Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range

• Published in: Diabetes therapy Vol. 14; no. 5; pp. 883 - 897
• Main Authors: Bailey, Timothy S., Bode, Bruce W., Wang, Qianqian, Knights, Alastair W., Chang, Annette M.
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01-05-2023; Springer; Springer Nature B.V
• Subjects: Cardiology; Diabetes; Dosage and administration; Drug therapy; Endocrinology; Glucose; Glycosylated hemoglobin; Health aspects; Hypoglycemia; Insulin; Insulin lispro; Internal Medicine; Medicine; Medicine & Public Health; NCT; NCT04605991; Original Research; Testing; Type 2 diabetes; United States; Continuous glucose monitoring; Type 2 diabetes; Ultra rapid lispro; Time in range
• ISSN: 1869-6953; 1869-6961
• DOI: 10.1007/s13300-023-01400-w

Introduction
To evaluate time in range metrics and HbA1c in people with type 2 diabetes (T2D) treated with ultra rapid lispro (URLi) using continuous glucose monitoring (CGM) for the first time in this population.
Methods
This was a Phase 3b, 12-week, single-treatment study in adults with T2D on basal-bolus multiple daily injection (MDI) therapy using basal insulin glargine U-100 along with a rapid-acting insulin analog. Following a 4-week baseline period, 176 participants were newly treated with prandial URLi. Participants used unblinded CGM (Freestyle Libre). Primary endpoint was time in range (TIR) (70–180 mg/dl) during the daytime period at Week 12 compared to baseline with gated secondary endpoints of HbA1c change from baseline and 24-h TIR (70–180 mg/dl).
Results
Improved glycemic control was observed at Week 12 versus baseline including mean daytime TIR (change from baseline [Δ] 3.8%;
P
 = 0.007), HbA1c (Δ − 0.44%;
P
 < 0.001), and 24-h TIR (Δ 3.3%;
P
 = 0.016) with no significant difference in time below range (TBR). After 12 weeks, there was a statistically significant decrease in postprandial glucose incremental area under curve, overall, across all meals, within 1 h (
P
 = 0.005) or 2 h (
P
 < 0.001) after the start of a meal. Basal, bolus, and total insulin dose were intensified with increased bolus/total dose ratio at Week 12 (50.7%) versus baseline (44.5%;
P
 < 0.001). There were no severe hypoglycemia events during the treatment period.
Conclusions
In people with T2D, URLi in an MDI regimen was efficacious with improved glycemic control including TIR, HbA1c, and postprandial glucose without increased hypoglycemia/TBR.
Clinical Trial registration number
NCT04605991.