Shares in California, USA-based Amylin Pharmaceuticals recently tumbled43% to $8.47 on news that a Phase III trial of its antidiabetes drug pramlintide had produced "disappointing" results, according to industry analysts. The share price was still falling towards the end of the week.
In one 12-month study involving 477 Type I diabetics administered either pramlintide 30mcg four times daily or placebo, results demonstrated that the reduction in glycated hemoglobin (HbA1c) at 12 months compared to the placebo group was 0.3%, a clinically significant result. Despite variation in insulin dosing, 46% of patients who were evaluable at trial-end had a significant reduction in HbA1c of more than 0.5%, compared to 29% of placebo patients. The average daily dose of insulin increased in the placebo group, but decreased for patients receiving pramlintide, which offset reductions in HbA1c level attributable to pramlintide, says the company.
In the patient sub-group with poor glucose control, the reduction in HbA1c at 12 months was 0.4% for patients treated with pramlintide versus placebo. This result was also statistically significant. Meanwhile, of 40 Type I patients with poor glucose control who maintained stable insulin dosing throughout the trial, the reduction in HbA1c at 12 months was 0.66% (p=0.0504) compared to placebo.
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