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Post by Deleted on May 9, 2017 9:55:07 GMT -5
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Post by dreamboatcruise on May 9, 2017 12:51:05 GMT -5
slapshot to make a comparative study both medications have to be administered at the same time, hence the possible need for corrections. I wouldn't think that is necessary. It could be a comparison of one drug with the best known dosing protocol for it compared to another drug with the best known dosing protocol for that one. Perhaps there were forces that argued against that within the FDA for our original trials, but there is no reason why that isn't a useful and scientifically valid way of devising a study. It makes it a little more complicated for the trial participants if it is double blinded as they need to dose two things at different times. But this trial isn't double blind (I believe, haven't read it in detail, but if it involves follow on doses I don't think it could be double blind).
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Post by peppy on May 9, 2017 12:56:33 GMT -5
slapshot to make a comparative study both medications have to be administered at the same time, hence the possible need for corrections. I wouldn't think that is necessary. It could be a comparison of one drug with the best known dosing protocol for it compared to another drug with the best known dosing protocol for that one. Perhaps there were forces that argued against that within the FDA for our original trials, but there is no reason why that isn't a useful and scientifically valid way of devising a study. It makes it a little more complicated for the trial participants if it is double blinded as they need to dose two things at different times. But this trial isn't double blind (I believe, haven't read it in detail, but if it involves follow on doses I don't think it could be double blind). Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment Official Title: Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study
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Post by zomzom00 on May 9, 2017 13:22:28 GMT -5
"•Change in HbA1c in one-month treatment [ Time Frame: 4 weeks ]"
That's not long enough to reflect the true benefit but will indicate trend.
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Post by zuegirdor on May 9, 2017 13:42:08 GMT -5
Not to throw a wrench in the study, but i thought a major problem with the nda clinical trial was the timing of the dosing, particularly that it (before the meal) was too soon? "Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B)" Yes, to compare to the 1st arm of the trial, as both arms dose before meals: "Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals." I think they had no choice. Perhaps they had no choice, perhaps because the method of administration must be the same for both which is the same as the protocol for the FDA trials. There should be two more arms for a "fair trial". Should have requested an arm that follows the recommended "10 minutes after eating" for both Afrezza and injected. We know how that would turn out and it SHOULD BE PUBLICIZED. Of course the suppliers of the injected would say that is not the correct protocol. Tough cookies. Dosing Afrezza any earlier than the first bite of food may cause users with a starting blood sugar around 80 to go low. That is not a fair trial protocol. Freakin' BOZOS!
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Post by compound26 on May 9, 2017 14:13:10 GMT -5
Yes, to compare to the 1st arm of the trial, as both arms dose before meals: "Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals." I think they had no choice. Perhaps they had no choice, perhaps because the method of administration must be the same for both which is the same as the protocol for the FDA trials. There should be two more arms for a "fair trial". Should have requested an arm that follows the recommended "10 minutes after eating" for both Afrezza and injected. We know how that would turn out and it SHOULD BE PUBLICIZED. Of course the suppliers of the injected would say that is not the correct protocol. Tough cookies. Dosing Afrezza any earlier than the first bite of food may cause users with a starting blood sugar around 80 to go low. That is not a fair trial protocol. Freakin' BOZOS! I guess if Afrezza is dosed right before meal (not 10 or 15 minutes before meal) and then any correction dose is administered relatively early (like whenever the BG level hits 120 and is rising), the result should be OK. Seems like Anthony Hightower is using this method of dosing and he has an A1C of 4.7/4.8 to back it up. $MNKD Prior 2 Titration Pack, My Doc ONLY Knew 90 units of 4, 8 &/or 12 Mixed, all B4 MEALS! Now ADD 90 More Units 4 AFTER MEALS! HOME RUN! View Message: stocktwits.com/message/79045530 Sent by Rick H (@rckhrrr) at Apr. 14 at 3:32 PM @livingandlearning @schtik 23/24 Days! I Inhale Before & After Meals & More If Needed For Bigger Meals! View Message: stocktwits.com/message/80262679 Sent by Rick H (@rckhrrr) at Apr. 2 at 1:03 PM @livingandlearning Anthony is the one who showed me the importance of Not Just Before Meals, But After as Well! 👍😍 View Message: stocktwits.com/message/79049813
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Post by Deleted on May 9, 2017 14:45:54 GMT -5
slapshot to make a comparative study both medications have to be administered at the same time, hence the possible need for corrections. I wouldn't think that is necessary. It could be a comparison of one drug with the best known dosing protocol for it compared to another drug with the best known dosing protocol for that one. Perhaps there were forces that argued against that within the FDA for our original trials, but there is no reason why that isn't a useful and scientifically valid way of devising a study. It makes it a little more complicated for the trial participants if it is double blinded as they need to dose two things at different times. But this trial isn't double blind (I believe, haven't read it in detail, but if it involves follow on doses I don't think it could be double blind). In any experiment, all variables are kept the same except for one;in this case it would be the different medications. If time was varied it would add a second variable not allowing for comparisons between medications.
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Post by me on May 9, 2017 14:55:41 GMT -5
I wouldn't think that is necessary. It could be a comparison of one drug with the best known dosing protocol for it compared to another drug with the best known dosing protocol for that one. Perhaps there were forces that argued against that within the FDA for our original trials, but there is no reason why that isn't a useful and scientifically valid way of devising a study. It makes it a little more complicated for the trial participants if it is double blinded as they need to dose two things at different times. But this trial isn't double blind (I believe, haven't read it in detail, but if it involves follow on doses I don't think it could be double blind). In any experiment, all variables are kept the same except for one;in this case it would be the different medications. If time was varied it would add a second variable not allowing for comparisons between medications. By this same reasoning, there is already a second variable - inhalation versus injection. Using the medication's dosing protocol should not create a second variable.
