Re: MannKind ASM Notes
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posted on
May 17, 2012 10:16PM
Edit this title from the Fast Facts Section
OPC,I think they are both superiority, here's what Hakan said about the Type 2 trial...
"Our pivotal Type 2 study, the MKC-175, was initiated on schedule following the start of the Type 1 pivotal study. Site activation is well underway, with 35 U.S. sites already established and with additional sites currently being activated. The MKC-175 investigator meeting in Russia was held last week and Russian site activation and recruitment are now beginning. This is to be a superiority study in early-stage Type 2 patients failing on Metformin or Metformin plus another oral drug."
And here's what Al said about the Type 1 trial...
"Even though AFREZZA does not have the late postprandial persistence, basal insulins have not been separately titrated for the AFREZZA cohorts in our trials, so that fasting levels are excessively high in those patients as well. Since the HbA1c is really an average glucose level over 2 to 3 months, these high fasting glucose levels tend to mask the more physiological prandial benefits of AFREZZA.
With our current study MKC-171, we are targeting this issue head on by requiring the fasting glucose level to be lower to under 110 milligram per deciliter, unless there is hypoglycemia. In earlier trials, even with AFREZZA cohorts, clinicians have generally not increased basal insulins to adjust fasting glucose to goal."