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Post by sayhey24 on Jun 22, 2018 19:09:22 GMT -5
What is the HbA1c for both groups? That was supposed to be a secondary end-point. During the hours of 8am to 8pm the average BG for the compliant afrezza user was about 110 mg/dl which converts to an A1c of 5.4.
I would say thats pretty damn good.
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ADA
Jun 22, 2018 19:09:22 GMT -5
Post by xanet on Jun 22, 2018 19:09:22 GMT -5
Can anyone comment on the statistical power of the study and type I error for this analysis? I think there is something to be said about the sample size and absolute difference in means between the treatment groups. Statistical significance may or may not be real. I think follow up studies will be key here, and I'm hoping Dr. Kendall will be able to design future studies to continue to convince endocrinologists of Afrezza's value. TIA. The authors used per protocol analysis, which divides participants into compliant and non-compliant groups. However, the trial was randomized into two similar groups, so dividing one group into two messes with the statistics. Also this approach tends to exaggerate the effects, compared to what would be expected in the real world. However, I don't really see a way around it with sample sizes this small. See more in this Article.
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Post by Deleted on Jun 22, 2018 19:23:50 GMT -5
sayhey24 I appreciate your input but it would have been informative to include the HbA1c values. When a company doesn't provide pertinent data, I start questioning.
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Post by sayhey24 on Jun 22, 2018 19:53:53 GMT -5
sayhey24 I appreciate your input but it would have been informative to include the HbA1c values. When a company doesn't provide pertinent data, I start questioning. I think they want people come and hear them talk. Maybe you should go? After they present I think you will have your answer.
But let me ask you, what does it matter? The job of a prandial is not to reduce A1c. Its job is to get you back to baseline in about 2 hours. Its job is to mimic first and second phase meal time release.
The 8am to 8pm is reflecting an A1c of 5.4. In a non-diabetic their fasting A1c is about 4.6 and during the mealtime period it is about 5.4. Afrezza in this study is perfectly mimicking a non-diabetic during meal time.
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ADA
Jun 22, 2018 20:10:21 GMT -5
Post by Deleted on Jun 22, 2018 20:10:21 GMT -5
"The job of a prandial is not to reduce A1c."
That is news to me. I was of the opinion all insulin products were intended to reduce glucose levels.
No wonder I have been wrong all these years!?
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ADA
Jun 22, 2018 20:13:26 GMT -5
via mobile
Post by golfeveryday on Jun 22, 2018 20:13:26 GMT -5
"The job of a prandial is not to reduce A1c." That is news to me. I was of the opinion all insulin products were intended to reduce glucose levels. No wonder I have been wrong all these years!? A1C is a 3 month average metric of glucose control. PPG is a a daily (in the moment) measure of glucose post meal.
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ADA
Jun 22, 2018 20:25:33 GMT -5
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Post by pguererro on Jun 22, 2018 20:25:33 GMT -5
About 38% of Type 1’s are on a pump
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ADA
Jun 22, 2018 20:39:49 GMT -5
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Post by Deleted on Jun 22, 2018 20:39:49 GMT -5
"The job of a prandial is not to reduce A1c." That is news to me. I was of the opinion all insulin products were intended to reduce glucose levels. No wonder I have been wrong all these years!? A1C is a 3 month average metric of glucose control. PPG is a a daily (in the moment) measure of glucose post meal. An HbA1C measurement can be performed anytime with one blood draw. It was the secondary endpoint. Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]
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Jun 22, 2018 22:36:45 GMT -5
Post by mnkdfann on Jun 22, 2018 22:36:45 GMT -5
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Post by brotherm1 on Jun 23, 2018 1:15:12 GMT -5
Thus If Afrezza keeps PWD’s in range during the vast majority of waking hours, and time in range with the best pump only does 72% (througout the entire day), it sounds to me a humongous opportunity exists for Afrezza to eat big into the large pump using population. With 1.25 million T1’s in the US and 1/3 using pumps, that’s quite an oppurtunity.
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ADA
Jun 23, 2018 6:34:04 GMT -5
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Post by cjm18 on Jun 23, 2018 6:34:04 GMT -5
What is the HbA1c for both groups? That was supposed to be a secondary end-point. During the hours of 8am to 8pm the average BG for the compliant afrezza user was about 110 mg/dl which converts to an A1c of 5.4.
I would say thats pretty damn good.
And for insulin aspart during 8 to 8 avg blood sugar and TIR was?
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Post by akemp3000 on Jun 23, 2018 7:18:04 GMT -5
In the big picture, Dr. Kendall, after being the Chief Scientific Medical Officer for the ADA, leaves an executive global position at Lilly most likely because of the data he sees in the STAT study and 65 prior studies. He states that the data contains veins of gold, that current RAAs are antiquated and barbaric and that Afrezza should be the standard of care...yet there are current attempts to downplay the significance of the data in the STAT study. IMO, the negativity just doesn’t have weight compared to Dr. Kendall’s perspective. I expect the company and Dr. Kendall to provide a lot more clarity in the coming days and weeks.
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Post by Deleted on Jun 23, 2018 7:55:25 GMT -5
In the big picture, Dr. Kendall, after being the Chief Scientific Medical Officer for the ADA, leaves an executive global position at Lilly most likely because of the data he sees in the STAT study and 65 prior studies. He states that the data contains veins of gold, that current RAAs are antiquated and barbaric and that Afrezza should be the standard of care...yet there are current attempts to downplay the significance of the data in the STAT study. IMO, the negativity just doesn’t have weight compared to Dr. Kendall’s perspective. I expect the company and Dr. Kendall to provide a lot more clarity in the coming days and weeks. Damn straight. So sick of so called pundits who claim they no more. He was the aforementioned "man" at the ADA. A top execute at Lilly. Now the new CMO backing Afrezza. Yet people spew trash. The trial design is flawed, there are no significant improvements, etc. To those I ask, do you know more than Kendall? I respond. Stick you head in icy cold. Reassess your POV. And buy more MNKD stock!!
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Post by peppy on Jun 23, 2018 8:06:34 GMT -5
In the big picture, Dr. Kendall, after being the Chief Scientific Medical Officer for the ADA, leaves an executive global position at Lilly most likely because of the data he sees in the STAT study and 65 prior studies. He states that the data contains veins of gold, that current RAAs are antiquated and barbaric and that Afrezza should be the standard of care...yet there are current attempts to downplay the significance of the data in the STAT study. IMO, the negativity just doesn’t have weight compared to Dr. Kendall’s perspective. I expect the company and Dr. Kendall to provide a lot more clarity in the coming days and weeks. Damn straight. So sick of so called pundits who claim they no more. He was the aforementioned "man" at the ADA. A top execute at Lilly. Now the new CMO backing Afrezza. Yet people spew trash. The trial design is flawed, there are no significant improvements, etc. To those I ask, do you know more than Kendall? I respond. Stick you head in icy cold. Reassess your POV. And buy more MNKD stock!! the STAT Study comes out in 6 hours? we will see.
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ADA
Jun 23, 2018 8:50:21 GMT -5
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Post by agedhippie on Jun 23, 2018 8:50:21 GMT -5
During the hours of 8am to 8pm the average BG for the compliant afrezza user was about 110 mg/dl which converts to an A1c of 5.4.
I would say thats pretty damn good.
And for insulin aspart during 8 to 8 avg blood sugar and TIR was? I would like to have seen that. It's annoying that they didn't put it out there, but I guess they wanted the focus on Afrezza.
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