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Post by wyattdog on Jun 22, 2021 15:06:27 GMT -5
22-P: Inhaled Insulin Improves Daytime Time-in-Range in People with Type 2 Diabetes 722-P: Inhaled Insulin Improves Daytime Time-in-Range in People with Type 2 Diabetes LANE DESBOROUGH, PHILIP LEVIN and LEE A. BROMBERGER +Author Affiliations Diabetes 2021 Jun; 70(Supplement 1): -. doi.org/10.2337/db21-722-P Previous ArticleFigures & TablesInfo & Metrics Abstract Background and Aims: Technosphere Insulin (TI), an inhaled insulin with ultra-rapid onset and short duration of action that more closely mimics physiologic insulin, may improve patient outcomes. To address the challenge of prandial control of glucose in type 2 diabetes (T2D), this study aimed to determine real-world dosing requirements, safety, and efficacy of TI in patients with uncontrolled T2D. Methods: Twenty patients with T2D inadequately controlled with oral/injectable combination therapy excluding prandial insulin in a real-world setting with TI added to current therapy. Dosing started at 4 units of TI per meal and increased up to 12 units per meal over a week and then titrated weekly based on postprandial SMBG. HbA1c and CGM profiles were collected at baseline and 12 weeks. Results: Nineteen patients completed the study with baseline and treatment CGM data. For the daytime period (6:00-24:00), there were significant decreases in mean CGM values, significant decreases in time spent in hyperglycemia, and significant increases in time-in-range without a significant increase in hypoglycemia. Conclusions: Addition of TI in patients with uncontrolled type 2 diabetes results in a significant increase in daytime CGM time-in-range (from 38.7% to 62.1%, a mean of over 4 hours of increased daytime time-in-range per day) without an increase in hypoglycemia and a significant reduction in both Level 1 and Level 2 hyperglycemia. Figure1 Download figureOpen in new tabDownload powerpoint Disclosure L. Desborough: Consultant; Self; Diabetes & Glandular Disease Clinic, Diasome Pharmaceuticals, Inc., Luna Health, MODEL Clinical Research, Roche Diabetes Care, Securecell AG, Tandem Diabetes Care, Tidepool. P. Levin: Research Support; Self; MannKind Corporation, Mylan N. V., Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Sanofi. L. A. Bromberger: None. © 2021 by the American Diabetes Association www.diabetesjournals.org/content/licenseReaders may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at www.diabetesjournals.org/content/license |
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Post by wyattdog on Jun 22, 2021 15:12:12 GMT -5
Tolerability and Time-Action Profile of Technosphere Insulin in Pediatric Subjects 923-P: Tolerability and Time-Action Profile of Technosphere Insulin in Pediatric Subjects MARISA C. JONES, MICHAEL J. HALLER, SAVANNAH E. NG, SUNIL BHAVSAR, KEVIN B. KAISERMAN and JOHN A. KRUEGER +Author Affiliations Diabetes 2021 Jun; 70(Supplement 1): -. doi.org/10.2337/db21-923-P Previous ArticleInfo & Metrics Abstract Introduction: Technosphere Insulin (TI) is an inhaled ultra-rapid-acting dry powder prandial insulin. Reported are the results of the first study of TI in pediatric patients. Methods: PK/PD and safety of TI was evaluated in a single-arm, 4-week study in 30, 8-17 years old subjects with T1DM on a stable MDI regimen, meeting pre-defined pulmonary function testing criteria. On day 1, subjects received an individualized single prandial dose of TI (4-16 U, in 4U increments) based on their usual meal-time dose and meal content. Serum insulin and blood glucose were measured -30 to 250 minutes relative to dosing. Over the next 4 weeks, each subject’s dose of TI was titrated, targeting a 120-150 minute post-prandial glucose level of 110-180 mg/dL. Safety and tolerability were assessed over the course of the study. Severe hypoglycemia was defined as an event associated with coma, loss of consciousness, or seizure. Results: Mean age of subjects was 12.7 years (60% Female; 83.3% White). Serum insulin rapidly increased post-dose and returned to baseline by 120 minutes. Mean serum insulin Cmax was 77.3 µU/ml, 119.15 µU/ml, 101.29 µU/ml and 104.86 µU/ml for doses of 4, 8, 12 and 16U respectively. Tmax occurred at 10.5, 13.9, 14.6, and 20.0 minutes post-dose for 4, 8, 12 and 16U respectively. Glucose lowering during 30-60 minutes post-dose was consistent with the PK profile. Over 4 weeks of study, 23 subjects (76.7%) reported 41 TEAEs. One subject had an SAE of diabetic ketoacidosis that was considered possibly related to TI. The most common AEs were hypoglycemia (none severe) and cough. No subjects had a clinically relevant decline in pulmonary function. Conclusion: Inhaled TI demonstrated an ultra-rapid time-action profile similar to that observed in adults. These data suggest TI can be safely administered to children and adolescents ages 8-17 with T1DM. Disclosure M. C. Jones: Employee; Self; MannKind Corporation, Stock/Shareholder; Self; MannKind Corporation. M. J. Haller: Board Member; Self; SAB Biotherapeutics, Inc., Consultant; Self; MannKind Corporation, Other Relationship; Self; Janssen Pharmaceuticals, Inc., Sanofi. S. E. Ng: Employee; Self; MannKind Corporation. S. Bhavsar: Employee; Self; MannKind Corporation. K. B. Kaiserman: Advisory Panel; Self; Medtronic, Consultant; Self; Medtronic, Employee; Self; MannKind Corporation, Research Support; Self; Medtronic, Speaker’s Bureau; Self; Medtronic, Stock/Shareholder; Self; MannKind Corporation. J. A. Krueger: Employee; Self; MannKind Corporation, Stock/Shareholder; Self; Eli Lilly and Company. Funding MannKind Corporation © 2021 by the American Diabetes Association www.diabetesjournals.org/content/licenseReaders may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at www.diabetesjournals.org/content/license. |
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Post by dh4mizzou on Jun 22, 2021 16:51:58 GMT -5
So how much weight will this carry since it was funded by Mannkind but published by the ADA?
