MannKind Presents Positive Afrezza® Clinical Data from STAT
Jun 23, 2018 9:18:46 GMT -5
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Post by robbmo on Jun 23, 2018 9:18:46 GMT -5
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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.
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.