The Fight to Save Levemir: Inside the Grassroots Push to Protect Insulin Choice

Summary

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Podcast Summary: The Fight to Save Levemir – Inside the Grassroots Push to Protect Insulin Choice

Podcast: Diabetes Connections | Type 1 Diabetes
Host: Stacey Simms
Date: April 28, 2026
Guests: Allison Smart (Alliance to Protect Insulin Choice), Dr. Florence Brown (Harvard Medical School), Dr. Amy Valent (Oregon Health and Science University)

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Overview

This episode addresses the urgent, grassroots movement to prevent the loss of Levemir (insulin detemir), a long-acting basal insulin recently discontinued by Novo Nordisk in the U.S. and soon globally. Host Stacey Simms speaks with key advocate Allison Smart, as well as leading clinicians Dr. Florence Brown and Dr. Amy Valent, to unpack why Levemir is uniquely vital, what its discontinuation means for people living with diabetes (especially pregnant women and young children), and how the diabetes community is mobilizing to fight for insulin choice.

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Key Discussion Points & Insights

1. Background: The Discontinuation of Levemir

• Announcement & Reasoning:
  • In November 2023, Novo Nordisk announced Levemir’s discontinuation, citing “global manufacturing constraints, formulary losses impacting patient access, and availability of alternative options.”
    (05:22, 06:14)
  • The discontinuation has begun in the U.S. and is planned globally.
• Immediate Community Response:
  • The diabetes community—patients, providers, advocates—quickly recognized that Levemir cannot easily be replaced by other basal insulins.

2. Why Levemir is Unique among Basal Insulins

• Pharmacological Advantages:

  • Shorter Duration: Lasts ~12 hours, while alternatives like Lantus and Tresiba last 20–42 hours—making Levemir highly adjustable and nimble.
    (06:14, 07:11, 19:11)
  • Nimbleness for Life Changes: Enables tailored insulin regimens especially for:
    • Pregnant and postpartum patients, who experience rapidly shifting insulin needs.
      (07:36, 10:25, 12:26)
    • Young children needing diluted doses for precision (the only long-acting insulin that can be diluted). (26:48, 27:17)
    • Athletes and people whose daily activity or hormonal fluctuations affect insulin sensitivity.

• Medical Endorsement:

  • Levemir is the most studied and recommended basal insulin for pregnancy, supported by robust randomized controlled trials.
    (21:53, 23:37)
  • Associated with less weight gain and fewer unpredictable side effects for some users.

• Notable Quote:

  “Levemir users love the ability to change that amount quickly or throughout the day.” — Allison Smart (06:14)

3. Why Pumps and Other Insulin Options Aren’t a Universal Solution

• Pumps Not for Everyone:
  • Not all patients want or can access insulin pumps due to:
    • Cost
    • Insurance hurdles
    • Provider expertise requirements
    • Personal preference (e.g., adhesives, lifestyle, etc.)
      (12:41, 13:27)
• Hybrid Closed-Loop Systems:
  • Current Automated Insulin Delivery (AID) systems are designed for non-pregnant populations and require significant manual adjustments for pregnant users.
• Backup Needs:
  • Even pump users need backup long-acting insulins for device failures or medical procedures. Levemir’s adjustability is critical here. (25:11)

4. The Grassroots Push to Save Levemir

• Alliance to Protect Insulin Choice:

  • Founded by Allison Smart—a parent of a teenager with T1D who personally benefits from Levemir.
  • Activities:
    • Communicating with FDA & manufacturers
    • Congressional outreach
    • Gathering and disseminating user stories, especially from uniquely affected groups
    • Petitioning for Levemir to be designated a drug “in shortage,” clearing the way for new manufacturing.
      (05:33, 21:53, 27:45)

• Barriers to Saving Levemir:

  • Regulatory and financial hurdles for new manufacturers, particularly as insulin manufacturers pivot to GLP-1 drugs.
    (24:45, 28:28)
  • No approved biosimilar or generic Levemir has entered production.

• Advocacy Fatigue:

  • The community is mobilized, but weary of the constant “call to action,” paperwork, and uncertainty.
    (31:01)

• Notable Quote:

  “At some point you realize… no one is going to do this, no one is going to do this [unless I step up].” — Allison Smart (21:53)

5. Clinical & Societal Implications

• Pregnancy & Pediatrics:

  • Pregnancy brings dramatic, rapid insulin requirement shifts that only a flexible basal insulin like Levemir can safely accommodate.
    (10:25)
  • In children, Levemir can be diluted for tiny, precise doses, a critical advantage over alternatives.
    (26:48–27:41)
  • Certain preservatives in other insulins can cause skin reactions; Levemir is better tolerated for some people.

