NCT07019012

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

Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes: A Multicenter, Randomized, Open-Label, Active-Controlled, Non-inferiority Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective of this study is 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, as well as the comparison of efficacy of cofrogliptin and linagliptin. Patients will be assigned to receive the treatment of SGLT2i+metformin+cofrogliptn or SGLT2i+metformin+linagliptin.

Conditions

• T2DM

Interventions

Type	Name	Description
DRUG	SGLT2i+Metformin+Cofrogliptin	The combination of SGLT2i+Metformin+Cofrogliptin
DRUG	SGLT2i+Metformin+Linagliptin	The combination of SGLT2i+Metformin+Linagliptin

Timeline

• Start date: 2025-07-30
• Primary completion: 2026-10-30
• Completion: 2026-12-30
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

2 sites across 1 country: China