Eli Lilly and Company has reported positive results from two Phase lll trials, PRONTO-T1D and PRONTO-T2D, which examined the safety and efficacy of Ultra Rapid Lispro (URLi) compared to Humalog to treat people with type 1 and type 2 diabetes, respectively.
The trial met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog (insulin lispro) at week 26.
The results also showed significantly improved post-meal glucose control in the type 1 and type 2 diabetes patients.
No major differences in severe, nocturnal or overall hypoglycemia rates were observed among the patients.
In addition, URLi demonstrated overall safety and tolerability similar to Humalog in both trials.
Based on the data, Lilly is expected to submit URLi to regulatory authorities next year.
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Eli Lilly and Company Insulins Product Development senior medical director Thomas Hardy said: “Despite progress in insulin and diabetes management, many people with diabetes find controlling high blood sugar levels after meals frustrating.
“If approved, URLi will be a new option in mealtime insulin therapy designed to help keep blood sugar in range after eating.”
Both the PRONTO-T1D and PRONTO-T2D trials were conducted in randomised, double-blind, controlled settings.
The PRONTO-T1D and PRONTO-T2D trials respectively compared the combination of URLi and Humalog with either insulin glargine or insulin degludec in adults with type 1 and type 2 diabetes.
PRONTO-T1D enrolled 1,222 patients, while PRONTO-T2D included 673 participants.
As part of the trials’ statistical arrangement, Lilly compared one and two-hour post-prandial glucose and A1C superiority of URLi and Humalog.
The comparisons were conducted after achieving the primary endpoint of non-inferiority.