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Post by mango on Jan 16, 2018 6:02:13 GMT -5
This is definitely my hope. Why doesn't MNKD simply recruit a hundred patients who use afrezza as their sole mealtime insulin, hook them to CGMs for six months and then report the results? That is essentially what the STAT clinical trial is and involves T1D. It's a Phase 4 trial though so the duration is much shorter—Afrezza vs Insulin Aspart. All participants will be using a Dexcom G5. Participants in the Afrezza arm will be using only Afrezza as their prandial insulin, and will have a Dexcom G5. After the trial is over the participants get to keep their CGMs. • The Primary Outcome Measures are: 1) Improved time in range 2) Better post-prandial glucose excursion • The Secondary Outcome Measures are: 1) Less glucose variability 2) The area under the curve calculation (AUC) in the PPBG and PPGE 3) Change in HbA1c in one-month treatment 4) Above the target time (>180 mg/dl) on CGM 5) Hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM
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Post by peppy on Jan 16, 2018 11:23:52 GMT -5
Why doesn't MNKD simply recruit a hundred patients who use afrezza as their sole mealtime insulin, hook them to CGMs for six months and then report the results? That is essentially what the STAT clinical trial is and involves T1D. It's a Phase 4 trial though so the duration is much shorter—Afrezza vs Insulin Aspart. All participants will be using a Dexcom G5. Participants in the Afrezza arm will be using only Afrezza as their prandial insulin, and will have a Dexcom G5. After the trial is over the participants get to keep their CGMs. • The Primary Outcome Measures are: 1) Improved time in range 2) Better post-prandial glucose excursion • The Secondary Outcome Measures are: 1) Less glucose variability 2) The area under the curve calculation (AUC) in the PPBG and PPGE 3) Change in HbA1c in one-month treatment 4) Above the target time (>180 mg/dl) on CGM 5) Hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM digger, this will be released at the ada meeting in June. the sponsor gets to decide when to release. Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center clinicaltrials.gov/ct2/show/NCT03143816the study is finished.
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Post by sportsrancho on Jan 19, 2018 11:35:20 GMT -5
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Post by digger on Jan 19, 2018 18:15:58 GMT -5
That is essentially what the STAT clinical trial is and involves T1D. It's a Phase 4 trial though so the duration is much shorter—Afrezza vs Insulin Aspart. All participants will be using a Dexcom G5. Participants in the Afrezza arm will be using only Afrezza as their prandial insulin, and will have a Dexcom G5. After the trial is over the participants get to keep their CGMs. • The Primary Outcome Measures are: 1) Improved time in range 2) Better post-prandial glucose excursion • The Secondary Outcome Measures are: 1) Less glucose variability 2) The area under the curve calculation (AUC) in the PPBG and PPGE 3) Change in HbA1c in one-month treatment 4) Above the target time (>180 mg/dl) on CGM 5) Hypoglycemia frequency (below the target <70, <60, <50 mg/dl) on CGM digger, this will be released at the ada meeting in June. the sponsor gets to decide when to release. Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center clinicaltrials.gov/ct2/show/NCT03143816the study is finished. And will they release the data if it turns out the humalog arm did better than the afrezza arm? My point is that the study declares itself to be a pilot study lasting only a month, which automatically means it won't be of any use to impress insurers. Also, the afrezza group appears to get a lot more attention in terms of consultations during the study than the humalog group which appears to get none; I suspect MDs and diabetic researchers will find fault with that. To me it would have been more rational and cheaper to do just an afrezza alone pilot study first to see if, in fact, the drug does produce better PPGE, etc, with the CGM and if it did and if there was an impressive enough difference, then move onto a bigger,longer study comparing to humalog.
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Post by sportsrancho on Jan 19, 2018 18:49:28 GMT -5
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Post by sportsrancho on Jan 19, 2018 19:07:47 GMT -5
Wow:-) I wonder what those flags mean?
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Post by xanet on Jan 19, 2018 19:14:41 GMT -5
digger, this will be released at the ada meeting in June. the sponsor gets to decide when to release. Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center clinicaltrials.gov/ct2/show/NCT03143816the study is finished. And will they release the data if it turns out the humalog arm did better than the afrezza arm? My point is that the study declares itself to be a pilot study lasting only a month, which automatically means it won't be of any use to impress insurers. Also, the afrezza group appears to get a lot more attention in terms of consultations during the study than the humalog group which appears to get none; I suspect MDs and diabetic researchers will find fault with that. To me it would have been more rational and cheaper to do just an afrezza alone pilot study first to see if, in fact, the drug does produce better PPGE, etc, with the CGM and if it did and if there was an impressive enough difference, then move onto a bigger,longer study comparing to humalog. Doubtful that humalog would get better results, but yes, they will present the results either way. I'm not sure what you mean in the second paragraph. What's your control?
