Efficacy and safety of Dapagliflozin vs. Canagliflozin in addition to metformin for treatment of type 2 diabetes, a randomized, double-blind, non-inferiority clinical trial

Abstract

Type 2 Diabetes is the plague of the 21st century; a chronic condition with complex pathogenetic mechanisms that require the use of multiple therapies to achieve optimal glycemic control. Although conventional therapies offer robust reduction in glycated hemoglobin (HbA1c), they are also associated with increased risks of hypoglycemia and weight gain over time.
SGLT-2 Inhibitors are the latest class in the diabetes armamentarium to emerge with the promise of minimal hypoglycemia risk and potential for weight loss based on their unique mechanism of action. They reduce hyperglycemia by promoting the excretion of glucose through the urine.
Several studies have demonstrated efficacy in HbA1c reduction of the SGLT-2 inhibitors dapagliflozin and canagliflozin, when compared with both placebos and other types of oral hypoglycemic agents. However, to date no head to head trials exist that have compared the efficacy of HbA1c reduction of these two agents.
We propose a randomized controlled double-blind non-inferiority trial that will examine the efficacy of Hba1c reduction of canagliflozin to dapagliflozin respectively in patients treated with metformin monotherapy with suboptimal glycemic control. We hypothesize that there will be no difference in efficacy of HbA1c reduction between these two agents.
Keywords: Type 2 Diabetes, HbA1c, SGLT-2 Inhibitors, dapagliflozin, canagliflozin, metformin.