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Post by harryx1 on May 14, 2015 15:31:14 GMT -5
Late Breaking Abstracts submitted to the AACE: am.aace.com/sites/all/files/Late-Breaking.pdfPage 12 Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk |
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Post by compound26 on May 14, 2015 15:36:51 GMT -5
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Post by s4cure on May 14, 2015 15:49:00 GMT -5
Late Breaking Abstracts submitted to the AACE: am.aace.com/sites/all/files/Late-Breaking.pdfPage 12 Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk Wonderful! You always find great information! |
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Post by newmnkdinvestor on May 14, 2015 17:16:44 GMT -5
Wow this makes me feel bettter
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Post by jpg on May 14, 2015 18:09:24 GMT -5
Late Breaking Abstracts submitted to the AACE: am.aace.com/sites/all/files/Late-Breaking.pdfPage 12 Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk Amazing stuff. This would deserve it's own tread. I obviously haven't seen the study but this is a very big deal. The first thing this does is give reason and an obligation for endos to acknowledge and think of Afrezza. It is now an obligation of competence to take Afrezza seriously. Again this is big. The second consequence is that it gives license or a reason for those who wanted to try it but didn't. Now there is a justification. Third it shows Mannkind and Sanofi know what they are doing. This is, as those who have followed my musings, is exactly what I was expecting and hoping (praying) for (but thinking ADA. This is even better! I might actually buy a few shares tomorrow... |
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Post by Deleted on May 14, 2015 18:33:50 GMT -5
Late Breaking Abstracts submitted to the AACE: am.aace.com/sites/all/files/Late-Breaking.pdfPage 12 Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk Amazing stuff. This would deserve it's own tread. I obviously haven't seen the study but this is a very big deal. The first thing this does is give reason and an obligation for endos to acknowledge and think of Afrezza. It is now an obligation of competence to take Afrezza seriously. Again this is big. The second consequence is that it gives license or a reason for those who wanted to try it but didn't. Now there is a justification. Third it shows Mannkind and Sanofi know what they are doing. This is, as those who have followed my musings, is exactly what I was expecting and hoping (praying) for (but thinking ADA. This is even better! I might actually buy a few shares tomorrow... Im curious your thoughts on the study abstract itself. If you read the data, it suggests that it blows the competition away in terms of much less occasions of hypoglycemia, but the conclusion is worded at best, weak. Can they for some reason not say this? Other questions: When was this conducted? tripoley or someone commented that it may just be the data from the 171 study rehashed? Is this the type of data that SNY is presenting for label expansion without conducing new trials? |
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Post by compound26 on May 14, 2015 18:35:23 GMT -5
Late Breaking Abstracts submitted to the AACE: am.aace.com/sites/all/files/Late-Breaking.pdfPage 12 Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk Amazing stuff. This would deserve it's own tread. I obviously haven't seen the study but this is a very big deal. The first thing this does is give reason and an obligation for endos to acknowledge and think of Afrezza. It is now an obligation of competence to take Afrezza seriously. Again this is big. The second consequence is that it gives license or a reason for those who wanted to try it but didn't. Now there is a justification. Third it shows Mannkind and Sanofi know what they are doing. This is, as those who have followed my musings, is exactly what I was expecting and hoping (praying) for (but thinking ADA. This is even better! I might actually buy a few shares tomorrow... JPG, totally agree with your analysis above. It's 39 weeks from the time (August 11, 2014) when Mannkind and Sanofi announced their partnership. If this report results from a study that just finished (or finished a few weeks ago),which appears to be the case, that means this is a Phase III study on Afrezza sponsored by Sanofi. If that is the case, then that will be a strong piece of evidence of Sanofi's long-term commitment to the Mannkind and Sanofi partnership and to Afrezza. It will be a slap on the face to the shorts who have been claiming that Sanofi will drop Afrezza prematurely or that Sanofi is dragging its feet (making no efforts) to promote Afrezza. |
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Post by compound26 on May 14, 2015 18:52:23 GMT -5
jpg Im curious your thoughts on the study abstract itself. If you read the data, it suggests that it blows the competition away in terms of much less occasions of hypoglycemia, but the conclusion is worded at best, weak. Can they for some reason not say this? Other questions: When was this conducted? tripoley or someone commented that it may just be the data from the 171 study rehashed? Is this the type of data that SNY is presenting for label expansion without conducing new trials? It probably is using the data from the 171 study. The abstract refers to study ID# NCT01445951, which points to the 171 study. clinicaltrials.gov/ct2/show/study/NCT01445951 |
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Post by jpg on May 14, 2015 20:14:09 GMT -5
If it refers to 171 as you seem to have demonstrated then that wouldn't be ad big a deal and would explain the weak wording for a conclusion.
I would certainly walk back my enthusiasm if this proves to be true (and apologize for getting anyone excited: there is only so much research you can do with a phone...)
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Post by jpg on May 14, 2015 20:41:21 GMT -5
Read the 'original abstract' and it's a retrospective reanalysis of old data. Not what I was hoping for. I should have read the source before posting. And yes the conclusion was a give away... Doing to many things at once.