• Loss of Choice Risks:

  • Reducing the range of basal insulins could lead to:
    • Poorer glycemic outcomes
    • Less personalized care
    • Increased provider and patient burden

• Notable Quote:

  “We really don’t want to lose any of our insulin options. They’re all really important.” — Dr. Florence Brown (19:11)

6. Regulatory & Business Context

• Novo Nordisk’s Position:

  • Decision to cease Levemir production is “business-based”; appeals and advocacy from the medical community and lawmakers have been unsuccessful so far.
    (28:28, 28:53)

• Alternative Sources:

  • Some users pay cash at select pharmacies or import from Europe where Levemir remains available (temporarily).

• Possible Solutions:

  • If FDA designates Levemir as a “drug in shortage,” it opens a regulatory path for other manufacturers.
  • Ongoing efforts for a biosimilar or alternative, but regulatory and economic challenges are steep.

• Notable Quote:

  “We need to have options. People need to have choices.” — Allison Smart (23:37)

7. Community Action: How to Help

• Current Needs:
  • Submitting comments on the citizen petition, especially from clinicians and affected individuals.
  • Contacting legislators, raising press awareness.
  • Joining organized advocacy efforts (e.g., Alliance to Protect Insulin Choice).
    (27:45, 31:01)

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Notable Quotes & Memorable Moments

• “I primarily love using Levemir in our pregnant and postpartum populations … it allows us to pivot when we need to.”
  — Dr. Amy Valent (07:36)

• “Dramatic changes in insulin requirements … and you need a flexible basal insulin that you can adjust frequently.”
  — Dr. Florence Brown (10:25)

• “She says, ‘Mom, you gotta do this for the babies’ … she just wants to live her life.”
  — Allison Smart on her daughter’s perspective (29:33)

• “What a luxury, not to struggle. Wow. I think that sums it up.”
  — Stacey Simms (32:36)

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Key Timestamps

• 05:33: State of Levemir’s discontinuation and advocacy update (Allison Smart)
• 06:14: Why Levemir is unique—clinical and personal perspectives
• 07:36: Clinical insights: Pregnant and postpartum patients need Levemir
• 10:25: Explaining dynamic insulin needs in pregnancy (Dr. Brown)
• 12:41: Why pumps and other technologies can’t replace Levemir for all
• 15:03: Allison Smart shares her daughter’s athlete perspective
• 19:11: The science of Levemir vs. other basal insulins
• 21:53: Grassroots movement: The beginning and current advocacy status
• 26:48: Levemir’s unique role in pediatric diabetes (dilution)
• 27:45: Action calls—how listeners can help
• 28:28: Exchanges with Novo Nordisk and state of manufacturer responses
• 30:12: Current availability: How some still find Levemir
• 31:01: Hope & fatigue within the advocacy community

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Resources & Links

• Alliance to Protect Insulin Choice: alliancetoprotectinsulinchoice.org
• Citizen Petition for Levemir drug shortage designation (further info via Alliance)
• Stacey’s social media and newsletter for ongoing updates

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Episode Tone

The conversation balances clinical expertise, personal testimony, and passionate advocacy. The tone is urgent but hopeful; pragmatic about barriers, but committed to building awareness and preserving insulin choice. There is deep empathy for people living with diabetes and those who care for them.

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For listeners concerned about insulin access or interested in advocacy, this episode is a call to action—grounded in personal stories, medical evidence, and clear explanations of what is at stake.

Transcript

[A]

