Insulin?

Many thanks to all! I stopped taking Januvia for one week, my vision seems to be blurry most of the time. By the way I have joint and muscle pain, some times so severe that I am bed ridden for days. My Endo will not listen to me about the side affects of the oral meds. His answer was to put me on Lyrica and Cymbalta to deal with the pain. Which really just masks and fools the brain not to acknowledge the pain receptors.

All that being said, I am so glad I asked you folks for advise. I have an appointment with my regular doctor early February, I will not be seeing my endo doctor anymore,maybe a new one but, not this one. Thanks to everyone’s input. I am grateful!

My BG is fine, A1c 6.1 first of the year. However, I’m really ready to move forward to something that works to treat the real problem (my pancreas)!
Thanks again folks!

Jamey - I had a posting here the other day but it mentioned a monomer human insulin which is inhaled and requires no shots. Some people complained because they felt it was an advertisement for this monomer human insulin so it was removed.

Why someone would not want you to know about it I clearly do not understand. From the AAEC page 8 of the pdf

“Insulin is the most potent antihyperglycemic agent.”

If that’s true why is insulin the last resort? One word “hypoglycemia” but then it goes deeper. If you had an insulin which was shown to work just like a healthy pancreas would hypoglycemia still be an issue? Clearly not, as healthy people don’t get hypos. This human insulin which is not an analog has a minimal chance of causing hypos when not being used in combination with a basal like Lantus or Tresiba.

The bigger issue is if insulin is the best way to control high BG and the AAEC clearly says it is and you have one which has limited hypo risk, why not insulin first? Why do we continue to put people on the metformin and the rest of the T2 meds and then after all beta cell function is lost put them on insulin? Unfortunately diabetes and T2 meds is a huge business.

If you want to stop T2 progression you have to keep near non-diabetic time in range. To do this you need to control the post meal spikes. The only things which will do this is insulin and hands down the best is the human monomer insulin which is inhaled since it mimics healthy pancreatic insulin release.

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Alright, thanks George44. I did see your original post, and I did take a look at the while paper. I admit I am still on orals and have a lot to learn before I have a handle on the insulin side of T2 diabetes. I will consider your information George, your post makes a lot of sense to me. I’ll discuss the issue with my doctor. Thank you for your passion on the subject and for caring about others with diabetes!

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After 3+ years on Metformin (& gradually raising numbers), I added a once a day Levemir. It was a surprisingly easy, effective addition to my regimen.

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I have to say, it is inappropriate to suggest that someone with T2 move to using a bolus insulin as a way of initiating insulin treatment. I know of no healthcare professional who would suggest such a move. The consensus from the “AACE” is to move to a basal insulin. Please don’t suggest that someone should move to a bolus insulin as a way of initiating insulin as a way managing their diabetes. I would recommend that you carefully reread the recommendations from the AACE.

ps. I know you have good success with Afrezza, but please carefully read the prescribing information, “Afrezza must be used with a basal insulin.”

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I have to say as someone who made my own choice to move to insulin, this is a very brave thing to do. You should feel empowered that this is your choice. I have to relate to you my choice to move to insulin as someone with T2. You can read my story here. I encountered significant “insulin resistance” to my starting insulin. No doctor wanted to “own” the decision to start insulin. In the end, I made my own decision. But I did so carefully and with conservatively. Insulin is powerful. Never underestimate it. It is safest to follow the recommended path, start a basal insulin. A good insulin would be Tresiba which is very long acting and isn’t prone to hypos. You can be very successful with insulin even if your doctor is “insulin resistant”

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Not trying to be a PITA but I have read studies that have examined whether Afrezza in combination with oral meds for Type 2 patients results in a lower A1c. To me, that would imply that it is a reasonable question to ask and is a valid area of study?

On the label of Afrezza, I do see that it should be used with basal for Type 1 but I do not see the same wording for Type 2. Certainly a drug can be used off-label if a doctor feels it is proper and there is no FDA restricting specifically to the contrary although it always makes sense to know the label and be fully aware if you are taking something off-label. The wording I saw that sounds to be relevant is:
“In patients with type 1 diabetes, must use with a long-acting insulin.”

Looking further at the Afrezza labeling, I don’t even see where it mentions basal in regards to Type 2. The more detailed information discusses Type 2 patients using Afrezza in conjunction with oral meds. No mention of additional basal insulin at all.

A total of 479 adult patients with type 2 diabetes inadequately controlled on
optimal/maximally tolerated doses of metformin only, or 2 or more oral antidiabetic (OAD)
agents participated in a 24-week, double-blind, placebo-controlled study. Following a 6­
week run-in period, 353 patients were randomized to AFREZZA (n=177) or an inhaled
placebo powder without insulin (n=176). Insulin doses were titrated for the first 12 weeks
and kept stable for the last 12 weeks of the study. OADs doses were kept stable. At Week
24, treatment with AFREZZA plus OADs provided a mean reduction in HbA1c that was
statistically significantly greater compared to the HbA1c reduction observed in the placebo
group (Table 5).

