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NCT06235086Not yet recruiting

Phase 3 Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus

A Multicenter, Randomized, Open-label, Controlled Phase 3 Trial of TG103 Injection in Combination With Metformin in Subjects With Type 2 Diabetes Mellitus
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Phase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Type 2 Diabetes Mellitus
Drug/Device/Intervention
TG103
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 3
Start date
Mar 01, 2024
End date
Nov 01, 2026
Enrollment
618 participants
Primary outcome

Changes in glycosylated hemoglobin (HbA1c) from baseline at 28 weeks of treatment

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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06235086
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06235086 through Pure Global AI's free database. This Phase 3 trial is sponsored by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Type 2 Diabetes Mellitus. Target enrollment is 618 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.