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Biodel Reports Positive Top-Line Results from Study of Experimental Ultra-Rapid-Acting Insulin Formulations
Date:4/15/2012

in the case of BIOD-123 and BIOD-125 and insulin lispro in the case of Humalog®.  The clinical trial was powered to measure differences in time to half maximal insulin concentrations.  Pharmacodynamic measurements were assessed using the euglycemic clamp method.  Local injection site discomfort was measured with a 100 mm visual analog scale (VAS) and patient questionnaires. 

In the Phase 1 clinical trial, absorption rates of BIOD-123 and BIOD-125 were significantly faster than that of Humalog® as indicated by 64% and 54% reductions, respectively, in mean times to half maximal insulin concentrations (p<0.001 for both BIOD-123 and BIOD-125 compared to Humalog®).  In a previous clinical trial, the Linjeta™ formulation demonstrated a 61% reduction compared to Humalog®.  Peak metabolic effects were not significantly different between the three study drugs. 

All three were well tolerated, with injection site tolerability generally perceived by patients to be similar to that of their usual mealtime injections used at home.  As measured on a 100 mm visual analog scale in which 100 mm is defined as the worst possible injection discomfort, local toleration was not significantly different for BIOD-123 compared to Humalog® (BIOD-123 mean VAS 3.6 +/- 2.1 mm, Humalog® 1.8 +/- 1.1 mm, p=NS).  The VAS score for BIOD-125 was slightly higher as compared to Humalog® (mean VAS 6.8 +/- 2.9 mm, p<0.05).  However, this score was markedly improved relative to the Linjeta™ formulation, which had a mean VAS of 22.0 +/- 2.8 mm in a previous study. 

Dr. Alan Krasner, Biodel's chief medical officer, stated: "Biodel's previous Linjeta™ formulation demonstrated a desirable ultra-rapid absorption profile, but had challenges with respect to local injection site toleration.  The goal of our subsequent formulation development has been to maintain the ultr
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SOURCE Biodel Inc.
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