Pediatric Trial

[Deleted]

A few years back the FDA came to Mannkind and asked that Afrezza be tested in kids down to 4 years old. A better mealtime insulin and no needles is obviously compelling.

Another article on a side note big companies fed up with rising healthcare costs taking matters into their own hands. That initiative with Buffett, Amazon and JPM will be interesting. Slowly, the DIC (Diabetes Industrial Complex) is going to go through a modernization from fee for service to fee for outcome. The ROI on Afrezza when the long term healthcare issues are decreased significantly for patients using Afrezza will be massive. Still need to see $$ pick up after ADA but if it ramps enough, Mannkind is here to stay and those unsavory entities and people who tried to destroy what Al created will have failed.

finance.yahoo.com/news/fed-rising-costs-big-u-firms-dig-healthcare-100535670--finance.html

[peppy]

Jun 9, 2018 17:31:05 GMT -5 @kastanes said:

Rising pointed out something interesting.

Up until March 26, it said:

"The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit.
Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year."

But as of May 18, it says only:

"The patients are expected to participate in the study for approximately 6 to 8 weeks from Screening to final follow-up visit."

Why would they remove the option to extend the treatment if the patient wanted it?

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Is it possible the trial will be completed in less than a year?

you are correct. I no longer see; "Patients who completed 4 weeks of Afrezza treatment and have shown to be safe and well controlled with Afrezza + basal insulin will have the option to continue the extension treatment up to 1 year." 
clinicaltrials.gov/ct2/show/NCT03143816

Use of CGM for Therapeutic Product Development and Regulatory Purposes in Clinical Trials

In clinical trials the roles of SMBG and CGM technologies substantially overlap. CGM has great potential for supporting clinical development, e.g., of new insulin products and other glucose-lowering agents in people with both T1D and T2D. Analysis of continuously registered glucose profiles provides much more information about the impact of drugs on ambient glucose levels than any form of episodic SMBG (e.g., 7-point glucose profiles). For example, the frequency of nocturnal or total daily hypoglycemic events as determined by CGM could be used as a clinical trial end point [1d]: no other feasible alternative technology for accessing nocturnal hypoglycemia is available. For CGM to provide evaluable end points, consensus on definitions of the various levels of time in range and hypoglycemia (in clinical practice and by CGM) is urgently required among payers and providers (21,43). There has been some very recent progress on this topic (58).

If the FDA and other regulators were to accept such consensus definitions, CGM could have significant impact on the development and refining of new diabetes treatment options. The same technology could be used for better studies of physiology and pathophysiology, e.g., understanding glucose metabolism during exercise and feeding in health and disease. A virtuous cycle could be created with increasing evidence for the value of monitoring technologies, improvement in these technologies, and demonstration of the favorable economics of wider availability. The FDA’s Center for Drug Evaluation and Research, which regulates drug therapies, recently examined new definitions and standards for measuring glucose control and other patient-reported outcomes beyond HbA1c in clinical trials and expressed willingness to continue a series of meetings in an attempt to reach a consensus (21). The FDA’s Center for Devices and Radiological Health (CDRH), which regulates devices and diagnostics, is supportive of the use of data from appropriately standardized CGM devices for clinical trials, as it has approved numerous trials using devices that regulate insulin delivery based on CGM values (36,39,59). The CDRH has generally requested that investigators utilize the key glucose outcome metrics outlined by Maahs et al. (21) in the Consensus Report on artificial pancreas outcome measures for clinical trials.
care.diabetesjournals.org/content/40/12/1614