RecruitingPhase 4NCT07019012

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

Sponsor

Huazhong University of Science and Technology

Enrollment

170 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

T2DM

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new diabetes drug called cofrogliptin (taken once every two weeks) against a daily pill called linagliptin, both used in addition to existing medications (metformin and dapagliflozin), in adults with type 2 diabetes whose blood sugar is not well controlled. **You may be eligible if...** - You are 18 or older with type 2 diabetes - You have been taking metformin (at least 1000 mg/day) and dapagliflozin (10 mg/day) for at least 12 weeks - Your HbA1c (average blood sugar over 3 months) is between 7.0% and 10.0% - Your fasting blood sugar is below 15 mmol/L - Your BMI is 40 or under and kidney function is adequate **You may NOT be eligible if...** - You have type 1 diabetes - You are currently taking other blood sugar-lowering medications not listed - You have significant kidney, liver, or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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