http://clinicaltrials.gov/ct2/show/NCT01445951?term=mkc&rank=41

The primary outcome, obviously, is A1C:

"Effect of treatment as measured by change in glycated hemoglobin (HbA1c): Comparison of baseline HbA1c to end of treatment HbA1c after 24 weeks [ Time Frame: 24 Weeks ] "

One question is:

What are the parameters / guidelines that will be used to compare the dreamboat (gen 2) to the Medtone C inhaler?

Do the groups need to lower A1C in a similar fashion for the study to be a success?

Another question is:

What if the dreamboat outperforms the Medtone C in lowering A1C? Does this invalidate the previous testing results, requiring further trials?

From my understanding, this is the pivotal trial that will allow the dreamboat to come to market, using all of the previous Phase 1/2 data.

After reading Afrezzausers testimony, I started thinking, and couldn't find a more finite description of the parameters on which the two devices were being comapred, and what would be considered a "success".

Input would be greatly appreciated!

I couldn't sleep last night worrying about the what-if scenario where the dreamboat outperforms the medtone-c and thus would require further trials!