Triple arm, prospective, real-world study comparing the efficacy of FDC teneligliptin + dapagliflozin to FDC sitagliptin + dapagliflozin, and FDC linagliptin + empagliflozin in Indian type 2 diabetes mellitus patients using CGM device: the Amplify-TIR study

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INTRODUCTION: Diabetes mellitus (DM) is a chronic metabolic disorder marked by persistent hyperglycemia. While HbA1c has traditionally been used to assess glycemic control, growing evidence highlights glycemic variability (GV) and Time in Range (TIR) as more precise indicators of glucose fluctuations, which are linked to diabetic complications, especially chronic kidney disease (CKD). Emerging combination therapies targeting different pathophysiologic mechanisms of type 2 diabetes mellitus (T2DM), such as SGLT2 inhibitors and DPP-4 inhibitors, offer promise in reducing GV. OBJECTIVE: To compare the efficacy of three commonly prescribed fixed-dose combination (FDC) therapies—Teneligliptin + Dapagliflozin (Arm-A), Sitagliptin + Dapagliflozin (Arm-B), and Linagliptin + Empagliflozin (Arm-C)—in improving glycemic control and renal parameters in Indian T2DM patients using continuous glucose monitoring (CGM). METHOD: This prospective, comparative study enrolled 90 patients (30 in each arm). CGM was used to evaluate glycemic parameters including TIR, TAR, TBR, MAGE, LAGE, MPPGE, HbA1c, FPG, PPG, and renal function indicators (eGFR, serum creatinine, BUN) at baseline and study conclusion. RESULTS: All arms demonstrated significant improvements in TIR, MAGE, LAGE, HbA1c, FPG, and PPG (p<0.001). Arm-A showed a significantly superior reduction in TAR and MPPGE compared to Arm-B (p=0.029 and p=0.040, respectively) and also outperformed Arm-B in reducing FPG (p=0.042). Renal function improved comparably across arms, with a significant decline in serum creatinine noted in Arm-A. CONCLUSION: All three FDC therapies significantly improved glycemia, with the Teneligliptin + Dapagliflozin combination offering slightly superior efficacy in reducing TAR, MPPGE, and FPG. These findings support its clinical utility in reducing glycemic variability in patients with T2DM in India. Although favorable trends were observed in renal parameters, the study duration was too short to draw definitive conclusions regarding renal safety. As such, references to renal outcomes should be interpreted with caution, and further long-term studies are warranted to validate these findings.

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