<54 mg/dL; 0.0 [0.0–0.2] vs 1.9 [0.0–5.6]) and nocturnal (00.00–06.00 hours) hypoglycemia (0.5 [0.0–5.9] vs 8.9 [3.1–11.8]) of Gla300/Glu were significantly lower than those of IDegAsp (P = 0.012, 0.036 and 0.007, respectively).ConclusionsWhen compared with the IDegAsp twice‐daily injections, Gla300/Glu basal–bolus therapy might achieve more effective glycemic control without hypoglycemic risk.

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

“…On the other hand, studies comparing IDegAsp once‐ to twice‐daily injection and basal bolus therapy have provided contradictory results. Among these, some studies found similar hypoglycaemia incidence rates, 9,12 whereas one study reported that IGlarU300 Insulin Glulisine basal‐bolus therapy had lower hypoglycaemia incidence rates compared to IDegAsp twice‐daily 13 . In our study, unlike in other studies, the insulin treatment of the patients using many different combinations was changed to IDegAsp twice‐daily injection.…”

“…However, Ozcelik et al found no significant change in FPG and HbA1c levels after switching from intensive insulin to IDegAsp 9 . By contrast, Kawaguchi et al used a blood glucose monitoring system showed that basal‐bolus therapy (IGlarU300—insulin glulisine) was superior to IDegAsp in terms of efficacy and safety 13 . Tsimikas et al reported that the administration of IDegAsp once‐ to twice‐daily injection showed similar efficacy in insulin intensification therapy when compared to multiple injection (basal‐bolus) therapy 12 …”

“…Insulin Glulisine basal-bolus therapy had lower hypoglycaemia incidence rates compared to IDegAsp twice-daily. 13 In our study, unlike in other studies, the insulin treatment of the patients using many different combinations was changed to IDegAsp twice-daily injection. Moreover, IDegAsp was found to have favourable effects on hypoglycaemia.…”

“…9 By contrast, Kawaguchi et al used a blood glucose monitoring system showed that basal-bolus therapy (IGlarU300-insulin glulisine) was superior to IDegAsp in terms of efficacy and safety. 13 Tsimikas et al reported that the administration of IDegAsp once-to twice-daily injection showed similar efficacy in insulin intensification therapy when compared to multiple injection (basal-bolus) therapy. 12 Taken together, our results indicated that IGlarU300 was mostly preferred in patients with higher BMI values and higher hypoglycaemia incidence rates who previously received basal-bolus therapy, used high-dose insulin, and had a higher frequency of retinopathy.…”

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

“…In a 12-week study comparing once-daily IDegAsp and basal insulin 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 ]. Our findings can be viewed as contradicting the previously held idea on the superiority of basal-bolus treatment over fixed-dose insulin preparations.…”