I recently interviewed Dan Pollom, a senior medical advisor at Lilly/Dexcom, about Lyumev, a new fast-acting insulin that has successfully shown its effectiveness against an older insulin, Humalog. Lilly’s collaboration with Dexcom joins the two companies in asking the FDA to approve the use of Lyumev as a part of a continuous glucose monitoring system.
Why did Lilly work on developing Lyumjev? How does it work?
We developed Lyumjev to provide another choice for people with diabetes who struggle to keep their blood glucose in the target range following meals. A rapid-acting insulin like Lyumjev helps to control blood glucose levels, specifically high blood sugars after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes.
Who is Lyumjev insulin approved for? Type 1’s Type 2’s Children with diabetes, gestational diabetes for Type 2s?
In the U.S., Lyumjev is indicated to improve glycemic control in adults with type 1 and type 2 diabetes. As part of our commitment to addressing unmet needs, we currently have ongoing Phase 3 trials to assess the use of Lyumjev in pediatric patients.
What is the difference between Humalog and Lyumjev?
Lyumjev is a novel, rapid-acting insulin lispro formulation which appears in the blood stream approximately one minute after injection. In clinical trials, Lyumjev provided non-inferior A1C reduction from baseline compared to Humalog (insulin lispro), at 26 weeks, when the two insulins were dosed right before the meal. Lyumjev demonstrated superior reductions in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog.
It’s important to note that people who successfully manage their diabetes using Humalog will continue to have that option.
Can you use Lyumjev in an insulin pump?
In the U.S., Lyumjev is currently only approved for use as part of a multiple daily injection regimen. We submitted an application to the U.S. Food and Drug Administration (FDA) to support the administration of Lyumjev via continuous subcutaneous insulin infusion (CSII) with an insulin pump in late 2020. If approved by the FDA, we look forward to providing an option for a new route of administration and supporting people with diabetes who use insulin pumps and are considering transitioning to an insulin like Lyumjev.
Who should not use Lyumjev and are possible side effects?
Lyumjev is approved in the U.S. for the treatment of type 1 and type 2 diabetes in adults. Adverse reactions observed with Lyumjev include hypoglycemia, injection site reactions, allergic reactions, lipodystrophy and weight gain. In our clinical studies, Lyumjev and Humalog had similar safety and tolerability profiles.
Hypoglycemia is the most common adverse reaction associated with insulins, including Lyumjev. Lyumjev is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of the excipients in Lyumjev. Hypoglycemia, which can be serious and life-threatening, is the most common adverse reaction associated with insulins, including Lyumjev.
The pronto study showed a lower A1c for participants- can you tell me more about the study?
The FDA decision for Lyumjev was based on the results of the PRONTO-T1D and PRONTO-T2D clinical trials. Designed as treat-to-target studies, the PRONTO clinical trials examined differences between Lyumjev and Humalog, as both arms were treated to achieve the same level of blood glucose control while evaluating other important treatment effects, such as rates of hypoglycemia and post-meal glucose control.
In the PRONTO clinical trial program, Lyumjev met the primary endpoint of non-inferior A1C reductionscompared to Humalog in people with type 1 and type 2 diabetes, respectively. Lyumjev demonstrated a -0.12 percent change from baseline (7.3 percent mean A1C) and a -0.36 percent change from baseline (7.3 percent mean A1C) at 26 weeks in the PRONTO-T1D and PRONTO-T2D trials respectively.
Lilly has a new partnership with Dexcom- The makers of the G6 Continues Glucose monitoring system. How did this come about? What are the benefits to the new partnership with Dexcom?
We partnered with Dexcom on a new program for U.S. HCPs about Lyumjev and Dexcom’s continuous glucose monitoring (CGM) – including Dexcom G6 CGM system. We share a mission to improve diabetes management and we work closely together on our connected diabetes solutions, which are currently in development. Dexcom is a natural partner to achieve our shared goal to help clinicians use data to inform diabetes management, including giving visibility to the benefits of a new mealtime insulin.
Our partnership may be impactful for HCPs who want to help their adult patients struggling to manage their blood glucose levels after meals. With the ability to assess glucose levels and time in range in real-time with the Dexcom G6 or Dexcom G6 Pro, either in a blinded or unblinded mode, HCPs can have more visibility to the day-to-day blood glucose levels of their patients with type 1 and type 2 diabetes.
What is the future of insulin R&D?
At Lilly, we believe there is a need to look at treatment outcome measures more holistically – including managing blood glucose levels at mealtime – while developing treatment options to support improved outcomes. We developed Lyumjev to provide an important new option for people managing their diabetes and this new, rapid-acting formulation of insulin lispro represents a meaningful development for people with diabetes who want their insulin to help manage their A1C and reduce those post-meal spikes.
As part of our commitment to addressing unmet needs, we currently have ongoing Phase 3 trials to assess the use of Lyumjev in pediatric patients while conducting Lyumjev clinical studies in insulin pumps. We also anticipate that Lyumjev will be an important component of our connected diabetes solutions, which are currently under development.
About Dan Pollom, Senior Medical Advisor at Lilly/Dexcom
Dan leads U.S. Medical Affairs for Lilly’s insulin portfolio, using his scientific expertise to build on Lilly’s rich history in insulin innovation Recently, he supported preparation for the launch of Lyumjev ® (insulin lispro-aabc, 100 units/mL and 200 units/mL), Lilly’s new rapid-acting insulin for people with type 1 and type 2 diabetes.