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

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.