drugset / Trial / NCT06235086

A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

NCT06235086

Phase 3 Completed 632 enrolled CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, open-label, dulaglutide-controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, and immunogenicity of different doses of TG103 injection in combination with metformin in subjects with type 2 diabetes with poor glycemic control treated with metformin monotherapy.

Timeline

Start
2024-04-08
Primary completion
2026-02-03
Completion
2026-02-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Dulaglutide Peptide Subcutaneous
Subject TG103 Protein / enzyme biologic 7.5 mg Subcutaneous
Subject TG103 Protein / enzyme biologic 15 mg Subcutaneous