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Post by mnholdem on Feb 22, 2019 23:56:51 GMT -5
Sayhey, you are spot on regarding the ADA’s viewpoint that insulin is not safe. I’ve read close to a hundred studies on this issue and the overriding concern of the ADA Standards Committees for 20 years is the risk of severe hypoglycemia that has been associated with insulin.
Lowering that level of risk, which Afrezza does, may lead to a new viewpoint of ultra-rapid acting insulin as an early treatment for T2 diabetes.
Real-world data is changing minds. If it weren’t, then why would Novo Nordisk be pushing its own brand of “ultra” rapid acting insulin?
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Post by longliner on Feb 23, 2019 0:01:29 GMT -5
Sayhey, you are spot on regarding the ADA’s viewpoint that insulin is not safe. I’ve read close to a hundred studies on this issue and the overriding concern of the ADA Standards Committees for 20 years is the risk of severe hypoglycemia that has been associated with insulin. Lowering that level of risk, which Afrezza does, may lead to a new viewpoint of ultra-rapid acting insulin as an early treatment for T2 diabetes. Real-world data is changing minds. If it weren’t, then why would Novo Nordisk be pushing its own brand of “ultra” rapid acting insulin? I only wish I could multiple thumbs up this!! Slow us down to get you in!! |
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Post by prcgorman2 on Feb 23, 2019 10:13:59 GMT -5
Sayhey, you are spot on regarding the ADA’s viewpoint that insulin is not safe. I’ve read close to a hundred studies on this issue and the overriding concern of the ADA Standards Committees for 20 years is the risk of severe hypoglycemia that has been associated with insulin. Lowering that level of risk, which Afrezza does, may lead to a new viewpoint of ultra-rapid acting insulin as an early treatment for T2 diabetes. Real-world data is changing minds. If it weren’t, then why would Novo Nordisk be pushing its own brand of “ultra” rapid acting insulin? Is it changing minds? I assume Novo Nordisk is just acknowledging the truth they and the other BP have known all along. |
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Post by mnholdem on Feb 23, 2019 10:42:51 GMT -5
Just like the irrefutable evidence that early short-term intensive insulin treatment results in a respite for an overwhelmed pancreas, enabling it to repair/regenerate its insulin-producing beta cells. STII therapy has repeatedly demonstrated up to 2 years of drug-free remission of Type 2 diabetes in 50% of treated patients.
Why isn’t it first line therapy? Because drug companies don’t want remission of diabetes. It would cost them $billions in revenue from OAD and insulin sales.
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Post by brotherm1 on Feb 23, 2019 11:19:08 GMT -5
“...irrefutable evidence that early short-term intensive insulin treatment results in a respite for an overwhelmed pancreas, enabling it to repair/regenerate its insulin-producing beta cells. STII therapy has repeatedly demonstrated up to 2 years of drug-free remission of Type 2 diabetes in 50% of treated patients.”
Are there any valid/significant clinical studies to show this?
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Post by lennymnkd on Feb 23, 2019 12:17:16 GMT -5
Afrezza coupled with CGM (safety) whole new ballgame if adherence is maintained.
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Post by sweedee79 on Feb 23, 2019 13:32:27 GMT -5
Just like the irrefutable evidence that early short-term intensive insulin treatment results in a respite for an overwhelmed pancreas, enabling it to repair/regenerate its insulin-producing beta cells. STII therapy has repeatedly demonstrated up to 2 years of drug-free remission of Type 2 diabetes in 50% of treated patients. Why isn’t it first line therapy? Because drug companies don’t want remission of diabetes. It would cost them $billions in revenue from OAD and insulin sales. Last night I watched this documentary called Living Proof about Matt Embry. He has MS.. There is no really good treatment for it.. Him and his dad who is a PhD. did their own research and have found help for MS on their own.. The Pharma industry, doctors and even charitable foundations only seem to care about money and protecting the status quo by pushing treatments that don't work and making lots of money. Matt has been pretty much symptom free for 20 years.. He has a website, MS Hope.. The doc Living Proof is on Prime.. really interesting and so sad and troubling... |
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Post by akemp3000 on Feb 23, 2019 13:48:18 GMT -5
With 70% of diabetics not reaching their A1c goal with current "barbaric" injectible drugs and standards of care, is it possible that T2's finally have an easily manageable disease and can "almost" live a normal non-diabetic life with Afrezza and One Drop. BPs and the ADA do not seem to have any answers for this. IMO, the ADA will have no choice but to improve the SOC. One BP will recognize the inevitable and buy Afrezza or possibly Mannkind. Tick tock.
