A Phase 3 clinical trial (NCT06235086) evaluating TG103 injection in combination with metformin for Type 2 Diabetes Mellitus, with dulaglutide as a comparator, completed its primary data collection phase on 2026-02-03. The study enrolled 632 participants to assess efficacy, safety, and immunogenicity.
Background
The trial, titled "A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus," aimed to assess a new treatment for individuals with Type 2 Diabetes Mellitus who have poor glycemic control despite metformin monotherapy. Dulaglutide served as an active comparator in this study.
Trial design
The study (NCT06235086) is a Phase 3, randomized, open-label, multicenter trial. It enrolled 632 participants diagnosed with Type 2 Diabetes Mellitus who had poor glycemic control while on metformin monotherapy. The trial's design included evaluating different doses of TG103 injection in combination with metformin, with dulaglutide serving as a comparator arm. The primary objectives were to evaluate the efficacy, safety, and immunogenicity of TG103, though specific primary outcome measures are not detailed in the available data.
What this means
The primary completion of this Phase 3 trial signifies that data collection for the main endpoints has concluded. Researchers will now proceed with data analysis to determine the efficacy, safety, and immunogenicity profile of TG103 injection compared to dulaglutide in patients with Type 2 Diabetes Mellitus. The results are highly anticipated as they could inform future treatment strategies for this condition.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT06235086, titled "A Study of TG103 Injection Combined With Metformin in Treatment of Type 2 Diabetes Mellitus," was updated to reflect primary completion on 2026-02-03 on clinicaltrials.gov.