BIOD-123: Preliminary Phase II data

Preliminary data from the open-label, U.S. Phase II Study 3-201 in 132 Type I diabetics showed that BIOD-123 plus Lantus insulin glargine met the primary endpoint of non-inferiority to Humalog insulin lispro plus Lantus in reducing HbA1c from baseline to week 18 (0.08% vs. 0.25%, 95% CI: -0.01%, 0.35%). The pre-specified threshold to meet the endpoint was indicated by a between-group difference of the 95% CI of <0.4%. There were no significant differences in hypoglycemia frequencies, mean hypoglycemia event rates or weight change between treatment groups. Both groups gained on average 1 kg in body weight over the course of the study. Maximal postprandial glucose excursion was significantly lower in the BIOD-123 arm compared to the Humalog arm (71.8 vs. 92.6 mg/dL, p=0.034). ...