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Post by harryx1 on Oct 27, 2015 6:07:16 GMT -5
Credit: fofos2000 Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) www.clinicaltrials.gov/ct2/show/NCT02585778 |
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Post by mnholdem on Oct 27, 2015 7:40:24 GMT -5
Why is Afrezza included?
Primary Objective #2 states: To evaluate the safety and tolerability of alirocumab in patients with diabetes treated with insulin.
Intervention
- Drug: ALIROCUMAB SAR236553 (REGN727) Pharmaceutical form:solution for injection Route of administration: subcutaneous. Other Name: Praluent.
- Drug: placebo. Pharmaceutical form:solution for injection Route of administration: subcutaneous.
- Drug: insulin. Pharmaceutical form:solution for injection Route of administration: subcutaneous. Other Name: Lantus (insulin glargine).
- Drug: insulin. Pharmaceutical form:powder Route of administration: inhalation. Other Name: Afrezza (insulin human).
- Drug: statin. Pharmaceutical form:tablet Route of administration: oral.
- Drug: lipid modifying therapy. Pharmaceutical form:tablet Route of administration: oral.
It's interesting that Sanofi/Regeneron chose to include Lantus and Afrezza, but no competing BP's insulin...  
NOTE: It was reported that fofos2000 posted that Joslin Diabetes was conducting this test, but this clinical trial is registered as Clinical Trials Identifier:NCT02585778 that is being sponsored by Sanofi and Regeneron.
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Post by centralcoastinvestor on Oct 27, 2015 7:59:52 GMT -5
Why is Afrezza included?
Primary Objective #2 states: To evaluate the safety and tolerability of alirocumab in patients with diabetes treated with insulin.
Intervention
- Drug: ALIROCUMAB SAR236553 (REGN727) Pharmaceutical form:solution for injection Route of administration: subcutaneous. Other Name: Praluent.
- Drug: placebo. Pharmaceutical form:solution for injection Route of administration: subcutaneous.
- Drug: insulin. Pharmaceutical form:solution for injection Route of administration: subcutaneous. Other Name: Lantus (insulin glargine).
- Drug: insulin. Pharmaceutical form:powder Route of administration: inhalation. Other Name: Afrezza (insulin human).
- Drug: statin. Pharmaceutical form:tablet Route of administration: oral.
- Drug: lipid modifying therapy. Pharmaceutical form:tablet Route of administration: oral.
It's interesting that Sanofi/Regeneron chose to include Lantus and Afrezza, but no competing BP's insulin...
NOTE: It was reported that fofos2000 posted that Joslin Diabetes was conducting this test, but this clinical trial is registered as Clinical Trials Identifier:NCT02585778 that is being sponsored by Sanofi and Regeneron.
It is a great sign that Afrezza is showing up as a "standard" treatment for diabetes. For those naysayers that are saying that Sanofi will abandon Afrezza in January, it is reports like this that disprove that theory. Why on earth would Sanofi begin a long term trial using Afrezza as one of the participating drugs, particularly involving Praluent, if they were going to abandon it next year? The answer: they are not abandoning Afrezza. |
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Post by tripoley on Oct 27, 2015 8:17:44 GMT -5
"Why is Afrezza included?"
Estimated enrollment is 500. To double script numbers? LOL.
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Post by mbseeking on Oct 27, 2015 8:20:24 GMT -5
"Why is Afrezza included?" Estimated enrollment is 500. To double script numbers? LOL. anyone else and we'd call you a basher, but when you walk around with an exubera jar superglued to your lips we know where your heart is. |
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Post by jpg on Oct 27, 2015 8:37:41 GMT -5
This is a great find.
It's also amazing the milage and uncertaintly that naysayers are causing with every new bashing point when they walk back on their failure claims.
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Post by harryx1 on Oct 27, 2015 8:40:33 GMT -5
mnholdem - Maybe SNY & REGN have been paying attention to the anecdotal side benefits Afrezza has been having on patients and decided to include it to see the results in a study. It's all speculation on my part but if Afrezza is having positive side effects of impacting other areas of labs as we have seen (e.g. AfrezzaGuy) then it could be a great combo for diabetics or even pre-diabetics with high Trigs, Cholesterol and/or blood pressure. Any docs want to chime in?
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Post by kball on Oct 27, 2015 9:09:38 GMT -5
Its interesting to note, but not surprising, that Afrezza guys regular doctor didnt know about afrezza. he's been on it awhile and shouldn't it fall under the Let Your Primary Know What Meds Youre On game plan?
Not important enough to mention?
Doesn't want to bother the doctors office between visits?
