A Phase III clinical trial of succinobucol for the treatment of Type 2 diabetes has met the primary endpoint of the reduction in glycosylated haemoglobin (HbA1c) versus placebo at the end of the six month dosing regimen.

In this multicentre study, 999 patients with Type 2 diabetes (ages 18-75) who were on one or no other oral anti-diabetes therapies and whose HbA1c level was greater than or equal to 7.5% and less than or equal to 10.5% were randomised to succinobucol (75mg or 150mg) or placebo.

The results demonstrated a dose-dependent, statistically significant drop in HbA1c of 0.6% and 0.4% in the 150mg and 75mg arms, respectively, at 6 months, compared to baseline (p < 0.001 for 150 mg versus placebo, p = 0.016 for 75 mg versus placebo). The placebo group decreased 0.2% from baseline.

The study was prospectively designed to detect and analyze the effect of regional differences. Eastern Europe showed a significant decrease of 0.5% for HbA1c in the placebo arm versus baseline. The other study regions (United States, South Africa, India) showed an increase of 0.1% in HbA1c in the placebo arm versus baseline. HbA1c reductions in both treatment arms were similar across all of the regions in the study.

Based on a preliminary safety review, succinobucol was reported to be well-tolerated and was not associated with weight gain or hypoglycemia in either of the treatment groups. One patient in the 150mg arm and two patients in the 75mg arm had unexplained liver enzyme elevations of greater than five times the upper limit of normal.

Succinobucol is a new oral drug with anti-inflammatory and antioxidant properties. It works by selectively inhibiting signalling pathways that are activated in response to oxidative stress and pro-inflammatory stimuli in the pathogenesis of insulin resistance and diabetes.