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Post by mannmade on Feb 23, 2019 13:49:28 GMT -5
With 70% of diabetics not reaching their A1c goal with current "barbaric" injectible drugs and standards of care, is it possible that T2's finally have an easily manageable disease and can "almost" live a normal non-diabetic life with Afrezza and One Drop. BPs and the ADA do not seem to have any answers for this. IMO, the ADA will have no choice but to improve the SOC. One BP will recognize the inevitable and buy Afrezza or possibly Mannkind. Tick tock. Let’s ask Spiro or Hillard...😊 |
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Post by mannupnow on Feb 23, 2019 14:38:46 GMT -5
This is the sort of thing that is immensely frustrating. This is a pointless trial. It has absolutely nothing to do with why endos should use Afrezza rather than other RAA insulins. The trial specifically excludes T2 who are using RAA ( Exclusion criteria: ... Currently using rapid acting insulins - Novolog, Humalog, Apidra), and there is no comparator arm using RAA to show Afrezza outperform RAA options. In the end all you can say is that adding meal time insulin for people who are failing on earlier steps will reduce their A1c. Sorry, but that's already established and covered in the SOC. This is effectively a small scale (40 patients!) rerun of the T2 phase 3 trial, but with CGMs. Stop doing this and have a proper large scale STAT trial that will provide the data to make a difference. Ok - I feel better for that rant. Aged - you seem to have a misunderstanding when it comes to T2 care.
Comparing afrezza to RAA in the T2 world makes ZERO sense. Adding RAAs is the last step in T2 care. RAAs require needles and are considered dangerous for T2s. It they were not they would be Step 1.
Afrezza on the other hand does not have the issues RAAs have. While you as a T1 have told us numerous times PWDs don't mind needles in the T2 world everything is done to avoid insulin because of needles and compliance. The mission of afrezza is to break that paradym and be used as a front line treatment, not Step 3 or Step 4 and not even Step 2. The goal is afrezza first, afrezza always.
That is the goal of this study as stated on the clinical page which says "The goal is to assess how the investigator can rapidly and safely initiate intensification in this patient population, where extensive delays in HbA1c improvement often occur." The key words are rapidly and safely. In other words, RAAs need not apply.
What Al Mann told us many years ago, as a T2 not on basil or other antiglycemics, getting a hypo on afrezza is really really hard. This was proved out in the Affinity 2 where the only severe hypos were due to TZD use.
What this study does is rebaseline the Affinity 2 results proper dosing with the adaptive algorithm. By doing this there is no need to do another large scale study. A bench study can be done. What we learned on Affinity 2 was PWDs were under-dosed.
seyhey - Thanks for your post. Hadn't thought about this study in awhile, and don't recall ever thinking closely about the safety validation, since hypo occurrences is not an explicitly stated objective. I loved the freeing up of the dosing algorithm to get closer to real world blood sugar reductions vs what previous trials could show with static/lame dosing. Now I'm also interested to see exactly how few hypos are experienced. I'm with you, I've always wanted to see the safety pushed harder as a benefit, and would be great if this gets us down the road toward that. |
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Post by lennymnkd on Feb 23, 2019 15:45:24 GMT -5
Ben saying it for a while ! With the accuracy of the CGM : the patient population mike not have to be as large / will get my answer at shareholders meeting soon .
