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Post by robsacher on Aug 26, 2015 6:49:14 GMT -5
rob, I wonder if perhaps compound26 might be willing to host selected articles of yours on his afrezzajustbreathe.com site? I'm thinking of the ones SA rejects (for their own rinky-dink reasons). They could be featured prominently on compound's site, perhaps getting more exposure than if just posted here. Rob, BD and xoxoxoxo, I can certainly post Rob's articles on afrezzajustbreathe.com site, with some revisions. As I previously stated, afrezzajustbreathe.com site is geared towards Afrezza the drug itself, removed of any financial/stock analysis of Mannkind. If Rob wants to, I will be more than happy to add Rob as a editor to the site so that he can post his articles to the afrezzajustbreathe.com site. Rob, if you are interested, you can PM me. compound26, Please feel free to do whatever is helpful for the diabetic community; take any articles you find here on the MannKind MNKD Message Board, edit, and repost at your site. Also, I ran across someone who has had difficulty in finding a doctor willing to prescribe Afrezza in Seattle. Perhaps a list of doctors who are prescribing Afrezza on your website, broken down by state and city, would be very helpful.  Best wishes, RS |
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Post by robsacher on Aug 26, 2015 6:53:59 GMT -5
If anyone has an idea for a new article that you think is worth exploring, let me know and I'll give it some thought... Rob, I don't know all of your articles but the current studies in progress like the "clamp study" and expected outcomes might be worth revisiting. Went through several pages of the thread here today, fascinating. I really truly think that attention spans out there are getting shorter and shorter, there are so many distractions and from what I've heard, the trend is moving back toward quality journalism and away from free media sources. I am unaware of the 'clamp study'. Can you please post a link or two and I'll take a look. Thanks. |
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Post by peppy on Aug 26, 2015 7:01:39 GMT -5
Rob, I don't know all of your articles but the current studies in progress like the "clamp study" and expected outcomes might be worth revisiting. Went through several pages of the thread here today, fascinating. I really truly think that attention spans out there are getting shorter and shorter, there are so many distractions and from what I've heard, the trend is moving back toward quality journalism and away from free media sources. I am unaware of the 'clamp study'. Can you please post a link or two and I'll take a look. Thanks. The Clamp Study Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus www.clinicaltrials.gov/ct2/show/NCT02470637 |
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Post by mssciguy on Aug 26, 2015 7:08:07 GMT -5
Rob, I don't know all of your articles but the current studies in progress like the "clamp study" and expected outcomes might be worth revisiting. Went through several pages of the thread here today, fascinating. I really truly think that attention spans out there are getting shorter and shorter, there are so many distractions and from what I've heard, the trend is moving back toward quality journalism and away from free media sources. I am unaware of the 'clamp study'. Can you please post a link or two and I'll take a look. Thanks. Also mnkd.proboards.com/thread/2757/sanofi-filed-afrezza-single-clamp |
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Post by brentie on Aug 26, 2015 7:59:56 GMT -5
I am unaware of the 'clamp study'. Can you please post a link or two and I'll take a look. Thanks. The Clamp Study Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus www.clinicaltrials.gov/ct2/show/NCT02470637It looks to be one of the trials required by the FDA for approval. --------------------------------------------------------------------------------------------------------- The FDA is requiring the following post-marketing studies for Afrezza: a clinical trial to evaluate pharmacokinetics, safety and efficacy in pediatric patients; a clinical trial to evaluate the potential risk of pulmonary malignancy with Afrezza (this trial will also assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function); two pharmacokinetic-pharmacodynamic euglycemic glucose-clamp clinical trials, one to characterize dose-response and one to characterize within-subject variability. |
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Post by compound26 on Aug 26, 2015 9:42:41 GMT -5
Rob, BD and xoxoxoxo, I can certainly post Rob's articles on afrezzajustbreathe.com site, with some revisions. As I previously stated, afrezzajustbreathe.com site is geared towards Afrezza the drug itself, removed of any financial/stock analysis of Mannkind. If Rob wants to, I will be more than happy to add Rob as a editor to the site so that he can post his articles to the afrezzajustbreathe.com site. Rob, if you are interested, you can PM me. compound26, Please feel free to do whatever is helpful for the diabetic community; take any articles you find here on the MannKind MNKD Message Board, edit, and repost at your site. Also, I ran across someone who has had difficulty in finding a doctor willing to prescribe Afrezza in Seattle. Perhaps a list of doctors who are prescribing Afrezza on your website, broken down by state and city, would be very helpful. Best wishes, RS Rob, great. Thanks! I will add some of your articles to the site. Probably over the weekend, as I am currently tied up in work. On the list of doctors who are prescribing Afrezza, I have a post on the site, however, so far I have only limited information. See the following post: mnkd.proboards.com/thread/3363/afrezza-prescribing-physicians |
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Post by dreamboatcruise on Aug 26, 2015 10:25:17 GMT -5
Those clamp studies seem to merely be more complete versions of what was already done and represented in the pk/pd profiles we've all seen. We'll just have more data showing the same sort of response for different doses and that it holds across more people. By definition of what is done it won't show improvement with regard to hypos or A1c.
