DANBURY, Conn., Sept. 18 /PRNewswire-FirstCall/-- Biodel Inc. (Nasdaq: BIOD) today announced additional clinical data from its VIAject(TM) program at the 43rd Scientific Sessions of the European Association for the Study of Diabetes (EASD).
VIAject(TM) Phase II meal study data was disclosed in an oral presentation at EASD entitled, "Pharmacokinetics and pharmacodynamics of insulin VIAject(TM), insulin lispro and regular human insulin when injected subcutaneously immediately before a meal in patients with Type 1 diabetes." The VIAject (TM) Phase II meal study results demonstrated statistically significant and clinically relevant improved glycemic control compared to regular human insulin (Humulin(R) R) and lispro (Humalog(R)).
"We are pleased that VIAject(TM) continues to yield improved pharmacokinetic and pharmacodynamic data when compared to both Humulin(R) R and Humalog(R)," commented Dr. Solomon Steiner, Chairman and CEO of Biodel. "These differences translate into better glycemic control and fewer hypoglycemic events which we continue to track in our ongoing Phase III VIAject(TM) clinical trials."
"The absorption of VIAject(TM), especially after the first 30 minutes, is much more rapid when compared to regular insulin and lispro," elaborated Dr. Lutz Heinemann, CEO of Profil Institute for Metabolic Research in Neuss, Germany. "Improvements in pharmacokinetic and pharmacodynamic parameters may translate into improved postprandial metabolic control, resulting in a safer treatment option for the diabetic population."
In the Phase II meal study of VIAject(TM), subjects received either
VIAject(TM), Humulin(R) R (regular recombinant human insulin) or Humalog(R)
(rapid acting insulin analog) in conjunction with a standardized meal.
Plasma insulin and blood glucose levels were monitored throughout the
study. Administration of VIAject(TM) resulted in statistically
significantly faster insulin absorption than Humulin(R) R and Humalog(R)
|SOURCE Biodel Inc.|
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