Study Comparing Cofrogliptin Added to Metformin and Dapagliflozin Every Two Weeks Versus Daily Linagliptin in Adults With Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the change in glycated hemoglobin HbA1c levels over 24 weeks in patients with type 2 diabetes mellitus T2DM who have poor glucose control despite treatment with metformin and SGLT2 inhibitors dapagliflozin. This study compares the effects of adding cofrogliptin every two weeks versus daily linagliptin to the existing combination therapy. The study is a phase 4, randomized, open-label trial led by Huazhong University of Science and Technology. Participants will be randomly assigned to one of two groups one receiving triple therapy with cofrogliptin added to metformin and SGLT2i, and the other receiving linagliptin added to metformin and SGLT2i. Both groups include patients who have been on stable doses of metformin and SGLT2i for at least 12 weeks but still have inadequate blood glucose control. Treatments will be administered according to these regimens for 24 weeks. During the study, participants will undergo assessments including HbA1c levels, 2-hour postprandial glucose 2h-PPG, fasting plasma glucose FPG, and weight measurements from enrollment through the 24-week treatment period. Participants will be asked to maintain consistent diet and exercise routines and use a home blood glucose meter to monitor and record their glucose levels. The main outcome measured is the change in HbA1c from baseline to 24 weeks, with additional safety and efficacy evaluations throughout the study period.

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