post hoc analysis from the STAT study
Jun 3, 2021 5:18:12 GMT -5
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Post by liane on Jun 3, 2021 5:18:12 GMT -5
WESTLAKE VILLAGE, Calif. , June 3, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD ), which focuses on the development of innovative medicines for patients with endocrine and orphan lung diseases, announced today that it will present a poster [Abstract #654 / Topic AS09 – New Insulin Delivery Systems: Inhaled, Transdermal, Implanted Devices] at the 14 th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2021) to be held virtually, June 2-5. The poster presents a post hoc analysis from the STAT study that demonstrates how Afrezza (Technosphere Insulin or TI) reduced nocturnal hypoglycemia compared to insulin aspart in adult patients with type 1 diabetes (T1D).
"When the STAT study was completed, it advanced our understanding of potential benefits of Afrezza for those living with Type 1 diabetes overall," said Dr. Kevin Kaiserman , Vice President, Medical Affairs and Safety of MannKind. "With this post hoc statistical analysis, we divided the CGM data into day and night and showed that using Technosphere Insulin versus aspart reduced Level 1 nocturnal hypoglycemia by 62% and Level 2 by 78%."
The ultra-rapid appearance and clearance of TI – which more closely mimics physiologic insulin compared with subcutaneous insulin aspart – may contribute to these findings, although larger studies are needed to confirm this hypothesis, Kaiserman explained.
The STAT study was a four-week, investigator-led, collaborative, open-label pilot study that included 60 patients with T1D on multiple daily injections of aspart who were randomized to either the control cohort using aspart (n=34) or the TI cohort (n=26). Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycemia measures were obtained from continuous glucose monitors (CGM). For purposes of the study, nighttime was defined as 12 am to 6 am .
The poster is authored by Janet K. Snell-Bergeon , PhD; Halis K. Akturk , MD; Anne Peters , MD; Kevin Kaiserman , MD and Satish K. Garg – representing a collaboration between the Barbara Davis Center for Diabetes ( University of Colorado -Aurora), Keck School of Medicine of USC , and MannKind.
"When the STAT study was completed, it advanced our understanding of potential benefits of Afrezza for those living with Type 1 diabetes overall," said Dr. Kevin Kaiserman , Vice President, Medical Affairs and Safety of MannKind. "With this post hoc statistical analysis, we divided the CGM data into day and night and showed that using Technosphere Insulin versus aspart reduced Level 1 nocturnal hypoglycemia by 62% and Level 2 by 78%."
The ultra-rapid appearance and clearance of TI – which more closely mimics physiologic insulin compared with subcutaneous insulin aspart – may contribute to these findings, although larger studies are needed to confirm this hypothesis, Kaiserman explained.
The STAT study was a four-week, investigator-led, collaborative, open-label pilot study that included 60 patients with T1D on multiple daily injections of aspart who were randomized to either the control cohort using aspart (n=34) or the TI cohort (n=26). Level 1 (<70 mg/dL) and Level 2 (<54 mg/dL) hypoglycemia measures were obtained from continuous glucose monitors (CGM). For purposes of the study, nighttime was defined as 12 am to 6 am .
The poster is authored by Janet K. Snell-Bergeon , PhD; Halis K. Akturk , MD; Anne Peters , MD; Kevin Kaiserman , MD and Satish K. Garg – representing a collaboration between the Barbara Davis Center for Diabetes ( University of Colorado -Aurora), Keck School of Medicine of USC , and MannKind.
