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.

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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.

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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.