No More Needles? What You Need to Know about Inhaled Insulin

The diabetes community is abuzz about inhaled insulin. On June 27, the U.S. Food and Drug Administration (FDA) approved a new product, called Afrezza, that has been years in the making. Many people with diabetes are quick to say: “Insulin that doesn’t need to be injected? No more needles? Sign me up!”

First, the basics. Afrezza is a rapid-acting insulin you take before each meal, or soon after you start to eat. It comes in a small inhaler, and each cartridge contains a single dose. Anyone who relies on insulin—that is, all people with type 1 diabetes and a growing number of those with type 2—can use Afrezza.

Because it’s inhaled, Afrezza is absorbed by your body more quickly and in a different way than injected insulin. It peaks about 12 to 15 minutes after you inhale it, much faster than either human regular or rapid-acting insulin analogues do. So inhaled insulin makes bolusing much easier; you can use it as you begin to eat, eliminating much of the guesswork as to exactly when your meal will be ready and you can begin to eat.

If your meal is delayed or you anticipate more carbohydrate than you actually eat, your blood glucose can crash. But Afrezza is broken down by the body more quickly than injected insulin. So not only does inhaled insulin help manage the rise in blood glucose from food, but it also lessens your risk for post-meal hypoglycemia, or very low blood glucose. On those occasions when you have a very prolonged meal—think Thanksgiving!—you may end up needing to take another dose. But that’s better than having taken too much.

When I testified at the FDA committee hearing on Afrezza, back in April, I spoke about this tension in diabetes management: preventing complications from hyperglycemia (high blood glucose) while also avoiding unacceptable levels of hypoglycemia. The complications of diabetes, such as heart disease, kidney disease and amputations, are very serious. But constant lows come with very real risks as well, including poor quality of life, hospitalizations and even death. Afrezza is an effective choice for managing post-meal blood glucose while also minimizing those debilitating lows.

Living with diabetes requires so much diligence, especially for people who use insulin. With every meal and snack, with every bout of exercise, with countless other everyday activities, they must stop to check their blood glucose and wonder, “How is what I am about to do going to change that number?” This internal conversation happens several times a day, for a lifetime.

Then there are the social influences. People with diabetes have every right to manage their health in public, such as pricking their fingers to test or giving themselves insulin before enjoying a meal. But in reality, people are not always kind to those with diabetes, whether out of fear or ignorance or squeamishness. That social pressure often gets in the way of proper diabetes care. If you don’t feel comfortable giving yourself a shot in front of others, say at a restaurant, you may just skip it. And that’s the last thing we want to see happen.

But a quick puff on an inhaler instead? Suddenly, taking mealtime insulin is much less obtrusive, for you and the people around you.

Until there is a cure, we need more options for managing diabetes. Very rapidly absorbed inhaled insulin would help overcome many of the limitations of the currently available forms. Diabetes care is highly personalized, and the best treatment plan is not only the one that gets good medical results—a healthy A1C, for example—but also the one that the patient can stick to. People with diabetes also deserve to be confident in knowing the precise amount of insulin they’re getting with each treatment, and that there will be predictable results (understanding that diabetes can always throw you a curve ball!).

When a person who relies on insulin to live gets to choose which method best suits his or her goals and lifestyle, that’s empowering. And that sets the scene for living well with diabetes.

Some caveats: Afrezza does not replace long-acting (basal) insulin for those who need it. And if you have asthma or chronic obstructive pulmonary disease (COPD), this would not be the drug for you. Same goes if you smoke (please think about quitting!).

If you have diabetes, talk with your diabetes care team about whether inhaled insulin would be a good fit for your lifestyle—as you would with any new element of your diabetes management plan.

We don’t know exactly when Afrezza will hit the market, or how much it will cost, although its manufacturer, MannKind Corporation, predicts the price will be comparable to that of today’s insulin pens. The FDA has asked for more studies and trials to look at long-term cancer, heart and infection risks, as well as to determine the safety for use in children.

