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Post by peppy on Jan 21, 2019 15:48:38 GMT -5
I think Eli Lilly is calling their RAA that's currently in clinical trials, Ultra Rapid. Looks like they're trying to pull what Novo did. These people are stupid. I can not figure out how Lilly got permission for that. Must be time to first measurable effect. However, NovoLog (insulin aspart)is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. NovoLog is a fast-acting insulin that begins to work very quickly. After using it, you should eat a meal within 5 to 10 minutes. They want pre-dose. *Molly and aged never pre-dose. www.drugs.com/novolog.htmlHumalog (insulin lispro) is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. www.drugs.com/humalog.htmlInappropriate comment, were bribes paid?
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Post by MnkdWASmyRtrmntPlan on Jan 21, 2019 16:51:20 GMT -5
I think Eli Lilly is calling their RAA that's currently in clinical trials, Ultra Rapid. Looks like they're trying to pull what Novo did. These people are stupid. I can not figure out how Lilly got permission for that. Must be time to first measurable effect. However, NovoLog (insulin aspart)is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. NovoLog is a fast-acting insulin that begins to work very quickly. After using it, you should eat a meal within 5 to 10 minutes. They want pre-dose. *Molly and aged never pre-dose. www.drugs.com/novolog.htmlHumalog (insulin lispro) is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. www.drugs.com/humalog.htmlInappropriate comment, were bribes paid? I am not sure Lilly really got permission to call that Ultra Rapid Lispro. investor.lilly.com/news-releases/news-release-details/results-two-phase-3-studies-show-lillys-ultra-rapid-lispro-urliThey can probably call it whatever they want in news bulletins, especially since it is only in phase 3 clinical trials and I don't think they even have a name for it yet. Looks like that trial will only get them "not inferior to Humalog" status. That's surely not saying much. While looking that up, I also see Lilly also has a new Phase 3 trial GIP/GLP for type 2's. pharmaphorum.com/news/lilly-diabetes-unveils-promising-data-from-dual-action-diabetes-drug/It looks like it is designed to work the already overworked pancreas to death, making T2's into T1's.
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Post by mango on Jan 21, 2019 19:01:18 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]
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Post by agedhippie on Jan 21, 2019 20:18:10 GMT -5
Lilly called it Ultra Rapid Lispro in the same way that Novo called theirs Fast Acting Aspart. It's branding and not an insulin class. If they had called it Ultra Rapid Insulin there would have been problems. Think of it in the same way that you cannot trademark a generic term.
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Post by peppy on Jan 21, 2019 20:22:42 GMT -5
Lilly called it Ultra Rapid Lispro in the same way that Novo called theirs Fast Acting Aspart. It's branding and not an insulin class. If they had called it Ultra Rapid Insulin there would have been problems. Think of it in the same way that you cannot trademark a generic term. so it could be said, Ultra Rapid Afrezza. insulin human. (?). I am asking.
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Post by longliner on Jan 21, 2019 20:23:12 GMT -5
Lilly called it Ultra Rapid Lispro in the same way that Novo called theirs Fast Acting Aspart. It's branding and not an insulin class. If they had called it Ultra Rapid Insulin there would have been problems. Think of it in the same way that you cannot trademark a generic term. I think, given your logic, we can agree that the term 'Ultra Rapid Afrezza, the fastest Prandial treatment available" is appropriate.
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Post by longliner on Jan 21, 2019 20:24:03 GMT -5
Lilly called it Ultra Rapid Lispro in the same way that Novo called theirs Fast Acting Aspart. It's branding and not an insulin class. If they had called it Ultra Rapid Insulin there would have been problems. Think of it in the same way that you cannot trademark a generic term. so it could be said, Ultra Rapid Afrezza. insulin human. (?) Wow Peppy! You beat me!
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Post by agedhippie on Jan 21, 2019 20:35:57 GMT -5
Lilly called it Ultra Rapid Lispro in the same way that Novo called theirs Fast Acting Aspart. It's branding and not an insulin class. If they had called it Ultra Rapid Insulin there would have been problems. Think of it in the same way that you cannot trademark a generic term. 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.
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Post by longliner on Jan 21, 2019 20:39:23 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. "Ultra rapid Afrezza, the fastest prandial treatment available" is not an option for either of the others. (And not because of the name)
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Post by mnholdem on Jan 21, 2019 20:49:09 GMT -5
Second dose, second poke... and more scar tissue. Is that what people with diabetes really want?
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Post by agedhippie on Jan 21, 2019 21:05:23 GMT -5
Second dose, second poke... and more scar tissue. Is that what people with diabetes really want? 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.
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Post by mango on Jan 21, 2019 21:33:11 GMT -5
Second dose, second poke... and more scar tissue. Is that what people with diabetes really want? 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. In the PRONTO-T1D study they required particpants in the URLi arm to administer a second dose 20 minutes after the start of each meal. Only in the T2D study did they not do follow on doses
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Post by peppy on Jan 21, 2019 22:38:35 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. In the PRONTO-T1D study they required particpants in the URLi arm to administer a second dose 20 minutes after the start of each meal. Only in the T2D study did they not do follow on doses clinicaltrials.gov/ct2/show/NCT03214367Experimental: LY900014 LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Active Comparator: Insulin Lispro Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Experimental: LY900014 Open Label LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. They are not using CGM's they are using, Mixed-Meal Tolerance Test (MMTT) agedhippie , what is an MMTT? The Mixed Meal Tolerance Test (MMTT) requires a person to drink a "mixed meal," such as Boost or Ensure, that contains, protein, carbohydrates, and fat. The goal of the test is to measure how much insulin your pancreas can make in response to food. 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 26 ] 1-hour PPG excursion during MMTT 2-hour PPG Excursion during MMTT [ Time Frame: Week 26 ] 2-hour PPG excursion during MMTT Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 26 ] Rate of severe hypoglycemia Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Baseline through Week 26 ] Rate of documented symptomatic hypoglycemia ============================================================================================= Aged or all, What? I did not see continuous glucose monitors mentioned at all. How are they going to measure 1 hour and two hours PPG excursion? PPG excursions are defined as the total glucose profile after meal ingestion from baseline to completion of absorption. In other words, the PPG excursion indicates the total glycemic elevation from baseline over time after eating a meal.
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Post by mango on Jan 21, 2019 22:43:15 GMT -5
In the PRONTO-T1D study they required particpants in the URLi arm to administer a second dose 20 minutes after the start of each meal. Only in the T2D study did they not do follow on doses clinicaltrials.gov/ct2/show/NCT03214367Experimental: LY900014 LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Active Comparator: Insulin Lispro Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Experimental: LY900014 Open Label LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. They are not using CGM's they are using, Mixed-Meal Tolerance Test (MMTT) agedhippie , what is an MMTT? They used Self-Monitoring Blood Glucose (SMBG) Values (finger pricks)
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Post by peppy on Jan 21, 2019 22:49:27 GMT -5
clinicaltrials.gov/ct2/show/NCT03214367Experimental: LY900014 LY900014 given subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Active Comparator: Insulin Lispro Insulin lispro given SC 0-2 minutes before each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. Experimental: LY900014 Open Label LY900014 given SC 20 minutes after the start of each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily. They are not using CGM's they are using, Mixed-Meal Tolerance Test (MMTT) agedhippie , what is an MMTT? They used Self-Monitoring Blood Glucose (SMBG) Values (finger pricks) well aren't they tech savvy. What the heck. Pick your data points carefully.
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