Comparison of the effects of empagliflozin and sitagliptin, as an add-on to metformin, on cardio-metabolic and glycemic parameters of patients with type 2 diabetes mellitus: a randomized, double-blind clinical trial
Abstract
OBJECTIVE: To evaluate the effects of empagliflozin, sitagliptin, and metformin on the glycemic indices and cardiometabolic control of patients with type 2 diabetes mellitus (T2DM).
RESULTS: The significant changes in FBS from baseline to week 12 were - 23.1, -16.15, and - 15.25 mg/dl in the empagliflozin, sitagliptin, and metformin arm, respectively. HbA1C decreased significantly from baseline to week 12 in the empagliflozin, sitagliptin, and metformin arm (-1.8, -1.35, -0.69%). The FBS and HbA1C changes were significant in the empagliflozin group compared to the metformin group (P = 0.027, P = 0.037, respectively). The weight changes were substantial in the empagliflozin group relative to the metformin group (-4.1 vs. -0.90 kg; p = 0.044). Compared with the metformin group, the adjusted mean difference in the empagliflozin group was - 12.91 mg/dl (95% CI: 31.82, 6; P = 0.001) for triglyceride (TG) levels and 6.47 mg/dl (95% CI: 2.93, 10.01; P = 0.010) for high-density lipoprotein (HDL-c) levels. Moreover, empagliflozin led to reductions in SBP about - 8.27 mm Hg (95% CI: -13.31, -3.23; P = 0.001) and in DBP about - 13.37 mm Hg (95% CI: -16.42, -10.32; P = 0.001) compared with metformin.
TRAIL REGISTRATION NUMBER: IRCT. ir (IRCT20191231045959N1).
TRAIL REGISTRATION DATE: 2020-01-19.
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.
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