From the very beginning, they mean everything to you, and that means you'd do anything for them, especially if they're at risk. So when it comes to type 1 diabetes, screen it like you mean it. Even if just one person in your family has type one, you are up to 15 times more likely to get it, too. Screen it like you mean it, because one blood test could help you spot type 1 long before you need insulin. Talk to your doctor about how to screen for type 1 diabetes, because the more you know, the more you can do. So don't wait. Visit screenfortype1.com to learn more. Again, that's screenfortype1.com. This week on Diabetes Connections A little over two years ago, Novo Nordisk announced it would discontinue Levemir insulin, leaving many people scrambling and kind of stunned. There's no other insulin on the market quite like this long acting, and it turns out the community wasn't letting it go without a fight. We're talking with advocate Allison Smart, who heads up the alliance to Protect Insulin Choice, as well as doctors who explain what makes Levemir unique, where the process to keep it on the market is right now, and what we can do to help. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your healthcare provider. Welcome to another week of the show. I am always so glad to have you here. I'm your host, Stacey Sims. You know we aim to educate and inspire about diabetes with a focus on people who use insulin. I hope you were able to check out the bonus episode we put out with Vivi Cap with some of their progress and new products. I am putting out a few bonus episodes in the next couple of weeks and the easiest way to make sure you don't miss those is to subscribe or follow in whatever podcast app you listen. Most of you know this, but just in case, and some of these apps do change the way they do this, there is always a little way to follow subscribe. They call it different things. It's always free. Just click that little button. Email me if you have any questions. You can always find the episodes on diabetes dash connections. Com, but if you subscribe on the apps, it'll come to you directly and automatically. You don't have to do anything. And I've explained this before, but we changed the release schedule this year to accommodate our changing schedule. Frankly, with all the events that we're doing and so rather than six episodes a month, I'm doing four. But you know me, I like to be up to date and talk to people and I found that I had more interviews kind of in the can in storage and I did not want them to get old. So I'm putting them out as bonus episodes. So there we go. We'll see how it goes. You know, we're always changing things around here. Just trying to do the best that I can to make sure you're getting the best information, and this episode is a good example of that. We did just tape it recently, so we're getting it out quickly. But this is a case where things may change. If you want to be optimistic, they may change at any minute. So quick background on this episode. In November of 2023, Novo Nordisk announced that it would discontinue Levemir, a long acting basal insulin. Levemir is the brand name. It is insulin Detamir and the company said it was due to quote unquote global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative options. I read that and like many of you, I just assumed everybody would just move over to Lantus or Treceba if they needed to use long acting. But it turns out Levemir is unique among basal insulins and many of the people who use it and prescribe it are passionate about not losing it. So my guests are going to tell you more about why that is. I am talking to Allison Smart. She is the founder of the alliance to Protect Insulin Choice. Her daughter lives with type 1. And we're talking to two doctors as well, Dr. Florence Brown and Dr. Amy Valent. Dr. Brown is co director at Joslin and BIDMC Diabetes in Pregnancy Program Assistant professor of Medicine, Harvard Medical School. Dr. Valent is Assistant professor of Obstetrics and Gynecology, School of Medicine at Oregon Health and Science University. My conversation with all of them right after this. Did you know all the sounds used to make that song come from a site change with the Omnipod 5 automated insulin delivery system? Pretty cool, huh? With Omnipod 5 pump site changes are simple. The pod lasts up to 3 days, 72 hours, and to change it, you just fill up the pod with insulin, place it on your body, tap a few buttons buttons in the Omnipod 5 app, and you're ready to go. There's no tubing to prime like with traditional insulin pumps, and it's virtually pain free so you never have to see or handle the insertion needle. Want to try Omnipod 5 for yourself? Request a free Omnipod 5 starter kit today by visiting omnipod.com diabetesconnections Terms and conditions apply. Eligibility may vary.

[B]

Did you hear the pod drop?

[A]

All right, we have lots of people to introduce today. Allison Smart, Dr. Florence Brown, Dr. Amy Valent. Welcome to Diabetes Connections. I really appreciate you all being here. Thanks for coming on the show.

[C]

Thanks. Glad to be here.

[D]

Yes, same. Wonderful.

[B]

Thanks, Stacy. Thank you.

[A]

You got it. Let's jump right in. Alison, give us the state of where we are right now with this issue. I understand things seem to be progressing, but tell us where we are.

[C]

Things are progressing. We're communicating with the fda, we're communicating with manufacturers. Nothing is set in stone yet. Manufacturing on Denomir insulin can begin if the FDA designates this a drug in shortage. So that's what we're asking for. We're asking manufacturing to get started. We're asking the FDA to designate this a drug in shortage that would allow manufacturing to begin so that we can get this insulin that many need.

[A]

All right, we're going to know where we stand. Let's back up, because I'm not sure that much of the diabetes community knows this is an issue. So, Allison, start us off. What happened here? You know, there was this headline, levemir, the brand name is discontinued. Can you tell us a little bit more about the background?

