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

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study ID
NCT06235086
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TG103 — DRUG
    TG103 injection, 7.5mg, 15 mg, SC, once a week
  • Dulaglutide — DRUG
    Dulaglutide, SC, once a week

Study Details

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.

Key Dates

Start date
Apr 8, 2024
Status verified
Mar 2026
Primary completion
Feb 3, 2026
Completion
Feb 3, 2026

Study Design

Enrollment
632 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Changes in glycosylated hemoglobin (HbA1c) from baseline at 28 weeks of treatment [ Time Frame: Baseline through Week28 ]

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