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Post by mnholdem on Jan 19, 2018 19:24:22 GMT -5
If Humalog claims victory, you can dismiss it. The STAT trial pitted Afrezza against Novolog's insulin aspart (chuckle). Teasing aside (humbly noted) the advantage of going against Novolog is that MannKind can claim to have beat the world's #1 prandial insulin. That's the kind of data that marketing executives truly relish! Me, too!
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Post by mnholdem on Jan 19, 2018 20:01:09 GMT -5
Successful business take advantage of opportunities. Take my beloved Minnesota Vikings, for example: Vikings seek trademarks for 'Minneapolis Miracle' and 'Minnesota Miracle'Excerpt: The filings showed up Friday in electronic records published by the U.S. Patent and Trademark Office.
The team seeks to own the monikers on more than 100 items, from football helmets to watches, golf bags to bowling bags, and bathing suits to parkas.
The team is selling a T-shirt with "Minneapolis Miracle 1-14-18." Diggs himself, with T-shirt seller Represent, began selling an NFLPA-licensed shirt with his image and the words "Minneapolis Miracle" on Wednesday.
More than 1,000 shirts were sold online within the first 48 hours.www.espn.com/nfl/story/_/id/22155136/minnesota-vikings-apply-two-trademarks-win-new-orleans-saints--- MannKind would benefit immensely by adopting the same spirit, IMO.
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Post by golfeveryday on Jan 19, 2018 20:03:02 GMT -5
If Humalog claims victory, you can dismiss it. The STAT trial pitted Afrezza against Novolog's insulin aspart (chuckle). Teasing aside (humbly noted) the advantage of going against Novolog is that MannKind can claim to have beat the world's #1 prandial insulin. That's the kind of data that marketing executives truly relish! Me, too! has anyone figured out with any confidence when this data will be released? I can not imagine they would hold it when it is needed so badly unless it is locked/embargoed. Can it be used behind the scenes for partner/insurance negotiations if not presented until June?
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Post by sayhey24 on Jan 19, 2018 20:08:21 GMT -5
digger, this will be released at the ada meeting in June. the sponsor gets to decide when to release. Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center clinicaltrials.gov/ct2/show/NCT03143816the study is finished. And will they release the data if it turns out the humalog arm did better than the afrezza arm? My point is that the study declares itself to be a pilot study lasting only a month, which automatically means it won't be of any use to impress insurers. Also, the afrezza group appears to get a lot more attention in terms of consultations during the study than the humalog group which appears to get none; I suspect MDs and diabetic researchers will find fault with that. To me it would have been more rational and cheaper to do just an afrezza alone pilot study first to see if, in fact, the drug does produce better PPGE, etc, with the CGM and if it did and if there was an impressive enough difference, then move onto a bigger,longer study comparing to humalog. This is primarily a time in range study. If you can show better time in range using a CGM for a month why would anyone think you can't do it for two or three months or even three years? United Health, Aetna and others want to make money. One of their biggest cost drivers is diabetes. These same companies have pilots with Dexcom, Libre, Apple and fitbit to better monitor. The problem after you monitor is you have to do something. Now our AACE friends say here www.aace.com/sites/all/files/diabetes-algorithm-executive-summary.pdf Insulin is the most potent antihyperglycemic agent on page 8. Why wouldn't you use the best? Well, until afrezza there was a huge concern about hypoglycemia. Thats not the case with afrezza. Moreover we are seeing more results coming in which are showing keeping the T2 in a near non-diabetic range not only stops but can even reverse progression. What insurance company that wants to save money would not be interested in a treatment which has minimal hypoglycemia risk and can reverse diabetes and save them a ton of money in the long run? Where I come from money talks. If you can provide a near cure which is very safe I think they will be interested. After 3 years and no lung issues the waiting time is over, I think they want to play ball. Now, we already know from years and years that Novolog is not great at time in range. We also know from over 60 studies Al Mann did and the clamp study that afrezza has a profile which mimics the natural pancreas and MNKD used that clamp data for the label change. Its not a question of is afrezza faster than Novolog. That ship has sailed. Its on the label. Its a question of proper timing with Novolog and the fact that stacking it is unpredictable. Not so with afrezza, in fact second and even third dosing is encouraged. For years and years some of the best tried to make Novolog/Humalog keep better time in range and they failed. Why should anyone think the trial participants can do better than the experts? Maybe they can but it would be surprising.
