Differential Effects of SGLT-2 Inhibitors on Liver Function and Nocturia in Patients with Type 2 Diabetes: A Randomized Controlled Trial
Abstract
Purpose This study investigated whether sodium-glucose cotransporter-2 inhibitors (SGLT-2is) improve liver function as a class effect and evaluated their effect on nocturia in patients with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD). Methods A total of 135 patients with type 2 diabetes and MASLD were randomly assigned to receive tofogliflozin (20 mg/day), dapagliflozin (5 mg/day), or empagliflozin (10 mg/day). Primary outcomes included changes in liver function and fibrosis markers—various transferases, fibrosis-4 index, mac-2 binding protein glycan isomer, and shear wave speed—along with nocturia frequency. Secondary outcomes were glycemic control, body weight, and lipid profiles. Patients were followed for seven months. Results The participants had a mean age of 61 years; 43% were female, HbA1c level was 8.7%, and the frequency of nocturia was 0.6 times. All three SGLT-2is significantly improved liver function markers, with no differences between groups. However, nocturia frequency significantly increased with empagliflozin (1.7 times) and dapagliflozin (1.9 times; both p < 0.001) but not with tofogliflozin (0.8 times; p = 0.503). Tofogliflozin resulted in a significantly smaller nocturia increase than the other two drugs (p < 0.001). However, this significant difference persisted up to 1 month; from 3 months onward, urinary frequency improved in all groups, and the difference was not observed. Glycemic control, body weight, 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: 135 participants or records.
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