[C]

So this insulin, it's dead. Amir insulin, known by Levomir, widely available in the United States for the past 20 years. It's recently been discontinued in the United States, and there's been announcement that it will be discontinued globally. So this insulin is preferred by many who want to adjust their insulin dosing, for example, the day versus night, differentiating that dosing. Many with a pump appreciate the ability to program in different amounts at different times of the day or to change it over time, as in with a menstrual cycle or with pregnancy. Less than half of those who use insulin use an insulin pump. So it's necessary to have access to this specific insulin that allows that differentiation in the quick changes. So this insulin lasts roughly 12 hours, and the alternatives last roughly 20 hours or 42 hours, which is a big difference when, even though you're taking each of these insulins every day, sometimes multiple times a day, Levemir users love the ability to change that amount quickly or throughout the day.

[A]

Dr. Valent, let me just bring you in to get more of a medical perspective on this. Tell me more about who uses. And I'm gonna use a brand name. Cause I'm. I'm more familiar with it. But, like, who really does use Levemir? And when my son was diagnosed, we used Lantus and then he went on a pump break and did a little bit of untethered, frankly, and he used Joseba and all those worked great. So why does it matter in this case?

[D]

Thanks so much for that question. So I have a little bit of a bias since my patient population is primarily people who are interested in being pregnant, who are pregnant or newly postpartum. And for those that have never been through those experiences before, they're extremely dynamic phases of life. I would say it's a life stage that is very new to people who have type 1 diabetes or type 2 diabetes and have never been pregnant before. And then those that would have gestational diabetes as well. That's a brand new diagnosis, having to understand how sugars are being challenged by pregnancy. And so with that, just like for all individuals who are having to use insulin, we have to be able to be able to tailor our care to our patients. And so I primarily love using, and I'll also use the brand name Levemir in particularly our pregnant population as well as our postpartum population. And I'll just take a few seconds to explain why. Mostly because, if you can imagine, a growing baby inside is different. Not only every week, but every day, we're having constant changes, and that requires our bodies to adapt to those changes. And unfortunately, we don't have ways to be able to make a decision right now and make sure that that is appropriate for the next nine months. That just doesn't happen. So we have to have some flexibility to be able to, one, keep up with the challenges of pregnancy. And two, there's as soon as a pregnancy is ended, when a baby in a placenta delivers, those are abrupt changes that happen immediately as well. And so really to be able to have some flexibility to keep our patients safe, having some element of having shorter, long acting, if you will, insulin is really useful because it allows us to pivot when we need to. We can titrate up really easily. And then primarily for our patients with type 1 diabetes who may be more sensitive in certain parts of the day than others, it's really helpful for us to be able to kind of change dosing strategies that you're not necessarily committed to with one dose. So it's really helpful for us to be able to keep up with the changes that are occurring that sometimes are really frightening for patients to experience just because they've never experienced one. They've been able to understand how their diabetes goes day to day. But when the day to day is not the same, that can be really challenging for Individuals. And so for us as providers, having a really broad toolbox of insulins to be able to help our patients achieve their goals is so useful.

[A]

And Dr. Brown, let me bring you the same question. Talk to me about your patients and how they use it.

[B]

Yeah, so I agree with everything Amy said there. And the pregnancy requires ongoing insulin adjustments, as Amy mentioned. And in the first nine weeks insulin requirements increase and then from 9 to 16 weeks they decrease. And then there's a steady climb from about 16 weeks to 36 weeks where during that period of time insulin requirements increase about 10% every two weeks. And then there's a falling off of insulin requirements after about 36 weeks. And then as Amy mentioned, an abrupt decrease in insulin requirements because of delivery of the placenta and increased insulin sensitivity, dramatic increased insulin sensitivity. And at that point insulin requirements go to about 60% of the preconception levels. So dramatic changes in insulin requirements. And you need a flexible basal insulin that you can adjust frequently. And when you have long acting, very long acting insulins like Glargine and Deglodac, which is Traceba, then you can't make adjustments that often. So you can't be so nimble about how you're addressing hyperglycemia in pregnancy. And we know that hyperglycemia in pregnancy is associated with adverse outcomes large for gestational age babies, increased risks of preeclampsia, preterm delivery, increased NICU stays. And so it's important to have an insulin that can, you can really fine tune what you are trying to achieve. And the difference also between daytime and nighttime is on requirements in pregnancy can vary from person to person. And some people really need more basal coverage at night and less during the day because they're also having to give high doses of mealtime insulin during the daytime. They don't may not need as much basil during the day. Can't do that with the longer acting insulins, the longer acting basal insulins.

