Saxagliptin, an experimental agent, found superior to placebo in achieving A1c target less than 7%.
SAN FRANCISCO—The investigational agent saxagliptin, which belongs to a new class of anti-diabetic drugs that is taken orally rather than by injection, is effective and safe in treatment-naïve, type 2 diabetics with inadequate glycemic control, new findings suggest.
The data showed that saxagliptin administered once daily as monotherapy for 24 weeks significantly reduced hemoglobin A1c, the study’s primary end point.
“New strategies to promote glycemic control are needed, as the majority of patients with type 2 diabetes are not achieving glycemic targets over the long term,” said principal investigator Julio Rosenstock, MD, clinical professor of medicine at the Dallas Diabetes and Endocrine Center at Medical City, in Dallas.
At the American Diabetes Association 68th Scientific Sessions here, Dr. Rosenstock presented phase III study findings in 401 patients who had been randomized to 24 weeks’ treatment with saxagliptin 2.5, 5, or 10 mg daily, or placebo. Participants in the trial ranged in age from 18 to 77 years and had A1c levels between 7% and 10%. Demographic and clinical characteristics were similar in all treatment groups.
The study found significant A1c decreases of 0.62% in the 2.5-mg group, 0.64% in the 5-mg group, and 0.73% in the 10-mg group at 24 weeks. Reductions were observed as early as week 4, the earliest point at which A1c was assessed.
More saxagliptin-treated patients achieved the ADA target A1c of less than 7% (35%, 38%, 41% for saxagliptin 2.5-, 5-, and 10-mg groups, respectively) than placebo (24%). The experimental treatment also was associated with significant decreases in fasting plasma glucose (FPG) and postprandial glucose.
Saxagliptin was well tolerated, and there was no clinically meaningful difference between the groups in the proportion of patients reporting adverse side effects. High-dose saxagliptin had caused skin lesion problems in monkeys. There were no cases of confirmed hypoglycemia with saxagliptin. Weight changes with saxagliptin were similar to placebo. “This is important as weight gain has been a significant limitation of some of the older treatments,” Dr. Rosenstock noted.
The study also included an open-label arm that enrolled 66 patients with an A1c between 10% and 12% who received saxagliptin 10 mg once daily. Reductions in A1c, FPG, and PPG were consistent with the main treatment cohort.