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Post by itellthefuture777 on Jan 22, 2019 0:19:25 GMT -5
In the PRONTO-T1D study participants in the experimental arm (Ultra Rapid Lispro) were required to administer a second dose 20 minutes after the start of each meal. Exclusion Criteria for that study included Afrezza: • Have used other antihyperglycemic medications or therapies ( inhaled, oral or injectable) within 90-days of screening. INDIANAPOLIS, Oct. 2, 2018 /PRNewswire/ -- Readouts from two phase 3 clinical trials demonstrated that Eli Lilly and Company's (NYSE: LLY) Ultra Rapid Lispro (URLi) met the primary efficacy endpoint of non-inferior A1C reduction from baseline compared to Humalog® (insulin lispro) and also demonstrated significantly improved post-meal glucose control in people with type 1 and type 2 diabetes.URLi is Lilly's novel mealtime insulin formulation that was developed to help better control blood glucose levels after meals by more closely mirroring the way insulin works in people without diabetes.The two phase 3 studies, PRONTO-T1D and PRONTO-T2D, evaluated the safety and efficacy of URLi compared to Humalog in people with type 1 and type 2 diabetes, respectively. The primary efficacy endpoint of non-inferiority to Humalog, as measured by A1C reduction from baseline, was met in both studies at 26 weeks. In both populations, URLi demonstrated superior reduction in glucose excursions at both one and two hours during a meal test. The studies showed no significant difference in severe, nocturnal or overall hypoglycemia rates reported by study participants.In both studies, URLi showed overall safety and tolerability similar to Humalog. Lilly plans to present detailed results from these studies in 2019. Based on these results, Lilly will submit URLi to regulatory authorities in 2019. ---------- Eli Lilly's new version of insulin lispro uses two new excipients: Treprostinil and citrate 🥴 assets.ctfassets.net/mpejy6umgthp/2dVCYhgahe6qeugw6kIqiY/8b348cbeccff4f233c1851a4dfa2b499/ADA2017_959-P.pdfclinicaltrials.gov/ct2/show/NCT03214367[/b][/quote] i Mannkind however..did report significant reduction in hypos...which goes to severity catagory..means way more then the other elements of the studies that lilly has..Nice try coat tail hugger Lilly
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Post by peppy on Jan 22, 2019 0:23:06 GMT -5
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Post by longliner on Jan 22, 2019 0:26:32 GMT -5
Not to be forward, but, I'm really warming up to your research.
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Post by itellthefuture777 on Jan 22, 2019 0:39:49 GMT -5
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Post by longliner on Jan 22, 2019 1:12:21 GMT -5
so it could be said, Ultra Rapid Afrezza. insulin human. (?). I am asking. You could call it Ultra Rapid Afrezza. Once you try to put insulin into the brand's name you are going to be in trouble though. Notice that neither of the others makes that mistake although I bet they would both love to. Aged "Ultra rapid Afrezza, the fastest prandial treatment available" You began to respond to this, but changed course?
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Post by peppy on Jan 22, 2019 1:36:31 GMT -5
You could call it Ultra Rapid Afrezza. Once you try to put insulin into the brand's name you are going to be in trouble though. Notice that neither of the others makes that mistake although I bet they would both love to. "Ultra rapid Afrezza, the fastest prandial treatment available" You began to respond to this, but changed course? MNKD has not gotten an ultra rapid designation from the FDA. It is a rapid acting insulin. MNKD got a warning letter a few months ago over a internet marketing picture advertisement. The warnings have to be front and center? What I have learned. Afrezza has a non inferior designation. I would think, great it is equal to. Turns out in order to get insurance coverage afrezza needed a grander label. Turns out, physicians and patients can't prescribe/request afrezza without throwing off the Rebate/kickback system that our health insurance system pays to the health insurance companies to allow their insurance coverage.
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Post by longliner on Jan 22, 2019 1:40:39 GMT -5
"Ultra rapid Afrezza, the fastest prandial treatment available" You began to respond to this, but changed course? MNKD has not gotten an ultra rapid designation from the FDA. It is a rapid acting insulin. MNKD got a warning letter a few months ago over a internet marketing picture advertisement. The warnings have to be front and center? What I have learned. Afrezza has a non inferior designation. I would think, great it is equal to. Turns out in order to get insurance coverage afrezza needed a grander label. Turns out, physicians and patients can't prescribe/request afrezza without throwing off the Rebate/kickback system that our health insurance system pays to the health insurance companies to allow their insurance coverage. Peppy, I did not call it an "ultra rapid insulin" (let Aged worry about that) I called it "Ultra rapid Afrezza, the fastest prandial treatment available". Prove that incorrect FDA (Grow a set) . And believe me, I clearly remember the warning letter!
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Post by travis1953 on Jan 22, 2019 7:29:38 GMT -5
How does Lilly's claim, "LY[ultra rapid insulin lispro] reduced the total postprandial glucose excursion by 44% relative to Humalog," compare to what afrezza produced?
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Post by agedhippie on Jan 22, 2019 9:48:46 GMT -5
They used Self-Monitoring Blood Glucose (SMBG) Values (finger pricks) Well of course no CGM....that would be a fair comparison. Nobody uses CGMs for phase 3 trials because of the number of participants, the cost would be crippling. This is 1,200 patients for a year and not 60 patients for a month. The only time you see large scale trials using CGMs is either for CGMs themselves, or for hybrid pumps.
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Post by agedhippie on Jan 22, 2019 9:53:12 GMT -5
You could call it Ultra Rapid Afrezza. Once you try to put insulin into the brand's name you are going to be in trouble though. Notice that neither of the others makes that mistake although I bet they would both love to. Aged "Ultra rapid Afrezza, the fastest prandial treatment available" You began to respond to this, but changed course? Yes, I was going to say that you can't have a product called, "ABC, the greatest floor cleaner" for example, but then I wasn't so sure that was absolutely true. I don't think you can put a claim into a name like that so I went with the part I knew to be true, you cannot trademark generic terms.
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Post by agedhippie on Jan 22, 2019 10:02:14 GMT -5
The long tail eliminates the need for the second dose because it covers the carbs that arrive later. The focus is on faster onset, not on faster exit - URLI looks identical or slightly longer than ordibary Humalog. Here's what Lilly actually says, they say the focus of URLi is the "ultra rapid on/off profile." It's highlighted in the yellow box. ... There is no way URLi has a rapid off profile. The clearance looks pretty much the same as RAA to me.
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Post by longliner on Jan 22, 2019 10:46:03 GMT -5
Aged "Ultra rapid Afrezza, the fastest prandial treatment available" You began to respond to this, but changed course? Yes, I was going to say that you can't have a product called, "ABC, the greatest floor cleaner" for example, but then I wasn't so sure that was absolutely true. I don't think you can put a claim into a name like that so I went with the part I knew to be true, you cannot trademark generic terms. Fair enough.
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Post by longliner on Jan 22, 2019 10:51:17 GMT -5
Well of course no CGM....that would be a fair comparison. Nobody uses CGMs for phase 3 trials because of the number of participants, the cost would be crippling. This is 1,200 patients for a year and not 60 patients for a month. The only time you see large scale trials using CGMs is either for CGMs themselves, or for hybrid pumps. Time changes things, who would have thought your computer would be your phone or watch? CGMs may become rapidly adopted as they evolve. Abbott or Dexcom may even provide them for free as advertising to create product awareness for themselves. Sometimes it pays to ask the right question, of the right person, when your incentives align.
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