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Post by Deleted on May 9, 2017 15:02:02 GMT -5
me I disagree. We will know for sure tomorrow.
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Post by ssiegel on May 9, 2017 16:50:57 GMT -5
I don't like a few things. They take diabetics who have been on whatever regimen they've been using and divide them into two groups. The one group simply continues its old regimen. The new group starts on afrezza.
One problem is the study is only 4 weeks long. One might expect the afrezza group to require a "learning curve" in order to grasp the most effective use. It's not clear how long that might be. In other words, the comparator group starts with an advantage since they are well skilled in managing the illness using their "old regimen."
Another, much bigger problem, is that, as I see it, the study really can only prove what is already known: tight control -- frequent monitoring or a CGM plus more frequent dosing -- results in better PPBG, PPGE, and time-in-range.
One would presume MNKD would like to demonstrate superiority to lispro. To do that they would need to make the comparator group do the same things as the afrezza group -- test 1 and 2 hours post-meals, adjust dosage accordingly, etc.
I see more risk than reward from the final results.
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Post by peppy on May 9, 2017 17:41:57 GMT -5
I don't like a few things. They take diabetics who have been on whatever regimen they've been using and divide them into two groups. The one group simply continues its old regimen. The new group starts on afrezza. One problem is the study is only 4 weeks long. One might expect the afrezza group to require a "learning curve" in order to grasp the most effective use. It's not clear how long that might be. In other words, the comparator group starts with an advantage since they are well skilled in managing the illness using their "old regimen." Another, much bigger problem, is that, as I see it, the study really can only prove what is already known: tight control -- frequent monitoring or a CGM plus more frequent dosing -- results in better PPBG, PPGE, and time-in-range. One would presume MNKD would like to demonstrate superiority to lispro. To do that they would need to make the comparator group do the same things as the afrezza group -- test 1 and 2 hours post-meals, adjust dosage accordingly, etc. I see more risk than reward from the final results. The learning curve is helped by the continuous glucose monitors. Plus they get correction doses. These people have probably been type one with a continuous glucose monitor for a while. They will be quick studies.
Laura K at the 28 min mark. www.facebook.com/bonniesingslena/videos/vb.298479940320027/786417348192948/?type=2&theater "I tell people it's like magic." "I know some people on the drug and they really like it." "If you have a forward thinking endo,"
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Post by cedafuntennis on May 9, 2017 18:03:39 GMT -5
Wrong. "Medication" includes the delivery method so that is not a second variable. You cannot inject Afrezza so that is not a variable but it is included with the Medication variable itself.
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Post by sayhey24 on May 9, 2017 18:56:42 GMT -5
Saw this posted on ST. New clinical trial: This is an investigator-initiated, prospective, randomized, multicenter, parallel, open-label, pilot clinical trial evaluating the efficacy of TI for PPBG, PPGE, and time-in-range on CGM download in patients with T1D. TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. This is a pilot, real-life study where patients will continue their routine diabetes care and use post-meal correction dosages as deemed necessary for normalizing PPBG as per the protocol. This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit. All patients will use real-time CGM (Dexcom G5®, San Diego, CA), which will be provided at the randomization visit for their day-to-day diabetes care. CGM data will be downloaded at every clinic visit on a secured computer. The data will be analyzed after the study for different primary and secondary end points. All patients will be allowed to keep the CGM after the study is over for their day-to-day diabetes care. clinicaltrials.gov/ct2/show/NCT03143816?term=afrezza&rcv_s=05%2F01%2F2017&rank=4Estimated Enrollment: 60 Anticipated Study Start Date: June 15, 2017 Estimated Study Completion Date: October 15, 2017 Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure) This is a pilot, real-life study. Someone should call the University of Colorado Denver School of Medicine Barbara Davis Center and suggest they dose about 10 minutes after starting eating and to make sure they know 4u - the small is closer to 3u of RAA and to have the TI always go to the bigger size if they can't decide. They copied the dosing right from 171. Whats this pilot for??? Setting up a long study? What are we going to find out at the end of these studies when it comes to A1c? Do we really need more of these studies - if on average we take the same amount of insulin or RAA over the long term we will get the same A1c. We don't need more studies to know this. I like to think of A1c in automotive terms as "Average Miles per gallon". For years diabetics have been driving a car with a gas gauge and an odometer and NO speedometer. Now with CGMs they have speedometers and can tell how fast they are driving and when they are driving fast. Shouldn't all these new studies be at time in range? We need to know what our BG is and when it is out of range and how fast we can knock it down. If I am driving a Porsche I think am more worried about how fast I can go not how much gas am I using.
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Post by radgray68 on May 9, 2017 19:42:32 GMT -5
Finally! The world will get to see what Afrezza can do all alone. For me, the greatest flaw with prior trial designs, aside from the timing of the dose, was including patients who also took one or two other oral medications. That added a certainty of getting the same average number of hypos as the other medications. On Afrezza alone, "You have to be trying to get a hypo"
I would like to see a longer trial to include real lowering of average A1c's but it would definitely be more costly. It may not be needed if we can show superiority in what has become the industry's most recent objective, Time In Range. I even heard time in range mentioned the other night on a T.V. ad for a competing medication.(I forget which, there are so many on t.v. these days)
Now, how many hours before AF or the SA goons put out a headline like "60 is not large enough sample", "too little too late", "They still need cash" etc. etc. etc.?
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Post by mnholdem on May 9, 2017 20:42:28 GMT -5
TI is an inhaled ultra-rapid-acting insulin, approved by the FDA. Mnkd must have anticipated the URA label approved before the above study starts. Anticipated Study Start Date: June 15, 2017 Can that the classification "ultra-rapid-acting insulin" even be used without the FDA's approval?
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