Longer Euglycemic Period With Bydureon Seen in Phase 4 Study
AstraZeneca announced data from a 10-week Phase 4 randomized, controlled, double-blind study assessing the quality of glucose control with Bydureon (exenatide extended-release) for injectable suspension vs. placebo using continuous glucose monitoring in patients with type 2 diabetes uncontrolled on metformin.
Bydureon, a GLP-1 receptor agonist, is indicated as adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes.
The study (n=117) randomized patients to Bydureon or placebo and included a 4-week lead-in period, a 10-week treatment period, and 4-week follow-up for standard safety assessments. Glucose concentrations were measured every 5 minutes over 7 days during the final week of the 4-week lead-in period and during Weeks 4 and 10 using a continuous glucose monitoring system.
Patients receiving Bydureon had significant improvements in overall 24-hour glucose control and reduced glucose fluctuations as early as Week 4.The primary endpoint of change from baseline in 24-hour mean weighted glucose was achieved. Bydureon plus metformin significantly (P<0.001) lowered 24-hour mean weighted glucose from baseline to Week 4 (–26mg/dL) and Week 10 (–31mg/dL) vs. placebo plus metformin. Bydureon also significantly improved secondary endpoints of fasting plasma glucose and postprandial glucose.
Bydureon led to a significantly greater reduction in mean amplitude of glucose excursions vs. placebo at Week 10 (–15.2mg/dL). No difference in 24-hour mean weighted glucose from Day 1 to 6 of Week 10 was seen. Moreover, Bydureon increased the time in euglycemic range (53% at baseline to 77% at Week 10).
Additional analysis of Bydureon and glucose fluctuations were presented at the 76th Scientific Sessions of the American Diabetes Association (ADA).
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