Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.

ConditionT2DM
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuazhong University of Science and Technology

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

170 Participants
are divided into 2 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