Lilly presented new data from a completed Phase 3 trial, AWARD-8, showing that once-weekly Trulicity (dulaglutide) 1.5mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering hemoglobin A1c (A1C) from baseline after 24 weeks of treatment. Findings were presented at the 2015 International Diabetes Federation (IDF) World Diabetes Congress in Vancouver, Canada.
AWARD-8 was a randomized, double-blind, placebo-controlled, 24-week Phase 3 trial which compared the efficacy and safety of once-weekly Trulicity 1.5mg to placebo in 299 sulfonylurea-treated patients with type 2 diabetes and inadequate glycemic control. The primary objective was to demonstrate superiority of Trulicity to placebo on A1C reduction in patients treated with sulfonylurea monotherapy at 24 weeks.
Data presented showed that Trulicity 1.5mg plus sulfonylurea provided superior A1C reduction from baseline (-1.38%) compared to sulfonylurea with placebo (-0.11%) at the primary endpoint of 24 weeks. Significantly more patients treated with Trulicity plus sulfonylurea achieved an A1C of <7% (55.3%) compared to sulfonylurea with placebo (18.9%). In addition, Trulicity plus a sulfonylurea significantly reduced fasting serum glucose levels compared to sulfonylurea with placebo, -30.60mg/dL vs. +2.93mg/dL respectively.
Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.
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