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

NCT06235086 · Completed

Last updated 2026-05-28

This clinical trial is testing whether an injection called TG103, combined with the medication metformin, can help manage type 2 diabetes in adults.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 632 people

Who can join Ages 18–75 · all sexes

Timeline Started 2024-04 · est. completion 2026-02

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06235086 ↗

Description as written by the study sponsor.

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.

Treatments tested

TG103 Drug

TG103 injection, 7.5mg, 15 mg, SC, once a week
Dulaglutide Drug

Dulaglutide, SC, once a week

Main thing measured	Changes in glycosylated hemoglobin (HbA1c) from baseline at 28 weeks of treatment
Sponsor	CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Conditions studied	Type 2 Diabetes Mellitus
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06235086 ↗