[A]

If, and I'll put this out to anybody who wants to jump in devil's advocate, if the goal is the most nimble, right, being able to adjust on the fly, why not put everybody on a pump or use fast acting right as much as possible?

[B]

Because some people just don't want to be on a pump. Some people really don't want to be on a pump. We have wonderful hybrid closed loop pumps that are improving and starting to achieve what we need for pregnancy, but people just may not want to be on a pump. And furthermore, their pumps are much more expensive and they require insurance coverage. And they require providers that know how to use insulin pumps and diabetes educators who can teach them how to use insulin pumps. Not everybody has access. And Allison may have more information about what percentage of people are on pumps in the US Currently, but it's not. There's a lot of people who are not on pumps.

[D]

And right now, just like Dr. Brown was saying, we have really amazing aid systems, but they're all developed for people outside of pregnancy. So even though our aid systems are really fantastic and have created such a wonderful opportunity for our patients, particularly with type 1 diabetes, I can tell you that our patients have to work so hard to manipulate their aid systems to meet our pregnancy targets. And some people just don't want to do that. They don't have the time. And for them, it's just as frustrating to have to pay attention to their aid systems all the time in pregnancy to continue to adapt to the changes that having an injection that we can adjust as providers, and they can just do that all day during the week, then that's. That's just potentially easier with all of the things that pregnancy has to bring, preparing for, building a family and doing all of that. And I think that the other aspects of even getting people on CGMS was a big leap for a lot of people as well, which luckily we're able to get all of our patients with type 1 diabetes on. But adhesive disease and adhesive concerns are also like a big complaint that we get with pumps, too. So I think that there's lots of different reasons why personally people may not want to be on a pump, which we are totally willing to support. But I think that's the goal here, really is whatever we can do to support our patients on whatever diabetes technology is available and the insulins, to be able to support those is the goal.

[A]

Alison, you have a personal story here. Your daughter lives with type 1. This is how you got involved. Tell me about her use of this insulin.

[C]

Oh, I'd love to. So she's had type 1 diabetes for four years. She's a teenager. She's got great management. She's an athlete. She has spent a significant amount of time using Lantus in a biosimilar, and it was harder for her to maneuver. Also being an athlete, she's also tried an insulin pump for several months, and for her, it was an extra kind of. With pregnancy, you're dealing with a lot of things going on, whether you're an athlete, when you've got a lot going on. For some people, it's just that extra Layer of difficulty. It didn't make things easier for her and she tried it for an extended amount of time. It was particularly troublesome for her when she's competing in day long, you know, weekends long tournaments where you're in a tennis match and you don't know if it's gonna last 30 minutes or three hours. You don't know if you're gonna have one match that day or four. Um, with the unpredictability of life, it just. Levemere allows this consistent ability to adjust and then on the days you have extensive activity and the days you don't. So our personal story is that it just allows her life to be much easier and much more calm.

[A]

What's interesting to me is that this is an insulin where if discontinued, it does not have an alternate. There's nobody else making something like this. And maybe Dr. Valent, you could start us off here, but could you explain what. I know you've talked about the timing and it's nimble, but like get a little granular. What does make it different? Is it a molecule, is it an additive? I mean, I don't know, maybe it's too sciency, but I'm really interested in that. I don't understand it. So could you jump in and kind of explain in layman's terms, right back to our conversation? But first, Diabetes Connections is brought to you by Dexcom. A very smart doctor told us ages ago, probably close to 19 years ago, when Benny was first diagnosed with diabetes, the person with the most data wins along with the most data. You need good data. And the Dexcom G7 CGM systems are the most accurate sensors on the market. And accuracy is what builds confidence. Benny can make decisions about food and activity in real time and we can easily follow his numbers remotely. The Dexcom Clarity app shows glucose trends and even a projected A1C in as little as two weeks. This isn't just about seeing numbers, it's about understanding them and living better because of it. Find out [e-mail]

