Phenomix reports positive results from Phase IIb diabetes trial

The 12-week, double-blind, placebo-controlled clinical trial involving 422 randomized patients compared PHX1149 in once-daily oral doses of 200mg and 400mg to placebo. Patients were allowed to continue selected anti-diabetic drugs, either metformin or a thiazolidinedione, or a combination of the two, at a constant dose during the trial.

PHX1149 demonstrated statistically significant reductions in hemoglobin A1c (HbA1c) in both the 200mg and 400mg dose groups. PHX1149 also demonstrated statistically significant effects on secondary efficacy endpoints, including change in fasting blood glucose levels, change in post-meal blood glucose levels and achievement of a target HbA1c level of less than 7%. The safety and tolerability of PHX1149 were not substantially different from placebo. The Phase IIb clinical trial was conducted at approximately 70 clinical sites worldwide.

Phenomix has said that patients who completed the Phase IIb clinical trial were given the option to enroll in an extension phase of the trial and receive a once-daily 400mg dose of PHX1149 for up to two years. More than 90% of these patients have elected to enroll in the extension trial, which will provide Phenomix with long-term safety data for PHX1149.