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Post by joeypotsandpans on Jan 19, 2018 20:20:22 GMT -5
And will they release the data if it turns out the humalog arm did better than the afrezza arm? My point is that the study declares itself to be a pilot study lasting only a month, which automatically means it won't be of any use to impress insurers. Also, the afrezza group appears to get a lot more attention in terms of consultations during the study than the humalog group which appears to get none; I suspect MDs and diabetic researchers will find fault with that. To me it would have been more rational and cheaper to do just an afrezza alone pilot study first to see if, in fact, the drug does produce better PPGE, etc, with the CGM and if it did and if there was an impressive enough difference, then move onto a bigger,longer study comparing to humalog. This is primarily a time in range study. If you can show better time in range using a CGM for a month why would anyone think you can't do it for two or three months or even three years? United Health, Aetna and others want to make money. One of their biggest cost drivers is diabetes. These same companies have pilots with Dexcom, Libre, Apple and fitbit to better monitor. The problem after you monitor is you have to do something. Now our AACE friends say here www.aace.com/sites/all/files/diabetes-algorithm-executive-summary.pdf Insulin is the most potent antihyperglycemic agent on page 8. Why wouldn't you use the best? Well, until afrezza there was a huge concern about hypoglycemia. Thats not the case with afrezza. Moreover we are seeing more results coming in which are showing keeping the T2 in a near non-diabetic range not only stops but can even reverse progression. What insurance company that wants to save money would not be interested in a treatment which has minimal hypoglycemia risk and can reverse diabetes and save them a ton of money in the long run? Where I come from money talks. If you can provide a near cure which is very safe I think they will be interested. After 3 years and no lung issues the waiting time is over, I think they want to play ball. Now, we already know from years and years that Novolog is not great at time in range. We also know from over 60 studies Al Mann did and the clamp study that afrezza has a profile which mimics the natural pancreas and MNKD used that clamp data for the label change. Its not a question of is afrezza faster than Novolog. That ship has sailed. Its on the label. Its a question of proper timing with Novolog and the fact that stacking it is unpredictable. Not so with afrezza, in fact second and even third dosing is encouraged. For years and years some of the best tried to make Novolog/Humalog keep better time in range and they failed. Why should anyone think the trial participants can do better than the experts? Maybe they can but it would be surprising. Very well stated, I am living it each day now!! Each day my daily avg. is improving, if I need a correction dose, no problemo, it's a beautiful thing if I must say so myself....feel like I'm on my own T2 STAT study
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Post by sportsrancho on Jan 19, 2018 20:40:12 GMT -5
So happy for you Joey! After all this time you finally get to reap the rewards!
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Post by agedhippie on Jan 19, 2018 21:02:32 GMT -5
This is primarily a time in range study. If you can show better time in range using a CGM for a month why would anyone think you can't do it for two or three months or even three years? The answer is because results vary over time. There is a known effect in studies where people do better than in real life because they have more resources and coaching available. To counter that you run longer studies. I was looking a a study the other days where the two results were radically different for the first month or so, but by the end of month three were neck and neck. Insurers are well aware of these possibilities and a month study will not change anything. What it will do is let Mannkind design a better long term follow on trial. The data will help pin down what behaviors worked best and next time they can focus on those to improve the outcome in the next study.
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Post by peppy on Jan 19, 2018 21:15:17 GMT -5
digger, this will be released at the ada meeting in June. the sponsor gets to decide when to release. Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center clinicaltrials.gov/ct2/show/NCT03143816the study is finished. And will they release the data if it turns out the humalog arm did better than the afrezza arm? My point is that the study declares itself to be a pilot study lasting only a month, which automatically means it won't be of any use to impress insurers. Also, the afrezza group appears to get a lot more attention in terms of consultations during the study than the humalog group which appears to get none; I suspect MDs and diabetic researchers will find fault with that. To me it would have been more rational and cheaper to do just an afrezza alone pilot study first to see if, in fact, the drug does produce better PPGE, etc, with the CGM and if it did and if there was an impressive enough difference, then move onto a bigger,longer study comparing to humalog. this study has continuous glucose monitors on everybody. The study will ALLOW physicians to look at Afrezza on a continuing glucose monitor.
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