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Post by BD on Jul 19, 2015 8:34:19 GMT -5
Leave it to smartest folks in the room to make Heart Attacks sound like attending some sort of charity gala. Or a track meet...
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Post by blindhog1 on Jul 19, 2015 10:09:39 GMT -5
Interesting that the Sponsor is Novo and that they are using Afrezza in the trial. Afrezza dosing is prior to each meal. This study has it administered only at dinner. A1c would be lower if the Afrezza is used prior to each meal, the way it's meant to be used. Your reply is interesting on several levels.
Novo isn't using Afrezza in its trial. I am. Don't try to read between the lines or add on your own tidbits to change my post. Stick to what I'm saying. You're beginning to sound like my ex-wife.
SNY is looking to use a combination of Afrezza and Toujeo. There is a reason that should have been made clear to authorities like you. I suggest you read the Dr's manual on dosing. The easiest way to understand the concept is: "If you control the day then you can control the long acting insulin at night and the A1C. Not everyone needs to take Afrezza at every meal."
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Post by Chris-C on Jul 19, 2015 11:04:49 GMT -5
Study title: A trial comparing cardiovascular safety of insulin degludec versus insulin glardine in subjects with T2 diabetes at high risk of cardiovascular events. SPONSOR: Novo Nordisk
Basically this is a substitute for Lantus. I had been taking Lantus for several years. I'm study participant NUMBER 0001. Leave it to smartest folks in the room to make Heart Attacks sound like attending some sort of charity gala. kball: LOL!!! language use (especially in English) can be an amusing facet of science and professional practice. It's almost as though holding any kind of doctorate makes it imperative that words be changed from everyday parlance, and this can lead to some fascinating jargon that appears not to have any logical principles. For example, it always amuses me when the clear, short word "use" is avoided in favor of the term "utilize.That's pretense. On the other hand, sometimes words are changed to remove any subjective nuances, to be more precise, to avoid legal complications or misinterpretations, or as a facet of "branding." To me, it made some sense in medicine to move from using the term "emergency room", to "emergency department", perhaps because specialists in emergency medicine thought it more prestigious to have a department than a room. (What's the implication for reruns of "ER" then, he asked?) Then MVA (motor vehicle accident) morphed into crash or collision, so as not to infer causality in word use, The change was apparently motivated by legal concerns of potential abuse by lawyers who examine incident reports. Alas, "cardiovascular event" is used in lieu of "heart attack", which remains in common parlance. Yet, some medical scientists have seemingly gone back to using the lay term "stroke" in lieu of the term "cerebral vascular accident (CVA). We used to have lunchtime debates about the multiple terms used for the same phenomenon, or the pervasive tendency for scientists to define the same term differently. Sometimes, there is good reason for this, but not always. In positive psychology (the label given to scientists who study what makes people feel good), a movement is well underway to switch from using the pretentious but accurate term "subjective well being" to "happiness". Indeed, there is a thriving and respected scientific journal called "The Journal of Happiness Studies." Go figure. GLTA ChrisC
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Post by od on Jul 19, 2015 11:41:17 GMT -5
Interesting that the Sponsor is Novo and that they are using Afrezza in the trial. Afrezza dosing is prior to each meal. This study has it administered only at dinner. A1c would be lower if the Afrezza is used prior to each meal, the way it's meant to be used. Your reply is interesting on several levels.
Novo isn't using Afrezza in its trial. I am. Don't try to read between the lines or add on your own tidbits to change my post. Stick to what I'm saying. You're beginning to sound like my ex-wife.
SNY is looking to use a combination of Afrezza and Toujeo. There is a reason that should have been made clear to authorities like you. I suggest you read the Dr's manual on dosing. The easiest way to understand the concept is: "If you control the day then you can control the long acting insulin at night and the A1C. Not everyone needs to take Afrezza at every meal."
Am I the only one confused? Is the trial 'allowing' you to use Afrezza and remain a participant?
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Post by liane on Jul 19, 2015 11:42:08 GMT -5
I have to laugh - back in my paramedic days, we were told to strike our use of the abbreviation for "shortness of breath" - "SOB" and instead use "difficulty in breathing" - "DIB". I guess "SOB" was thought to be pejorative by any attorney reading our run reports without understanding the context.
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Post by blindhog1 on Jul 19, 2015 11:57:44 GMT -5
Am I the only one confused? Is the trial 'allowing' you to use Afrezza and remain a participant? YES, now join me when I say: "I was as shocked as anyone!" Understand that Afrezza doesn't change the study drug.
Here's the bottom line. I can always leave the study and return to Lantus. BUT, if this works as expected "The study could take a long breath and put out a position paper on my immediate results. That is something I can live with." I can't lose.
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Post by jpg on Jul 19, 2015 17:22:43 GMT -5
Cardiovascular events does not equal heart attack alone. It includes other cardiovascular complications like strokes.
I haven't looked at the study but there is probably no language in the study that specifies which mealtime insulin should or shouldn't be used. If Afrezza (or switching type of mealtime insulin) is not allowed this would be considered a protocol violation and the data from that patient would be dealt with as such.
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Post by peppy on Jul 19, 2015 18:08:24 GMT -5
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) clinicaltrials.gov/ct2/show/NCT01959529
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Post by blindhog1 on Jul 19, 2015 20:17:18 GMT -5
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) clinicaltrials.gov/ct2/show/NCT01959529Thanks peppy, I know someone in that very study. Do you think they should give Afrezza a try? Just a bunch of old cardiac cripples with diabetes. Do you think anyone will give them static for their stance? Do you think they give a damn what anyone else thinks? Good for them.
