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Diabetes - Biodel Announces Preliminary Results Of Pivotal Phase III Clinical Trials For VIAject

At the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Rome, Biodel Inc. (Nasdaq: BIOD) reported results from its two pivotal Phase III clinical trials designed to compare the efficacy and safety of VIAject™ to Humulin® R, a regular human insulin (RHI), in the treatment of patients with Type 1 and Type 2 diabetes. The primary objective of the trials was to determine if VIAject™ is non- inferior to RHI in the management of blood glucose levels, as measured by the mean change in patients' glycosylated hemoglobin, or HbA1c, levels from baseline. HbA1c is a measure of average blood glucose level and an indication of how well patients are controlling their blood glucose. Based on the initial analyses, both clinical trials met the primary endpoint of non-inferior mean change in HbA1c over six months of treatment.

VIAject™ is Biodel's proprietary injectable formulation of recombinant human insulin designed to be absorbed into the blood more rapidly than currently marketed rapid-acting insulin analogs. Two posters summarizing the preliminary Phase III clinical trials results are being presented at the EASD conference and are now available on the Biodel website, http://www.biodel.com. The first poster is entitled "Insulin VIAject™ and Regular Human Insulin in Patients with Type 2 Diabetes; Efficacy and Safety in an Open Label Multicenter Clinical Trial." The second poster is entitled "Insulin VIAject™ and Regular Human Insulin in Patients with Type 1 Diabetes; Efficacy and Safety in an Open Label Multicenter Clinical Trial."

Type 2 Clinical Trial

The Type 2 trial was an open-label, parallel group, randomized study conducted at 47 centers in the United States, Germany, and India. In this trial, 186 patients receiving VIAject™ and 205 patients receiving RHI were evaluable, and HbA1c decreased comparably in the two treatment groups with an adjusted difference between the groups of -0.2%. With a 95% confidence interval of -0.4 to -0.1, non-inferiority between VIAject™ and RHI was established.

Type 2 patients receiving VIAject™ experienced statistically significant (p





Diabetul - Biodel anunþã rezultatele preliminare Din pivot de fazã III Studii clinice Pentru VIAject - Diabetes - Biodel Announces Preliminary Results Of Pivotal Phase III Clinical Trials For VIAject - articole medicale engleza - startsanatate