Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL) is a rapid-acting human insulin analog.
Lyumjev is specifically indicated to improve glycemic control in adults with diabetes mellitus.
Lyumjev is supplied as an injection for subcutaneous or intravenous administration. The recommended dose is as follows:
Intravenous Administration for Lyumjev U-100 Only
The FDA approval of Lyumjev was based on data from the Phase 3 studies PRONTO-T1D and PRONTO-T2D, which were randomized, active controlled, treat-to-target comparisons of Lyumjev and Humalog (insulin lispro injection, 100 units/mL) in adults with type 1 and type 2 diabetes, respectively. The studies were designed as treat-to-target trials in which each arm was treated to achieve the same level of blood glucose control and evaluated other important treatment effects, such as rates of hypoglycemia and post-meal glucose control. A subset of patients randomized to PRONTO-T1D participated in an evaluation of 24-hour ambulatory glucose profiles captured with blinded continuous glucose monitoring (CGM) over a two-week period. Both studies met the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime. Key endpoints were adjusted for multiple testing, including the comparisons of one- and two-hour postprandial glucose. In both studies, Lyumjev demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Additionally, in studies evaluating the time action profile of this new insulin, Lyumjev appeared in the blood stream approximately one minute after injection.
Adverse effects associated with the use of Lyumjev may include, but are not limited to, the following:
For additional information regarding Lyumjev or diabetes, please visit the Lyumjev website.