AtheroGenics has released positive data from its 6,144-patient ARISE phase 3 clinical study of AGI-1067 (succinobucol), a novel oral drug candidate for the treatment of type 2 diabetes.
Jean-Claude Tardif, MD, ARISE co-principal investigator, director of research, professor of medicine at Montreal Heart Institute, University of Montreal in Montreal presented the findings in a Late Breaking Clinical Study oral presentation at the American Diabetes Association (ADA) scientific sessions in San Francisco.
Results were reported from AtheroGenics’ ARISE trial of patients with cardiovascular disease, approximately one-third of whom had a previous diagnosis of diabetes. The trial showed that the patients who did not have diabetes when beginning treatment and assigned to the AGI-1067 dosage group saw a 63 percent reduction in progression to new onset diabetes, compared to the patients receiving placebo, the company said.
The patients without diabetes at the beginning of the trial, but whose tests showed a pre-diabetes state referred to as impaired fasting glucose, showed a 60 percent reduction in progression to diabetes.
Lead author and ARISE clinical investigator, Eric Klug, MD, from Sunninghill Hospital in Gauteng, South Africa, highlighted the therapeutic effects of AGI-1067 in the diabetes patients in ARISE.
Clinically significant improvements in glycemic control were seen over a one-year treatment period with AGI-1067 in patients already taking commonly used anti-diabetes medications, according to the researchers.
In an analysis of 2,271 diabetes patients, 31 percent more patients on AGI-1067 achieved the ADA goal of hemoglobin A1c below 7 percent, compared to placebo, according to the Atlanta-based AtheroGenics.
Researchers said that diabetes patients in the AGI-1067 group experienced an A1c reduction of 0.5 percent from a baseline A1c level of 7.2 percent. AGI-1067 also caused a reduction in insulin resistance, as measured by changes in HOMA-IR levels, at both one month and 12 months. The results support the potential benefit of the new anti-inflammatory anti-oxidant approach to treating patients with type 2 diabetes, according to the company.
Investigators said that patients receiving AGI-1067 had no significant increases in edema, weight gain or hypoglycemia.
"The unique mechanism of action and encouraging effects on glycemic control with AGI-1067, when used in combination with existing oral anti-diabetic treatments or insulin, support its potential as a future treatment option for patients," said Russell M. Medford, MD, PhD, president and CEO of AtheroGenics. "We are looking forward to gaining additional insight into AGI-1067's impact on controlling blood sugar when final results from the ANDES phase 3 clinical trial of AGI-1067 in diabetes are available in the third quarter of this year.”