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Post by hellodolly on Jun 5, 2019 10:17:47 GMT -5
1350-P - Safety and Pharmacokinetics of Technosphere Insulin in Pediatric Patients
Pediatric Study is now on the 2019 ADA Meeting website. The abstract provides inclusion data and information about the entire study and includes results for Cohort 1 patients ages 13 -18 up through August 16, 2018. Cohort 1 through August 16, 2018, 15 patients were enrolled & 8 patients completed titration period. 6 patients developed mild cough & 1 patient severe cough. PK results were similar to what was seen in adults patients. 7 patients experienced a total of 41 hypoglycemic events none requiring assistance of another person to administer corrective carbohydrates. It doesn't break down number of hypoglycemic events per patient. No clinically relevant declines in pulmonary function were reported. Two patients discontinued the study due to adverse events (cough, diabetic ketoacidosis). Will Monday's abstract include more current results ? plan.core-apps.com/tristar_ada19/abstract/23b1b637ba2e46d4ad6b8619bbf7c669
Above from ST today.
From ADA Poster:
Safety and Pharmacokinetics of Technosphere Insulin in Pediatric Patients
Author Block: MARSHALL L. GRANT, JOHN A. KRUEGER, MARK FINEMAN, GAURAV SHARMA, FRANK POMPILIO, DAVID M. KENDALL, Westlake Village, CA, San Diego, CA
Technosphere Insulin (TI) is an ultra-rapid, short-acting inhaled insulin that provides glycemic control in patients with diabetes. This ongoing, 2-part, open-label, interventional study aims to assess the efficacy and safety of TI in children aged 4 to 17 years with type 1 diabetes mellitus (T1DM) who are on a stable regimen of basal-bolus insulin therapy. Part 1 is a single-arm study that includes evaluation of insulin pharmacokinetics (PK) after a single prandial dose of TI (4, 8, or 12 units), followed by a 4-week titration period. Approximately 46 patients will be enrolled across 3 age cohorts: cohort 1 (13-17 years), cohort 2 (8-12 years), and cohort 3 (4-7 years). As of August 16, 2018, 15 patients had enrolled in cohort 1, 14 had received at least 1 dose, and 8 completed the titration period. Overall, 50% of the safety population (n=14) was female, mean duration of T1DM was 6.2 years, mean age was 15 years, and mean body mass index was 22.4 kg/m2. Initial PK results from cohort 1 demonstrated insulin metabolism similar to that in adult patients receiving TI. Insulin concentrations rapidly increased in the first 30 minutes after TI treatment and returned to baseline by 120 minutes for the 4-, 8-, and 12-unit doses. Mean postprandial glucose levels decreased within 1-hour postdose for the 8- and 12-unit dose groups. Seven patients developed treatment-related cough of mild (6 events) or moderate (1 event) severity. Seven patients experienced a total of 41 hypoglycemic events, but no patient required the assistance of another person to administer corrective carbohydrates. No clinically relevant declines in pulmonary function were reported. Two patients discontinued the study due to adverse events (cough, diabetic ketoacidosis). These data will help determine the appropriate age range for inclusion and recommended dosing for part 2, which will be a 1-year efficacy and safety study.
Disclosures: M.L.Grant: Employee; Self; MannKind Corporation, Stock/Shareholder; Self; MannKind Corporation. J.A.Krueger: Employee; Self; Eli Lilly and Company, MannKind Corporation, Stock/Shareholder; Self; Eli Lilly and Company. M.Fineman: Consultant; Self; MannKind Corporation, Employee; Self; Elcelyx Therapeutics, Inc., Stock/Shareholder; Self; Elcelyx Therapeutics, Inc.. G.Sharma: Employee; Self; MannKind Corporation. F.Pompilio: Employee; Self; MannKind Corporation, Stock/Shareholder; Self; Amgen Inc., MannKind Corporation. D.M.Kendall: Employee; Self; MannKind Corporation, Employee; Spouse/Partner; Amgen Inc., Stock/Shareholder; Self; MannKind Corporation.
Sessions
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Post by #NoMoreNeedles on Jun 5, 2019 10:33:59 GMT -5
Where is the booth? Oh, no sorry ... where is the PR?
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Post by awesomo on Jun 5, 2019 10:38:43 GMT -5
So only the oldest age group cohort has been filled and 2 out of 15 patients dropped out because of adverse effects?