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Post by mnholdem on Feb 24, 2019 13:28:02 GMT -5
“...irrefutable evidence that early short-term intensive insulin treatment results in a respite for an overwhelmed pancreas, enabling it to repair/regenerate its insulin-producing beta cells. STII therapy has repeatedly demonstrated up to 2 years of drug-free remission of Type 2 diabetes in 50% of treated patients.” Are there any valid/significant clinical studies to show this? I've posted links about STII therapy within various threads in the Resources folder. There's one link in my thread Blood Sugar 101. |
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Post by joeypotsandpans on Feb 24, 2019 15:42:29 GMT -5
With 70% of diabetics not reaching their A1c goal with current "barbaric" injectible drugs and standards of care, is it possible that T2's finally have an easily manageable disease and can "almost" live a normal non-diabetic life with Afrezza and One Drop. BPs and the ADA do not seem to have any answers for this. IMO, the ADA will have no choice but to improve the SOC. One BP will recognize the inevitable and buy Afrezza or possibly Mannkind. Tick tock. Let’s ask Spiro or Hillard...😊 I'll answer for both of them including myself, the answer is NO, reason being we can do it with Afrezza and CGM alone, really don't need one drop and I don't believe any of us use one drop. At least I know Spiro and I don't (use one drop) and can't remember Hillard or any others that use Afrezza that have posted for that matter that use them. That's not saying anything negative about them rather it's fairly rudimentary and easy to use once you get it "down" (implementing Afrezza) that even a caveman could do it (was not paid by Geico)😉. My opinion of course but there have been numerous testimonials and postings of same since it's inception. |
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Post by mnholdem on Feb 25, 2019 5:18:02 GMT -5
This is a preview from an article in a periodical (subscription required to read full article) but it encapsulates what I've been posting for a few years: Insulin Therapy for Type 2 Diabetes: Social, Psychological, and Clinical Factors Full text preview Initially, most people with type 2 diabetes are started on oral antidiabetic medications, but often they will need insulin therapy to maintain glycemic control because of the progressive beta-cell function decline in the pancreas. Both the American Diabetes Association (ADA) and the American Association of Clinical Endocrinologists (AACE) recommend that patients with type 2 diabetes should have therapy titrated and/or intensified every three months and should be started on insulin therapy within nine months after being treated with oral medications if their blood glucose levels are not at goal. 1,2
Some studies have shown that using insulin as the initial treatment strategy for type 2 diabetes can provide a period of diabetic euglycemia or remission. 3,4 Despite the well-established clinical treatment guidelines and research findings advocating the use of insulin as the initial agent after the diagnosis, early insulin initiation or insulin intensification as recommended does not occur often enough during medical appointments. Because of its progressive nature, effective glycemic control in type 2 diabetes depends on timely initiation of insulin and the gradual increase in daily dose. Thus, clinicians are urged to emphasize the initiation and titration of insulin therapy. Clinical inertia, defined as a lack of action on an identified clinical problem, is one factor that contributes to the initiation and titration of insulin therapy. 1 The insulin market has expanded in the last 15 years, with more insulin products made available for prescription. There are two types of human insulin (regular and NPH), four U-100 basal insulin analogs (Lantus, Basaglar, Levemir, and Tresiba), five mealtime insulin analogs (NovoLog, Humalog, Apidra, Fiasp, and Admelog), and one inhaled insulin (Afrezza). In addition, U-500 regular insulin, U-200 Tresiba, U-300 Toujeo, and U-200 Humalog are the commercially available concentrated insulin products for patients who use high doses of insulin. There are three... Link: search.proquest.com/openview/43e4a8affd097844a1ce3cde185eaafc/1?pq-origsite=gscholar&cbl=136143 |
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Post by agedhippie on Feb 25, 2019 9:53:31 GMT -5
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