33-PUB: Triple-Arm, Prospective, Multicentre, Randomized, Open-Label, Active-Controlled Study to Assess Effect on FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg Compared with FDC of Sitagliptin 100 mg + Dapagliflozin 10 mg and FDC of Linagliptin 5 mg+ Empagliflozin 25 mg on 24-Hour Glucose Profile Assessed by Continuous Glucose Monitoring (CGM) in Indian Patients of Type 2 Diabetes Mellitus In Real-World Setting (AMPLIFY-TIR STUDY)—Interim Report

Introduction & Objective: Fixed dose combination (FDC) of Teneligliptin 20 mg + Dapagliflozin 10 mg has been recently approved in India for treatment of T2DM. Study was designed to compare effect of FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg (Arm A) with FDC of Sitagliptin 100 mg + Dapagliflozin 10 mg (Arm B) & FDC of Linagliptin 5 mg + Empagliflozin 25 mg (Arm C) with parameters derived from CGM in Indian T2DM

Results: Present interim analysis report of 50 T2DM patients shows changes in CGM parameters when compared as intergroup between FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg, FDC of Sitagliptin 100 mg + Dapagliflozin 10 mg & FDC of Linagliptin 5 mg + Empagliflozin 25 mg at end of phase II as non-significant (p>0.05). Significant improvement seen in intragroup from Pre-treatment to End of phase II in all efficacy parameter. No serious adverse event reported.

Conclusion: FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg, Sitagliptin 100 mg + Dapagliflozin 10 mg & FDC of Linagliptin 5 mg + Empagliflozin 25 mg had significant improvement in CGM & Glycemic parameters.

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