Comparing Postprandial Glycemic Control Using Fiasp vs Insulin Aspart in Hospitalized Patients With Type 2 Diabetes.

Objective: 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 noninferiority in efficacy and safety of Fiasp vs aspart (Novolog) as part of a basal-bolus insulin regimen in noncritically ill patients with type 2 diabetes in a safety-net hospital.

Methods: This prospective, open-label, randomized trial included 137 patients with diabetes admitted to a non-intensive care unit 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.

Results: Four-hour postprandial time in range 100-180 mg/dL was 45% in the Fiasp group vs 36% in the Novolog group (P = .012; meeting prespecified noninferiority criteria). Other glycemic metrics were similar between groups with no difference in time spent in hypoglycemic ranges.

Conclusion: Fiasp provides noninferior postprandial glucose control in hospitalized patients with type 2 diabetes when compared to Novolog with no increase in rates of hypoglycemia.