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Biotech / Medical : AMLN (DIABETES DRUGS)

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To: Jeffers Hughes who wrote (391)	8/16/1997 8:27:00 AM
From: tonyt	of 2173

However, "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. There was no increase in the frequency or severity of hypoglycemia in the pramlintide treatment groups compared to placebo. Pramlintide produced statistically significant weight loss in all drug groups compared to placebo." Also: "The results in type 2 diabetes point to a role for amylin replacement among insulin-using patients," said Dr. Kolterman. "We believe the statistically significant glucose-lowering effect seen in the intent-to-treat analysis of patients who had poor glucose control combined with the magnitude of effect seen in those same patients who also maintained stable insulin bodes well in terms of the likelihood of achieving improved intent-to-treat results in the other two ongoing studies. Furthermore, the secondary benefit of improved weight control is a very important additional attribute of pramlintide therapy."

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