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Post by kball on Jul 19, 2015 20:37:01 GMT -5
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) clinicaltrials.gov/ct2/show/NCT01959529 Thanks peppy, I know someone in that very study. Do you think they should give Afrezza a try? Just a bunch of old cardiac cripples with diabetes. Do you think anyone will give them static for their stance? Do you think they give a damn what anyone else thinks? Good for them. Helping you reevaluate what and how much you eat, drink, smoke and exercise brought to you by newcomer blindhog! Thanks for that. And i already don't smoke or drink.
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Post by peppy on Jul 19, 2015 21:33:56 GMT -5
A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) clinicaltrials.gov/ct2/show/NCT01959529Thanks peppy, I know someone in that very study. Do you think they should give Afrezza a try? Just a bunch of old cardiac cripples with diabetes. Do you think anyone will give them static for their stance? Do you think they give a damn what anyone else thinks? Good for them. Hopefully Afrezza will help. Hopefully it will be a good choice for yourself. Regarding hbA1c 7.4 your starting point.
Here is my take. We are all just visiting this place. I hope the old cardiac cripples are having fun while they can.
We are alive.
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Post by 4Balance on Jul 20, 2015 14:57:23 GMT -5
I'm not familiar with the terms "insulin degludec" and "insulin Glardine", so I did some quick research. It looks like degludec is an uptra-long-acting basal (> 24 hours), and glardine is "regular" basal like Lantus and Toujeo. Sources: en.wikipedia.org/wiki/Insulin_degludecen.wikipedia.org/wiki/Insulin_glargineThis might be "old news", but here's a 2012 article on Novolog's "insulin degludec" that also tells us more about the makeup of Novolog. In the Exec Sum: "Novo Nordisk is seeking approval for insulin degludec (IDeg), a basal insulin for once-daily (OD) subcutaneous (s.c.) administration, to improve glycemic control in adults with diabetes mellitus (NDA 203314). IDeg was developed to cover basal insulin needs in patients with diabetes mellitus, either alone or in combination with bolus (mealtime) insulin and/or oral antidiabetic drugs (OADs). Novo Nordisk is also seeking approval for insulin degludec/insulin aspart (IDegAsp), a soluble coformulation of 70% IDeg and 30% of the rapid-acting insulin analogue, insulin aspart (IAsp, marketed as NovoLog®, for once- or twice-daily s.c. administration to improve glycemic control in adults with diabetes mellitus (NDA 203313)." Source: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM327017.pdfI guess it's good that Novo Nordisk is including Afrezza in the trials, but I'm wondering how well we can trust the outcome. Won't their competing product...Novolog...also be tested?? Does anyone have the authoritative description of the trial and its objectives..?? --4Balance
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Post by liane on Jul 20, 2015 15:16:17 GMT -5
4Balance, It's not that Novo is specifically including Afrezza in their trial. There are 2 study arms - insulin degludec and insulin glargine. The study is comparing these two drugs for long term cardiovascular events. In studies like this, participants are assigned to receive one drug or the other, but they are kept on all their other meds.
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Post by blindhog1 on Jul 20, 2015 15:44:31 GMT -5
4Balance, It's not that Novo is specifically including Afrezza in their trial. There are 2 study arms - insulin degludec and insulin glargine. The study is comparing these two drugs for long term cardiovascular events. In studies like this, participants are assigned to receive one drug or the other, but they are kept on all their other meds. Thank you liane. Like I said yesterday, everything remains the same. One nice part about this study is I get my A1C taken every month. It's going to be more interesting than every 90 days. Watch this space.
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Post by mnholdem on Jul 21, 2015 7:28:47 GMT -5
Interesting that the Sponsor is Novo and that they are using Afrezza in the trial. Afrezza dosing is prior to each meal. This study has it administered only at dinner. A1c would be lower if the Afrezza is used prior to each meal, the way it's meant to be used. Your reply is interesting on several levels.
Novo isn't using Afrezza in its trial. I am. Don't try to read between the lines or add on your own tidbits to change my post. Stick to what I'm saying. You're beginning to sound like my ex-wife.
SNY is looking to use a combination of Afrezza and Toujeo. There is a reason that should have been made clear to authorities like you. I suggest you read the Dr's manual on dosing. The easiest way to understand the concept is: "If you control the day then you can control the long acting insulin at night and the A1C. Not everyone needs to take Afrezza at every meal."
I haven't ruled out the possibility that Sanofi is working with MannKind toward developing a combo-pack. At their first conference after launch, Sanofi stated that their initial target for Afrezza was the 5 million Lantus using, out of which they estimate 3.1 million patients will switch from their current RAA to Afrezza.
If patients / payers get a slight price discount for prescribing both Toujeo/Afrezza in a combo-pack, it could catch on. It could also help explain why Sanofi pushed Toujeo ahead of Afrezza.
Well, now Lantus patients will become Toujeo patients, but the target for Afrezza remains the same, which is 3.1 million. This also might help explain why Toujeo is getting a higher priority from Sanofi. It's quite possible that they are laying the foundation for Afrezza.
At that same conference, Sanofi also revealed that their secondary target for Afrezza is pre- and early-diabetics, which has an estimated target population of 9 million in the U.S.
----
Oh, an regarding wives (including ex-wives) I have known for a very long time that a wife will ALWAYS win the last word in any argument, because if you add any type of response to the end of an argument, in your wife's eyes you are simply starting a new argument.
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