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Efficacy and safety of ultra-rapid acting oral prandial insulin Tregopil was compared with insulin aspart (IAsp) in patients with type 2 diabetes (T2D) on insulin glargine and metformin. In this open-label, active-controlled trial, patients with T2D, HbA 1c  ≥7%–≤9% and 2-h postprandial glucose (PPG) ≥180 mg/dL were randomized 1:1:1 to Tregopil (30 mg,  n  = 30; 45 mg,  n  = 31) and IAsp,  n  = 30. Primary outcome was change from baseline (CFB) in HbA 1c  at week 24. Secondary outcomes included PPG excursion (PPGE) and PPG assessed from standardized test meal (STM) and 9-point self-monitored blood glucose. The observed mean HbA 1c  did not improve at week 24 in Tregopil groups (30 mg [0.15%], 45 mg [0.22%] vs. a reduction in IAsp group [−0.77%]). Combined Tregopil group showed better 1-h PPGE control versus IAsp following STM (CFB, estimated treatment difference, 95% CI, −45.33 mg/dL [−71.91, −18.75], p = 0.001) and 1-h PPG trended toward better control. Tregopil showed lower PPGE at 15 min versus IAsp. Clinically significant hypoglycemia was lower with Tregopil versus. IAsp (rate ratio: 0.69). Tregopil demonstrated an ultrafast, short-duration prandial profile with good safety. While Tregopil’s early postprandial effects were comparable to IAsp, its late postprandial effects were inferior. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT03430856).

expert opinion on pharmacotherapy

Efficacy and safety of Tregopil, a novel, ultra-rapid acting oral prandial insulin analog, as part of a basal-bolus regimen in type 2 diabetes: a randomized, active-controlled phase 2/3 study