Eli Lilly (NYSE: LLY) announced that its Phase III AWARD-CHN3 study of Trulicity (dulaglutide) combined with titrated insulin glargine in Chinese patients with type 2 diabetes met the primary endpoint and all key secondary endpoints. The 28-week trial showed significant reductions in glycated hemoglobin (HbA1c), body weight, and fasting serum glucose.
Study Details
The multi-center, randomized, double-blind, placebo-controlled trial enrolled 291 subjects across 27 centers. Participants had poorly controlled diabetes (mean duration: 11.8 years; baseline HbA1c: 8.59%) despite insulin glargine (± metformin/ acarbose). The study compared dulaglutide 1.5 mg + insulin glargine vs. placebo + insulin.
Results
- Primary Endpoint: Dulaglutide combo outperformed placebo in reducing HbA1c at 28 weeks.
- Secondary Endpoints: Achieved superiority in HbA1c <7% attainment, body weight loss, and fasting serum glucose reduction.
- Safety: Consistent with prior AWARD studies; common adverse effects were mild (e.g., appetite loss, diarrhea). No severe hypoglycemia (<3.0 mmol/L) reported.
Drug Profile
Trulicity, a GLP-1 receptor agonist, was approved in the US (2014) and Europe (2014) for type 2 diabetes. It was greenlit in China in 2019 for monotherapy or combination use. The drug activates GLP-1 receptors, boosting insulin release and suppressing glucagon secretion.-Fineline Info & Tech
