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Post by peppy on Jun 5, 2018 14:21:59 GMT -5
Fine. Now I realize we're talking about anecdotal evidence but you're telling me that the people who have posted via social media about their A1C dropping to non-diabetic levels would be even better off using Novolog? Or is it that all of those folks are T2 and that is the difference?
I am not telling you that at all. Afrezza works well for the people on social media, but that is both a very small and a self-selecting group which makes their conclusions interesting but not actionable. The flip side to the social media group is buried in the renewal rate which would seem to indicate a lot of people for whom Afrezza is not working. I feel that the social media group is probably predominantly Type 1. At root there is an idea that diabetes is deterministic - if I do X I will get Y, and that is repeatable. Doctors are particularly susceptible to this and it's a long standing gripe among diabetics. If your numbers don't line up with what is expected then you cannot be following instruction, or are making things up. I had an interesting conversation with an endo from Mt Sinai who was honest enough to confess that he used to think like that as well until his wife got gestational diabetes and he saw how random things could get. This study dosed differently and dosed with continuing glucose monitors. HbA1c @ 30 days. WE WILL SEE. RBC's live @ 120 days. Let's see aged. The Study you are quoting did not have the continuous glucose monitors. (CGM On both groups) Has a study like this ever been done with continuous glucose monitors before? “Improved Postprandial Blood Glucose (PPBG) Excursions with Technosphere Inhaled Insulin Compared with Aspart in T1D Patients – STAT Study” will be an oral presentation “Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM)with Technosphere Inhaled Insulin (TI) Compared with Aspart in T1D Patients – STAT Study” will be presented during the scientific poster session Additionally Kendalls' hypoglycemia poster session. Any chance we steal the show? clinicaltrials.gov/ct2/show/NCT03143816
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Post by mannmade on Jun 5, 2018 14:26:11 GMT -5
Let’s not forget for whatever reason, Dr. K said he does not think any additional studies are needed right now. So he must feel he has the research information and results to back his stmt that AFREZZA will become the soc.
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Post by dreamboatcruise on Jun 5, 2018 14:32:40 GMT -5
I am more excited by STAT rather than a reworking of the hypo data. peppy... no, MNKD has not had a trial with CGM in the past. It has already been presented that Afrezza achieved statistically significant reduction in total hypos, with slightly worse but deemed non inferior A1c. Severe hypos were less but deemed not statistically significant because of small study size and thus very infrequent severe hypos in either arm. If they are simply reworking this data, I don't think it will be considered a show stopper. But I'm holding off judgement, as I really don't know what they have up their sleeve.
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Post by peppy on Jun 5, 2018 14:36:47 GMT -5
I am more excited by STAT rather than a reworking of the hypo data. peppy ... no, MNKD has not had a trial with CGM in the past.It has already been presented that Afrezza achieved statistically significant reduction in total hypos, with slightly worse but deemed non inferior A1c. Severe hypos were less but deemed not statistically significant because of small study size and thus very infrequent severe hypos in either arm. If they are simply reworking this data, I don't think it will be considered a show stopper. But I'm holding off judgement, as I really don't know what they have up their sleeve. To clarify, has ANY insulin trial used CGM to date dream? Is this the first trial ever looking at insulins and comparing them using continuous glucose monitors, dream? Geez louise.
