P IV clinical study

[myocat]

clinicaltrials.gov/ct2/show/NCT03143816

The start date seems incorrect. 

Estimated Enrollment: 60

Anticipated Study Start Date: September 30, 2017

Estimated Study Completion Date: October 15, 2017

Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)

[sellhighdrinklow]

Sept 24, 2017 7:19:35 GMT -5 myocat said:

clinicaltrials.gov/ct2/show/NCT03143816

The start date seems incorrect. 

Estimated Enrollment: 60

Anticipated Study Start Date: September 30, 2017

Estimated Study Completion Date: October 15, 2017

Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)

I thought this study was a 4 month study , ending October 15. Now it says start date of September 30 w end date October 15. ...what am I missing?

[mnholdem]

The timeframes on the Primary and Secondary outcomes are all 4 weeks, not 4 months, although recruitment began a couple months ago. 

[timri]

TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. That’s from the study info. How are they already giving it that designation with out fda approval. 

[mnholdem]

Because it's an investigator-initiated study. Whether MannKind will be able to use this study data for future label upgrades depends upon the protocols. A better road would be to get the results published in Lancet and other major medical journals. It's important to bring the debate (initiated last summer by the FDA) of using more accurate measurements, such as Time-in-Range, to more thoroughly evaluate diabetes treatments.

Endocronologists may be aware of the FDA initiative to supplant the decades-old a1C test with better key measurements made possible by continuous glucose monitors and other advances, but many primary care physicians remain uneducated on the subject.

That's why publishing research studies can bear fruit for MannKind, who is one of the sponsors, and benefit the medical industry as a whole.

[dreamboatcruise]

Sept 24, 2017 12:55:22 GMT -5 timri said:

TI is an inhaled ultra-rapid-acting insulin, approved by the FDA for use in patients with diabetes. That’s from the study info. How are they already giving it that designation with out fda approval. 

It probably boils down to the FDA regulating what is said "marketing" a drug, not what is said in researching a drug.

[timri]

Thanks for clarification makes sense. 

[myocat]

Thanks for the insight, it's another date to look forward to "Oct 15, 2017".