|
|
Post by mnholdem on Jun 13, 2015 11:02:06 GMT -5
Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus clinicaltrials.gov/ct2/show/NCT02470637ClinicalTrials.gov Identifier: NCT02470637 First received: June 10, 2015 Last updated: June 11, 2015 Last verified: June 2015 |
|
|
|
Post by kc on Jun 13, 2015 11:10:41 GMT -5
So can anybody explain what this study is about? Is Lispro a Lily product? Lispro is called a rapid acting injectable? Is this to study why Afrezza should earn a rapid acting label? I see that it involves the FDA and the Germany Ethics Commission.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02470637 History of Changes
Other Study ID Numbers: PDY14324, 2015-000231-33, U1111-1166-5431
Study First Received: June 10, 2015
Last Updated: June 11, 2015
Health Authority: Germany: Ethics Commission
United States: Food and Drug Administration
|
|
|
|
Post by oscarlonzo on Jun 13, 2015 11:17:43 GMT -5
"Randomized, Controlled, 6-treatment, 6-sequence, 6-period Cross-over Dose Response Study of 3 Single Doses of Afrezza Inhaled Technosphere Insulin and of 3 Single Doses of SC Insulin Lispro in Patients With Diabetes Mellitus Type 1 Using the Euglycemic Clamp Technique"
"To assess the dose-response pattern of the glucose consumption (GIR-AUC0-end) of 3 different single doses of Afrezza inhaled Technosphere insulin and of 3 single doses of subcutaneous (SC) insulin lispro in a euglycemic clamp setting."
Why? Shouldn't that already have been done like years ago? Although I notice a lot of people are reporting the need to use considerably more afrezza insulin than lispro insulin, maybe trying to figure that out.
Only 30 subjects so it shouldn't take long to do at least.
|
|
Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Jun 13, 2015 12:11:01 GMT -5
Why? Because they are subject matter experts of a multibillion dollar company and they determined that this is the proper approach? And because the result will allow them to term the drug ultra-fast acting, allow differentiation between the direct competition and all but put to bed any insurance issues that it's just "replacement in kind"?
Seriously Oscar, you should disclose your position because your posts are nothing but cynical garbage.
|
|
|
|
Post by savzak on Jun 13, 2015 12:37:49 GMT -5
Why? Because they are subject matter experts of a multibillion dollar company and they determined that this is the proper approach? And because the result will allow them to term the drug ultra-fast acting, allow differentiation between the direct competition and all but put to bed any insurance issues that it's just "replacement in kind"? Seriously Oscar, you should disclose your position because your posts are nothing but cynical garbage. Oscar posted that the MNKD board is paid a half million a year. I asked him to back it up or risk losing credibility. Instead of coming clean and acknowledging he was wrong, he maintained he was right, thereby doubling down on his credibility deficit. There's been precious little in his posts to either redeem his credibility or to suggest an open minded, intellectually transparent attitude; in my opinion, of course. |
|
|
|
Post by mnholdem on Jun 13, 2015 14:28:40 GMT -5
I posted this news at YaZoo. It is creating quite a buzz over there. Apparently a board member thinks this trial is "The Afrezza Challenge" that he's heard talk of via a Sanofi insider.
Incidentally, insulin lispro is Eli-Lilly's Humalog. Novolog (Novo-Nordisk) is aka insulin aspart and Apridra (Sanofi) is insulin glulinine. Those are the Big Three of the Rapid-Acting Analog (RAA) insulins.
I believe this 6-month trial is specifically meant to prove "superiority". Getting that on the label is worth $billions. My only question is will Sanofi also issue The Afrezza Challenge to Novo-Nordisk now that they are facing off against Lilly's Humolog?
|
|
|
|
Post by EveningOfTheDay on Jun 13, 2015 15:48:13 GMT -5
Well, finally something exciting happening. 6 months should go by relatively quickly, although between one thing and another it probably will be a few more before results are accepted and approved, if they actually have to be approved. Anyway, as mnholdem very well points out, this could be the way to tier 2 and a sit at the insurance companies' preferred insulin table; therefore, worth billions. Things are starting to look up.