[Note. I just realized this is the slightly older label dated 05/2015 which I was looking at. Apologies if the recent label change is inconsistent with anything I posted.]

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Thanks @Tim35 , it is important to note that the prescribing information says that Afrezza isn’t indicated for T2 and even for T1, a basal insulin is a must.

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I plan to act on my the recommendation of my doctor. My motivation for posting a query here, is informational. I have followed posts here and know there is wisdom and as is evidence in this thread, caution.
I was diagnosed in 2014 T2, high blood pressure and, Hashimoto hypo-thyroidism. So 10 oral meds everyday, well it’s a lot. My primary issue Brian, is the joint, muscle pain, and fatigue caused by the diabetes meds.

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Brian - For starters the 175 Study did not use basal. It was the medformin/afrezza study and was for the T2s. You are miss reading the label. Additionally, anyone taking afrezza should discontinue metformin as it affects the liver and you want the natural state between the liver and pancreas with affrezza to prevent any chance of hypo. However the FDA designed the 175 study.

Now the issue T2s have is not during fasting. They lose the robust first phase insulin release. If you treat at meals with afrezza you will blunt the spike and get the PWD back to a non-diabetic TIR. Thats a fact.

Why the AAEC currently recommends basal first is fear of hypos and who wants to take 3 shots a day. The problem is if you want to stop the progression as Ralph DeFronza is showing in his Qatar study is you need to keep TIR.

In the AAEC they lump afrezza in with other insulin categories. Inhaleable insulin should have had its own category. Why? Its not about the insulin. Its about the delivery. Its the fact it gets into your blood immediately. afrezza is not a miracle “drug”. Its human insulin. Thats all it is. At the molecule level it is the exact same insulin the pancreas releases. However, because afrezza gets into the blood immediately it is NOT subq. The body sees it like the pancreas is releasing it.

The AAEC should have two categories now for insulin. Subq and inhaled. They are very different and have very different outcomes. Lumping them together is doing a dis-service to the uninformed.

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Brian - here is the afrezza label https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf

Page 4 - Insulin Naïve Individuals Start on 4 units of AFREZZA at each meal.

Page 17 - 14.1 Overview of Clinical Studies of AFREZZA for Diabetes Mellitus - AFREZZA has been studied in adults with type 1 diabetes in combination with basal insulin. The efficacy of AFREZZA in type 1 diabetes patients was compared to insulin aspart in combination with basal insulin. **AFREZZA has been studied in adults with type 2 diabetes in **combination with oral antidiabetic drugs.

They are referring to metformin. This was only done because the FDA designed the study and the current Step program says metformin first. As Ralph Defronzo has finally realized metformin provides little benefit and we know this because 70%+ of current metformin users are not even meeting an average 154 BG level.

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@George44, why in the world would you suggest that someone should initiate insulin therapy wiih Afrezza. Afrezza is indicated for use in people with T1 and it says you “must use a basal insulin.” And it generally isn’t covered so people will pay through the nose for it. And if Afrezza was approved by the FDA as a standalone insulin treatment it would appear in the prescribing information. The AACE doesn’t recommend any rapid insulin as an appropriate choice for initiating insulin therapy. You can read their T2 treatment guidelines here. So this suggestion is inappropriate. I don’t understand why you are so focused on this. Are you a representative of Mannkind or a shareholder?

My suggestion would be to stick with a discussion on the medications and uses thereof and avoid jumping into the weeds.

In any event…

Afrezza is FDA approved for Adults with Diabetes.
(ie - without regard to what TYPE of diabetes)

The first bullet point of Afrezza (per FDA currently approved label) is:
“AFREZZA® is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus”

The additional mention on the label in regards to long-acting insulin is in regards to Type 1 is a restriction for patients with Type 1 but has no further implication on patients with other forms of diagnosed diabetes.

The FDA approved label for Afrezza DOES have a number of restrictions (which again a doctor can choose to ignore and prescribe off-label although certainly that should be a discussion with both the doctor and the patient being well informed). However a blanket restriction for Type 2 patients is not listed. At least I don’t see it although I am certainly open to correction (as these labels do get long and wordy and easy to miss something).

Certainly there are many discussions on these forums about the use of medications and technology which is outside an FDA approval but for which (hopefully) a Doctor has properly decided it is in the patients best interest and has prescribed something off-label. Although Afrezza is FDA approved for Adults only, we discussed with our Doctor about having this prescribed and used for Pediatric use. Certainly it seemed a reasonable conversation to us and the Doc did not think anything wrong (with the conversation) even though it clearly is not covered per the label. Ultimately we decided not to go with Afrezza for Pediatric usage mostly due to the Doctor having zero experience using this for Pediatrics and simply not having an adequate level of comfort. All in all it was a good conversation.

In my previous post, I had erroneously been looking at an Afrezza FDA approved Label which was not the latest. Here is a link which I believe is the most recent label revised as of September 2017.

https://www.afrezza.com/wp-content/uploads/Prescribinginfo.pdf

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One can go to a state like Arizona and find a doctor who will do all kinds of strange and dangerous things. That doesn’t mean it is recommended. Many doctors will prescribe Afrezza for off-label use, but I suspect there would be very few that would suggest it as a way of initiating insulin therapy. That is just way out of the lane of recommended standards of care and most allopathic doctors would go screaming and running away at the idea of prescribing only a rapid insulin as a way of initiating insulin therapy.