171 was in no way set up to get that kind of answer and this will get few executed. I was hoping they would come up with a trial but I guess we won't be seeing that anytime soon... I was hoping they had run a small pilot trial and had surprisingly good results (but it wasn't registered which makes little sense I know!).
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Post by doubleo7 on May 15, 2015 1:46:55 GMT -5
Abstract #1220 REDUCED HYPOGLYCEMIA IS OBSERVED WITH INHALED INSULIN VERSUS SUBCUTANEOUS INSULIN ASPART IN PATIENTS (PTS) WITH TYPE 1 DIABETES MELLITUS (T1DM) Lawrence Blonde, MD1, Jasvinder Gill2, Elena Nikonova2, John Stewart3, Bruce Bode4 1. Ochsner Medical Center, 2. Sanofi US, Inc., 3. Sanofi Canada, 4. Atlanta Diabetes Associates Objective: Conduct a post hoc analysis of hypoglycemia rates from a 24-week, phase 3 randomized study of prandial Technosphere Insulin Inhalation Powder (TI; N=172) versus insulin aspart (IA; N=167) added to basal insulin in pts with T1DM (NCT01445951). Methods: Annualized hypoglycemia event rates were determined in the overall study population, pts taking ≥1 postmeal supplemental dose (TI n=111; IA n=91), and pts not taking a supplemental dose (TI n=61; IA n=76). Hypoglycemia rates during study weeks 0-12 (dose adjustment) and 12-24 (stable dosing) were assessed. Hypoglycemia was defined as total (all events), confirmed (blood glucose <49 mg/dL), nocturnal (0:00−6:00 AM), and severe (assistance required). Data were adjusted for baseline A1C level. Results: There was no significant difference in the mean number of supplemental doses taken between the TI and IA arms (34.1 vs 26.6, respectively; P=0.1907). Significantly higher hypoglycemia rates (events per pt/year) were seen for IA versus TI in the overall population (total 81.1 vs 55.2; confirmed 15.0 vs 9.0; nocturnal 8.8 vs 5.9; severe 0.9 vs 0.5; all P<0.05) and pts taking ≥1 supplemental dose (total 96.3 vs 60.9; confirmed 18.6 vs 9.8; nocturnal 11.5 vs 6.5; and severe 1.1 vs 0.6; all P<0.05). In pts not taking a supplemental dose, a significantly higher total hypoglycemia rate was seen with IA versus TI (64.9 vs 46.0 events per pt/year; P=0.0160). Within each arm there was a trend for higher total hypoglycemia rates ≥1 hour after supplemental dosing (events per pt/year) in pts with a higher supplemental dose frequency (TI vs IA: 0.4 vs 0.4; 1.7 vs 2.2; 4.9 vs 6.6 for pts receiving 1-5, 6-20, and 21-60 supplemental doses during the study); there was no significant difference between the TI and IA arms. In the overall study population, within both treatments arms there was a trend for a higher rate of all types of hypoglycemia during weeks 0-12 (titration) versus 12-24 (stable dosing). In pts taking a supplemental dose, a similar trend was seen in the IA arm only. In pts not taking a supplemental dose, there was a trend for higher total, confirmed, and nocturnal hypoglycemia rates during weeks 0-12 versus 12-24 for IA; and total, confirmed, and severe hypoglycemia for TI. Discussion: These data show that the more rapid onset and offset of action with TI versus IA was not associated with greater supplemental dosing. There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing. Conclusion: These data show that supplemental TI dosing does not result in an increased hypoglycemia risk.
Late Breaking Abstracts submitted to the AACE:
am.aace.com/sites/all/files/Late-Breaking.pdf
Page 12
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Post by doubleo7 on May 15, 2015 6:15:36 GMT -5
Late abstract for AACE.com #Afrezza = significantly fewer hypos than injected insulin. am.aace.com/sites/all/files/Late-Breaking.pdf … Search "inhaled" Abstract for the 24th Annual Scientific and Clinical Congress happening right now in nashville Aace are the clinical endo guys .. Just to put things in perspective... |
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Post by Deleted on May 15, 2015 7:20:46 GMT -5
Harry beat you to it in another thread.
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Post by harryx1 on May 15, 2015 7:25:47 GMT -5
Read the 'original abstract' and it's a retrospective reanalysis of old data. Not what I was hoping for. I should have read the source before posting. And yes the conclusion was a give away... Doing to many things at once. 171 was in no way set up to get that kind of answer and this will get few executed. I was hoping they would come up with a trial but I guess we won't be seeing that anytime soon... I was hoping they had run a small pilot trial and had surprisingly good results (but it wasn't registered which makes little sense I know!). I agree with you jpg and not as excited as when I posted however I believe it's still good news because Sanofi US and Sanofi Canada names are on it. Also I'm not sure why it's on the late breaking addition list as the study was completed on Oct 20, 2014. Unless they just decided at the last minute to submit it to the conference. As fugacity stated the conclusion is weak however the data seems strong compared to the competitors. "There was a consistently lower hypoglycemia rate in pts with T1DM treated with TI versus IA, including those taking supplemental doses, and during dose adjustment and stable dosing." So my question is was the abstract submitted to the conference to help with the potential label change for Hypos? |
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Post by mnholdem on May 15, 2015 7:35:15 GMT -5
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