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
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.
• 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.
• Have received metformin treatment for ≥12 weeks, with a stable dose maintained during the screening period (≥1500 mg/day if tolerable or at the maximum tolerated dose (\<1500 mg/day but ≥1000 mg/day), and no dosage adjustment).
• HbA1c levels within the range: 7.0% \< HbA1c ≤ 10.0%.
• Fasting plasma glucose (FPG) \< 15 mmol/L.
• Body Mass Index (BMI) ≤ 40 kg/m2.
• Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml/min/1.73m2.
• Agree to maintain the same diet and exercise habits throughout the trial period, willing and able to accurately use a home blood glucose meter for self-monitoring of blood glucose (SMBG) and keep records.