Afrezza studies.

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Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT)

clinicaltrials.gov/ct2/show/NCT03143816

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The dose optimization study is the Afrezza dynamic dosing study, which we're calling [AED-1] study. This protocol is very close to finalization and we're aiming for a July/August start with the possible Q4 completion, date available soon after.

Read more: mnkd.proboards.com/thread/7987/meet-satish-conduct-range-study#ixzz4iwiAGc5Z

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2017 study slide.

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We are putting together an Afrezza pediatric program that will include not only the regulatory required studies, but ancillary studies to address patient, provider and payer needs. We anticipate the first study in this program the PK-Start program I should say to start around June 15th. We are hoping to capitalize on the summer months to recruit these pediatric patients a little bit more quickly.

Read more: mnkd.proboards.com/thread/7987/meet-satish-conduct-range-study#ixzz4iwk8gWQH

[lakers]

Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
clinicaltrials.gov/ct2/show/NCT02527265

Pediatric PK Study is supposed to start 6/15/17.

JDRF Round-Up with Aaron Kowalski

Kowalski mentioned how much he likes using Afrezza, an inhaled insulin. “It’s almost a miracle drug for me.” But the company that created it, MannKind, “is having a hard time staying afloat. If MannKind fails, that’s a big deal for other companies spending money on better diabetes treatments.”)

asweetlife.org/jdrf-round-up-with-aaron-kowalski/

Next slide, the subsequent pediatric Phase 3 trial which we will file for pediatric indication, we will incorporate evidence not only from the PK study that we have conducted previously but as well as data from recent publications. These publications, as you can see on this slide, include dosing simulation work and the Afrezza with the artificial pancreas. The use of Afrezza with the artificial pancreas is impressive and promising and an area that we are actively investigating.

When you take all of this data around the dosing and titration of Afrezza it helps to inform us as to the proposed pediatric protocol changes that we will need in the Phase 3 trial, which we believe will substantially improve study recruitment and retention and thereby expediting our filing dates.

Read more: mnkd.proboards.com/thread/6959/afrezza-safety-pharmacokinetics-study-pediatric#ixzz4k383IUIq

Improving Efficacy of Inhaled Technosphere Insulin (Afrezza) by Postmeal Dosing:
In-silico Clinical Trial with the University
of Virginia/Padova Type 1 Diabetes Simulator
Roberto Visentin, PhD,1 Clemens Giegerich, MS,2 Robert Ja ̈ger, PhD,2 Raphael Dahmen, MD,2 Anders Boss, MD,3 Marshall Grant, PhD,4
Chiara Dalla Man, PhD,1 Claudio Cobelli, PhD,1 and Thomas Klabunde, PhD2
Abstract
Background: TechnosphereÒ insulin (TI), an inhaled human insulin with a fast onset of action, provides a novel option for the control of prandial glucose. We used the University of Virginia (UVA)/Padova simulator to explore in-silico the potential benefit of different dosing regimens on postprandial glucose (PPG) control to support the design of further clinical trials. Tested dosing regimens included at-meal or postmeal dosing, or dosing before and after a meal (split dosing).
Methods: Various dosing regimens of TI were compared among one another and to insulin lispro in 100 virtual type-1 patients. Individual doses were identified for each regimen following different titration rules. The resulting postprandial glucose profiles were analyzed to quantify efficacy and the risk for hypoglycemic events. Results: This approach allowed us to assess the benefit/risk for each TI dosing regimen and to compare results with simulations of insulin lispro. We identified a new titration rule for TI that could significantly improve the efficacy of treatment with TI.
Conclusion: In-silico clinical trials comparing the treatment effect of different dosing regimens with TI and of insulin lispro suggest that postmeal dosing or split dosing of TI, in combination with an appropriate titration rule, can achieve a superior postprandial glucose control while providing a lower risk for hypoglycemic events than conventional treatment with subcutaneously administered rapid-acting insulin products.

online.liebertpub.com/doi/pdfplus/10.1089/dia.2016.0128?download=true