AtheroGenics, a pharmaceutical company, has released its results from a planned interim analysis of its ongoing ANDES Phase 3 clinical trial of AGI-1067 for the treatment of Type 2 diabetes.
ANDES is evaluating two-dose levels of AGI-1067 given once daily over six months. The primary efficacy endpoint is changed in hemoglobin A1 from baseline compared to placebo in patients with Type 2 diabetes, according to the Atlanta-based AtheroGenics.
The company said its interim analysis of 806 patients who completed three months in the study showed dose-related, statistically significant reductions in A1c. The mean changes for patients in the 150 mg, 75 mg, and placebo arms were 0.5 percent, 0.3 percent and 0.1 percent respectively.
“The interim data also suggest that this three month assessment may not be capturing the full effect of AGI-1067 on A1c reduction, which show a meaningful reduction in blood sugar for patients with diabetes taking AGI-1067,” said Alexander Fleming, MD, acting chief medical officer of AtheroGenics.
Based on a preliminary review of the safety data, AtheroGenics said its AGI-1067 was well-tolerated, showing no difference in discontinuations between groups receiving active drug and placebo. However, the company did report one unexplained case of elevated liver enzymes greater than five times the upper limit of normal in each of the drug arms.
The overall primary endpoint of ANDES (AGI-1067 as a Novel anti-Diabetic agent Evaluation Study) is an improvement in A1c at six months, evaluating two doses of AGI-1067 (75 mg and 150 mg) compared to placebo, on a background of one or no other oral anti-diabetes medicines, according to AtheroGenics.