I think these study subjects are not yet on insulin since this is to show Afrezza's potential for earlier adoption of inhalable insulin in the progression of the disease. The subjects, i believe are only on Metformin, or Metformin with another oral treatment. Hence a placebo with no insulin would not be any worse than the regimine the placebo group is already on, and the active group would hopefully show imporved GC control as a result of the TI. I'm not an expert on this, so take it for what it is worth.