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SAN FRANCISCO — Ultra-rapid lispro (URLi), a new prandial insulin lispro formulation that closely resembles physiological insulin secretion, demonstrated superiority to insulin lispro in controlling postprandial glucose excursions in individuals with type 2 diabetes, according to research results presented at the American Diabetes Association 79th Scientific Sessions, held June 7 to 11, 2019, in San Francisco, California.
This phase 3 trial included individuals with type 2 diabetes who were randomly assigned to receive either lispro (n = 337) or URLi (n = 336). Change in hemoglobin A1c (HbA1c) between baseline and week 26 constituted the primary end point, with objectives adjusted for multiplicity for postprandial glucose excursions with a meal test. An 8-week lead-in was taken to switch to prandial lispro treatment and optimize basal insulin glargine or degludec, after which participants were randomly assigned to their treatments. Both lispro and URLi were injected 0 to 2 minutes before mealtime. Continuation of sodium-glucose cotransporter 2 inhibitor and/or metformin therapy was permitted.
URLi was found to be noninferior with regard to changes in HbA1c, with a mean HbA1c decrease of 0.38% with URLi compared with a decrease of 0.43% with lispro, yielding an estimated treatment difference of 0.06% (95% CI, -0.05% to 0.16%). At week 26, mean HbA1c was 6.92% with URLi compared with 6.86% with lispro, and postprandial glucose excursions were lower within 0.5 to 4 hours after injection with the standardized meal test.
Hypoglycemia rates did not differ between treatments, nor did incidence of treatment-emergent adverse events.
The study researchers concluded that compared with insulin lispro, URLi in a basal-bolus regimen demonstrated superiority in terms of postprandial glucose control.
Multiple authors disclosed associations with the pharmaceutical industry. Please see the original abstract for a full list of authors’ disclosures.
Reference
Blevins T, Zhang Q, Frias JP, Jinnouchi H, Chang AM. Ultra Rapid Lispro (URLi) improves postprandial glucose (PPG) control vs. Humalog (lispro) in patients with Type 2 Diabetes (T2D): PRONTO-T2D. Presented at: American Diabetes Association 79th Scientific Sessions; June 7-11, 2019; San Francisco, CA. Oral Presentation 145-OR.