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Post by sayhey24 on Jun 22, 2021 17:54:42 GMT -5
So how much weight will this carry since it was funded by Mannkind but published by the ADA? The Philip Levin study is out of Baltimore's Model Clinical Research LLC and the results were published last year. The pediatric one is a probable sign afrezza will get approved for the kids. For the kids, I would think the moms and social media will drive sales. If the mom's see afrezza as a major leap forward in keeping their kids safe, they will drive sales but it needs approval first. The study in itself will do little for current sales. The T2 study is nothing new for most on this board. When afrezza is coupled with a CGM and properly dosed it can nearly mimic a healthy pancreas especially if you can factor out basal insulin. This study was for out of control T2's which probably means they were taking a basal. Of course the obvious question is why are they out of control and the simple answer is their doctors followed the treat to fail SoC - the gold standard for diabetic care. If these T2s were treated early with afrezza most would probably not have progressed and some may have actually seen regression. For this study to help, Mike needs to develop a T2 marketing plan which includes CGM monitoring and dose instruction. Its definitely doable but its not what MNKD has been doing to date. |
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Post by porkini on Jun 22, 2021 18:32:58 GMT -5
So how much weight will this carry since it was funded by Mannkind but published by the ADA? I will assure you that I found it educational and will not use it for profit. Good enough?   |
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Post by radgray68 on Jun 22, 2021 20:17:04 GMT -5
dmsjournal.biomedcentral.com/articles/10.1186/s13098-020-00529-zHere's an interesting article published last year on the topic. Time in range is especially important in pregnancy. Also, models show $Billions could be saved in cost of care if TIR is increased from 70% to 80%. Alas, the brilliant FDA wont even allow it to be included as a secondary outcome in our peds trial. I hope they will be wearing them and keep the info for a later date when the FDA will HAVE to consider TIR. Hope the link is useable. Ludite here.
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Post by buyitonsale on Jun 22, 2021 20:58:56 GMT -5
from pediatric study - "Over 4 weeks of study, 23 subjects (76.7%) reported 41 TEAEs."
Is this a concern for this type of study ?
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Post by radgray68 on Jun 22, 2021 21:29:13 GMT -5
from pediatric study - "Over 4 weeks of study, 23 subjects (76.7%) reported 41 TEAEs." Is this a concern for this type of study ? It's a concern for all drugs in clinical trials. Always tracked diligently. Let's do the math. If 23 subjects used the product 3 times a day for 28 days, that means they dosed 1932 times. 41 events would be 2%. However, there were 30 participants or 2520 doses, I'm assuming, in the trial. Some reported no TEAEs. 41 events would then be 1.6%. How many of these events are due to basal vs. Afrezza? That's for the brilliant lab coat guys to figure out. Is this a concern for us? Due to the small numbers, I'm thinking no. |
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Post by porkini on Jun 22, 2021 22:20:46 GMT -5
dmsjournal.biomedcentral.com/articles/10.1186/s13098-020-00529-zHere's an interesting article published last year on the topic. Time in range is especially important in pregnancy. Also, models show $Billions could be saved in cost of care if TIR is increased from 70% to 80%. Alas, the brilliant FDA wont even allow it to be included as a secondary outcome in our peds trial. I hope they will be wearing them and keep the info for a later date when the FDA will HAVE to consider TIR. Hope the link is useable. Ludite here. Just trying to understand and keep up here... Luddite? en.wikipedia.org/wiki/Luddite#EtymologyThe name Luddite (/ˈlʌd.aɪt/) is of uncertain origin. The movement was said to be named after Ned Ludd, an apprentice who allegedly smashed two stocking frames in 1779 and whose name had become emblematic of machine destroyers. Ned Ludd, however, was completely fictional and used as a way to shock and provoke the government.[7][8][9] The name developed into the imaginary General Ludd or King Ludd, who was reputed to live in Sherwood Forest like Robin Hood.[10] |
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Post by mytakeonit on Jun 22, 2021 22:42:31 GMT -5
Ludite - A person who is averse to addapting to technology.
But, that's mywinetakeonit
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Post by mango on Jun 23, 2021 7:38:01 GMT -5
Excellent studies. Nothing but the best with Afrezza 💪
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Post by mango on Jun 23, 2021 7:55:39 GMT -5
The A1c hypothesis has long been proven wrong by TIR via CGMs. As if we didn't already know this, but because of the significant increase in hypos caused by RAAs we see a significantly lower A1c. Afrezza maintains incredible TIR, significantly better in fact than RAAs, and causes significantly less hypos and a more natural decrease in A1c. A1c is merely a proxy though and does not accurately assess glucose homeostasis. Time in range does. Afrezza brings postprandial blood glucose levels back to balance. Afrezza restores postprandial glucose homeostasis. I would like to see MannKind spearhead the new TIR hypothesis for accurately assessing glucose homeostasis and put an end to the A1c quackery. STAT was the POC.   |
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