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news.TWi Biotechnology has completed patient enrollment in a double-blind, randomized, multicenter, placebo-controlled, dose-ranging Phase IIb trial to evaluate AC-201 as a treatment for type II diabetes.
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The company has enrolled around 240 patients in the trial in US and Taiwan sites.
The primary endpoint of the trial is the change in glycated hemoglobin A1c (HbA1c) from baseline compared to placebo after twenty-four weeks of treatment.
TWi Biotech president and CSO Sherry Ku said during the previous Phase IIa study, those patients with inadequate blood glucose control by multiple drug combinations of currently available oral anti-diabetic drugs were treated with AC-201 as an add-on therapy.
"The Phase IIa proof-of-concept study showed a mean reduction of 0.63% for HbA1c at the end of 24 weeks treatment period," Ku said.