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/Introduction: We 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 Methods: A 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. Results: Considering 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). Conclusions: When compared with the IDegAsp twice-daily injections, Gla300/Glu basal–bolus therapy might achieve more effective glycemic control without hypoglycemic risk.