But for many affected by diabetes, it will be an exciting day, and very understandably so.

Robert E. Ratner, MD, FACP, FACE
Chief Scientific & Medical Officer
American Diabetes Association

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17 Responses to No More Needles? What You Need to Know about Inhaled Insulin

  1. Lady Imp says:

    I think this is a very good start, but it seems to me like there’s a long way to go with this. Peak action in 12-15 minutes is great – if all carbohydrates spiked blood glucose levels in 12-15 minutes. Unfortunately, that is completely not the case, different foods have different peak actions. Also, the amount of fat eaten in a meal can delay carbohydrate spikes as well – for example, a slice of pizza in some can leave blood glucose levels completely balanced until 4 hours later, requiring you to a) remember to check your blood glucose 4 hours later and b) take another puff. Sounds to me like this insulin is good if you want to eat a bowl of M&Ms – but not much else. Unless, that is, if you’re completely all right with your blood sugars see-sawing. Which I personally am not. I find that the mechanism of action of the insulin is heavily restricting. Now, if we could make it liquid and put it in the artificial pancreas that I’ve been hearing so much about, you will definitely get my attention.

    • John S says:

      Since you mentioned the artificial pancreas, you could go to youtube and see it in action. Type in “JDRF inhaled insulin”and learn more.

      The only insulin they found that would cover the “prandial problem” as they term it was Afrezza. They used it in conjunction with their artificial pancreas system and had zero hypos. The people in the study who discussed using Afrezza said it was like inhaling through a whistle and was quite pleasant.

    • Regie says:

      Lady Imp, good to see input from real diabetics with expert nutritional knowledge. I suppose your notion of see-sawing blood sugar is beyond the comprehension of the Chief Scientific & Medical Officer of the American Diabetes Association. And guess carb spikes probably never happened in the thousands of patients tested, so you just might be that unique case. Hmm, liquid insulin, yeah sounds like the body can get rid of that faster than inhaled if you’re to be believed. Oh well, I hope your wait is worth it. For everyone else, Afrezza will be a Godsent.

  2. Kerry says:

    Agree that this is a great start, and would be especially good for select social circumstances, minor glucose corrections, and snacks of fast-acting carbs (agree with Lady Imp’s comment about carb spike timing for different food types). More options for diabetes management are always better. My big concern with this as a primary insulin delivery device is the risk of proper dosage delivery due to inhaler technique. Anyone who’s ever used an inhaler knows that the amount of drug actually received depends significantly on proper technique (one doctor I know called improperly used inhalers “very expensive mouth spray.”) And even someone with excellent technique sometimes messes up. With many inhalants such as albuterol, you can just take an extra puff if you’re not sure – it will be OK. With rapid acting insulin? Not so much. So while spray can have a great place in the pantheon of management tools, and I’ll probably discuss it with my T1D daughter and our medical team after its release, I too am waiting for the artificial pancreas as the next major breakthrough.

  3. Karen says:

    Please do not use the hype of “no more needles”. About 15 years ago I was part of an inhaled insulin study and because I was only receiving fast acting insulin through the inhaler, I still needed to take a daily shot of long acting insulin. I realize that the number of shots for many will be reduced with this method but please don’t market this with the headlines of “Diabetes without the Shots” because for many, that is just not true.
    Secondly and more importantly – is taking a shot really that horrible. If you put finger pricks and insulin injections into prospective with small children going through chemo treatments, we really have nothing to complain about. It is an inconvenience and sometimes a downright pain in the tushy but when you look at the suffering endured by so many others with life threatening diseases, we are pretty lucky. And this has been my attitude since I was diagnosed with Type 1 Diabetes at age 11, almost 30 years ago.

    • John S says:

      The key benefit of Afrezza is that it mimics the faster action of the normal pancreas. Check your blood sugar 2 hrs after a meal and you don’t have to worry about crashing.

