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Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program
Date:7/16/2008

) R (p<0.001). Type 2 patients (n=173) receiving VIAject(TM) showed a weight reduction (-0.5 +/- 4.7 kg) compared to baseline, while a weight gain (0.8 +/- 6.2 kg) was seen in the patients (n=180) receiving Humulin(R) R (p<0.05), for a net difference of 1.3 kg.

The interim results demonstrated statistically significant daily meal-time (prandial) dose reductions in patients with Type 1 and Type 2 diabetes using VIAject(TM) compared to Humulin(R) R in the first six weeks of the study. With comparable glycemic control targets between treatment groups, Type 1 patients (n=106) receiving VIAject(TM) showed a 34 percent reduction in daily prandial dose (10 units; p<0.001) compared to baseline, while control patients receiving Humulin(R) R showed a non-significant 7 percent reduction (2.4 units). Type 2 patients receiving VIAject(TM) showed a 36 percent reduction (16 units; p<0.001), while control patients receiving Humulin(R) R showed an increase of 15 percent (6 units; p<0.01), for a net difference of 51 percent.

The interim results demonstrated statistically significant reductions in mild and moderate hypoglycemic events in patients with Type 1 and Type 2 diabetes using VIAject(TM) compared to Humulin(R) R. Type 1 patients recorded 8,111 mild and moderate hypoglycemic events, with a significantly lower number of incidents in the VIAject(TM) group (3,691; p<0.001) than in the Humulin(R) R group (4,420). Type 2 patients recorded 2,438 mild and moderate hypoglycemic events with a significantly lower number of incidents in the VIAject(TM) group (844 events) than in the Humulin(R) R group (1,594 events; p<0.001).

Biodel noted that the final data from these trials may differ from those suggested by the preliminary interim analysis. Furthermore the primary efficacy endpoint for the studies, change in HbA1c, has not been analyzed. Both HbA1c and incidences of severe hypoglycemic events will be analyzed and reported after the clinical trial database for the s
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SOURCE Biodel Inc.
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