Two phase III studies of Ultra Rapid Lispro show A1C reductions in type 1&2 diabetes
Two phase III studies show that Ultra Rapid Lispro (URLi), from Eli Lilly, provided non-inferior A1C reductions compared to Humalog (insulin lispro) at 26 weeks in people with type 1 and type 2 diabetes. The data from these treat-to-target studies showed URLi also significantly reduced the rise in blood glucose one hour and two hours after a test meal compared to Humalog. Additional data from the study in people with type 1 diabetes demonstrated URLi significantly improved glucose time in range during the day. URLi is an investigational novel mealtime insulin formulation being developed to better manage blood glucose levels.
The two phase III studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when the insulins were dosed at mealtime. Further, URLi demonstrated superior reduction in blood glucose spikes at both one hour (-27.9 mg/dL [T1D], -11.8 mg/dL [T2D]) and two hours (-31.2 mg/dL [T1D] and -17.4 mg/dL [T2D]) after a test meal compared to Humalog. Hypoglycemia is the most common adverse reaction associated with insulin. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.
A sub-set of participants in PRONTO-T1D were evaluated using blinded continuous glucose monitoring to provide more complete information on daily blood glucose patterns. At 26 weeks, URLi demonstrated a significantly better blood glucose profile up to four hours after breakfast compared to Humalog. The study further showed that URLi had significantly longer (+43.6 minutes) time in range (71-180 mg/dL) during the day and similar time in range during the night compared to Humalog. These data and several other studies were presented at the American Diabetes Association's 79th Scientific Sessions.
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