Biodel Inc. researchers presented results of a clinical study evaluating a new pH-neutral formulation of Linjeta(TM) (VIAject(R)) at the 46th annual meeting of the European Association for the Study of Diabetes (EASD) in Stockholm today. Dr. Tim Heise (Profil Institute for Metabolic Research, Neuss, Germany) and colleagues reported that the new pH-neutral, 100 IU/ml formulation of Linjeta(TM) was bioequivalent to the previously studied pH-4, 25 IU/ml formulation of Linjeta(TM), and had faster absorption and onset of action than insulin lispro. These findings were also presented by Dr. Heise in June at the 70th scientific sessions of the American Diabetes Association in Orlando, Florida.
Linjeta(TM) is Biodel’s more-ultra-rapid-acting insulin formulation that is currently under review by the U.S. Food and Drug Administration. The purpose of this study was to demonstrate the bioequivalence of the two formulations of Linjeta(TM), compare the pharmacokinetic and pharmacodynamic characteristics of pH-neutral, 100 IU/ml Linjeta(TM) and insulin lispro in 43 patients with Type 1 diabetes. The trial was conducted as a randomized, double-blind crossover study. There were no serious adverse events or discontinuations because of treatment-emergent adverse events; headache was the most frequent adverse event reported (8 patients). Additional studies are planned to evaluate the impact of Linjeta(TM) on glucose control.
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