Bentley Pharmaceuticals, Inc. (NYSE: BNT), a specialty pharmaceutical company, announced completion of treatment in an 80 patient multi-center open label, randomized, parallel group Phase II study in India to determine the safety and efficacy of add-on intranasal insulin spray (Nasulin®) in patients with type 2 diabetes mellitus on oral anti-diabetic therapy. The clinical study report is expected to be completed later this month, but preliminary clinical results are being released today.
The primary study endpoints were reduction of Post Prandial Blood Sugar (PPBS) by 20mg/dl from the baseline value and reduction of glycosylated hemoglobin (HbA1c) by 0.7% from the baseline value, both by the end of three months treatment with Nasulin. Tolerability of the study drug was a secondary study endpoint.
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