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Efficacy and Safety of Dulaglutide Biosimilar LY05008 Versus the Reference Product Dulaglutide (Trulicity) in Chinese Adults With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Active Comparator Study

Clinical Trial Summary: LY05008 vs. Dulaglutide

Background

Dulaglutide is a medication for type 2 diabetes that helps control blood sugar and lower heart disease risks. A new drug, LY05008, was tested to see if it works similarly to dulaglutide.

Study Design

In this study, 440 Chinese adults with type 2 diabetes were randomly assigned to receive either LY05008 or dulaglutide as an injection once a week for 24 weeks. The main goal was to measure how much their blood sugar levels (HbA1c) changed over time.

Results

The results showed that both medications reduced HbA1c levels almost equally:

  • LY05008: Decrease of 1.44%
  • Dulaglutide: Decrease of 1.41%

At 12 weeks, about 40% of patients using LY05008 and 42% using dulaglutide reached a target HbA1c of 6.5% or lower. At 24 weeks, these numbers were 41% for LY05008 and 43.6% for dulaglutide.

Weight and Blood Sugar Levels

Both medications also resulted in weight loss and lower blood sugar levels:

  • Weight loss: LY05008 lost an average of 2.01 kg, and dulaglutide lost 1.71 kg.
  • Fasting plasma glucose levels decreased similarly in both groups.

Safety Profile

Adverse events were similar between both groups, with common side effects including:

  • Decreased appetite
  • Diarrhea
  • Nausea
  • Vomiting

Most side effects were mild to moderate. Serious side effects occurred in about 4% of patients in both groups. Hypoglycemic events were rare.

Conclusion

This study shows that LY05008 is as effective and safe as dulaglutide for treating type 2 diabetes in Chinese adults. This offers a new option for patients needing diabetes management.

Next Steps in Healthcare

To improve diabetes care based on these findings, clinics can:

  • Set clear goals for patient outcomes, focusing on HbA1c reduction.
  • Choose AI tools that assist in monitoring and managing diabetes.
  • Implement pilot projects to track the effectiveness of these medications in real-world settings.

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