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Post by peppy on Jun 5, 2019 11:03:50 GMT -5
So only the oldest age group cohort has been filled and 2 out of 15 patients dropped out because of adverse effects? get a grip. This is insulin. You think if people had a choice they would choose subq? Insulin dosing is learned. learn to accept the technosphere by lung, or subq, pod, what ever type one diabetes needs to be managed. People learned to smoke cigarettes to be "in." They were in all the movies, Humphrey Bogart, smoking jackets. People can learn to inhale insulin. Was it the 1980's on the news there used to be talk about heroin being smoke, They called it horse. Heroin is the street name for morphine, little did I know. Hell people were even smoking morphine. |
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Post by agedhippie on Jun 5, 2019 11:06:02 GMT -5
So only the oldest age group cohort has been filled and 2 out of 15 patients dropped out because of adverse effects? DKA. I wonder what the circumstances around that were. |
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Post by shawnonafrezza on Jun 5, 2019 11:27:34 GMT -5
From the abstract nothing really calls out to me. I'm curious about the DKA patient because DKA doesn't come from lack of bolus insulin (usually) unless something is horribly wrong.
Hope the study has numbers on hypoglycemia. Are we talking 65mg/dl or 55mg/dl. Self treat means probably not too low but I'm more or less fully functional all the way to 35mg/dl.
Doctors fear hypoglycemia so much but it's just T1 life. I don't know a single patient who is honest with how often they go low because they get chewed out.
Wish they got more patients. Also wish they bothered with 2U. I know adults sensitive enough to need them, I can't imagine a little 5 year old not needing them. Maybe that's later.
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Post by mannmade on Jun 5, 2019 11:27:57 GMT -5
Cough?
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Post by buyitonsale on Jun 5, 2019 12:08:33 GMT -5
1. Why is the data almost a year old?
2. When will patients be instructed on how to properly position inhaler, how slow to inhale and sip water before / after, to eliminate the coughing? Nobody should drop out these days due to coughing if they are coached how to use DPI ... imo
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Post by seanismorris on Jun 5, 2019 12:25:05 GMT -5
Those results are terrible. The study sounds mishandled.
Afrezza might cause a mild cough, but few should discontinue Afrezza because of it and it should go away as they get used to it.
We need a lot more details. The ADA presentation better impress more than the abstract...
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Post by awesomo on Jun 5, 2019 12:29:55 GMT -5
Those results are terrible. The study sounds mishandled. Afrezza might cause a mild cough, but few should discontinue Afrezza because of it and it should go away as they get used to it. We need a lot more details. The ADA presentation better impress more than the abstract... It's not a presentation, it is Kendall (I hope) standing next to a poster with these results in a giant hall of hundreds of posters. |
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Post by peppy on Jun 5, 2019 13:02:53 GMT -5
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Post by casualinvestor on Jun 5, 2019 13:10:27 GMT -5
IMO a cough is a more likely with pediatric than adult. Kids are just going to breathe in the way they want to breathe. They're also less used to suppressing a cough, or breathing irritating air in general
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Post by sportsrancho on Jun 5, 2019 13:20:50 GMT -5
1. Why is the data almost a year old? 2. When will patients be instructed on how to properly position inhaler, how slow to inhale and sip water before / after, to eliminate the coughing? Nobody should drop out these days due to coughing if they are coached how to use DPI ... imo !!!! 🤦🏼‍♀️Exactly |
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Post by nylefty on Jun 5, 2019 13:22:40 GMT -5
Those results are terrible. The study sounds mishandled. Afrezza might cause a mild cough, but few should discontinue Afrezza because of it and it should go away as they get used to it. We need a lot more details. The ADA presentation better impress more than the abstract... Disappointing results. Those calling for PR on this should think again. |
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Post by seanismorris on Jun 5, 2019 13:27:32 GMT -5
So only the oldest age group cohort has been filled and 2 out of 15 patients dropped out because of adverse effects? get a grip. This is insulin. You think if people had a choice they would choose subq? Insulin dosing is learned. learn to accept the technosphere by lung, or subq, pod, what ever type one diabetes needs to be managed. People learned to smoke cigarettes to be "in." They were in all the movies, Humphrey Bogart, smoking jackets. People can learn to inhale insulin. Was it the 1980's on the news there used to be talk about heroin being smoke, They called it horse. Heroin is the street name for morphine, little did I know. Hell people were even smoking morphine. awesomo has valid questions. I was also shocked. You said “You think if people had a choice they would choose subq?”. Apparently, the answer is yes... It says “15 patients were enrolled & 8 patients completed titration period.” I don’t know about you, but this created so serious questions... Where did these people go? Why didn’t they complete the titration period? Did the move away from the testing location? We know 2 dropped out because of events... Were the patients not properly trained? Expectations managed, with regards to the cough... The pediatric study should have been a slam dunk, with people/kids very motivated to avoid a lifetime of shots. The only good thing was “No clinically relevant declines in pulmonary function were reported.” but that was expected. |
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