Rakesh K Sahay, Richa Giri, Jayashree V Shembalkar, Sandeep K Gupta, Brij Mohan, Prakash Kurmi, S Ravindra Kumar, Vinayak M Sawardekar, Ashutosh Mishra, L Sreenivasa Murthy, Vivek V Arya, Abhijit R Sonawane, Pravin N Soni, Sandip K Gofne, Shital R Karnawat, Mandodari N Rajurkar, Piyush M Patel, Lalit K Lakhwani, Suyog C Mehta, Sadhna J Joglekar
INTRODUCTION: This study compared efficacy and safety of triple drug fixed-dose combination (FDC) of dapagliflozin (DAPA) + sitagliptin (SITA) + metformin (MET) extended release (ER) with SITA + MET sustained release (SR) and DAPA + MET ER in patients with type 2 diabetes poorly controlled with metformin. METHODS: This phase 3, randomized, open-label, active-controlled study included adult patients with glycated hemoglobin (HbA1c) ≥ 8% (64 mmol/mol) and ≤ 11% (97 mmol/mol), randomized in 1:1:1 ratio to receive either FDC of DAPA + SITA + MET ER (10 mg + 100 mg + 1000 mg) tablets once daily (n = 137) or co-administration of SITA + MET SR (100 mg + 1000 mg) tablets once daily (n = 139) or FDC of DAPA + MET ER (10 mg + 1000 mg) tablets once daily (n = 139)...
July 2023: Advances in Therapy