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Post by sportsrancho on Jun 23, 2018 9:01:58 GMT -5
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Post by sayhey24 on Jun 23, 2018 9:04:28 GMT -5
"The job of a prandial is not to reduce A1c." That is news to me. I was of the opinion all insulin products were intended to reduce glucose levels. No wonder I have been wrong all these years!? No problem, I am glad I could help. This is a common misunderstanding because we have never had a prandial insulin which could mimic first and second phase release. Guys like Aged have been taught to use their prandial to try and adjust their baseline which is medically incorrect. This is because the old school insulin is all over the place and hangs around forever.
Think of it this way - If a non diabetic; - has 3 meals per day - are back to baseline 2 hours after each meal
- their A1c during those 6 hours is 5.4 - assuming 85mg/dl baseline their A1c for the remaining 18 hours is 4.6
Those 18 hours is when the pancreas is in a fasting state and those 18 hours have 3x the impact on A1c. Thats the job of afrezza, get them back to baseline in 2 hours without significant swings, especially lows. If you can eliminate the lows you can increase the basal and lower the baseline. What you see is afrezza nearly perfectly mimicked a non-diabetic pancreas which is pretty awesome.
This study targeted about 160 but guys like afrezzauser and others are targeting 120, 130, and 140 according to Mike C.
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Post by sportsrancho on Jun 23, 2018 9:05:24 GMT -5
MannKind Presents Positive Afrezza® Clinical Data from STAT and AFFINITY Studies at ADA 78th Scientific Sessions
June 23, 2018 10:00 ET | Source: MannKind Poster 1017-P: Afrezza provides improved Time-in-Range on Continuous Glucose Monitoring compared to insulin aspart
Poster 102-LB: Hypoglycemia is reduced with use of Afrezza compared to insulin aspart
WESTLAKE VILLAGE, Calif., June 23, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) announced that new data for Afrezza from the STAT study (STudy comparing prandial insulin Aspart vs. Technosphere insulin in patients with Type 1 diabetes on multiple daily injections) were released today at the American Diabetes Association’s 78th Scientific Sessions, being held June 22-26, 2018, in Orlando, Florida. The STAT study involved 60 patients with Type 1 diabetes and is the first randomized, controlled study to use continuous glucose monitoring (CGM) with Afrezza. The dual primary endpoints were assessment of glucose time-in-range and postprandial glucose (PPG) excursions in the 1-4 hour post-meal period. PPG control results from this study will be presented as an oral presentation on Monday June 25th, 2018 in Session 348-OR.
STAT Study Poster Highlights:
Title: Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) compared to insulin Aspart in Patients with T1D—STAT Study Presenter: Janet-Snell-Bergeon, Ph.D. Highlights: Compared to insulin aspart, the per-protocol use of Afrezza (i.e., with supplemental doses 1 and/or 2 hours post-meal): Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12% Significantly decreased daytime glucose variability by 17% Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day Conclusion: The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia
“We are very pleased to present results of the novel STAT trial. This is the first time we have seen a rapid-acting mealtime insulin provide a superior outcome when utilized with CGM in a treat-to-target dosing strategy. The results demonstrated that Afrezza dosed before and (as needed) after meals significantly improved all-day glucose time-in-range, limited daytime glucose variability and significantly reduced the overall rate and time spent in hypoglycemia,” stated David Kendall, M.D., Chief Medical Officer of MannKind Corporation.
MannKind also presented a late-breaking poster presenting a post-hoc analysis of a representative subset of the AFFINITY 1 study that demonstrated the use of Afrezza significantly lowers the rate of hypoglycemia in patients with Type 1 diabetes while providing non-inferior glycemic control.
Affinity-1 Late Breaking Poster Highlights:
Title: Total and Severe Hypoglycemia is Reduced With Use of Inhaled Technosphere® Insulin (AFREZZA®) Relative to Insulin Aspart in Type 1 Diabetes Presenter: Lawrence Blonde Highlights: Compared to insulin aspart: Use of Afrezza significantly lowers the rate of hypoglycemia in Type 1 diabetes while providing similar or better glycemic control (54.1 events per subject vs. 78.2 events per subject, a reduction of 31%) On average, 26% lower rates of hypoglycemia were observed with Afrezza across the range of HbA1c levels, allowing the same degree of glycemic control with less hypoglycemia than insulin aspart. For example, a patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%) Alternatively, patients with HbA1c of 6.8% on Afrezza would be estimated to experience 4 fewer hypoglycemic events per month than a similar patient on insulin aspart Conclusion: Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events.
