A Real-World Observational Study on Diabetes Mellitus Patients Administering Dual Combination Therapy of Teneligliptin and Metformin to Evaluate Renal Function

Abstract

Introduction: Despite the improvements in our knowledge of the pathophysiology of Type 2 Diabetes Mellitus (T2DM) and the development of new therapeutic approaches, the management of T2DM patients is still suboptimum. Objective: The aim of the ADMIRE study was to evaluate the renal function (serum creatinine and estimated Glomerular Filtration Rate (eGFR)) of the patients who were receiving teneligliptin and metformin combination therapy for T2DM in a real-world setting. Design/ Settings/Participants: This was a multicenter, real-world, observational, cohort study; conducted across 600 centers in India from July 2021 to September 2022. Patients aged ≥ 18 to ≤ 85 years with uncontrolled T2DM (HbA1c ≥7.0 %) and eGFR of 60 mL/min/1.73m 2 receiving combination therapy of teneligliptin and metformin as part of routine clinical practice were included in the trial. Results: Of the total 15,321 subjects enrolled in the study renal parameters were available for 1019 patients which were analyzed for the study objective (N=1019). At the end of six months, the mean eGFR improved by 13.54 mL/min/1.73m 2 (p -0.0013). A significant reduction was observed in (mean) serum creatinine (by 0.6 mg/dl), FPG (by 36.77 mg/dL), PPG (by 66.79 mg/dL), HbA1c (by 1.07%). A total of 27.70% of the patients achieved an HbA1c value that was less than 7%. Conclusion: ADMIRE study showed that the introduction of combination therapy with metformin and teneligliptin significantly improves the renal profile and glycemic control in the Indian population with uncontrolled DM in real-world settings; demonstrating that it is safe and effective.