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

NCT06235086 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TG103

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

DRUG

Dulaglutide

Dulaglutide, SC, once a week

Sponsors & Collaborators

  • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06235086 on ClinicalTrials.gov