“The late breaking poster presentation, from a post-hoc regression analysis of a representative subset of the AFFINITY 1 study patient, evaluated overall and severe hypoglycemia event rates with AFREZZA relative to insulin aspart in Type 1 diabetes patients. This analysis, which controlled for a number of variables that can impact glucose control and rates of hypoglycemia, demonstrated that use of Afrezza resulted in significantly lower rates of hypoglycemia in Type 1 diabetes patients across a wide range of HbA1c as compared to insulin aspart. Hypoglycemia remains one of the major factors that limit to the ability of healthcare providers and patients to intensify insulin therapy and can further limit the ability to achieve optimal glucose control,” continued Dr. Kendall.
About Afrezza®
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Post by sayhey24 on Jun 23, 2018 9:07:32 GMT -5
Kastanes - I just saw the press release, see the daytime wording Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12% Significantly decreased daytime glucose variability by 17% Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day Conclusion: The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia
Let me add the 41% allows the flexibility to adjust the basal and get the better A1c numbers you are looking for. Adjusting baseline was not part of the study. - "A patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%)" I think thats the number you were looking for and its HUGE.
It looks like afrezza just obsoleted the RAAs and its easier to use!
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Post by peppy on Jun 23, 2018 9:07:53 GMT -5
Poster 1017-P: Afrezza provides improved Time-in-Range on Continuous Glucose Monitoring compared to insulin aspart Poster 102-LB: Hypoglycemia is reduced with use of Afrezza compared to insulin aspart WESTLAKE VILLAGE, Calif., June 23, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) announced that new data for Afrezza from the STAT study (STudy comparing prandial insulin Aspart vs. Technosphere insulin in patients with Type 1 diabetes on multiple daily injections) were released today at the American Diabetes Association’s 78th Scientific Sessions, being held June 22-26, 2018, in Orlando, Florida. The STAT study involved 60 patients with Type 1 diabetes and is the first randomized, controlled study to use continuous glucose monitoring (CGM) with Afrezza. The dual primary endpoints were assessment of glucose time-in-range and postprandial glucose (PPG) excursions in the 1-4 hour post-meal period. PPG control results from this study will be presented as an oral presentation on Monday June 25th, 2018 in Session 348-OR. STAT Study Poster Highlights: Title: Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) compared to insulin Aspart in Patients with T1D—STAT Study Presenter: Janet-Snell-Bergeon, Ph.D. Highlights: Compared to insulin aspart, the per-protocol use of Afrezza (i.e., with supplemental doses 1 and/or 2 hours post-meal): Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12% Significantly decreased daytime glucose variability by 17% Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per dayConclusion: The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia “We are very pleased to present results of the novel STAT trial. This is the first time we have seen a rapid-acting mealtime insulin provide a superior outcome when utilized with CGM in a treat-to-target dosing strategy. The results demonstrated that Afrezza dosed before and (as needed) after meals significantly improved all-day glucose time-in-range, limited daytime glucose variability and significantly reduced the overall rate and time spent in hypoglycemia,” stated David Kendall, M.D., Chief Medical Officer of MannKind Corporation. MannKind also presented a late-breaking poster presenting a post-hoc analysis of a representative subset of the AFFINITY 1 study that demonstrated the use of Afrezza significantly lowers the rate of hypoglycemia in patients with Type 1 diabetes while providing non-inferior glycemic control. Affinity-1 Late Breaking Poster Highlights: Title: Total and Severe Hypoglycemia is Reduced With Use of Inhaled Technosphere® Insulin (AFREZZA®) Relative to Insulin Aspart in Type 1 Diabetes Presenter: Lawrence Blonde Highlights: Compared to insulin aspart: Use of Afrezza significantly lowers the rate of hypoglycemia in Type 1 diabetes while providing similar or better glycemic control (54.1 events per subject vs. 78.2 events per subject, a reduction of 31%) On average, 26% lower rates of hypoglycemia were observed with Afrezza across the range of HbA1c levels, allowing the same degree of glycemic control with less hypoglycemia than insulin aspart. For example, a patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%) Alternatively, patients with HbA1c of 6.8% on Afrezza would be estimated to experience 4 fewer hypoglycemic events per month than a similar patient on insulin aspart Conclusion: Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events. “The late breaking poster presentation, from a post-hoc regression analysis of a representative subset of the AFFINITY 1 study patient, evaluated overall and severe hypoglycemia event rates with AFREZZA relative to insulin aspart in Type 1 diabetes patients. This analysis, which controlled for a number of variables that can impact glucose control and rates of hypoglycemia, demonstrated that use of Afrezza resulted in significantly lower rates of hypoglycemia in Type 1 diabetes patients across a wide range of HbA1c as compared to insulin aspart. Hypoglycemia remains one of the major factors that limit to the ability of healthcare providers and patients to intensify insulin therapy and can further limit the ability to achieve optimal glucose control,” continued Dr. Kendall. About Afrezza®
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Post by factspls88 on Jun 23, 2018 9:11:03 GMT -5
The finding on hypoglycemia, which we investors knew was a key benefit of Afrezza, is huge imo.
