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Positive effects of once-weekly exenatide on HbA1c, weight observed 3 years later

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ADA 71st Scientific Sessions

SAN DIEGO — Results from the long-term extensions of the DURATION-1 and DURATION-3 studies evaluating once-weekly exenatide demonstrate that the investigational drug’s positive effects on HbA1c and weight in patients with type 2 diabetes were sustained for up to 3 years.

Exenatide extended-release for injectable suspension (Bydureon; Eli Lilly, Amylin and Alkermes) is being investigated as a therapy for type 2 diabetes, for which it is approved in Europe. It is a once-weekly formulation of daily exenatide injection (Byetta), which was approved for use in the US in 2005.

Longer-term data

Previous findings from the DURATION studies of once-weekly exenatide were presented in 2010 at the American Diabetes Association’s 70th Scientific Sessions.

In the open-label extension of the DURATION-1 study, patients with diabetes on a range of background treatments who were assigned to once-weekly therapy experienced significant reductions in HbA1c (1.6%) and weight (5.1 lb) after 3 years of treatment, as compared with baseline measurements. The weekly dose was also associated with improvements from baseline in several cardiometabolic risk markers, including systolic blood pressure (–2.1 mm Hg), total cholesterol (–9.9 mg/dL), LDL (–7 mg/dL) and triglycerides (–12%).

Results from the DURATION-3 extension study showed that, after 84 weeks, patients assigned to once-weekly exenatide, who were also taking metformin alone or metformin with or without a sulfonylurea, experienced significantly greater HbA1c reductions from baseline, sustained weight loss and had a lower risk for hypoglycemia compared with patients assigned to insulin glargine (Lantus, Sanofi-Aventis). The mean HbA1c reduction was 1.2% for the once-weekly formulation vs. 1% for insulin glargine. Additionally, significantly more patients assigned to weekly treatment achieved an HbA1c level of 6.5% or lower (31% vs. 20%; P=.009). The average weight loss associated with weekly exenatide was 4.5 lb, while patients assigned to insulin glargine gained an average of 5.3 lb during the study, according to the results.

The once-weekly formulation was well tolerated in both studies. Nausea was the most commonly reported adverse event during the initial controlled period of the DURATION-1 study (27%), and the incidence decreased to 16% from week 30 to week 156. Nasopharyngitis was common in both treatment arms of the DURATION-3 study, as well as nausea in the extended-release group and headache in the insulin glargine group. No major hypoglycemia was observed in DURATION-1 and there were no confirmed cases of hypoglycemia in DURATION-3, according to a company press release.

Cardiovascular effect

In other data presented at the American Diabetes Association’s 71st Scientific Sessions, Amylin, Eli Lilly and Company and Alkermes announced results from another analysis of the DURATION-1 study showing that once-weekly exenatide is not associated with clinically relevant QT prolongation in patients with type 2 diabetes.

The analysis used data from the DURATION-1 study (n=148) to evaluate changes in the QT interval associated with once-weekly therapy, correcting for heart rate with Friderica’s formula (QTcF). The change in QTcF from baseline was small and clinically insignificant at 14 weeks (1.7 milliseconds) and 30 weeks (3 milliseconds). There was no correlation between change in QTcF and exenatide blood plasma concentrations or renal status, according to a company press release.

To further examine the QT-related safety of this formulation, researchers are conducting a thorough QT study according to guidelines set by the FDA, Christian Weyer, MD, senior vice president, research and development, Amylin, said in a press release.

For more information:

• Diamant M. 277-OR.
• Macconnell L. 969-P.
• Sager P. 1070-P. All presented at: American Diabetes Association’s 71st Scientific Sessions; June 24-28, 2011; San Diego, Calif.

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