Comparative effects of Imeglimin and empagliflozin on the redox-inflammation-organ stress axis in type 2 diabetes: a randomized controlled trial
Abstract
Oxidative stress and inflammation contribute to diabetes-related organ damage beyond hyperglycemia. Imeglimin and sodium-glucose cotransporter 2 inhibitors may modulate redox balance through distinct mitochondrial pathways, but their comparative effects on organ-level stress remain unclear. To compare the effects of imeglimin and empagliflozin on oxidative stress, inflammation, and subclinical organ stress markers in type 2 diabetes mellitus (T2DM). In this 24-week, prospective, randomized, open-label study, people with T2DM received imeglimin (n = 34) or empagliflozin (n = 42). Changes in urinary 8-hydroxy-2′-deoxyguanosine (u8-OHdG) and liver-type fatty acid-binding protein (L-FABP) were assessed as co-primary endpoints. Secondary endpoints included serum diacron-reactive oxygen metabolites (d-ROM), biological antioxidant potential (BAP), serum 8-OHdG (s8-OHdG), tumor necrosis factor receptors 1/2 (TNFR1/2), and organ stress markers: N-terminal pro-brain natriuretic peptide (NT-proBNP), Fibrosis-4 index (FIB-4), and cardio-ankle vascular index (CAVI). u8-OHdG levels increased significantly, while L-FABP levels were not significantly changed at 24 weeks, suggesting a systemic rather than renal oxidative response. Only empagliflozin improved FIB-4, NT-proBNP, and CAVI values. Both treatments reduced TNFR1/2 values and increased BAP values. In the empagliflozin group, univariate analysis showed that ΔFIB-4 was positively correlated with ΔTNFR1 and ΔTNFR2, while ΔNT-proBNP and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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