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Post by mango on Jun 3, 2017 13:49:29 GMT -5
A Population Dose–Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects—Published June 1, 2017 AbstractTechnosphere insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. A euglycemic glucose clamp study was performed to compare the effects of TI and regular human insulin (RHI) on the induced glucose infusion rate (GIR) in healthy volunteers. Generation of a dose–response relationship between insulin dose and effect (expressed as AUC of GIR) was not possible from the clinical data directly. The GIR recording time was too short to capture the full effect and higher doses were not tested. Thus, a pharmacokinetic-GIR model was developed to simulate GIR for a sufficient time window of 20 h and for higher doses. A dose–response model was then generated from the simulated GIR profiles. The resulting model provides an ED50 for TI that is 5-fold higher than for RHI, a ratio that can be used as conversion factor for equivalent doses of RHI and TI. Conflict of InterestThe clinical study was sponsored by MannKind Corporation. MG and RB are employees of MannKind. DR, TK, RD, RJ, and AB are employees of Sanofi. Technosphere and Afrezza are registered trademarks of MannKind Corporation. onlinelibrary.wiley.com/doi/10.1002/psp4.12189/full
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Post by peppy on Jun 5, 2017 0:17:41 GMT -5
A Population Dose–Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects—Published June 1, 2017 AbstractTechnosphere insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. A euglycemic glucose clamp study was performed to compare the effects of TI and regular human insulin (RHI) on the induced glucose infusion rate (GIR) in healthy volunteers. Generation of a dose–response relationship between insulin dose and effect (expressed as AUC of GIR) was not possible from the clinical data directly. The GIR recording time was too short to capture the full effect and higher doses were not tested. Thus, a pharmacokinetic-GIR model was developed to simulate GIR for a sufficient time window of 20 h and for higher doses. A dose–response model was then generated from the simulated GIR profiles. The resulting model provides an ED50 for TI that is 5-fold higher than for RHI, a ratio that can be used as conversion factor for equivalent doses of RHI and TI. Conflict of InterestThe clinical study was sponsored by MannKind Corporation. MG and RB are employees of MannKind. DR, TK, RD, RJ, and AB are employees of Sanofi. Technosphere and Afrezza are registered trademarks of MannKind Corporation. onlinelibrary.wiley.com/doi/10.1002/psp4.12189/full It took one year to publish? www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
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Post by mnkdfann on Jun 5, 2017 1:00:25 GMT -5
A Population Dose–Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects—Published June 1, 2017 AbstractTechnosphere insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. A euglycemic glucose clamp study was performed to compare the effects of TI and regular human insulin (RHI) on the induced glucose infusion rate (GIR) in healthy volunteers. Generation of a dose–response relationship between insulin dose and effect (expressed as AUC of GIR) was not possible from the clinical data directly. The GIR recording time was too short to capture the full effect and higher doses were not tested. Thus, a pharmacokinetic-GIR model was developed to simulate GIR for a sufficient time window of 20 h and for higher doses. A dose–response model was then generated from the simulated GIR profiles. The resulting model provides an ED50 for TI that is 5-fold higher than for RHI, a ratio that can be used as conversion factor for equivalent doses of RHI and TI. Conflict of InterestThe clinical study was sponsored by MannKind Corporation. MG and RB are employees of MannKind. DR, TK, RD, RJ, and AB are employees of Sanofi. Technosphere and Afrezza are registered trademarks of MannKind Corporation. onlinelibrary.wiley.com/doi/10.1002/psp4.12189/full It took one year to publish? www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
Not sure what the date associated with the conference poster was. But the paper was actually accepted and published fairly quickly. Publication History Version of record online: 1 June 2017 Manuscript Accepted: 16 February 2017 Manuscript Revised: 24 January 2017 Manuscript Received: 9 December 2016 |
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Post by mango on Jun 5, 2017 1:11:55 GMT -5
A Population Dose–Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects—Published June 1, 2017 AbstractTechnosphere insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. A euglycemic glucose clamp study was performed to compare the effects of TI and regular human insulin (RHI) on the induced glucose infusion rate (GIR) in healthy volunteers. Generation of a dose–response relationship between insulin dose and effect (expressed as AUC of GIR) was not possible from the clinical data directly. The GIR recording time was too short to capture the full effect and higher doses were not tested. Thus, a pharmacokinetic-GIR model was developed to simulate GIR for a sufficient time window of 20 h and for higher doses. A dose–response model was then generated from the simulated GIR profiles. The resulting model provides an ED50 for TI that is 5-fold higher than for RHI, a ratio that can be used as conversion factor for equivalent doses of RHI and TI. Conflict of InterestThe clinical study was sponsored by MannKind Corporation. MG and RB are employees of MannKind. DR, TK, RD, RJ, and AB are employees of Sanofi. Technosphere and Afrezza are registered trademarks of MannKind Corporation. onlinelibrary.wiley.com/doi/10.1002/psp4.12189/full It took one year to publish? www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
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Post by peppy on Jun 5, 2017 6:15:48 GMT -5
I remember now mango, thanks.