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Post by peppy on Jun 5, 2018 14:39:57 GMT -5
This was an interesting look at studies/statistics. H Gilbert Welch - The Two Most Misleading Numbers in Medicine
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Post by dreamboatcruise on Jun 5, 2018 14:48:51 GMT -5
I am more excited by STAT rather than a reworking of the hypo data. peppy ... no, MNKD has not had a trial with CGM in the past.It has already been presented that Afrezza achieved statistically significant reduction in total hypos, with slightly worse but deemed non inferior A1c. Severe hypos were less but deemed not statistically significant because of small study size and thus very infrequent severe hypos in either arm. If they are simply reworking this data, I don't think it will be considered a show stopper. But I'm holding off judgement, as I really don't know what they have up their sleeve. To clarify, has ANY insulin trial used CGM to date dream? Is this the first trial ever looking at insulins and comparing them using continuous glucose monitors, dream? Geez louise. Lizards have very tiny brains I assume Dexcom had to do trials to get approved to be used for dosing, comparing an arm using finger stick to an arm using CGM. I know I remember some trial that made use of blinded CGM. I did quick google and turned up these articles. www.ncbi.nlm.nih.gov/pmc/articles/PMC3192633/www.ncbi.nlm.nih.gov/pmc/articles/PMC5038541/
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Post by tomson1355 on Jun 5, 2018 14:50:50 GMT -5
Aged, are you saying that Afrezza results in higher (worse) A1Cs than "injectable" insulins? If so where did you get that from? The Phase 3 trial for Type 1 diabetics, aka the 171 trial ( link). From the Mannkind press release for the trial: Over the 24-week treatment period of this study, A1c levels decreased comparably in the AFREZZA-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The reduction from Afrezza is virtually half the reduction from Novolog. The difference between lowering A1c by 0.21% and by 0.40% is negligible, which is why MNKD called them comparable. It's as if a 7.00 A1c was reduced to 6.985 and 6.972, respectively. It negates the argument that the reduced hypos were a result of a higher A1c, because the A1c was not meaningfully higher.
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Post by mango on Jun 5, 2018 15:57:47 GMT -5
The Phase 3 trial for Type 1 diabetics, aka the 171 trial ( link). From the Mannkind press release for the trial: Over the 24-week treatment period of this study, A1c levels decreased comparably in the AFREZZA-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The reduction from Afrezza is virtually half the reduction from Novolog. The difference between lowering A1c by 0.21% and by 0.40% is negligible, which is why MNKD called them comparable. It's as if a 7.00 A1c was reduced to 6.985 and 6.972, respectively. It negates the argument that the reduced hypos were a result of a higher A1c, because the A1c was not meaningfully higher. Aspart had a lower HbA1c because aspart group had frequent hypoglycemic events. Hypoglycemia dramatically effects HbA1c.
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Post by agedhippie on Jun 5, 2018 16:39:42 GMT -5
The Phase 3 trial for Type 1 diabetics, aka the 171 trial ( link). From the Mannkind press release for the trial: Over the 24-week treatment period of this study, A1c levels decreased comparably in the AFREZZA-Gen2 group (-0.21%) and the insulin aspart group (-0.40%). The reduction from Afrezza is virtually half the reduction from Novolog. The difference between lowering A1c by 0.21% and by 0.40% is negligible, which is why MNKD called them comparable. It's as if a 7.00 A1c was reduced to 6.985 and 6.972, respectively. It negates the argument that the reduced hypos were a result of a higher A1c, because the A1c was not meaningfully higher. Umm, no It is the difference between a 7.00 A1c being reduced to 6.79 and 6.60 respectively (it's not quite that simple since they started at a higher HbA1c of around 7.9%). It's an easy mistake, but those are HbA1c values and in absolute terms as you are thinking of it would be 2.6% and 5.0% respectively - making Novolog almost twice as effective.
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Post by brotherm1 on Jun 5, 2018 16:51:58 GMT -5
So .21% and .40% do not equal .0021 and .0040 ? Just axin
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Post by peppy on Jun 5, 2018 16:59:11 GMT -5
The difference between lowering A1c by 0.21% and by 0.40% is negligible, which is why MNKD called them comparable. It's as if a 7.00 A1c was reduced to 6.985 and 6.972, respectively. It negates the argument that the reduced hypos were a result of a higher A1c, because the A1c was not meaningfully higher. Umm, no It is the difference between a 7.00 A1c being reduced to 6.79 and 6.60 respectively (it's not quite that simple since they started at a higher HbA1c of around 7.9%). It's an easy mistake, but those are HbA1c values and in absolute terms as you are thinking of it would be 2.6% and 5.0% respectively - making Novolog almost twice as effective. Absolute terms, the terms prior to the %. Absolute terms show the numerator and denominator. SHOW YOUR WORK>www.youtube.com/watch?v=rcHQElKhWFcH Gilbert Welch - The Two Most Misleading Numbers in Medicine Love you.
