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Post by peppy on Apr 22, 2016 8:18:58 GMT -5
Why isn't anyone worried about "Terminated upon recommendation of the Data Safety Monitoring Board (DSMB)" Doesn't that suggest something showed up that suggested a danger to participants? Here is what the DSMB does - grants.nih.gov/grants/guide/notice-files/not98-084.html"It is the policy of the NIH that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or þconducted clinical trials. . . ." additionally, I am twisted. consider, COPD Chronic OBSTRUCTIVE Pulmonary Dis ease.
who is to say the proteins in Insulin and technosphere insulin Afrezza isn't cutting the tar/obstruction. images.rxlist.com/images/rxlist/novolog1.gif
Additionally we know the ph of technosphere insulin is 7. likes cut likes. Pep
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Post by tchalaa on Apr 22, 2016 8:33:49 GMT -5
While I think a label change would certainly help, I don't think I can agree with a change "sooner rather than later". This was an extremely small study, just 34 patients across four different arms, so an average of just 8.5 subjects per arm. That makes for some very weak statistical power and as a matter of pure mathematics the study cannot meet the FDA's criteria for a label change; that will take a much larger study. Note that the study was originally designed in 2008 and just terminated (for undisclosed reasons) in 2016. Nothing happens fast in pharma, especially when rolling back a safety measure is concerned. You might be right, from a patient's statistic point of view, but on the fact that the study went on for more than 7 years in different area i have some reserve. During a study when 1% of the enrolled population is affected it is scary, but here no information or confirmation COPD reaction since 7 years, why? Can you provide some insight here. thx |
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Post by sweedee79 on Apr 22, 2016 10:20:22 GMT -5
there needs to be label changes on the dosing... The insert says Afrezza is the same dose for dose. I don't believe that it is. That may be a good starting point, but in our experience and what Ive heard from others is that Afrezza often requires a larger dose. Also, with Afrezza you can be a bit more free because of less risk of hypo .. Docs are very conservative right now.. And Afrezza promotes weight loss .. all of these things are important to the label change as far as marketing goes..
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Post by end2war on Apr 22, 2016 15:14:51 GMT -5
Will someone please correct me if I am wrong, but didn't MNKD management tell us that they had good results to report from some follow up clinical trial studies that have been completed? Doesn't this mean that MNKD thinks they will get a label improvement of some kind?
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Post by agedhippie on Apr 22, 2016 15:18:53 GMT -5
there needs to be label changes on the dosing... The insert says Afrezza is the same dose for dose. I don't believe that it is. That may be a good starting point, but in our experience and what Ive heard from others is that Afrezza often requires a larger dose. Also, with Afrezza you can be a bit more free because of less risk of hypo .. Docs are very conservative right now.. And Afrezza promotes weight loss .. all of these things are important to the label change as far as marketing goes.. I don't think the dosing label change is a big deal since patients need to titrated their dose to the correct value anyway according to their level of insulin resistance. Lantus is a good example as that never works correctly out of the box! |
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Post by dreamboatcruise on Apr 22, 2016 15:21:22 GMT -5
Will someone please correct me if I am wrong, but didn't MNKD management tell us that they had good results to report from some follow up clinical trial studies that have been completed? Doesn't this mean that MNKD thinks they will get a label improvement of some kind? One of the clamp studies had some wording in its description saying that it may be relevant to ketoacidosis warning on label. IMHO, that is not major issue one way or another. I will be surprised if there is anything else that comes from the clamp studies... very pleasantly surprised. |
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Post by agedhippie on Apr 22, 2016 15:24:17 GMT -5
Will someone please correct me if I am wrong, but didn't MNKD management tell us that they had good results to report from some follow up clinical trial studies that have been completed? Doesn't this mean that MNKD thinks they will get a label improvement of some kind? Good results do not mean a label change if it's a small trial although we might see the DKA label modified.. The only two trials I see out there that could get a label change are the pediatric trial, and the long term lung trial. Everything else is small scale which provides good direction for designing bigger trials but not much else. |