[D]

yeah, so I think that this is the beauty of insulins currently, which is where we started off with mph and that was about all we had. And now we are able to manipulate how insulin is broken down to be able to get into the system. Right? So the delivery methods of these are becoming so much more of an ala carte toolkit, if you will, which is what we love. And so, particularly for Levemir, I think the beauty of this, and I think Dr. Brown can probably speak to it a little bit more, is how flat the insulin can be. And that's because of the way that it is. You're right. Similar to glargine where we can have a relatively flat. Again, everybody's metabolism is a little bit different. But the duration of action I think is where the beauty of Levomir is specifically. And because of that we're able to, I think the difference, some people would say, well, you have MPH as an intermediate acting that kind of generally lasts 12 to 14 hours. But the way that the pharmacokinetics of MPH are peaking somewhere between 4 to 6 to potentially 8 even in some individuals can be very problematic, especially if you don't have very good timing, et cetera. And so for the ability of Levemir to be able to relatively stable after injection is also one of the beauties of that insulin specifically, particularly for patients that do have variability in their sensitivity throughout the day or who are really, particularly during the day, really good about their rapid acting insulin administration. So I think that the ability to be able to kind of tailor that during the day is great. But I'll let Dr. Brown talk more about the science.

[A]

Go for it.

[B]

Yeah, no, just so different. Insulins are formulated in different ways so that absorption of insulin, beginning of insulin activity, peaking of insulin and duration of action can vary. And that's how Levemir happens to be on the short acting of the basal insulins. And then Glargine, which is Lantus in the biosimilars, has a longer duration, more of 24 hours, 22 to 24 hours. And then Deglodec, which is Traceba, has up to 42 hours of duration of action. That's just how they're formulated and how their molecular characteristics are and their pharmacokinetics. And so it's nice to have broad choices. And as Amy was saying, MPH has more of a peak to it. Levemir actually has a little bit of a peak to it at the beginning and then falls off and is gone by 12 hours. So these are all great options. For us to lose one of these important options really will affect people with type 1 diabetes especially. But even so, even with patients who use it for type 2 diabetes and pregnancy, there are improved outcomes, say over MPH. But we really don't want to lose any of our insulin options. They're all really important.

[A]

Yeah, let me just stop you right there. That's interesting because I would not think anybody would want to keep NPH and regular around. But you're saying, hey, there's a use case for this yeah.

[B]

So some people with gestational diabetes, for example, they need just coverage for the night. They have hyperglycemia overnight. They do not have hyperglycemia during the day. You don't want a long acting insulin that's flat for the whole day for those people. So you have to tailor what the glucose patterns are. You look at the glucose patterns and you determine this person just needs an intermediate acting insulin or a short acting basal insulin like Lebomir. It's important. And recently in Massachusetts I was learned that they were gonna take MPH off the formulary for public insurance. And that I think is terrible. We don't wanna lose Levemir and mph. We need short acting insulins for pregnancy.

[A]

So Alison, when this news broke, it was almost two years ago now that Novo said they were gonna discontinue it. I got a lot of emails and a lot of concern. But you are one who stepped forward and said we're going to fight this. Tell me about the start of that. How did you get involved to do this? Because you've been pretty successful in getting a large group of people now to try to take action.

[C]

Well, we're hoping. I just started talking to people and at the beginning I didn't think I was going to be the one going off to Washington D.C. all the time and personally discussing this. But at some point you realize, you start talking to people realizing, oh my God, no one is going to do this, no one is going to do this. And I developed some pretty good connections early on. I, I met Dr. Brown at an early American Diabetes association conference and I'll be going back there in a few weeks. It's in June. It just kind of started and snowballed and we've just said we've got to do this, we've got to turn this into a, into a registered nonprofit. We've got to start communicating with all the, with congressional staff and with physicians and with patients and we've got to get our stories out there, other people who need this and even, you know, we're focusing on the duration, which is a huge important point point of this insulin. But there are other aspects of this insulin that some people tolerate much better than glargine or deglodec or a pump. There's other aspects of it. It's well known to be the one that causes, that leads to the less weight gain. We have a website, alliancetoprotectinsulenchoice.org and you can find medical studies that we've posted there. This is the one most proven in randomized controlled trials in pregnancy. It also, for some people, glargine, it acts differently. It has to form precipitates under subcutaneously, and for some people, it can cause occasional unpredictable hypoglycemia, which is shown in the literature. And we have that on our website. For some people, that, that is really a problem there. You know, it's well known in other drugs that if some people don't tolerate one specific antibiotic or pain medication that they need another one. It should be the same with insulin. The insulins are different. And there are currently new manufacturers of glargine. There's currently three manufacturers and five more coming. But we need to have options. People need to have choices.

[A]

Is there. There's nobody. Just to be clear, we've heard a lot like you said about biosimilars, other companies starting to make those insulins, but nobody making, not yet, generic Levemir.