paraphrasing, "a simulation of sorts" not sure I choose the correct word there.
thanks
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Post by tingtongtung on Jun 5, 2017 19:16:21 GMT -5
A Population Dose–Response Model for Inhaled Technosphere Insulin Administered to Healthy Subjects—Published June 1, 2017 AbstractTechnosphere insulin (TI), an inhaled insulin with a fast onset of action, provides a novel option for the control of prandial glucose. A euglycemic glucose clamp study was performed to compare the effects of TI and regular human insulin (RHI) on the induced glucose infusion rate (GIR) in healthy volunteers. Generation of a dose–response relationship between insulin dose and effect (expressed as AUC of GIR) was not possible from the clinical data directly. The GIR recording time was too short to capture the full effect and higher doses were not tested. Thus, a pharmacokinetic-GIR model was developed to simulate GIR for a sufficient time window of 20 h and for higher doses. A dose–response model was then generated from the simulated GIR profiles. The resulting model provides an ED50 for TI that is 5-fold higher than for RHI, a ratio that can be used as conversion factor for equivalent doses of RHI and TI. Conflict of InterestThe clinical study was sponsored by MannKind Corporation. MG and RB are employees of MannKind. DR, TK, RD, RJ, and AB are employees of Sanofi. Technosphere and Afrezza are registered trademarks of MannKind Corporation. onlinelibrary.wiley.com/doi/10.1002/psp4.12189/full It took one year to publish? www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf
Baughman is out of MNKD as per his Linkedin. Just an FYI. |
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Post by cyn on Jun 5, 2017 20:12:07 GMT -5
Just a thought... wouldn't this study be critical to laying the foundation for a dosage conversion rate of Afrezza as a possible Over-the-Counter drug since it attempts to compare the affects of TI and subcutaneous injected regular human insulin (RHI)?
Excerpt of study...
"DISCUSSION... TI, an inhaled human insulin with a fast onset of action, provides a novel option for postprandial glucose control. However, the sharp and high insulin peaks after TI dosing have raised concerns that its PD effects (e.g., glucose disposal) might be saturated at doses within the therapeutic range. This would contrast with regular human insulin or prandial insulin analogs administered via the s.c. route, where saturation is only seen beyond the therapeutic range. Differences in the dose–response behavior, in bioavailability, and in the time-action profiles between RHI and TI might lead to complex dose conversion rules for patients switching from TI to RHI or vice versa. Thus, it is of utmost importance to compare the dose–response relationships of TI and RHI."
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Post by agedhippie on Jun 5, 2017 20:38:03 GMT -5
Just a thought... wouldn't this study be critical to laying the foundation for a dosage conversion rate of Afrezza as a possible Over-the-Counter drug since it attempts to compare the affects of TI and subcutaneous injected regular human insulin (RHI)? No. They always do this with human insulin as a reference point. |
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Post by kc on Jun 5, 2017 20:56:06 GMT -5
Published just in time to release during ADA later this week. TickTock.
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Post by kc on Jun 5, 2017 21:02:48 GMT -5
I remember now mango, thanks. paraphrasing, "a simulation of sorts" not sure I choose the correct word there. thanks Computer simulation / modeling is what MannKind had said back in 2016 giving and getting faster trial data. It was in a call April or may 2016 |
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