|
|
|
|
Post by jpg on Jun 13, 2015 16:05:53 GMT -5
Why? Because they are subject matter experts of a multibillion dollar company and they determined that this is the proper approach? And because the result will allow them to term the drug ultra-fast acting, allow differentiation between the direct competition and all but put to bed any insurance issues that it's just "replacement in kind"? Seriously Oscar, you should disclose your position because your posts are nothing but cynical garbage. Oscar posted that the MNKD board is paid a half million a year. I asked him to back it up or risk losing credibility. Instead of coming clean and acknowledging he was wrong, he maintained he was right, thereby doubling down on his credibility deficit. There's been precious little in his posts to either redeem his credibility or to suggest an open minded, intellectually transparent attitude; in my opinion, of course. Where was this posted by Oscarlonza? How do we split the 500000$? Is Oscar (my best friend forever) in charge of distribution? |
|
|
|
Post by savzak on Jun 13, 2015 16:44:35 GMT -5
|
|
|
|
Post by jpg on Jun 13, 2015 16:55:14 GMT -5
Yes I now recall having read that and found it strange that the poster did not correct himself. I did not realize it was Oscar who started that false idea. Sadly I read your post quickly and thought it was MNkD ProBoard getting that money. Oh well... Why don't we get paid to post so much?  |
|
|
|
Post by spiro on Jun 13, 2015 16:58:30 GMT -5
The CEO's Liane and BD get $250,000 each. They would have to give Spiro $100,000 if he got the Lead Global Moderator promotion. It's in the corporation bylaws. Regular Global Moderators get zero.
Spiro here, uncompensated
|
|
|
|
Post by liane on Jun 13, 2015 17:05:07 GMT -5
The CEO's Liane and BD get $250,000 each. They would have to give Spiro $100,000 if he got the Lead Global Moderator promotion. It's in the corporation bylaws. Regular Global Moderators get zero. Spiro here, uncompensated Don't I wish!!  |
|
|
|
Post by benh on Jun 13, 2015 17:51:34 GMT -5
I posted this news at YaZoo. It is creating quite a buzz over there. Apparently a board member thinks this trial is "The Afrezza Challenge" that he's heard talk of via a Sanofi insider. Incidentally, insulin lispro is Eli-Lilly's Humalog. Novolog (Novo-Nordisk) is aka insulin aspart and Apridra (Sanofi) is insulin glulinine. Those are the Big Three of the Rapid-Acting Analog (RAA) insulins. I believe this 6-month trial is specifically meant to prove "superiority". Getting that on the label is worth $billions. My only question is will Sanofi also issue The Afrezza Challenge to Novo-Nordisk now that they are facing off against Lilly's Humolog? I'm not surprised Lilly has been picked out. They are in legal battles over the off-patent patent infringement. And the Twit FUD had links to Lilly staff and/or sympathisers to their reps. There may be a better reason related to the PKD that one of the Docs and clever folk on here could highlight. Until then, I prefer the school yard fight rationale. |
|
|
|
Post by robsacher on Jun 13, 2015 20:14:52 GMT -5
Spiro,
Glad to see your comment. I trust that you are home from your vacation and enjoyed your time sailing around the Greek Islands. Did you talk with anyone there about Afrezza? Or, did you take some time off from this endeavor?
This is wonderful news about a new study comparing the time profiles of Afrezza and Humalog. There is no doubt which company and which drug will win this comparison and the results of such should give doctors a significant reason to prescribe Afrezza, probably in late 2016 or the first half of 2017.
In fact, this one bit of news may turn out to be the most important news we have heard since partnership last year. Next year, Afrezza may gain the "Ultra Rapid Acting" label based on these results.
Also, the stock could easily hit and stay in double digits upon receiving that vaunted classification. It's really valuable.
|
|
|
|
Post by kc on Jun 13, 2015 20:20:34 GMT -5
An attorney never asks a question that he didn't already know the answer so I believe that SANOFI knows what the study is going to prove out. SANOFI already knows that Afrezza is superior and will earn the RAPID ONSET LABEL.
|
|