[C]

We're speaking to one in particular that if we get. And nothing is, is set in stone. In order for this to happen, there need to be some regulatory actions. This needs to be declared a drug and shortage. It does fill that definition and then manufacturing can begin.

[A]

It's amazing to me how the conversation we were having for many years around insulin and insulin pricing seems to have almost morphed into now a conversation around GLP1 medications. Because all of these companies have set, you know, they've looked at the numbers. A lot more people can, they can put on Ozempic and on Manjaro than they can put on Humalog and Novalog. And I, I think there's a big worry about all of the insulins now. I mean, I don't think anyone's gonna stop making all the insulins, but there, there is a concern about these being orphaned in a way. Right. And we have groups like Civica Rx and we have, you know, California now saying they're gonna make their own insulins. But nobody's stepping up like that for this particular medication. Okay.

[C]

Not yet. Because of the regulatory hurdles, the great expense, people think insulin is so cheap and easy to make. It's not that expensive to make once you've got manufacturing set in place. But as the traditional insulin manufacturers are transitioning those manufacturing facilities to GLP1s, it's really a problem.

[A]

I want to clarify something that went by very quickly at the very beginning of the interview, and that is this insulin cannot be used in an insulin pump. This is a traditional long acting, right? Okay.

[C]

Yeah, that's correct.

[A]

I think I misheard that at one

[C]

point, and remember that even insulin pump users need backup. They need, you know, there are pump failures, there are, people need, you know, medical procedures. There are a lot of reasons people need good backup insulin.

[D]

And I will say, you know, to the point that Allison was making about the different glar genes and biosimilars and such, the preservatives are interesting because we have a lot of people that react to the preservative and it's either creates lots of skin irritation or pain, et cetera. And that was also some of the beautiful aspects of Levemir is that we didn't see as much people reacting to the insulin. And to your point about insulins being orphaned, I mean, I always feel like pregnancy is always forgotten. But if we think about the 4 million pregnancies that we have approximately per year, and our rates of gestational diabetes are only increasing, and those that require medications to manage their gestational diabetes is also increasing. And really we don't have a lot of alternatives we cannot use. At least we should not be using for now, GLP1s and pregnancy. And we have plenty of patients that have type 1 diabetes, although the incidence of type 1 diabetes in pregnancy has relatively been stable. But really, probably the biggest growing area is type 2 diabetes and they absolutely need insulin. So, you know, we just can't let pregnancy just be a forgotten population, especially when we're responsible for the growing generations.

[A]

Yeah. And I want to clarify, when I was talking about GLP1s, I certainly, as you listen here, I did not mean them as a substitute for insulin. So just to be clear, Dr. Brand, I know you wanted to say something.

[B]

Oh, yes. And I also wanted to say, and this is not my field, but in very small children who have new onset type 1 diabetes who need very tiny, tiny doses of basal insulin, Levemir can be diluted so that you can get more precise dosing. And Allison, I learned this from Allison and one of the, our pediatric colleagues that I've met that it's the only long acting insulin that you can actually dilute.

[C]

That's a huge reason. We even had a congressional meeting where the congressional aide was a physician who worked at an inpatient psychiatric pediatric unit. And she said, I have personally diluted Levomir from my patients. So it, it's known that this, you cannot dilute glargine and deglodec. And even, even Levomir on its own is known as being a very sensitive, a great insulin for these very small children that need tiny, tiny doses.

[A]

So what can we do? Alison, tell me about your actions and what you need.

[C]

That's been the million dollar question. We've said a lot of reach out to your legislators, reach out to organizations, to the pharmaceutical manufacturers. At this point, we've had high level meetings with the fda. We need high level comments. We've filed a citizen petition, and if physicians are listening to this or Levemir users, it would be helpful. Reach out to us and we can help. You know how to make a comment on that petition. That would be the FDA wants to hear from clinicians and from people uniquely affected. So increasing awareness and reaching out to us, because what the action that's needed has changed over time. So please make your voice heard. If you have contacts in the press or any way to increase awareness would be very helpful.

[A]

Has anybody talked to Novo? Like, have they ever said anything about this?

[C]

Yes. All your faces? Yes. And it's a business decision. It's a decision they've made. And we were hoping for support and help, but we still would love, if we had their help and support, it would make a major difference. But at this point, we're thinking it will have to be done without their help. So we need to get this done.

