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

C

CSPC Pharmaceutical Group

Status and phase

Not yet enrolling
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: TG103
Drug: Dulaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06235086
SYSA1803-009

Details and patient eligibility

About

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.

Enrollment

618 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 or maximum tolerated dose (<1500 mg/ day but ≥1000 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.

Exclusion criteria

  • Type 1 diabetes;

  • Body weight change more than 5% within 1 month prior to screening;

  • Received any of the following medications:

    1. Prior discontinuation of DPP-4 inhibitors or GLP-1 receptor agonists for efficacy, tolerability, and safety reasons;
    2. Systemic glucocorticoid and growth hormone 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, or prior to randomization;

  • 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 or acute infection within 4 weeks prior to screening, or refractory urinary tract or genital infection within 6 months prior to screening;

  • Having a significant blood system disease (e.g., aplastic anemia, myelodysplastic syndrome) or any disease causing hemolysis or red blood cell instability (e.g., malaria) at screening;

  • Subjects with thyroid dysfunction that cannot be controlled by a stable drug dose at screening, or with clinically significant abnormalities in thyroid function examination results requiring drug treatment at screening;

  • Personal or family history of medullary thyroid cancer (MTC) or type 2 multiple endocrine tumor syndrome at screening;

  • Any of the indicators meet the following criteria:

    • i. Systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥ 100mmHg at screening or before randomization;

    • ii. Laboratory tests show any of the following abnormalities:

      1. FPG≥13.9 mmol/L;
      2. ALT or AST≥2.5×ULN;
      3. Total bilirubin (TBiL) ≥2.0×ULN;
      4. Triglyceride >5.7 mmol/L;
      5. eGFR<45 mL/(min*1.73 m^2);
      6. Serum amylase and/or lipase ≥3×ULN;
      7. Hemoglobin <100 g/L;
      8. Calcitonin≥50 ng/L(pg/mL);
    • iii. Serological examination:

      1. Human immunodeficiency virus antibody or treponema pallidum antibody is positive;
      2. Hepatitis C antibody is positive, and HCV RNA was higher than the lower limit of the detection reference range;
      3. Hepatitis B surface antigen is positive, and the quantitative detection result of HBV DNA was higher than the lower limit of the detection reference range;
  • Known allergy to the test drug, Dulaglutide, Empagliflozin, or related excipients;

  • Subjects who have lost more than 400 mL blood due to blood donation or other reasons within 3 months prior to screening;

  • Average alcohol intake more than 21 units of alcohol (male)/14 units of alcohol (female) per week within the 3 months prior to screening (1 unit ≈360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine);

  • Subject participated in any drug or medical device clinical study within 3 months prior to screening (except for screening failure);

  • Pregnant or lactating female;

  • Not suitable for this study in the investigator's opinion.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

618 participants in 3 patient groups

TG103, 7.5 mg
Experimental group
Description:
TG103 (7.5 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.
Treatment:
Drug: TG103
TG103, 15 mg
Experimental group
Description:
TG103 (15 mg) will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.
Treatment:
Drug: TG103
Dulaglutide
Experimental group
Description:
Dulaglutide will be administered via subcutaneous injection once a week in subjects with type 2 diabetes.
Treatment:
Drug: Dulaglutide

Trial contacts and locations

1

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Central trial contact

Clinical Trials Information Group officer

Data sourced from clinicaltrials.gov

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