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Post by mnholdem on Aug 24, 2018 12:40:41 GMT -5
Take an injection...  |
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Post by mnholdem on Aug 24, 2018 12:29:36 GMT -5
Peppy - afrezza is not selling because it is not properly represented in the standards of care. For example, if you want to reduce hypos the current standard says use RAAs with the T1s yet we know afrezza is better. If the standard said use afrezza before trying the RAA you would have insurance coverage and endo's prescribing. What are you talking about sayhey? I see meal time insulin. All they do is have to flunk. They are flunking. Additionally as you know type one's the standard of care IS meal time insulin. I will dig up the picture and post if I have to. ADDED: OK< I see what you are saying, Yes it says Injectable. We have to change that.  Insulin Therapy
Insulin is the mainstay of therapy for individuals with type 1 diabetes. Generally, the starting insulin dose is based on weight, with doses ranging from 0.4 to 1.0 units/kg/day of total insulin with higher amounts required during puberty. The American Diabetes Association/JDRF Type 1 Diabetes Sourcebook notes 0.5 units/kg/day as a typical starting dose in patients with type 1 diabetes who are metabolically stable, with higher weight-based dosing required immediately following presentation with ketoacidosis (1), and provides detailed information on intensification of therapy to meet individualized needs. The American Diabetes Association (ADA) position statement “Type 1 Diabetes Management Through the Life Span” additionally provides a thorough overview of type 1 diabetes treatment (2).  This is where Dr Kendall needs to push for an updated Standards of Care. "Add rapid-acting insulin injections before meals" excludes inhaled insulin. Both should be listed. |
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Post by mnholdem on Aug 23, 2018 15:04:55 GMT -5
I am not sure the Baltimore study is for "early T2s". Its for HbA1c of 7.5 or higher, despite at least 6 months of prior therapy with diabetes medications. They could be at step 3 and still OK for the study. The title of the study is “Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients”. It doesn’t get much clearer than that. |
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Post by mnholdem on Aug 23, 2018 14:41:27 GMT -5
Very informative info for clinicians. It’s a shame that STAT and other recent study findings didn’t make it into the article but overall the article answers many questions practitioners may have about Afrezza.
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Post by mnholdem on Aug 23, 2018 9:24:11 GMT -5
Guys, keep in mind that this thread’s topic is a trial targeting early Type 2 patients.
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Post by mnholdem on Aug 22, 2018 20:48:14 GMT -5
Tomtabb, are you ignorant or are you intentionally just trying to sound ignorant? Try doing a bit of research before you post your wild ass guesses. Please stop being so argumentative unless you have facts (and sources) to back up your conjectures.
Thank you!
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Post by mnholdem on Aug 22, 2018 15:07:29 GMT -5
I would agree with both those points. It would be extremely surprising if adding Afrezza to a failed OAD regime would not reduce the A1c, adding RAA would as well. This is largely replicating the 175 trial isn't it? And +1 for using insulin far earlier in the Standard of Care. It's a data point for the use of insulin, but what is really needed is a multi-arm trial for insulin (basal and/or prandial), GLP-1, SGLT-2, and DPP-4. That's a huge trial and it would be expensive to cover the cost. What it would do is provided a strong answer to the what next question. Reviewing trial 175, I have to agree this latest basically just looks like a repeat. I don't quite see the "1+ for using insulin far earlier," however. They say at least six months following standard of care, so all they seem to be doing is following the usual standard of care and just substituting afrezza for a rapid acting insulin at the end of their flowchart. What you just posted is factually incorrect. Insulin therapy is currently the last step on the ADA Standard of Care. The time that elapses between the first and last steps can be 2-3 years. By then the unchecked damage to the pancreas could be permanent. Also, MannKind is not following the SOC by introducing Technosphere Insulin 6 months after Metformin. Have you even read the Standards? There are multiple medications and/or combinations of medications recommended to be prescribed before insulin and the SOC is the primary reason many insurers insist on Prior Authorization or of step therapy requiring the patient has followed the steps recommended in the Standards of Care before they’ll cover insulin. Peppy could you post the Standards of Care chart you keep? Thanks! |
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Post by mnholdem on Aug 22, 2018 14:50:16 GMT -5
I stand corrected. Thank you.
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Post by mnholdem on Aug 22, 2018 8:47:39 GMT -5
MannKind is allocating its limited resources but is open to development partners for several of its Technosphere API.
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Post by mnholdem on Aug 22, 2018 8:44:03 GMT -5
My impression is that Liquidia has already demonstrated that LIQ861 can achieve serum levels of treprostinil equivalent to tyvaso with reasonable safety. That's why the FDA allowed them to move onto phase 3 so quickly; they were able to "seek approval of LIQ861 under the 505(b)(2) pathway, which will allow us to rely in part on the FDA’s previous findings of efficacy and safety of Tyvaso® (U.T.C.) and the active ingredient treprostinil." The current phase 3 is just to assess long term safety and tolerability. Did MNKD's phase 1 do the same? Has MNKD discussed 505(b2) with the FDA yet? People living with PAH need more convenient and tolerable treprostinil treatment options to help them live a less intrusive lifestyle. I am excited to see that MannKind was safely able to achieve higher plasma levels than reported for the current standard of care using Technosphere-based treprostinil,” stated Lewis Rubin, MD, Emeritus Professor of Medicine at the University of California, San Diego School of Medicine. Source: investors.mannkindcorp.com/news-releases/news-release-details/mannkind-successfully-completes-phase-1-trial-treprostinil |
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Post by mnholdem on Aug 22, 2018 7:33:27 GMT -5
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Post by mnholdem on Aug 22, 2018 7:04:56 GMT -5
Article: dlife.com/down-the-inhaled-insulin-path-the-road-to-approval-and-acceptance/It wasn’t until the late 1990’s that the idea of inhaled insulin actually came to fruition. Researchers found ways to develop an insulin powder that could be administered with the help of an inhaler, much like the ones used for asthma. After all the developments, however, the use of inhaled insulin is not widespread. Let’s learn more about inhaled insulin, what hurdles were crossed for its approval, and how it’s received today by the medical community. |
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Post by mnholdem on Aug 22, 2018 6:50:20 GMT -5
tomtab, I think you are correct that this particular study is not a short-term intensive insulin therapy (STII) treatment. It comes close though. I think that the primary goal is to demonstrate Afrezza as a safe and more effective treatment for early Type 2 than OAD treatments alone.
For quite some time, I’ve encouraged management to pursue a grant (Gates Foundation, government or other private) for a major clinical study on STII using Afrezza.
My intent with the OP was to convey two things;
1. This study will likely show significant results;
2. Early intensive insulin treatment should come much earlier in the ADA Standards of Care for treatment of Diabetes.
The study will be another in among the growing body of clinical evidence for the ADA/AACE to consider.
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Post by mnholdem on Aug 18, 2018 5:16:56 GMT -5
I believe that the trial mentioned in the OP is the first using Afrezza inhalable insulin, which wasn't available for past clinical studies on early intensive insulin treatment. If RAA insulin can demonstrate these kinds of results (i.e. remission) it would beg the question of whether Technosphere insulin may demonstrate even better results. One important note. In a number of these trial papers, researchers have noted that patients in early stages of diabetes may be resistant to a treatment which involves multiple daily injections. This represents another distinct advantage that Afrezza may have over RAA insulin.  |
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Post by mnholdem on Aug 17, 2018 11:53:17 GMT -5
Wow, what a memory!  |
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