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Post by sportsrancho on Apr 22, 2016 15:38:13 GMT -5
there needs to be label changes on the dosing... The insert says Afrezza is the same dose for dose. I don't believe that it is. That may be a good starting point, but in our experience and what Ive heard from others is that Afrezza often requires a larger dose. Also, with Afrezza you can be a bit more free because of less risk of hypo .. Docs are very conservative right now.. And Afrezza promotes weight loss .. all of these things are important to the label change as far as marketing goes.. I don't think the dosing label change is a big deal since patients need to titrated their dose to the correct value anyway according to their level of insulin resistance. Lantus is a good example as that never works correctly out of the box! The problem is the doctors don't seem to know that. And don't want to increase the dose. I think it should be changed also. It's way off. IMO |
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Post by sweedee79 on Apr 22, 2016 16:53:43 GMT -5
there needs to be label changes on the dosing... The insert says Afrezza is the same dose for dose. I don't believe that it is. That may be a good starting point, but in our experience and what Ive heard from others is that Afrezza often requires a larger dose. Also, with Afrezza you can be a bit more free because of less risk of hypo .. Docs are very conservative right now.. And Afrezza promotes weight loss .. all of these things are important to the label change as far as marketing goes.. I don't think the dosing label change is a big deal since patients need to titrated their dose to the correct value anyway according to their level of insulin resistance. Lantus is a good example as that never works correctly out of the box! The dosing was an issue for my dad when he switched from Novolog to Afrezza .. the docs didn't know what they were doing.. They started him on the same dose as Novolog .. 12 units .. it was apparent he needed larger doses but they wouldn't raise it .. so he was having to barely eat. we had to go and argue to get his dose raised.. then they would only raise the morning one. It was terrible.
Also, when on injectable insulin they give the smallest dose possible and make people have to watch everything they eat(standard of care) .. On Afrezza they can give larger doses without as much risk of hypo.. docs don't know this.. so yeah I think dosing is an issue. It was for us because the insert says the same dose for dose.. and also, they aren't too willing to go higher because they are fearful of hypo especially in older patients... and also weight gain. Again. its the current standard of care. My dad isn't that great at following rules, so they are especially ridged with him.
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Post by factspls88 on Apr 22, 2016 17:51:17 GMT -5
Why isn't anyone worried about "Terminated upon recommendation of the Data Safety Monitoring Board (DSMB)" Doesn't that suggest something showed up that suggested a danger to participants? Here is what the DSMB does - grants.nih.gov/grants/guide/notice-files/not98-084.html"It is the policy of the NIH that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or þconducted clinical trials. . . ." That was my first reaction, especially since it was done with subjects with Moderate Obstructive Pulmonary Disease. I could be wrong but I wouldn't start breaking out the champagne with this one. |
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Post by peppy on Apr 22, 2016 18:36:12 GMT -5
Why isn't anyone worried about "Terminated upon recommendation of the Data Safety Monitoring Board (DSMB)" Doesn't that suggest something showed up that suggested a danger to participants? Here is what the DSMB does - grants.nih.gov/grants/guide/notice-files/not98-084.html"It is the policy of the NIH that each Institute and Center (IC) should have a system for the appropriate oversight and monitoring of the conduct of clinical trials to ensure the safety of participants and the validity and integrity of the data for all NIH-supported or þconducted clinical trials. . . ." Sponsor:
Sanofi
Collaborator:
Mannkind Corporation
Information provided by (Responsible Party):
Sanofi Enrollment: 34
Study Start Date: March 2009
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00642616 History of Changes
Other Study ID Numbers: MKC-TI-134
Study First Received: March 21, 2008
Results First Received: November 23, 2015
Last Updated: February 12, 2016
Health Authority: United States: Food and Drug Administration
My take is a bunch of nervous nelly's on this board.
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Post by agedhippie on Apr 22, 2016 20:37:34 GMT -5
If you look at the Results tab there were severe adverse events for two of the nine asthmatics (22.22%) and none for the usual care asthmatics, that might be the reason. Difficult to say if that was it though.
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Post by lakon on May 3, 2016 13:57:01 GMT -5
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