Trials / Completed
CompletedNCT06235086
A 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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 632 (actual)
- Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TG103 | TG103 injection, 7.5mg, 15 mg, SC, once a week |
| DRUG | Dulaglutide | Dulaglutide, SC, once a week |
Timeline
- Start date
- 2024-04-08
- Primary completion
- 2026-02-03
- Completion
- 2026-02-03
- First posted
- 2024-01-31
- Last updated
- 2026-04-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06235086. Inclusion in this directory is not an endorsement.