[B]

Yeah. On the institutional level, the American Diabetes association reached out to Novo Nordisk. We had letters from senators. Alison, you can talk maybe more about that. There was a Senate help committee. I forget what the HELP stands for. That some of the senators asked the former CEO of Novo Nordisk about Levemir. There have been many attempts at intervening and speaking to Novo Nordisk, and it hasn't been fruitful.

[C]

That's really it.

[A]

Before I let you go, Alison, I'm curious, what does your daughter think of all this?

[C]

She doesn't really want to be the the point. I mean, she's a high schooler. She just wants to worry about prom and everything else going on. She just wants to live her life. But she says, mom, you gotta do this for the babies. You gotta do this for the babies. So she. And we have a good stock. She's still using it and she understands that. Or she has recognized also that it's difficult if she doesn't have access to this. But you don't really think about that when you've got enough in the fridge. But so many people reach out and she hears the stories too. And we need to find a solution.

[A]

Yeah. And I should have asked this right at the top. As of this date, as of our taping, can you still get it? Can you still be prescribed Levemir and Fill it at a regular pharmacy in the U.S. new.

[C]

New people can't usually get it. I've actually found it in a few pharmacies because it was removed from almost everyone's formulary plan. So there are a few of us who have still been able to pay cash and find some. There are some people who are ordering it from other countries, some people getting it from relatives and travel to other countries that be discontinued globally. But it's still typically available in most European countries right now. So there definitely are a group of people who have found ways to get it, but many have transitioned. But are many are still involved in trying to find a solution? Because many are really struggling without this.

[A]

It's such a tough situation. Alison, are you hopeful. Are you encouraged by the fact that. And, you know, your website is. You can see how many people are speaking out about this. It seems like there's a little bit of a, you know, I don't want to get too optimistic, but it does seem like there is a swell of

[C]

support happening, and we're encouraged by that, really. Things. Things change by the week. Absolutely. And. And we're hopeful. I think the FDA is. There's a growing awareness there that something needs to be done. It's always been, how do we get this done? It needs to happen, but how do we get this to happen? So we're encouraged. I will say many of the community get frustrated because we keep getting asked, okay, send comments here. You know, talk to your congressional representatives. People are tired, and you. You want to focus. Type 1 is tough, and you want to focus on your life. And. And some of those who have switched are doing okay with switching, but some aren't, but some just. The continual reminder we have to do more, we have to do more is exhausting. But overall, we're thrilled by the progress and we will keep working, and something needs to happen here.

[D]

And I'll also say, like, I think it's worth speaking for the people that don't know the benefits of it as well, because I do see that often where people are just. They just assume that it's challenging and diabetes is challenging and that the insulins that they've been prescribed are what they know. Right. And so I think that being able to have options and being able to support, you know, and that's really what we do a lot through our physician education is how to effectively use a lot of these different insulins in combination together to be able to actually support our patients. And I think, you know, just to be able to advocate for choice. So that our patients can have that luxury that they don't have to just, like, struggle. And I think that that's really helpful.

[A]

What a luxury, not to struggle. Wow. I think that sums it up. I mean, it really is incredible to think about how a small change that we don't know. Right? We don't know what we don't know. I love that point. That's a great way to end because it's not our fault. Usually in diabetes, Diabetes is hard. And if something's going wrong, it could be a better product, it could be a better insulin, it could be a better technique. We need the education around it. So, Dr. Valent, thank you for that reminder. Thank you all so much for joining me. Dr. Amy Vallant, Dr. Florence Brown, Allison Smart. We will link up all of the information. I really appreciate it. Keep us posted.

[B]

Thank you so much. Pleasure.

[D]

Yes, thank you so much.

[A]

There is a lot of information at the alliance to Protect Insulin Choice. I'm gonna link that up. I would recommend that if you are interested in learning more about this or getting involved, that you start there. Alison emailed me the day after our interview to tell me that she had spoken to the distributor who is preparing to submit a plan to the FDA requesting permission to move forward the distributor of an alternate insulin. So we will continue to follow what's happening there. This will obviously be an ongoing story, so look for future updates in our in the news episodes over on social. It really would be something if the community was able to save insulin Detemir. And who else was shocked to find out that Dr. Brown was making the case to keep NPH on the market as well? You never know. I'm still learning stuff after more than 11 years of this podcast. Thanks to my editor, John Buchenis from Audio Editing Solutions. Thank you so much for listening. I'm Stacey Sims. I'll see you back here soon. Until then, be kind to yourself.

[C]

Diabetes Connections is a production of Stacey Sims Media. All rights reserved. All wrongs avenged.