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Post by robsacher on Aug 26, 2015 18:00:38 GMT -5
I am unaware of the 'clamp study'. Can you please post a link or two and I'll take a look. Thanks. The Clamp Study Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes Mellitus www.clinicaltrials.gov/ct2/show/NCT02470637Thanks. I'll check this out asap. |
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Post by tayl5 on Aug 27, 2015 15:46:02 GMT -5
If I understand correctly, the idea behind a euglycemic clamp test is to establish a constant concentration of insulin and vary the amount of glucose injected until it reaches a predetermined steady state. I can understand how one would do that with an injected insulin. Any ideas how it would be done with an inhaled insulin? If the blood glucose level is proportional to the amount of systemic insulin, I could see titrating the insulin with variable glucose, but Afrezza seems to keep glucose more-or-less flat within a relatively narrow range as it enters, peaks and recedes.
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Post by dreamboatcruise on Aug 27, 2015 15:54:16 GMT -5
tayl5... there shouldn't be any difference in the way the study is/was done. Give a fixed dose of insulin, whether injection or inhaled and then titrate glucose to maintain the steady target healthy blood glucose level. This shows the body's response regarding how much glucose is being removed from blood due to the insulin action from a particular set dose. It's not trying to establish a constant concentration of insulin in the blood. It is a fixed dose that is administered.
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Post by tayl5 on Aug 29, 2015 16:29:22 GMT -5
tayl5... there shouldn't be any difference in the way the study is/was done. Give a fixed dose of insulin, whether injection or inhaled and then titrate glucose to maintain the steady target healthy blood glucose level. This shows the body's response regarding how much glucose is being removed from blood due to the insulin action from a particular set dose. It's not trying to establish a constant concentration of insulin in the blood. It is a fixed dose that is administered. Everything I know I learned from Wikipedia: Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained at 100 μU/ml by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity. The hyperinsulinemic clamps are often used to measure insulin resistance. |
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Post by dreamboatcruise on Aug 29, 2015 17:08:07 GMT -5
tayl5... There are different uses for clamp studies and that wikipedia page describes it in the most general sense which in some cases does require titrating the insulin. Sometimes they are used to evaluate the state of a patient's insulin production and insulin sensitivity rather than related to characterizing effect of a new drug. For evaluation of an insulin drug product pk/pd, I believe the dose of insulin is fixed. See the link below that describes such experiment. Here is the part about administration of the insulin... "Subjects will usually be cannulated in both arms, one for blood sampling and intravenous saline, and the other for a glucose infusion. The subject is then administered the protocol-specified dose of insulin, for example, using an insulin pen and administering a 0.2U/kg dose, or using a needle with a specified volume of insulin."from illingworthresearch.com/2012/07/20/glucose-clamping-in-clinical-trials/
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Post by tayl5 on Aug 30, 2015 16:06:38 GMT -5
tayl5... There are different uses for clamp studies and that wikipedia page describes it in the most general sense which in some cases does require titrating the insulin. Sometimes they are used to evaluate the state of a patient's insulin production and insulin sensitivity rather than related to characterizing effect of a new drug. For evaluation of an insulin drug product pk/pd, I believe the dose of insulin is fixed. See the link below that describes such experiment. Here is the part about administration of the insulin... "Subjects will usually be cannulated in both arms, one for blood sampling and intravenous saline, and the other for a glucose infusion. The subject is then administered the protocol-specified dose of insulin, for example, using an insulin pen and administering a 0.2U/kg dose, or using a needle with a specified volume of insulin."from illingworthresearch.com/2012/07/20/glucose-clamping-in-clinical-trials/ Thanks for the additional information, DBC. The clinical trial page specified that the method they will use is euglycemic clamp. I think that means they will maintain a constant does of insulin. I wonder if there's a way to liquify and instantly inject Technosphere insulin? Would that be considered a fair comparator to insulin that passed through the lungs? |
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Post by dreamboatcruise on Aug 30, 2015 17:01:20 GMT -5
tayl5... There are different uses for clamp studies and that wikipedia page describes it in the most general sense which in some cases does require titrating the insulin. Sometimes they are used to evaluate the state of a patient's insulin production and insulin sensitivity rather than related to characterizing effect of a new drug. For evaluation of an insulin drug product pk/pd, I believe the dose of insulin is fixed. See the link below that describes such experiment. Here is the part about administration of the insulin... "Subjects will usually be cannulated in both arms, one for blood sampling and intravenous saline, and the other for a glucose infusion. The subject is then administered the protocol-specified dose of insulin, for example, using an insulin pen and administering a 0.2U/kg dose, or using a needle with a specified volume of insulin."from illingworthresearch.com/2012/07/20/glucose-clamping-in-clinical-trials/ Thanks for the additional information, DBC. The clinical trial page specified that the method they will use is euglycemic clamp. I think that means they will maintain a constant does of insulin. I wonder if there's a way to liquify and instantly inject Technosphere insulin? Would that be considered a fair comparator to insulin that passed through the lungs? p10 of www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM390864.pdf discusses a prior euglycemic clamp study making it clear that Afrezza was delivered via an inhaler... in this case the "gen 2" device. |
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