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Post by agedhippie on Jun 23, 2018 9:27:05 GMT -5
Thus If Afrezza keeps PWD’s in range during the vast majority of waking hours, and time in range with the best pump only does 72% (througout the entire day), it sounds to me a humongous opportunity exists for Afrezza to eat big into the large pump using population. With 1.25 million T1’s in the US and 1/3 using pumps, that’s quite an oppurtunity. Ok - correction. I really should read these things better: The 670G gives 72% TIR during the day, and 75% TIR during the night. They probably split that because the 670G is a hybrid so nights are entirely under the pump's control but the user has to tell it when they eat so there is a certain amount of user error in the day time. The FDA restricts how aggressive the 670G can be (it cannot do large doses so it is slow to respond to events). The OpenAPS doesn't have that limitation and consequently has a much higher TIR. As the algorithms get better the FDA regulated pumps will get better scores. Pumps like the T:Slim are designed to have regular algorithm upgrades for just that reason. What can OpenAPS do? Here is a recent tweet:
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Post by sportsrancho on Jun 23, 2018 9:36:31 GMT -5
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Post by peppy on Jun 23, 2018 9:54:16 GMT -5
WESTLAKE VILLAGE, Calif., June 23, 2018 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) announced that new data for Afrezza from the STAT study (STudy comparing prandial insulin Aspart vs. Technosphere insulin in patients with Type 1 diabetes on multiple daily injections) were released today at the American Diabetes Association’s 78th Scientific Sessions, being held June 22-26, 2018, in Orlando, Florida. The STAT study involved 60 patients with Type 1 diabetes and is the first randomized, controlled study to use continuous glucose monitoring (CGM) with Afrezza. The dual primary endpoints were assessment of glucose time-in-range and postprandial glucose (PPG) excursions in the 1-4 hour post-meal period. PPG control results from this study will be presented as an oral presentation on Monday June 25th, 2018 in Session 348-OR. STAT Study Poster Highlights: Title: Improved Time-in-Range (TIR) on Continuous Glucose Monitor (CGM) with Technosphere Inhaled Insulin (TI) compared to insulin Aspart in Patients with T1D—STAT Study Presenter: Janet-Snell-Bergeon, Ph.D. Highlights: Compared to insulin aspart, the per-protocol use of Afrezza (i.e., with supplemental doses 1 and/or 2 hours post-meal): Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12% Significantly decreased daytime glucose variability by 17% Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day Conclusion: The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia “We are very pleased to present results of the novel STAT trial. This is the first time we have seen a rapid-acting mealtime insulin provide a superior outcome when utilized with CGM in a treat-to-target dosing strategy. The results demonstrated that Afrezza dosed before and (as needed) after meals significantly improved all-day glucose time-in-range, limited daytime glucose variability and significantly reduced the overall rate and time spent in hypoglycemia,” stated David Kendall, M.D., Chief Medical Officer of MannKind Corporation. MannKind also presented a late-breaking poster presenting a post-hoc analysis of a representative subset of the AFFINITY 1 study that demonstrated the use of Afrezza significantly lowers the rate of hypoglycemia in patients with Type 1 diabetes while providing non-inferior glycemic control. Affinity-1 Late Breaking Poster Highlights: Title: Total and Severe Hypoglycemia is Reduced With Use of Inhaled Technosphere® Insulin (AFREZZA®) Relative to Insulin Aspart in Type 1 Diabetes Presenter: Lawrence Blonde Highlights: Compared to insulin aspart: Use of Afrezza significantly lowers the rate of hypoglycemia in Type 1 diabetes while providing similar or better glycemic control (54.1 events per subject vs. 78.2 events per subject, a reduction of 31%) On average, 26% lower rates of hypoglycemia were observed with Afrezza across the range of HbA1c levels, allowing the same degree of glycemic control with less hypoglycemia than insulin aspart. For example, a patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%) Alternatively, patients with HbA1c of 6.8% on Afrezza would be estimated to experience 4 fewer hypoglycemic events per month than a similar patient on insulin aspart Conclusion: Use of Afrezza in a multi-dose insulin regimen may permit treatment intensification to be achieved with less hypoglycemia. Switching to Afrezza may also benefit patients already at goal by reducing the frequency of hypoglycemia events. “The late breaking poster presentation, from a post-hoc regression analysis of a representative subset of the AFFINITY 1 study patient, evaluated overall and severe hypoglycemia event rates with AFREZZA relative to insulin aspart in Type 1 diabetes patients. This analysis, which controlled for a number of variables that can impact glucose control and rates of hypoglycemia, demonstrated that use of Afrezza resulted in significantly lower rates of hypoglycemia in Type 1 diabetes patients across a wide range of HbA1c as compared to insulin aspart. Hypoglycemia remains one of the major factors that limit to the ability of healthcare providers and patients to intensify insulin therapy and can further limit the ability to achieve optimal glucose control,” continued Dr. Kendall.
