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Post by agedhippie on Jan 28, 2019 10:17:31 GMT -5
The problem is that while the analysis shows a reduction in hypos it's still within the margin of error unless the original math was wrong. Mannkind made the reduced hypo claim in a PR and then had to issue a correction for that reason. STAT is a pilot, until there is a proper trial using that protocol it's not going to get any traction. Likewise adding insulin to oral meds when those meds have failed and getting a reduction in A1c is hardly revolutionary. There needs to be a new large scale trial using the STAT protocol if the SOC is to change. Until that happens it's just going to be minor changes at best. I think if I was designing a trial though I would pick on reliability of action between Afrezza and RAA because the predictable absorption would nail that. Aged - the problem is those in the trials that got the hypos where on TZDs. They should have been excluded from the trial data.
I don't remember the retraction, can you post it please?
Adding afrezza to oral meds I do not believe is the goal As VDex has shown the oral meds provide no value but worse they get in the way of the liver properly responding. The goal is afrezza first, afrezza last.
In the short term we have the A-One study and the Baltimore study. We will have to wait on Dr. Kendall's net move. The affinity 2 is already a large study with afrezza as a front line treatment. If Dr. Kendall can reconstruct the root cause of the hypos and get them excluded it would seem the large scale study is done.
I think we are talking about different trials, I am talking about Affinity-1 which was the Type 1 trial. The retraction is on the Mannkind site - CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes. CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 DiabetesVALENCIA, Calif.--(BUSINESS WIRE)--Aug. 14, 2013-- Second graph under Other Results subhead, second sentence should read: The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per 100 subject-months) than in the insulin aspart group (14.45 events per 100 subject-months); however, this difference was not statistically significant (p=0.1022) (sted The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per subject-month) than in the insulin aspart group (14.45 events per subject-month); however, this difference was not statistically significant (p=0.1022)). [My highlighting]
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Post by harryx1 on Jan 28, 2019 10:39:46 GMT -5
I would normally put this in the Afrezza on Twitter section but thought more people would see it here, very powerful! Real World Evidence
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Post by mannmade on Jan 28, 2019 10:50:56 GMT -5
Think would be ok to put under both. Thanks Harry for all the work you out in on behalf of mannkind and this board! You are very much appreciated!
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Post by mango on Jan 28, 2019 10:57:00 GMT -5
Aged - the problem is those in the trials that got the hypos where on TZDs. They should have been excluded from the trial data. I don't remember the retraction, can you post it please? Adding afrezza to oral meds I do not believe is the goal As VDex has shown the oral meds provide no value but worse they get in the way of the liver properly responding. The goal is afrezza first, afrezza last. In the short term we have the A-One study and the Baltimore study. We will have to wait on Dr. Kendall's net move. The affinity 2 is already a large study with afrezza as a front line treatment. If Dr. Kendall can reconstruct the root cause of the hypos and get them excluded it would seem the large scale study is done.
I think we are talking about different trials, I am talking about Affinity-1 which was the Type 1 trial. The retraction is on the Mannkind site - CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 Diabetes. CORRECTING and REPLACING MannKind Reports Positive Data from a Phase 3 Clinical Study of AFREZZA in Patients with Type 1 DiabetesVALENCIA, Calif.--(BUSINESS WIRE)--Aug. 14, 2013-- Second graph under Other Results subhead, second sentence should read: The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per 100 subject-months) than in the insulin aspart group (14.45 events per 100 subject-months); however, this difference was not statistically significant (p=0.1022) (sted The event rate of severe hypoglycemia was also lower in the AFREZZA-Gen2 group (8.05 events per subject-month) than in the insulin aspart group (14.45 events per subject-month); however, this difference was not statistically significant (p=0.1022)). [My highlighting] Aged, what you are referring to is severe hypos. You left out the significant data. Highlights AFREZZA-Gen2, compared to insulin aspart, showed: "Non-inferior decreases in A1c levels; Significantly less hypoglycemia; Significant decreases in fasting blood glucose levels; and Significant weight advantage. In addition, the changes in pulmonary function observed in the AFREZZA-Gen2 group were no different than those observed in an AFREZZA treatment group that utilized MannKind's first-generation (MedTone) inhaler. This finding will facilitate bridging the Gen2 inhaler to the pulmonary safety data that was collected in earlier clinical studies using the MedTone inhaler."
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