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Biotech / Medical : AMLN (DIABETES DRUGS)
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To: Henry Niman who wrote (543)8/20/1997 1:19:00 PM
From: David Bogdanoff   of 2173
 
Henry;

Your citations do not contradict nor detract from my point, imo.
The company offers as a reason for the 12 m. failure in glucose reduction in type 2 diabetes patients the following:

>>In a parallel type 2 diabetes study, the lowering of glucose on an intent- to-treat basis in two of the
three pramlintide dose groups achieved statistical significance after six months, but not after 12
months. These results may not have achieved statistical significance due to relatively large changes in
insulin dosing by about 70% of patients and the smaller number of patients completing 12-months of
treatment per group in this study compared to the type 1 study. Since insulin alone lowers glucose
concentrations, this variability in insulin dosing obfuscated the pramlintide drug effect.<<

Hence, they did not initially control for insulin usage variability and they are modifying their clinical studies to do so now (I would be interested to know how they are doing that). Since insulin usage variability should have been known to them, the fact that they did not initially design this variable into their design leads me to conclude that they had a poor design.

Actually, I hope that is their biggest problem as it is correctable and more positive than the alternative explanation.(i.e. their drug doesn't work in type 2 diabetics).

David
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