About this trial
This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy.
Eligibility criteria
Qualifiers
Able to understand and voluntarily sign a written informed consent form.
Male or female subjects aged 18 years and above .
Meet the diagnostic criteria for Type 2 Diabetes Mellitus (T2DM).
Have been on initial SGLT2i monotherapy (dapagliflozin) at a dose of 10 mg daily for at least 12 weeks.
Disqualifiers
Type 1 Diabetes Mellitus.
Any type of secondary diabetes.
Pending or having undergone pancreatic or β-cell transplantation.
History of pancreatitis or pancreatic resection.
Trial design
Treatments tested in this trial
- SGLT2i+Metformin+Cofrogliptin
- SGLT2i+Metformin+Linagliptin
Treatment groups
Sponsors and collaborators
Huazhong University of Science and Technology
Lead sponsor
Renmin Hospital of Wuhan University
Collaborator
Wuhan Central Hospital
Collaborator
Taihe Hospital
Collaborator
Xiangyang No.1 People's Hospital
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator