“This is the longest controlled clinical trial of EQW yet reported,” note Dr. Michaela Diamant, at the Vrije University Medical Center, Amsterdam, the Netherlands, and colleagues.
The group previously reported positive 26-week results from an open-label, randomized trial of exenatide once weekly versus daily insulin glargine in 456 patients with type 2 diabetes who were also taking metformin with or without a sulfonylurea. (See Reuters Health report “Weekly exenatide tops insulin glargine: study” on June 24, 2010.)
The current paper reports results in 415 patients who completed the 26-week trial and entered an extension trial to assess long-term safety and efficacy up to 84 weeks.
The baseline A1C of 8.3% decreased by -1.2% in the EQW arm and by -1.0% in the insulin glargine arm (p=0.029) at 84 weeks, the team found.
The endpoint A1C target of <7% was achieved by 44.6% and 36.8% of patients in the two groups, respectively – a nonsignificant difference (p=0.084). However, the difference in the proportion of patients achieving an A1C of 6.5% or less (31.3% vs 20.6%, respectively) was significant (p=0.009).
Over the study period, body weight decreased by -2.1 kg in the EQW group but increased by 2.4 kg in the insulin group, the report indicates.
As for safety, the incidence of minor hypoglycemia was 24% in patients taking EQW compared with 54% among those on insulin glargine. Diarrhea occurred in 12% vs 6% of patients in the two arms, respectively, while corresponding rates of nausea were 15% versus 1%, Dr. Diamant and colleagues report.
They conclude that the results indicate that “EQW can be a therapeutic option for patients with type 2 diabetes for whom the convenience of once-a-week dosing, weight loss, and reduction of risk for hypoglycemia are important.”
On January 30, the US Food and Drug Administration approved exenatide once weekly under the brand name Bydureon for treating adults with type 2 diabetes. European regulators approved Bydureon for type 2 diabetes in April 2011.
Diabetes Care 2012.