      No drug is perfect, but to think this is a drug of convenience is to miss the point entirely. It’s monomeric insulin, and the only way to get it in your system to act so quickly is by inhalation.

      This is the first prandial insulin that mimics the fast action of the human pancreas, thus allowing you to spend much more time in zone and also will allow patients to treat more aggressively with their basal dosing, which will keep them in zone longer for the other 15 hours of the day.

      It just so happens that the only way to administer this medication is via the lungs. It was not created to be inhaled and then see how well it can work. It was created to work as well as possible and it just happens to be inhaled.

      The CEO, Al Mann, invented the insulin pump and sold it to Medtronics. He wanted them to collaborate with Afrezza, but they weren’t interested, so he started his own company. It’s really and amazing story. He doesn’t need the money, he is truly trying to help mankind.

      It’s worth digging a little deeper and learning more for anyone who uses prandial insulin in my opinion. At least you will then understand all of the current available options for you. There are many situations that it could benefit someone who stays with their current injectables, whether that is traveling, trying to bring their blood sugar down with a nominal dose without stacking, etc… Bottom line is, it can’t hurt anyone to become educated on current options.

    • claude says:

      My child has type 1 for a month now she is 6 is it better to inject in her butt as her stomach is taking strain

  4. Dr. P says:

    As a physician I advise everyone to look at the research on Afrezza and come to your own conclusions. This drug acts in an entirely new way and mimics the pharmacokinetics of insulin release in non diabetics. The tissue damage caused by post meal blood sugar spikes is an under recognized concern and this can be a powerful tool to attenuate this.

  5. Michael says:

    Great idea…….too bad it will take about 50 years before Canada will even consider thinking about approving it……

  6. Mario says:

    10 years of development and at least 2B $ spent on research… I think that it is good for much more than eating a bowl of M&M’s.
    https://www.youtube.com/watch?v=ylin1ZSDo0o These real trial users seem pretty excited.
    I agree that it tends to be complicated to use inhalers as I had asthma as a child, but I think this goes more for “pressurised aerosol” inhalers as you have to time the press on the cartridge and your inhalation. With Afrezza this should be solved by the fact that it is a single use cartridge.
    And yes the biggest part is that this is an entirely new type of insulin in sense of pharmacokinetics that is the closest to the response of healthy individuals.

  7. SGS says:

    Folks-

    Al Mann developed the current state of the art insulin pumps then sold the company to Medtronic around 2000.

    Dissatisfied with the performance of the current class of RA Insulins and the limitations of current treatments, he sought to find something that would limit the cell damage from the high and low excursions in blood glucose, and improve Quality of Life. He then developed this drug-carrier-device combination now called Afrezza, and parlayed nearly a billion of his gains from the sale of Medtronic into it’s development; not to make more money (he is 89 now and will give nearly his estate to science, philantthropy, and charirty), but because this advances the state of the art in diabetes treatment and fills an unmet need in the treatment spectrum. This new drug device may become the best treatment available once it comes to market, specifically because (according to the data) it is very meal carb / calorie / drug-dose forgiving. This paradigm will take a lot of education to change for long term diabetics.

  8. Greg says:

    The Artificial Pancreas problem is that is hasn’t yet been able to automatically administer the correct meal time insulin. The AP is an insulin pump that uses a blood glucose monitor to tell when the diabetic needs insulin and then administers it. But it can’t yet correctly give the right amount of insulin for a meal that hasn’t happened yet. I imagine this problem will be solved eventually. The Joslin Diabetes Center aware of this limitation on the Artificial Pancreas studied Afrezza with an Artificial Pancreas and found it solved the problem. Also the AF is very expensive. So Insurance Companies might favor Afrezza used in conjunction with a morning shot. Until a cure for Diabetes is found. The AP is the future no doubt.