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Post by peppy on Jun 23, 2018 10:01:42 GMT -5
Thus If Afrezza keeps PWD’s in range during the vast majority of waking hours, and time in range with the best pump only does 72% (througout the entire day), it sounds to me a humongous opportunity exists for Afrezza to eat big into the large pump using population. With 1.25 million T1’s in the US and 1/3 using pumps, that’s quite an oppurtunity. Ok - correction. I really should read these things better: The 670G gives 72% TIR during the day, and 75% TIR during the night. They probably split that because the 670G is a hybrid so nights are entirely under the pump's control but the user has to tell it when they eat so there is a certain amount of user error in the day time. The FDA restricts how aggressive the 670G can be (it cannot do large doses so it is slow to respond to events). The OpenAPS doesn't have that limitation and consequently has a much higher TIR. As the algorithms get better the FDA regulated pumps will get better scores. Pumps like the T:Slim are designed to have regular algorithm upgrades for just that reason. What can OpenAPS do? Here is a recent tweet: Humalog , this person is on humalog.
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Post by brotherm1 on Jun 23, 2018 10:12:18 GMT -5
Kastanes - I just saw the press release, see the daytime wording Significantly improved all-day glucose time-in-range by an average of 1.5 hours, or 12% Significantly decreased daytime glucose variability by 17% Significantly reduced the time spent in hypoglycemia (i.e., <70 mg/dl) by 41% or approximately 23 minutes per day Conclusion: The faster action with shorter duration profile of Afrezza when compared to rapid-acting insulin analogs may provide a flexible approach for patients to optimize post-prandial glucose control without increasing risk of hypoglycemia
Let me add the 41% allows the flexibility to adjust the basal and get the better A1c numbers you are looking for. Adjusting baseline was not part of the study. - "A patient with an HbA1c of 8.0% on insulin aspart would experience the same rate of hypoglycemia (12.2 events per month) as a patient on Afrezza with an HbA1c of 6.8% (ΔHbA1c = -1.2%)" I think thats the number you were looking for and its HUGE.
It looks like afrezza just obsoleted the RAAs and its easier to use!
Sayhey, I can actually now follow what you are saying clearly now. This is really great! 🎯 Speaking of obsolete, it appears to me Agedhippie might now be obsolete. 😆
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Post by churchmouse on Jun 23, 2018 10:17:55 GMT -5
In real terms how much could insurance companies save by a 41% hypo reduction/day? I am sure these costs are projected to rise dramatically over the course of time.
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Post by centralcoastinvestor on Jun 23, 2018 10:32:25 GMT -5
It was very interesting to me that over the last couple of days how the naysayers have been frantic to downplay the results. The shorts attacked the share price while all of this FUD has been spread about the STAT study being a dud. Thank goodness the medical world doesn’t care about what people on Stocktwits or SA post. What the medical world cares about is honest trial data. What the medical world considers to be significant is different than we might expect. That is why I am grateful that MannKind published the news release explaining that Dr. Kendall believes that the STAT study and the late breaking poster are significant results. Dr. Kendall will be preaching these results everywhere. Good news indeed.
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Post by babaoriley on Jun 23, 2018 11:08:51 GMT -5
sayhey24 I appreciate your input but it would have been informative to include the HbA1c values. When a company doesn't provide pertinent data, I start questioning. "When a company doesn't provide pertinent data, I start questioning." I doubt the foregoing is a prerequisite for you to question...
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Post by joeypotsandpans on Jun 23, 2018 11:09:32 GMT -5
It was very interesting to me that over the last couple of days how the naysayers have been frantic to downplay the results. The shorts attacked the share price while all of this FUD has been spread about the STAT study being a dud. Thank goodness the medical world doesn’t care about what people on Stocktwits or SA post. What the medical world cares about is honest trial data. What the medical world considers to be significant is different than we might expect. That is why I am grateful that MannKind published the news release explaining that Dr. Kendall believes that the STAT study and the late breaking poster are significant results. Dr. Kendall will be preaching these results everywhere. Good news indeed. Unfortunately it is on your screen, it's tough to wipe your rear end with it, that's the only thing they're useful for. The one question I asked that was consistently passed over.... can you tell me if you know what the statistical significance is regarding the numbers? Please note the following for the carrier pigeon's and you know who you are Dr. Kendall >>> than two bit writers (that is a greater sign btw) as I have stated over and over again.... you can't fix stupid because as they understand and interpret it a statistically significant reduction in hypo risk while being allowed to increase one's (PWD) BG control with Afrezza is not going to be translated into saving lives. Let alone translate into the investment world either. sayhey24 you have been spot on, no need to waste anymore time trying to educate that which cannot be helped. Enjoy the rest of your weekends!!
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