drugset / Trial / NCT06863532
Efficacy and Safety Comparison of Cofrogliptin Add-on Versus Metformin Dose-escalation in Type 2 Diabetes Patients Inadequately Controlled With SGLT-2 Inhibitors Plus Low-Dose Metformin:A Multicenter, Open-Label Trial
Recruiting
80 enrolled
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou Traditional Chinese Medicine Hospital · collabNingbo Medical Center Lihuili Hospital · collabThe Second Affiliated Hospital of Dalian Medical University · collabWenzhou Central Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate the change in glycated hemoglobin (HbA1c) levels of adding cofrogliptin compared to escalation of metformin dose after 24 weeks in type 2 diabetes patients who have failed to achieve adequate glycemic control despite receiving combination therapy with SGLT2i and metformin. Participants will be asked to use either cofrogliptin combined with SGLT2i and metformin or SGLT2i combined with increased dose of metformin.
Timeline
- Start
- 2025-03-30
- Primary completion
- 2026-06-30
- Completion
- 2026-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cofrogliptin | Small molecule | — | — |
| Subject | Metformin | Small molecule | — | — |