Amylin Pharmaceuticals has presented clinical data at the Hambrecht & Quist Life Sciences conference in San Francisco, USA, which indicate for the first time that the company's AC137 (tripro-amylin) can reduce post-prandial glucose levels in late-stage type II (maturity-onset) diabetes mellitus.
If these results are confirmed in further trials, the potential applicability of AC137 for improving glucose control could increase to include a significant proportion of the world's 100 million type II diabetic patients, in addition to the several million type I diabetics targeted in the company's ongoing Phase IIb trials. Amylin's Phase IIb trials of AC137 in type I diabetics will involve over 300 patients, and Phase III studies are scheduled to begin in the second half of 1995.
In the study, "11 late-stage, insulin-using type II diabetics who received a five-hour intravenous infusion of tripro-amylin (100mcg/hour) in a double-blind cross-over study had statistically significant reductions in post-meal blood glucose levels (average reduction, 66mg/dl) compared to placebo," said Richard Thompson, vice president of clinical development at Amylin. He added that three previous clinical studies had shown that tripro-amylin reduced excessive post-meal increases in blood glucose in patients with type I diabetes.
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