Technology and unique rapid–acting insulin Lyumjev can improve time in range and Quality of Life for patients with diabetes.
Diabetes in Control interviews Dan Pollom, MD, Senior Medical Advisor, Eli Lilly, and Company, about Lilly’s new rapid-acting insulin Lyumjev and how it increases TIR (Time in Range) and lowers A1C.
Why is postprandial glucose a risk factor for cardiovascular disease? What are the benefits of postprandial glucose as it relates to A1C and cardiovascular disease?
People with diabetes are at a greater risk for cardiovascular disease, and postprandial glucose (PPG) is an essential metric in diabetes management and contributor to A1C levels. While A1C reflects average blood glucose over two to three months, it only reflects one part of the larger picture in helping people with diabetes manage their condition and does not capture blood glucose highs and lows on a day-to-day basis. For those who are not achieving their target A1C despite reaching their target pre-meal glucose levels, measuring and treating PPG may help.
What are the significant benefits of using Lyumjev and Dexcom G6 CGM? What have you seen in the studies using Lyumjev and Dexcom CGM — what has been the average A1c?
In the absence of a clinical trial, we can’t speculate on the exact A1C reductions people with diabetes may see from taking Lyumjev and using the Dexcom G6 CGM. We are confident in the value of assessing glucose levels and time in range in real-time with Dexcom CGMs. Doing so can help HCPs better support people living with diabetes who struggle to manage their PPG levels and benefit from a treatment like Lyumjev. PPG is often overlooked as a significant contributor to A1C, and our partnership with Dexcom aims to elevate PPG monitoring as an essential component of treatment management.
Time in range (TIR) is an indicator of glycemic control, as it measures the percentage of time that a person spends with their blood glucose levels in a specific target range. Maintaining blood glucose levels in the target range is a daily balancing act for people living with diabetes.
In PRONTO-T1D, a clinical study evaluating Lyumjev in adults with type 1 diabetes, continuous glucose monitoring was performed in a subset of participants. At 26 weeks, Lyumjev provided significantly more time in range during the day (+44 minutes, 4% increase) and a similar time in range during the night than Humalog (insulin lispro).
That’s one reason why we believe Lyumjev is an important treatment option to help adults with diabetes manage their blood glucose. With the ability to assess glucose levels and time in range in real-time with Dexcom G6 or Dexcom G6 Pro, either in a blinded or unblinded mode, HCPs can quickly identify their adult patients with type 1 and type 2 diabetes who struggle to manage their PPG levels and who may benefit from a treatment like Lyumjev. Overall, this data can be used to help inform diabetes management.
What are any significant side effects associated with Lyumjev?
Adverse reactions observed with Lyumjev include hypoglycemia, injection site reactions, allergic reactions, lipodystrophy, and weight gain. In clinical studies, Lyumjev and Humalog had similar safety and tolerability profiles.
What percentage of reduction in PPG do you foresee when using Lyumjev?
In the Phase 3 trials PRONTO-T1D and PRONTO-T2D, Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog.
What percentage of reduction seen in A1C using Lyumjev?
In the PRONTO clinical trial program, Lyumjev met the primary endpoint of non-inferior A1C reductions compared 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 PRONTO-T1D and PRONTO-T2D trials, respectively.
How will using both the Lyumjev and Dexcom G6 CGM benefit the patients and healthcare providers? Who will benefit from using Lyumjev and Dexcom G6 CGM?
Our partnership may be impactful for HCPs who want to help their adult patients who may be 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 makes Lyumjev superior over other antihyperglycemic medications?
The only head-to-head trial for Lyumjev is versus Humalog in phase 3 clinical trials. In the Phase 3 trials PRONTO-T1D and PRONTO-T2D, Lyumjev provided non-inferior A1C reductions compared to Humalog in people with type 1 and type 2 diabetes, respectively. Lyumjev demonstrated a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog.
What future technology and medicines do you see that will enhance controlling diabetes?
At Lilly, we believe there is a need to look at treatment outcome measures more holistically – including managing blood glucose levels at mealtime – and develop treatment options to support improved outcomes. We developed Lyumjev to provide a significant new opportunity for people managing their diabetes. This unique, 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, and we plan to conduct additional clinical studies of Lyumjev in insulin pumps. We also anticipate that Lyumjev will be an essential component of our connected diabetes solutions currently under development.
Tarshay Boyd, PharmD. Candidate, LECOM School of Pharmacy