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

NCT06235086 | Active Not Recruiting Phase 3

• 1 other identifier: SYSA1803-009
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

  Baseline through Week28

Secondary Outcomes (11)

• Changes in HbA1c from baseline at 52 weeks of treatment

  Baseline through Week52

• The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 28 and 52

  Week28 and 52

• Change in fasting plasma glucose (FPG) from baseline at week 28 and 52

  Baseline through Week28 and 52

• Change in weight from baseline at week 28 and 52

  Baseline through Week28 and 52

• Change in 2h-postprandial plasma glucose (2h-PPG) from baseline at week 28 and 52

  Baseline through Week28 and 52

Study Arms (3)

TG103, 7.5 mg

EXPERIMENTAL

TG103 (7.5 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.

Drug: TG103

TG103, 15 mg

EXPERIMENTAL

TG103 (15 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.

Drug: TG103

Dulaglutide

EXPERIMENTAL

Dulaglutide will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.

Drug: Dulaglutide

Interventions

TG103 DRUG

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

TG103, 15 mg; TG103, 7.5 mg

Dulaglutide DRUG

Dulaglutide, SC, once a week

Dulaglutide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects have diagnosed with type 2 diabetes according to the Guidelines for prevention and treatment of type 2 diabetes in China (2020 Edition), T2DM was diagnosed at least 8 weeks before screening;
• Aged 18 to 75 years (inclusive), no gender limitation;
• Body Mass Index (BMI): 18.5≤BMI≤40;
• Received stable dose of metformin hydrochloride monotherapy for ≥8 weeks before screening and metformin dose ≥1500 mg/ day ;
• HbA1c must meet the following criteria:
• Screening: 7.5% ≤ HbA1c ≤ 11.0% (Local laboratory)
• Baseline: 7.0% ≤ HbA1c ≤ 10.5% (Central laboratory)
• Subjects of childbearing potential must use reliable methods of contraception throughout the study period and at least 3 months after the last dose to avoid pregnancy in female subjects or pregnancy in the male subject's partner;
• Willing and able to accurately use home glucose meter for self-glucose monitoring;
• Be able to understand and follow the trial procedure, voluntarily participate in the trial and sign the informed consent form.

You may not qualify if:

• Type 1 diabetes;
• Body weight change more than 5% within 1 month prior to screening;
• Received any of the following medications:
• Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;
• Systemic glucocorticoid and growth hormone,or other drugs affecting glucose metabolism have been used within 8 weeks before screening;
• History of ≥2 episodes of grade 3 hypoglycemia within 6 months prior to screening, or grade 3 hypoglycemia between screening to randomization;
• Acute complications of diabetes, such as diabetic ketoacidosis and hyperglycemic hyperosmolar status, occurred ≥1 time within 6 months prior to screening;
• Severe chronic complications of diabetes (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months prior to screening
• History of acute or chronic pancreatitis prior to screening;
• Subjects with clinically significant gastric emptying abnormalities (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., gastroparesis, inflammatory bowel disease, or intestinal obstruction) within 6 months prior to screening, or who have undergone gastrointestinal surgery that affects gastric emptying;
• Any of the following cardiovascular events within 6 months prior to screening: decompensated cardiac insufficiency (NYHA class III or IV); history of unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; or long QT syndrome or prolonged QTcF interval (QTcF: male \>450 ms, female \>470 ms) on 12-lead ECG; severe arrhythmias that are evaluated by the investigator to be inappropriate for participation in this clinical trial;
• Hemorrhagic stroke or acute ischemic stroke disease occurred within 6 months prior to screening;
• History of psychiatric diseases (such as depression, anxiety, etc.) during screening; or symptomatic gallbladder disease; or history of other diseases that may endanger the safety of the subject and that the investigator deems inappropriate for enrollment;
• Any type of malignant tumor treated or untreated within 5 years prior to screening (except for clinically cured basal cell carcinoma or carcinoma in situ);
• Severe infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening;

Sponsors & Collaborators

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

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: April 8, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (1)