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Message: Re: MannKind ASM Notes
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May 17, 2012 06:18PM

May 17, 2012 06:59PM
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May 17, 2012 07:01PM

May 17, 2012 07:14PM

I hear ya.I was just hoping that they only try for superiority in the Type 2 trial and not screw around with the all important Type 1 trial.However,I have since done a little checking and they apparently are also going for superiority in the Type 1 trial ...

Al:

"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."


May 17, 2012 08:18PM

opc
May 17, 2012 09:55PM

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