Seems odd
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Post by mbseeking on Oct 27, 2015 9:18:11 GMT -5
mnholdem - Maybe SNY & REGN have been paying attention to the anecdotal side benefits Afrezza has been having on patients and decided to include it to see the results in a study. It's all speculation on my part but if Afrezza is having positive side effects of impacting other areas of labs as we have seen (e.g. AfrezzaGuy) then it could be a great combo for diabetics or even pre-diabetics with high Trigs, Cholesterol and/or blood pressure. Any docs want to chime in? Let me give you the super cynical view. I have these moments occasionally . First accept these assumptions if you will. Afrezza cures diabetes. T1 or T2. Cures it as good as anything will in our generation and for the last 150 years. Second, cardiovascular disease (CVD) events are correlated to A1C not cholesterol. (The more I read on the second point the more I believe we have been conned, and there are numerous scholarly articles linking elevated A1Cs to cardio events. Just accept for this argument,, you can challenge later). Ok..if the academics know this, and the industry know this, but the population does not yet, then the the industry would be scared witless that not only would Afrezza obsolete most of the other diabetes drugs but also most of the statin business. This is certainly upward of 50% of the whole pharma business. (btw this could explain the intensity and tenacity of the shorts on MNKD..) But what about SNY. Are they scared? Well yes, they have Afrezza, but they also have other diabetic and cholesterol lowering drugs . Why hasn't SNY announced a trial to prove exclusively , the superiority of Afrezza already? If Afrezza is shown to be a grand success addressing both diabetes , and then by extension drastically reducing CVD events then they stop selling a lot of other stuff too. Now the cynical bit. This trial gets around that. IF it works then no one will be able to separate the cholesterol-> heart argument benefits from SNYs Praluent / Lantus / Afrezza combo.. it will table great results for a1c, reduced CVD issues and reduced cholesterol. No other company will be able to match this (because they dont have Afrezza), but Praluent will be in the limelight. The public logic (common wisdom) will be its the Pralulent reducing the cholesterol and hence reducing the CVDs..but actually it was AFrezza reducing the A1cs which reduced the CVDs with Praluent going along for a ride.. Sorry in advance if this too cynical by half. (More anecdotal proof on Afrezza mnkd.proboards.com/post/42569/thread) |
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Post by jbe on Oct 27, 2015 9:37:53 GMT -5
If the Proluent/Afrezza combination is the one that proves superior than any other Proluent combination, then its not Proluent that will be in the spotlight, it will be Afrezza.
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Post by rrtzmd on Oct 27, 2015 9:59:05 GMT -5
If the Proluent/Afrezza combination is the one that proves superior than any other Proluent combination, then its not Proluent that will be in the spotlight, it will be Afrezza. I cannot agree given the objectives: "To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. To evaluate the safety and tolerability of alirocumab in patients with diabetes treated with insulin." Whatever the results, praluent will get the limelight for anything positive. Sanofi may even resort to blaming afrezza for any bad results. I believe the reason they chose afrezza is because praluent itself is injected and they likely don't want any skin reactions that might arise from injected insulin to be blamed on praluent: "The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given..." |
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Post by tchalaa on Oct 27, 2015 10:27:16 GMT -5
"Why is Afrezza included?" Estimated enrollment is 500. To double script numbers? LOL. At least we have already 500 NRX coming in sooner than later |
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Post by compound26 on Oct 27, 2015 10:29:40 GMT -5
This study is another piece of evidence of Sanofi's commitment to Afrezza. The study won't complete until Feb. 2017. If, as some shorts (e.g., AF and his friends) have claimed, Sanofi will dump Afrezza as soon as possible (AF and his friends have mentioned early 2016), why would Sanofi choose to use Afrezza in this study? Think about it, if Afrezza becomes unavailable in the middle of the study, what will happen to the study? And by the way, according this article, on average, Phase 3 Clinical Trial Costs Exceed $26,000 per Patient. "Estimated Enrollment: 500 Study Start Date: October 2015 Estimated Study Completion Date: February 2017 Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)" |
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Post by jpg on Oct 27, 2015 10:29:44 GMT -5
If the Proluent/Afrezza combination is the one that proves superior than any other Proluent combination, then its not Proluent that will be in the spotlight, it will be Afrezza. I cannot agree given the objectives: "To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. To evaluate the safety and tolerability of alirocumab in patients with diabetes treated with insulin." Whatever the results, praluent will get the limelight for anything positive. Sanofi may even resort to blaming afrezza for any bad results. I believe the reason they chose afrezza is because praluent itself is injected and they likely don't want any skin reactions that might arise from injected insulin to be blamed on praluent: "The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given..." Afrezza will be blamed? What are you talking about again? This seems like another attempt to diffuse a good news story? You seem to have a glass empty type of view of all things Afrezza... |
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Post by mbseeking on Oct 27, 2015 10:41:28 GMT -5
I cannot agree given the objectives: "To demonstrate the superiority of alirocumab in comparison with placebo in the reduction of calculated low-density lipoprotein cholesterol (LDL-C) in patients with diabetes treated with insulin and with hypercholesterolemia at high cardiovascular risk not adequately controlled on maximally tolerated LDL-C lowering therapy. To evaluate the safety and tolerability of alirocumab in patients with diabetes treated with insulin." Whatever the results, praluent will get the limelight for anything positive. Sanofi may even resort to blaming afrezza for any bad results. I believe the reason they chose afrezza is because praluent itself is injected and they likely don't want any skin reactions that might arise from injected insulin to be blamed on praluent: "The most common side effects of Praluent include itching, swelling, pain, or bruising where injection is given..." Afrezza will be blamed? What are you talking about again? This seems like another attempt to diffuse a good news story? You seem to have a glass empty type of view of all things Afrezza... Its a good news, bad news story. Let me try and thread that needle, and I admit I'm in a bit of a dark mood this morning. Good news. SNY runs a long trial with Afrezza , so wont drop it. Bad news. They dont want to prove Afrezza the blockbuster many of us here believe it could be , obsoleting many other diabetic and cholesterol lowering drugs. So this limbo status continues for 2, 3 or how many years. This clinical trial does nothing to justify to insurers to improve their coverage, nor to does it suggest to doctors a new protocol where nothing other than Afrezza and metformin is all most T2s needs (as do probably most pre-diabetics as that will nix their CVD risk too) |
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