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Post by spikespiegel on Jun 6, 2019 4:35:00 GMT -5
Abstract Fourteen T2D subjects in a real-world practice setting, uncontrolled on oral/injectable combo therapy (mean A1C 9%), received inhaled human insulin (INH-Afrezza), added to current therapy and titrated weekly for up to 12 weeks. A1C and 2-week continuous glucose monitoring (CGMS) profiles (Libre Pro) were collected at baseline and after 3 months. All subjects started INH 4 units (u) prior to each meal and titrated rapidly to 12 u/meal over 9 days. Thereafter, INH was adjusted for each meal once weekly, based on PPG at 2-2.5 hours measured on days 1 and 2 of each week, as follows: Add 4 u if PPG > 160 mg/dl, no change if PPG 90-160 mg/dl and decrease by 4 u if PPG < 90 mg/dl. More than 1/2 of subjects were taking basal insulin. Addition of the only available inhaled ultra-rapid rapid mealtime insulin (Afrezza) lowered glucose safely in patients with T2D inadequately controlled on oral and/or injectable therapy. Initiation and titration, following a simple algorithm, resulted in significant A1c reduction (-1.6%, p<.0001), a decrease in mean daily glucose (∼50 mg/dl), and a 76% increase in time-in-range on CGMS, with no significant increase in hypoglycemia (Time<70 mg/dL). No severe hypoglycemia occurred. Final mealtime Afrezza doses achieved were 18, 16 and 20 u at breakfast, lunch, dinner respectively. link to the abstract
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Post by cjm18 on Jun 6, 2019 7:08:06 GMT -5
So patients added a libre and Afrezza??
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Post by Clement on Jun 6, 2019 7:25:34 GMT -5
Very nicely done. I hope this can help position Afrezza as a go-to for uncontrolled T2.
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Post by kite on Jun 6, 2019 7:31:22 GMT -5
Very nicely done. I hope this can help position Afrezza as a go-to for uncontrolled T2. Why is MNKD slow to post this type of news on their website or social media....
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Post by goyocafe on Jun 6, 2019 7:34:04 GMT -5
Very nicely done. I hope this can help position Afrezza as a go-to for uncontrolled T2. Why is MNKD slow to post this type of news on their website or social media.... I suspect the ADA has similar rules for posters, mainly “show results here first, or you can’t show them”.
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Post by goyocafe on Jun 6, 2019 7:38:41 GMT -5
I like this study for its simplicity and the dosing protocol used. I’m sure it be be much more tightly controlled, but it looks like a label when I read the dosing parameters, and see it as something docs could get their arms around.
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Post by agedhippie on Jun 6, 2019 7:41:31 GMT -5
Very nicely done. I hope this can help position Afrezza as a go-to for uncontrolled T2. Not as it stands. Insulin gives better control than taking no action if the patient's existing drugs have failed. That's not news, it's the SoC guidance! I am curious why there is no comparator arm using RAA because while it should have produced comparable HbA1c results the CGM results should have been better and that would be good in a paper. Anyway - a link to the results table: Table
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Post by boca1girl on Jun 6, 2019 7:41:45 GMT -5
Very nicely done. I hope this can help position Afrezza as a go-to for uncontrolled T2. Why is MNKD slow to post this type of news on their website or social media.... This is being presented at the ADA this weekend. They may be forced to wait until after it is presented.
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Post by sellhighdrinklow on Jun 6, 2019 8:14:31 GMT -5
"...and a 76% increase in time-in-range on CGMS, with no significant increase in hypoglycemia (Time<70 mg/dL)."
76% !!!
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Post by goyocafe on Jun 6, 2019 8:25:32 GMT -5
"...and a 76% increase in time-in-range on CGMS, with no significant increase in hypoglycemia (Time<70 mg/dL)." 76% !!! I’d like to see that stated as total TIR since someone with uncontrolled bg probably doesn’t spend a lot of time in range to begin with. Increasing it by 100% may not yield a high total depending on the starting point. Kind of like increasing sales by 100% by selling two units versus one.
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Post by kimi on Jun 6, 2019 9:29:15 GMT -5
© 2019 by the American Diabetes Association.
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Post by rtmd on Jun 6, 2019 9:38:57 GMT -5
They should have included a control group following the same instructions but using a RAA. As it stands, there's no way to determine whether the patients would have done just as well following the same regimen with a RAA, a libre, and titration instructions.
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Post by prcgorman2 on Jun 6, 2019 9:48:18 GMT -5
Maybe it's a throw-down? How about Sanofi run the same protocol with Afrezza as the comparator? Or would that kill the patients at those unit levels?
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Post by hellodolly on Jun 6, 2019 9:49:13 GMT -5
They should have included a control group following the same instructions but using a RAA. As it stands, there's no way to determine whether the patients would have done just as well following the same regimen with a RAA, a libre, and titration instructions. I believe that study came out earlier this year or something similar compared to FIASP and Lispro?
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Post by shawnonafrezza on Jun 6, 2019 9:53:28 GMT -5
Maybe it's a throw-down? How about Sanofi run the same protocol with Afrezza as the comparator? Or would that kill the patients at those unit levels? When dealing with Afrezza, units are near meaningless. 100% meaningless compared to RAA. Dose is the poison with all insulin and I could go on someone doses and be dead in a few hour. But 20U of RAA in a meal is a lot to me. I didn't take that much RAA in a day. It would drop my blood sugar either 900 mg/dl or need 280g of carbs... But that is the fun part of Afrezza which I don't know if it can be highlighted. I had to bust out my calculator to get the 900/280 numbers. Afrezza doesn't need that accuracy.
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