The first fast-acting insulin to earn the “ultra” label is now available in the United States, and those who’ve tried are saying they definitely find it quicker compared to other insulins used to cover meals and make blood glucose corrections.
Yet there appear to be open questions about whether this new formulation continues working well after its initial fast onset, whether it is more painful to inject, and whether it will perform well in insulin pumps.
Named Lyumjev (pronounced LOOM-JEV), from Eli Lilly, this new insulin snagged FDA clearance in June 2020, right about the time of the American Diabetes Association’s annual Scientific Sessions conference, and is beginning to get into the hands of patients now.
Here’s what you should know about this new brand of insulin.
Lyumjev is now available in U.S. pharmacies, indicated for both type 1 and type 2 diabetes. But at the moment, it’s only cleared for use in adults. Lilly has a Phase III clinical trial underway for Lyumjev use in kids and teens, and that’s expected to wrap up in mid-2021.
Why the name?
The pronunciation of the name Lyumjev is certainly not intuitive. Where do insulin manufacturers even come up with these strange brand names? Turns out it’s quite a complicated process. We asked Lilly about the specific origins here, but they declined to provide any details.
Scientifically, this new insulin is referred to as insulin lispro-aabc, which is essentially a meshing of traditional insulin lispro (i.e., Humalog) with two additives to help it work more quickly: Treprostinil, which helps to open up blood vessels for faster absorption, and sodium citrate to also enhance the insulin’s action time.
How fast-acting is it?
Per the clinical trial data submitted to regulators, Lyumjev begins working in the body within 13 minutes, compared to Humalog and other meal-time insulins that can take as long as 27 minutes to start impacting glucose levels.
Lilly points out that it can be taken at the start of a meal, or within 20 minutes of starting to eat or drink anything that requires a bolus dose.
This faster-action providing flexibility is key, given that many people with diabetes (PWDs) struggle with keeping glucose levels in target range following meals. This more rapid-acting formulation should allow them to better avoid glucose spikes that often come after eating.
Accounts from those who’ve used Lyumjev say that it seems to bring their glucose levels down 5 to 10 minutes faster than what they typically see with other injected insulins, including Novo Nordisk’s newest fast-acting insulin Fiasp.
But many have also reported that Lyumjev’s fast action may be short-lived, as it appears to fade after initial use. Also, while Lyumjev isn’t yet FDA-approved for insulin pump use, those who have tried it say it isn’t as fast-acting when used in these devices. (See user testimonials below.)
Pens and vials, but not pumps
Lilly is selling this new insulin in 10 mL vials and also pre-filled Kwik pens that carry 300 units total, available in both 100 units/mL and 200 units/mL concentrations.
They plan to present a new study on Lyumjev use in insulin pens during the big EASD (European Association for the Study of Diabetes) conference in late September, the first fully virtual event the organization has held due to the continuing COVID-19 pandemic.
Lilly says it is aiming to submit Lyumjev to FDA for insulin pump use by year’s end 2020.
How much does Lyumjev cost?
Unfortunately, we’re told Lilly plans to sell Lyumjev at the same $287 list price as Humalog — meaning that short of any decent insurance coverage or eligible financial assistance, this new faster insulin will be just as unaffordable as most other insulins on the market.
Lilly does offer financial assistance through its Lilly Insulin Value Program, and this new Lyumjev is included, so that will allow some eligible patients to get it for $35 per prescription. The pharma giant is continuing that program through 2020 at least, we’re told, but as always eligibility requirements vary, and there’s lots of red tape to get through in order to apply.
When it comes to any new drug, it’s always interesting to see how the info in marketing materials and clinical data actually translates into real-life experiences. For that, we queried some early users of Lyumjev.
Gary Scheiner, a well-respected diabetes care and education specialist (DCES) who lives with T1D himself, has been using Lyumjev along with others he works with at Integrated Diabetes Services in the greater Philadelphia area.
Three of his five team members who’ve used it report fast action, but have experienced acute site irritation ranging from “minor tingling” to a full-on burning sensation, he says.
Despite it not being FDA-cleared for pumps, Scheiner says he personally is trying out that delivery method.
“Any time I’ve used my abdomen, the site starts to itch and become inflamed by day two,” he told DiabetesMine, adding that the added stinging sensations forced him to go back to Novolog/Humalog.
“Lyumjev does work faster than traditional rapid-acting insulin, so for those who can tolerate the potential skin issues, it should produce flatter post-meal glucose patterns. But for those who are comfortable pre-bolusing, it really doesn’t offer any significant advantages.”
Kelly Schmidt, a registered dietician and longtime type 1 in Ohio, echoes much of what Scheiner and team say about Lyumjev. She had been taking two shots of Fiasp daily for the past few years because of pump site absorption issues, but decided to try new Lyumjev for even faster action.
While Lyumjev accomplished that goal at first, eventually it tapered off. For the first 3 days on Lyumjev, she says she experienced “wild low blood sugars,” but after a week she felt the new insulin wasn’t as effective as it had been initially.
Using her Dexcom CGM, Schmidt saw her blood sugars were an additional 4 percent out of range compared to before, which was a deal-breaker given her tight glucose range for the last decade or so.
“I would also say the onset was the same as Fiasp as for timing, but worked more like a freight train at first,” she explained. “If I saw a mid-meal reading rise above 130 mg/dL, I’d be tempted to correct. But with Lyumjev it would intercept rising blood sugars more aggressively. I had a hard time getting a rhythm with it after 3 weeks and just switched back to Fiasp.”
As to the burning, Schmidt said injecting Lyumjev was more painful but not quite a full burning sensation, compared to other medications she’s used.
Type 1 PWD Justin Lewis in Tampa, Florida, shared this online in late August after he started using Lyumjev in his Tandem t:slim X2 insulin pump: “I can already see a difference in how much faster it acts as opposed to just regular Humalog. My only issue so far is it is painful when bolusing. I don’t feel it much with just the regular basal but boy do I feel it when I have to bolus. I know I have seen that with some others that have posted about it… Does anyone notice that it goes away after a while or it’s just something I would need to get used to?”
Overseas in the United Kingdom, fellow type 1 blogger Tim Street conducted an experiment with Lyumjev with both injections as well as using it in his hybrid closed loop device. He wrote about his experiences on his DiabetTech blog, and summed up his findings for us at DiabetesMine.
Within 30 minutes, he saw his CGM reflecting a dramatic decrease in glucose readings compared to how long it traditionally took with other insulin brands.
“When injecting, I found it super-fast. But when used with a pump, I found that the boluses seemed to work at normal Humalog rates, and took ages to have an effect. I also needed more insulin,” he shared. “Having used Fiasp and recalling the immediate, obvious impact that I saw with it, it doesn’t feel like I’m getting the same thing with the Lyumjev. It doesn’t feel like it’s particularly early. In fact, it really feels like it’s a bit late.”
As to the burning sensation others have reported, Street says he didn’t find that Lyumjev hurt while bolusing via his pump, but his infusion sites became irritated in ways he didn’t typically experience.
“The site itself became quite tender and felt like there was a large bruise,” he said. “This made it quite painful and sensitive to touch. This was highlighted when I was in bed and rolled into the site, and the pain woke me up.”
Of course, those using Lyumjev in insulin pumps are doing so off-label at this time. Still, the real-world testimony of PWDs using new medications is invaluable — even before formal
We are pleased to see new types of insulin being pursued and made available, though still the pricing always remains a barrier, and in this case, it seems effectiveness may vary.