I’m not sure I understand your motivation in commenting on this? Afrezza is used by T2’s without a basal and it’s not considered off label. Do you have alternative motive? Does your Dr know your treatment better then you? I think your suggestions are way off base, to warn people away from an approved therapy makes no sense to me. What is your experience with it? Why even mention costs? Did you have experience with it that caused such a warning? I think there are some people on this forum need to look at themselves in the mirror.
Yes, don’t try anything different, stay down the same path of failure. Exactly why I’m not impressed by this forum.

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I’m personally impressed by this forum but I am not impressed by this conversation. If this was the first discussion I had seen on Tudiabetes I would have run screaming in the other direction especially since this organization is supposed to be about supporting diabetics and not down putting other peoples experiences and advice.
People who receive advice from the internet need to make their own decisions, and talk to their own doctors, and take what they read with a grain of salt. Please stop this mean spirited discussion because the person who originally asked the question about insulin has said he will be talking to his Dr. and that is exactly what he should be doing.

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I agree with parts of your post. The attacking was started by a person in power, I think it’s awful.

Brian - why would you keep saying something which is just wrong? Did you not read the label I posted above?

Now, why would a T2 who still has some beta cell functionality left take a basal? Historically its fear of hypos and to limit the PWDs hypo risk. Before afrezza, insulin was just too damn slow. With afrezza as long as you are not taking a basal you have very little chance of a hypo. As Al Mann said, you really have to try.

T2s first lose post-meal first phase insulin release. The way to treat that is to blunt the spike before its goes 140+. To do that you need an insulin which works like the pancreas and there is only one.

Now why does it work like the pancreas? Two reasons; the delivery methods gets it into the blood immediately like taking it IV or through the pancreatic canal; the second is because it was stabilized as a monomer so speed of action is very consistent.

Now as far as cost, its way too expensive. I would like to see a 90 cartridge box being sold OTC for $29.95. Maybe if more people started understanding what afrezza is and what it can do, more people will start demanding it and more insurance companies will cover it. Once the insurance companies start understanding that in the long run it will be a huge money saver for them they will all cover it.

But if people keep saying things like it must be taken with a basal and keep insisting with authority they are right the average PWD won’t know the truth and will never even ask about it. It will go to the dump heap just like BP would like and never become the paradigm shifting treatment Al Mann envisioned.

Do you realized Al Mann in his studies actually showed T2 beta cell improvement? Now that DeFronzo is showing the same with his TZD/GLP-1 cocktail we have to different approaches achieving the same result both by keeping non-diabetic TIR. The key in stopping T2 progression is non-diabetic TIR.

Now would you rather take the human insulin with minimal chance of hypo or the Actos/Byetta cocktail? Additionally, afrezza is NOT a subq RAA. Its human insulin which is delivered almost immediately into the blood. When the AACE finally catches up in a few years they will get it right and it will be in its own category. Right now the AACE document needs a clean-up. How long did it take the FDA to get the speed right on the afrezza label, 3 years?, and that was a no-brainer.

Here is a video you may want to watch where Al Mann talks pros/cons of current insulins. Al was one of the great minds in diabetes. He invented the insulin pump; the CGM; first implantable pacemaker; solar panel; etc. He starts talking diabetes at 8:30m but it gets interesting at 11:00m and then talks about stopping T2 progression at 15:00M “interesting this lowers insulin resistance… this is even likely to slow and even stop the progression of Type 2 diabetes” www.youtube.com/watch?v=SvZxYmYPXYQ

Why does it seem you don’t want people to know about afrezza and what it can do? I know from personal experience it works and stops the progression. I also know from personal experience the dangers of the T2 orals and the deadly consequence some have had like Orinase. Do you think UpJohn did not know the dangers of Orinase? Why was Trulicty rushed to market? What was done, 5 small studies?

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You are missing an important point; insulin is not the only hormone the body uses to control glucose. Insulin’s affect is modified by the bodies use of glucagon to counteract the affect of insulin as needed. That’s why a person with normal pancreas and endo response does not have lows. If the body detects an incipient low it secretes glucagon to counteract the insulin. That’s why development is underway for a pump that delivers both insulin and glucagon.

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Sally and Jerry - you are absolutely correct. I think in my first post to Brian I mentioned afrezza working in conjunction with the liver. By replicating a true first phase insulin release afrezza blocks the alpha cells. They stop producing glucagon which is huge not only in stopping the after meal spike but also in preventing the low.

Once in a resting state when the BG starts to go low they too have a first phase release and stop the low by signalling the liver. This is why it is very difficult to get hypos with a healthy pancreas and with afrezza. Just don’t use metformin as it will affect this release and so will a basal btw. Here is what Dr. Alan Marcus who helped develop the insulin pump at Minimed said about it starting at the 2:55Mark https://youtu.be/LO886BKhGek

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