Bentley Completes Treatment in Phase II Diabetes Study
Posted on: Tuesday, 12 February 2008, 09:01 CST
Bentley Pharmaceuticals has completed 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 in patients with type 2 diabetes mellitus on oral anti-diabetic therapy.
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.
Although final analysis of the data has not yet been completed, it appears that patients on Nasulin reached their primary endpoint for PPBS after two months with an average decline of 49mg/dl, although PPBS values increased in month three, apparently to levels above the primary endpoint. It appears that HbA1c levels also reached their primary endpoint of an average decline of 0.7 or more after two months, although HbA1c levels also increased in month three, apparently to levels above the primary endpoint. In addition, control group patients on oral antidiabetic agents showed similar declines.
The India study demonstrated that Nasulin was well tolerated during the three months that it was used three times per day. In the 60 type 2 diabetics taking Nasulin over three months reported in the study, no patient dropped out because of nasal symptoms or other study drug related phenomena. In contrast to studies by others in which insulin was administered by injection, patients on Nasulin in this study showed no overall weight gain over the three month interval and no indication of severe hypoglycemia.
Source: Datamonitor
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