Patients treated with weekly exenatide have better glycemic control and weight loss than patients treated with insulin glargine

August 9, 2013

A recent international, open-label, randomized, controlled study of patients with type 2 diabetes mellitus compared once-weekly exenatide to titrated insulin glargine.

A recent international, open-label, randomized, controlled study of patients with type 2 diabetes mellitus compared once-weekly exenatide to titrated insulin glargine.

The results of the study were presented in June at the American Diabetes Association's 73rd Scientific Sessions, in Chicago.

The study included 467 patients; 140 patients who received exenatide and 147 who received insulin glargine completed 3 years in their original treatment group. In both groups, the most common reason for discontinuation was subject decision (11% in the exenatide group and 16% in the insulin group).

In the intent-to-treat population, the LS mean reduction in A1C from baseline at 3 years was significantly greater in the group receiving exenatide than in the group receiving insulin, despite adherence to a treat-to-target insulin titration algorithm. In the exenatide group, body weight decreased significantly, (-2.49 kg) while patients in the insulin group experienced significant weight gain (+2.01 kg).

Sixty-eight percent of patients treated with exenatide achieved reduction in both A1C and body weight at 3 years compared to 34% of patients treated with insulin. Additionally, the decrease in fasting glucose was significantly less in the group taking exenatide (-31.1 mg/dL) than in the group taking insulin (-47.7 mg/dL).

During the 3 years of the study, gastrointestinal adverse events occurred more often in patients taking exenatide (16% nausea; 6% vomiting; 14% diarrhea) than in patients taking insulin (2% nausea; 3% vomiting; 7% diarrhea, respectively). However, the incidence of nausea and vomiting decreased after 26 weeks in the group taking exenatide.

The percentage of patients who tested positive for anti-exenatide antibodies decreased from 26 weeks to 3 years (56% to 19%), and the exposure-adjusted rate of hypoglycemia in the exenatide group was 0.3 events per year compared with 0.9 for the insulin group.

In summary, this was the longest controlled study of a long-acting GLP-1 receptor agonist to-date, and the study found that patients treated with exenatide experienced significantly better sustained glycemic control and weight loss with lower risk of hypoglycemia than patients treated with insulin glargine.