  9. eric says:

    Dr. Robert: thanks for posting this and getting the word out…at the moment i wish more diabetices knew about afrezza and mannkind and how great it would work for people…I was public speaker #11 at the adcomm….i actually asked mannkind for a job that day….it is my dream to work for mannkind and use afrezza….we 100% need a faster insulin…nothing is worse than playing the waiting game for your insulin to start working…Its true that shots after a while dont “hurt” as much, but there still in a pain in the rear….not only is afrezza inhalable but it works faster…..after im done eating a mean i almost always start to go over 200 (blood sugar) thats horrible ….i need a faster insulin to work along with MY insulin pump, and CGM. Al Mann is one of americans greatest heros….My goal is to meet the man….If anyone can help me that would be great…..you can also find me on twitter @peakabull where anything related to mannkind is found on there….diabetes is a horrible disease and we NEED better treatments like afrezza!!! #inalmannitrust

  10. Dondo says:

    Before people dismiss Afrezza they should take the time to thoroughly understand its science. No one who doubts Afrezza expected the outcome of the vote at the ADCOM meeting in April. Overwhelmingly, the experts voted positively for Afrezza. Why do so many people think they know more than the experts and continue to insist they will “stick” to their current regimens. I’ll bet half of the detractors will be trying Afrezza within 2 years.

  11. Dennis Hodges says:

    I have been a diabetic for 66 years dependent on taking insulin shots four times a day. I was on Exubra for a very short time and I loved it. I feel that Afrezza is the first diabetic treatment of its kind that will gave diabetic’s a small ray of hope to make their life a little easier.

  12. Brendan Hyland says:

    I am 39 years old and I have had type 1 diabetes since the age of 10. I shipped Afreza from America to trial it and it was truly amazing. As mentioned above blood sugar swings increase the risk of complications and these are not adequately shown in HbA1c. I suffer from highs after eating due to the inadequacies in prandial insulin. Injectable prandial insulin is a complex molecule that needs to be broken down and absorbed into the blood stream. I have found that I tend to overeat sometimes and it takes forever for the glucose to get into my cells. Afrezza is different. It peaked in me within 15 minutes and was out by an hour followed by non diabetic flat blood sugars thereafter. My energy soared. I had a feeling of wellness. I also noticed that I had a better sensation of feeling in my hands and feet. I never thought I had a problem here but Afrezza showed it up. I use a Freestyle Libre to confirm my results.
    The fact that Afrezza is inhalable is nice but the REAL deal about Afrezza is it’s ability to mimic the pancreas and as was rightly pointed out above, realise an insulin monomor into the bloodstream in much the same way as a normal functioning pancreas would. When I inject insulin my glucose levels are either going down or going up in response to food. It is very rare for them to flatline and for me to feel full and energetic. This is the real deal from Afrezza. There is currently nothing close to this. Yes they have used Afrezza with insulin pumps and got good results. I take on average 4 injections a day (sometimes 7 depending on correction doses if I miscalculate due to fat, protein etc in food and a delayed sugar dump from this sort of food eg pizza) including my basal insulin. All diabetics need to keep taking their basal as Afrezza does not replace this but this is fine by me. Afrezza allows diabetics to live in real time with their diabetes and eat when they wish. There was no micro management for me. I had a 4unit or 8 unit dose. It is not like injectable where one unit can make all the difference. I was also less likely to go low as the body was able to deal with the insulin when it needed it. I am not a doctor and although I understand why this may be the case, I am not qualified to discuss it. The one negative is that when I became a real blood glucose pro with non-diabetic numbers I did find that the 4unit dose was a little much if my levels were slightly high so I would like a 2 unit dose as I would need to eat a bit of fruit. This is me being highly critical. On injectable many of us have to eat additional snacks to keep levels in range which has the annoying side effect of weight gain!. I live in the UK. I would do anything to get Afrezza here. I have written to Sanofi and I think if diabetics get the chance to trial it, they definitely should at least consider it. Enough said.

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