Hyperglycemia in hospitalized patients is associated with increased morbidity and mortality. Basal-bolus insulin therapy is the treatment of choice for most patients. The efficacy of an ultrarapid vs. rapid-acting insulin in hospitalized patients with diabetes has not been evaluated. We assessed non-inferiority in efficacy and safety of Fiasp vs. aspart (Novolog) as part of a basal-bolus insulin regimen in non-critically ill patients with type 2 diabetes in a safety-net hospital. This prospective, open-label, randomized trial included 137 patients with diabetes admitted to a non-ICU setting. Subjects were treated with glargine at bedtime and either Fiasp or Novolog for prandial and correction insulin. Subjects were enrolled for a minimum of 4 or maximum of 6 meal boluses. Capillary blood glucose was used for insulin adjustment and a blinded Dexcom G6 Pro captured data for study analysis. The primary endpoint was time spent in sensor glucose range 100-180 mg/dL in the 4-hour postprandial period (assessed among 106 participants with ≥ 4 meals with a 4-hour postprandial period). Time spent in hypoglycemic ranges (<70, <54, <40 mg/dL) was assessed for safety. Four-hour postprandial time in range 100-180 mg/dL was 45% in the Fiasp group vs. 36% in the Novolog group (p=0.012; meeting prespecified non-inferiority criteria). Other glycemic metrics were similar between groups with no difference in time spent in hypoglycemic ranges. Fiasp provides non-inferior postprandial glucose control in hospitalized patients with type 2 diabetes when compared to Novolog with no increase in rates of hypoglycemia.
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