Efficacy and safety of enavogliflozin versus dapagliflozin added to metformin plus gemigliptin treatment in patients with type 2 diabetes: A double-blind, randomized, comparator-active study: ENHANCE-D study

A 52‐week efficacy and safety study of enavogliflozin versus dapagliflozin as an add‐on to metformin in patients with type 2 diabetes mellitus: ENHANCE‐M extension study

“…Enavogliflozin is a novel SGLT‐2‐selective inhibitor developed in South Korea 11 . Its pharmacokinetic and pharmacodynamic properties were verified in preclinical studies involving in vitro and animal models and healthy volunteers, 12–16 and its efficacy and safety in patients with T2DM were confirmed in several randomized trials analysing various clinical scenarios 17–20 . In one of those trials, a double‐blind (DB) randomized phase 3 study, the efficacy and safety of enavogliflozin (0.3 mg/day) as an add‐on to metformin were verified against dapagliflozin (10 mg/day) 18 .…”

“…11 Its pharmacokinetic and pharmacodynamic properties were verified in preclinical studies involving in vitro and animal models and healthy volunteers, [12][13][14][15][16] and its efficacy and safety in patients with T2DM were confirmed in several randomized trials analysing various clinical scenarios. [17][18][19][20] In one of those trials, a double-blind (DB) randomized phase 3 study, the efficacy and safety of enavogliflozin (0.3 mg/day) as an add-on to metformin were verified against dapagliflozin (10 mg/day). 18 The study, lasting for 24 weeks, showed that enavogliflozin added to metformin significantly improved glycaemic control in patients with T2DM and was noninferior to dapagliflozin, hence appearing as a viable treatment option for patients with inadequate glycaemic control on metformin alone.…”

Efficacy and safety of enavogliflozin vs. dapagliflozin as add-on therapy in patients with type 2 diabetes mellitus based on renal function: A pooled analysis of two randomized controlled trials

“…In one phase III study, the patients with inadequate glycemic control, despite receiving metformin monotherapy (≥ 1,000 mg/day), were candidates for screening [8]. In the other phase III study, patients with inadequate glycemic control, despite receiving a combination of metformin (≥ 1,000 mg/day) and gemigliptin therapies, were screened [9]. In these two studies, 274 and 385 patients were expected to be enrolled, respectively; however, 200 and 270 patients were ultimately included and randomized, respectively.…”

“…Recently, two randomized controlled phase III studies investigated the e cacy and safety of enavogli ozin 0.3 mg and compared them with those of dapagli ozin 10 mg in patients with inadequate blood glucose control, using metformin monotherapy [8] or a combination of metformin and the dipeptidyl peptidase-4 inhibitor (DPP-4i) gemigliptin [9]. The primary aim of these studies was to demonstrate the non-inferiority of enavogli ozin compared with dapagli ozin in terms of glycemic control.…”

S100A9 exerts insulin-independent antidiabetic and anti-inflammatory effects

“…Harnessing of these mechanisms is set to improve metabolic control and reduce insulin needs thus hampering the risk of iatrogenic hypoglycemia. Hence, this approach is broader as compared to other glucosecentric approaches that only aim at reducing hyperglycemia and therapeutic insulin needs without tackling other ID-driven defects, for example, DKA (31). S100 calcium-binding protein A9 (S100A9) belongs to the EF-hand superfamily of Ca 2+ -binding proteins and is a leptin-induced molecule underlying, in part, the insulin signaling-independent mechanisms permitting life without insulin (38).…”