A Study of TG103 Injection in Type 2 Diabetes Subjects

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Study ID
NCT05348122
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • TG103,Q2W — DRUG
    TG103 injection will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
  • TG103,QW — DRUG
    TG103 injection will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
  • Placebo,Q2W — DRUG
    Placebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
  • Placebo,QW — DRUG
    Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
  • Dulaglutide,QW — DRUG
    Dulaglutide will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.

Study Details

The primary objective of this trial is to evaluate the efficacy of different doses and frequencies of administration of TG103 injection in the treatment of type 2 diabetes.

Key Dates

Start date
Jun 15, 2022
Status verified
Apr 2022
Primary completion
Nov 1, 2023
Completion
Nov 1, 2023

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TG103, 15 mg,Q2W
    TG103 (15 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
  • Experimental: TG103, 22.5 mg,Q2W
    TG103 (22.5 mg) will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
  • Placebo Comparator: Placebo,Q2W
    Placebo will be administered via subcutaneous injection once every two weeks in subjects with type 2 diabetes.
  • Experimental: TG103, 7.5 mg,QW
    TG103 (7.5 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
  • Experimental: TG103, 15 mg,QW
    TG103 (15 mg) will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
  • Placebo Comparator: Placebo,QW
    Placebo will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.
  • Active Comparator: Dulaglutide,QW
    Dulaglutide will be administered via subcutaneous injection once weekly in subjects with type 2 diabetes.

Primary Outcome Measure

Changes in glycosylated hemoglobin (HbA1c) from baseline to week 17 [ Time Frame: Baseline through Day 113 ]

Central Contacts

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