Diabetes Patients Taking Exenatide See Improvements In Glycemic, Weight Control

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Amylin Pharmaceuticals, Eli Lilly and Company, and Alkermes announced results from a 52-week open-label clinical study that showed the durable efficacy of exenatide once weekly, a long-acting release formulation of exenatide. Patients taking exenatide once weekly over the course of one year sustained a similar improvement in glucose control [A1C: -2.0%+/-0.08; fasting plasma glucose (FPG) -47+/-3 mg/dL] compared to those receiving treatment for 30 weeks [A1C change from baseline: -1.9%+/-0.08 (LS mean+/-SE)].

This study also showed that patients who switched from BYETTA (exenatide) injection after 30 weeks to exenatide once weekly experienced additional improvements in A1C and fasting plasma glucose. Seventy-four percent of all patients in the study achieved an endpoint A1C of 7 percent or less at 52 weeks. Patients in both treatment groups experienced a statistically significant and sustained average weight loss of 9.5 pounds over 52 weeks. These findings were presented at the 68th Annual Scientific Sessions of the American Diabetes Association (ADA) in San Francisco.

BYETTA is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, a thiazolidinedione, a combination of metformin and a sulfonylurea, or a combination of metformin and a thiazolidinedione, but have not achieved adequate glycemic control.

"Diabetes is a lifelong condition that requires constant management of blood glucose or blood sugar as well as weight. In DURATION-1 trial, patients significantly reduced their blood glucose levels and, on average, lost a total of over nine pounds. These improvements were sustained for a year," said John B. Buse, M.D., Ph.D., Professor of Medicine, Director of the Diabetes Care Center, and Chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "Importantly, the study results also showed that steady-state levels of exenatide may result in improvements in a variety of glucose parameters. If approved, exenatide once weekly may provide patients with a treatment option that is on board 24 hours a day, seven days a week, helping manage their blood sugar and, secondarily, their weight."

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Study Design and Findings

The Diabetes Therapy Utilization: Researching Changes in A1C, Weight and Other Factors Through Intervention with Exenatide ONce Weekly (DURATION-1) study was a 30-week, randomized, open-label study of 295 patients with type 2 diabetes (baseline values: A1C 8.3%+/-1.0, FPG 169+/-43 mg/dL, weight 225+/-44lbs., BMI 35+/-5.0 kg/m2, diabetes duration 6.7+/-5.0 years; mean+/-SD) who were treated with exenatide once weekly 2.0 mg or BYETTA twice daily as outlined in the approved label subcutaneously. Following the first 30 weeks of treatment, 258 patients entered an open-label treatment with exenatide once weekly. Patients either remained on exenatide once weekly or switched from BYETTA to exenatide once weekly for an additional 22 weeks.

Following the 30-week comparison period, patients (evaluable population N=241) who continued on exenatide once weekly showed sustained improvements in A1C and fasting plasma glucose levels at week 52 [A1C: -2.0%+/-0.1; FPG -47+/-3 mg/dL (LS mean+/-SE)]. Patients who switched from BYETTA to exenatide once weekly had further improvements in glycemic control [A1C: -2.0% +/-0.1; FPG - 43+/-3 mg/dL] that were consistent with those of patients receiving exenatide once weekly for 52 weeks. These data suggested the additional impact of continuous exenatide levels on glycemic control.

In both groups, A1C reduction was similar at 52 weeks. Seventy-two percent of patients treated with exenatide once weekly achieved an endpoint A1C of 7 percent or less, and 54 percent achieved an A1C of 6.5 percent or less. In patients who switched from BYETTA to exenatide once weekly, 75 percent of patients achieved an endpoint A1C of 7 percent or less and 53 percent achieved an A1C of 6.5 percent or less. An A1C of below 7 percent is the target for good glucose control as recommended by the ADA. Unlike the weight gain that is commonly associated with insulin therapy and many oral diabetes medications, exenatide once weekly was associated with an average weight loss of 9.5 pounds over 52 weeks.

Exenatide once weekly uses a proprietary technology for long-acting medications developed by Alkermes. The technology encapsulates active medication into polymer-based microspheres that are injected into the body where they degrade slowly, gradually releasing the drug in a controlled manner to provide continuous therapeutic exenatide levels in plasma.

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