Diabetes In Control. A free weekly diabetes newsletter for Medical Professionals. News and information for Medical Professionals.
Lyumjev, recently approved by the FDA, reaches the bloodstream only one minute after injection; how does its performance compare to Humalog?
Insulin is required for all patients with type 1 diabetes and sometimes required for patients with type 2 diabetes, depending on their HbA1C levels. Insulin must be injected into subcutaneous fat to be able to appropriately control blood glucose, and must be timed appropriately according to patient meals and time of day. Typically, rapid-acting insulin reaches the bloodstream 15 minutes after injection, peaks in one or two hours, and lasts between two and four hours. Regular, or short-acting, insulin reaches the bloodstream within 30 minutes after injection, peaks in two to three hours after injection, and lasts for about three to six hours. Intermediate-acting insulin reaches the bloodstream about two to four hours after injection, peaks four to 12 hours later, and lasts for about 12 to 18 hours. Long-acting insulin reaches the bloodstream several hours after injection and tends to lower blood glucose levels for about 24 hours. Ultra long-acting reaches the bloodstream in six hours, does not peak, and lasts for about 36 hours, sometimes longer. Managing blood glucose throughout the day, particularly after meals, can be quite a task for some patients, especially when multiple insulin types may be involved. It is essential to maintain a regimen that works best for the lifestyles of the patients.
The FDA has just approved the new rapid-acting insulin Lyumjev, also known as insulin lispro-aabc, injection that comes in 100 units/mL and 200 units/mL. It is indicated to improve glycemic control in adults with type 1 and type 2 diabetes. In phase 3, 26-week clinical trials, PRONTO-T1D and PRONTO-T2D, Lyumjev and Humalog (insulin lispro injection) were compared both in combination with either insulin glargine or insulin degludec in patients with type 1 (PRONTO-T1D) and type 2 diabetes (PRONTO-T2D). In a treat-to-target fashion, each arm was treated to achieve the same level of blood glucose control, while also evaluating rates of hypoglycemia and post-meal glucose control.
In both studies, Lyumjev demonstrated to be non-inferior to Humalog in lowering HbA1C levels. However, Lyumjev was superior in terms of reduction in blood glucose spikes after eating. In PRONTO-T2D, at one hour [95% CI -18.1 to -5.5; p<0.001] and two hours [95% CI -25.3 to -9.5; p<0.001]; and in PRONTO-T1D, at one hour [95% CI -35.3 to -20.6; p<0.001 and two hours [95% CI -41.1 to -21.2; p<0.001] after eating, Lyumjev provided more control over blood glucose spikes compared to Humalog. Lyumjev has been shown to appear in the bloodstream in as little as one minute following injection. Due to this quick onset, Lyumjev can be taken at the beginning of the meal or 20 minutes after starting the meal, allowing for dosing flexibility. Hypoglycemia is still a concern because Lyumjev is a type of insulin, but the risk of hypoglycemia with the use of Lyumjev is similar to that of Humalog. The success that presented in both trials is what led to the approval of Lyumjev by the FDA.
This study was funded by Eli Lilly and Company (Lilly). Lilly’s Lyumjev is a valuable new treatment addition to rapid-acting insulin to help control blood glucose spikes after eating. Additionally, to ensure that Lyumjev is affordable, Lyumjev is offered via the Lilly Insulin Value Program. This medication will also be available to the uninsured.
A drawback of this study is that Lyumjev is currently not indicated for children with diabetes because its effectiveness and safety profile in children is unknown. It is currently approved for adults with type 1 and type 2 diabetes. However, type 1 diabetes has a high chance of presenting in children, as well as adults. There is also increasing prevalence of type 2 diabetes occurring in children due to an increase in childhood obesity. Studies should be done to determine the safe use of Lyumjev in children for both type 1 and type 2 diabetes.
Practice Pearls:
- Lyumjev (insulin lispro-aabc injection) is a new rapid-acting insulin that was recently approved by the FDA for glycemic control in adults with type 1 and type 2 diabetes.
- Lyumjev was found to be non-inferior to Humalog in reducing HbA1c levels, but superior in reducing blood glucose spikes one hour and two hours after eating.
- Lyumjev is currently not approved for use in children. However, studies should be done in children due to the prevalence of both type 1 and type 2 diabetes in children.
Brianna Belton, PharmD. Candidate, Florida Agricultural & Mechanical University, College of Pharmacy and Pharmaceutical Sciences