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Post by MnkdWASmyRtrmntPlan on Jun 5, 2018 17:44:19 GMT -5
Good work, Mango!
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Post by peppy on Jun 5, 2018 18:15:56 GMT -5
To clarify, has ANY insulin trial used CGM to date dream? Is this the first trial ever looking at insulins and comparing them using continuous glucose monitors, dream? Geez louise. Lizards have very tiny brains I assume Dexcom had to do trials to get approved to be used for dosing, comparing an arm using finger stick to an arm using CGM. I know I remember some trial that made use of blinded CGM. I did quick google and turned up these articles. www.ncbi.nlm.nih.gov/pmc/articles/PMC3192633/www.ncbi.nlm.nih.gov/pmc/articles/PMC5038541/Thank you dream boat. Those are studies on continuous glucose monitors and their data accuracy and equipment function. As far as I can tell, This is the first clinical trial comparing/contrasting the action of insulins as read on a continuous glucose monitors. This is pretty big I think. "I'm going to be in pictures, I'm going to be a star."
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Post by agedhippie on Jun 5, 2018 18:16:26 GMT -5
Umm, no It is the difference between a 7.00 A1c being reduced to 6.79 and 6.60 respectively (it's not quite that simple since they started at a higher HbA1c of around 7.9%). It's an easy mistake, but those are HbA1c values and in absolute terms as you are thinking of it would be 2.6% and 5.0% respectively - making Novolog almost twice as effective. Absolute terms, the terms prior to the %. Absolute terms show the numerator and denominator. SHOW YOUR WORK>www.youtube.com/watch?v=rcHQElKhWFcH Gilbert Welch - The Two Most Misleading Numbers in Medicine Love you. Here you go The starting HbA1c is 7.98% for Afrezza and 7.88% for Novolog. Over the 24 weeks of the trial the Afrezza HbA1c dropped by 0.21% to 7.77% and the Novolog dropped by 0.40% to 7.48%. That make 0.21/7.98 = 0.0263 or 2.63% drop vs. 0.40/7.88 = 0.0508 or 5.08%. The confusion is because HbA1c is measured in percentage of Hb so everything is measured in percentages, both the HbA1c change, and the amount of change.
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Post by peppy on Jun 5, 2018 18:18:05 GMT -5
Absolute terms, the terms prior to the %. Absolute terms show the numerator and denominator. SHOW YOUR WORK>www.youtube.com/watch?v=rcHQElKhWFcH Gilbert Welch - The Two Most Misleading Numbers in Medicine Love you. Here you go The starting HbA1c is 7.98% for Afrezza and 7.88% for Novolog. Over the 24 weeks of the trial the Afrezza HbA1c dropped by 0.21% to 7.77% and the Novolog dropped by 0.40% to 7.48%. That make 0.21/7.98 = 0.0263 or 2.63% drop vs. 0.40/7.88 = 0.0508 or 5.08%. The confusion is because HbA1c is measured in percentage of Hb so everything is measured in percentages, both the HbA1c change, and the amount of change. good work. Afrezza. 7.98% - 7.77% = .21 Hba1c which is measured in %. Novolog 7.88% - 7.48% = .40 hbA1c which is measured in %. That is the absolute change aged. statistics, mathematics whatever is applied, the % above is the absolute change. so .21 % of 7.98% = 2.63% is what you are calculating. and .40% of a smaller number 7.88% = 5.08%. These calculations are made to baffle. let's see what the absolute change is this go around over 4 weeks.
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