A 26-Week,Randomised,Open-Label,Multicenter,Active-Controlled,Parallel-Design,Phase III Clinical Trial to Compare the Efficacy and Safety of Insulin Degludec/Liraglutide Injection With XULTOPHY® Once Daily Via Subcutaneous Injection in Chinese Subjects With Type 2 Diabetes

Clinical Trial19 Aug 2024Phase 3● 5/10i

A 26-Week,Randomised,Open-Label,Multicenter,Active-Controlled,Parallel-Design,Phase III Clinical Trial to Compare the Efficacy and Safety of Insulin Degludec/Liraglutide Injection With XULTOPHY® Once Daily Via Subcutaneous Injection in Chinese Subjects With Type 2 Diabetes

Tonghua Dongbao Pharmaceutical Co.,Ltd

Phase 3 trial compares Chinese-manufactured insulin degludec/liraglutide combination to Novo Nordisk's Xultophy in adults with type 2 diabetes. Open-label study targets 510 participants over 26 weeks with HbA1c reduction as primary endpoint, expected completion October 2025. Tonghua Dongbao tests its biosimilar combination against the established Novo Nordisk product in the Chinese market. This represents China's push toward domestic alternatives in the GLP-1/insulin combination space.

Strategic Signal

Chinese biosimilar manufacturers are targeting high-value combination therapies like GLP-1/insulin products to capture domestic market share. Successful approval of Tonghua Dongbao's combination could pressure Novo's Xultophy pricing in China and establish precedent for complex biosimilar approvals in Asia's largest diabetes market. This mirrors the SGLT2 biosimilar wave that reshaped diabetes treatment costs across emerging markets in 2022-2024.

GLP-1Type 2 diabetesDrug comparisonsTonghua Dongbao Pharmaceutical Co.,Ltd Novo Nordisk

Original Abstract

This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes. | Condition(s): Type 2 Diabetes | Primary endpoint(s): Change from baseline in HbA1c after 26 weeks of treatment | Enrollment: 510 (estimated) | Phase: Phase 3 | Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd | Expected completion: 2025-10 | Status: Not Yet Recruiting | Last update: 2024-08-19

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