ADA 2010: One-year data on exenatide show that improvements in glycated hemoglobin and CV risk markers are maintained

June 29, 2010

In patients with type 2 diabetes, treatment with exenatide once weekly for 1 year results in sustained improvements in glycemic control, body weight, cardiovascular risk markers, and markers of hepatic injury, according to a pooled analysis of 2 large clinical trials.

In patients with type 2 diabetes, treatment with exenatide once weekly for 1 year results in sustained improvements in glycemic control, body weight, cardiovascular risk markers, and markers of hepatic injury, according to a pooled analysis of 2 large clinical trials. The data were presented by Edward Horton, MD, associate program director, Joslin Clinical Research Center, Boston.

The analysis included 223 patients who were treated with exenatide during the first 52 weeks of the DURATION-1 and DURATION-2 randomized clinical trials of patients with type 2 diabetes and baseline glycated hemoglobin values of 7.1% to 11%. Patients in these trials were on background therapy with either diet and exercise, metformin, a sulfonylurea, or a thiazolidinedione (or 2 such agents in combination).

Levels of glycated hemoglobin declined by a mean of more than 0.8% by 6 weeks of treatment with exenatide, a reduction that was maintained to 52 weeks with continuation of weekly exenatide (final mean reduction in glycated hemoglobin, 1.5%).

Similarly, the mean fasting plasma glucose level improved by more than 35 mg/dL at 6 weeks, with a final reduction of 37 mg/dL at week 52. At 52 weeks, 65% of exenatide-treated patients achieved the ADA glycated hemoglobin target of less than 7%.

A significant reduction in body weight was observed by week 6; and at week 52, the mean reduction in body weight from baseline was 3.0 kg.

Significant reductions in systolic blood pressure, diastolic blood pressure, high-density lipoprotein cholesterol, and levels of the hepatic injury markers alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were also observed with exenatide for 52 weeks.

The incidence of minor hypoglycemia was 5%, and there were no instances of major hypoglycemia with exenatide.