Eli Lilly presented new Phase 3 study data showing that Trulicity (dulaglutide) 1.5mg significantly lowered HbA1c and body weight as an add-on to insulin glargine without increasing the risk of low blood sugar after 28 weeks vs. placebo plus insulin glargine.
The AWARD-9 study (n=300) was a randomized, double-blind, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly Trulicity 1.5mg as an add-on to insulin glargine vs. placebo plus insulin glargine. The primary objective was to demonstrate superiority of Trulicity on HbA1c reduction in patients with type 2 diabetes inadequately treated with insulin glargine, with or without metformin.
After 28 weeks, Trulicity plus insulin significantly reduced HbA1c from baseline vs. placebo plus insulin (1.44% vs. 0.67%). Also, significantly more patients treated with Trulicity plus insulin achieved HbA1c <7% vs. placebo plus insulin (69.3% vs. 35.1%). Significant reductions in fasting serum glucose levels were seen in patients treated with Trulicity plus insulin vs. placebo plus insulin (44.63mg/dL vs. 27.90mg/dL). Further, patients in the Trulicity arm experienced significant weight loss vs. patients in the placebo arm (-1.91kg vs. +0.50kg).
In both groups, insulin glargine was titrated via a treat-to-target algorithm. After 28 weeks, patients treated with Trulicity took an average of 13.19 units less of insulin glargine vs. patients treated with placebo (51.42 units vs. 64.61 units).
Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist, is used along with diet and exercise for the treatment of type 2 diabetes. It is available as 0.75mg/0.5mL and 1.5mg/0.5mL strength solutions in single-dose pens and single-dose prefilled syringes.
For more information call (800) 545-5979 or visit Trulicity.com.