Empagliflozin 12.5mg / Metformin 850mg tablets

BackgroundType 2 diabetes mellitus (T2DM) often requires combination therapy when metformin alone becomes insufficient. Empagliflozin (SGLT2 inhibitor) and sitagliptin (DPP-4 inhibitor) are commonly used add-on agents with differing metabolic profiles. This systematic review and meta-analysis compared their glycaemic, cardiometabolic and safety outcomes when added to metformin.MethodsFollowing PRISMA guidelines, PubMed, Embase, Cochrane, Scopus and ClinicalTrials.gov were searched from inception to September 2025. Randomized trials and observational studies comparing empagliflozin + metformin versus sitagliptin + metformin in adults with T2DM were included. Primary outcomes were changes in HbA1c, body weight, fasting glucose, lipid profile and blood pressure. Safety outcomes included urinary tract infections, genital infections, gastrointestinal disturbances and rash. Risk of bias was assessed using RoB 2.0 and the Newcastle-Ottawa Scale. Random-effects models were used for meta-analyses, and meta-regression explored the impact of empagliflozin dose.ResultsEleven studies met eligibility criteria. Empagliflozin produced greater reductions in HbA1c, body weight, fasting glucose and systolic blood pressure compared with sitagliptin. Lipid changes were modest and inconsistent. Rates of urinary infections, gastrointestinal symptoms and rash were comparable between groups, whereas genital infections were significantly higher with empagliflozin. Rare but serious adverse events associated with SGLT2 inhibitors, including Fournier's gangrene and lower limb amputations, were not reported in the included trials. Meta-regression showed no meaningful dose-response relationship for glycaemic or weight outcomes.ConclusionsIn patients with T2DM on metformin, empagliflozin offers superior glycaemic and cardiometabolic benefits compared with sitagliptin, with an increase in genital infections. Both therapies are well tolerated, supporting empagliflozin as an effective metabolic add-on option.Trial registrationPROSPERO ID: CRD420251152360.

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BackgroundTriple oral therapy combining metformin, sodium-glucose cotransporter 2 inhibitor, and a dipeptidyl peptidase-4 inhibitor has been proposed as a synergistic approach to intensify glycemic control in patients with type 2 diabetes mellitus. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of triple therapy compared to dual therapy (metformin plus either sodium-glucose cotransporter 2 or dipeptidyl peptidase-4 inhibitor).MethodsFollowing preferred reporting items for systematic review and meta-analysis guidelines, we searched PubMed, Embase, Scopus, and Web of Science through January 2026. Studies included randomized controlled trials comparing triple versus dual therapy in adults with type 2 diabetes mellitus. Outcomes included hemoglobin A1c (HbA1c), fasting plasma glucose, body weight, achievement of HbA1c ResultsEight studies encompassing 2606 participants were included. Findings indicate triple therapy significantly reduced HbA1c levels compared to dual therapy, with a SMD of - 0.54 (95% confidence interval [CI]: -0.92 to -0.16; P = .005). Triple therapy resulted in greater reduction in fasting plasma glucose, with an SMD of -0.30 (95% CI: -0.62 to 0.01; P = .06). Patients on triple therapy were more likely to achieve HbA1c levels below 7% (RR: 2.02; 95% CI: 1.55-2.63; P ConclusionTriple therapy offers superior glycemic control over dual therapy without major safety trade-offs, though tolerability may affect long-term adherence.

Abstract licence: CC BY-NC

BackgroundMetabolic dysfunction-associated steatotic liver disease (MASLD), formerly nonalcoholic fatty liver disease (NAFLD), often coexists with type 2 diabetes mellitus (T2DM) due to shared metabolic pathways such as insulin resistance. Empagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, may provide hepatic and metabolic benefits. This study evaluated its effects on liver fat, enzymes, fibrosis, metabolic parameters, and inflammation in T2DM with MASLD.MethodsA systematic review and meta-analysis of randomized controlled trials (RCTs) was performed according to PRISMA guidelines. Primary outcomes included liver fat content, enzymes, and fibrosis markers. Secondary outcomes were metabolic and inflammatory parameters.ResultsEleven RCTs (n = 3077) were included. Empagliflozin significantly reduced liver fat (MD = -3.11%; 95% CI: -4.12 to -2.11; p ConclusionEmpagliflozin improves liver fat, stiffness, glycemic control, body weight, and uric acid in T2DM with MASLD, but its effects on fibrosis and inflammation remain uncertain. Larger, long-term histologic trials are needed to confirm these outcomes.

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AimsTo compare up-to-date efficacy and safety data of sodium-glucose cotransporter-2 inhibitors (SGLT-2is) versus other metformin-containing oral dual-therapies (ODTs) in type 2 diabetes mellitus.MethodsWe updated a 2016 systematic literature review (SLR), searching MEDLINE, Embase, the Cochrane Database of Systematic Reviews, congress abstracts and SLR/meta-analysis (MA) bibliographies to identify randomised controlled trials. Two independent reviewers determined eligible studies, which were extracted and assessed using the Cochrane Risk of Bias tool. MA was conducted using random-effects pairwise models.ResultsWe included 36 publications (23 unique studies). Mean differences (MD) indicated comparable change in HbA1c from baseline at Weeks 24 and 52 between SGLT-2i plus metformin and other metformin-containing ODTs. Patients on SGLT-2i plus metformin showed a significantly lower risk of hypoglycaemia (risk ratio [RR]: 0.27, 95% CI: 0.09, 0.84) and significantly greater weight reduction (MD: -2.59; 95% CI: -4.42, -0.77), but an elevated risk of genital infection (RR: 5.08; 95% CI: 3.49, 7.38) at Week 52 compared with other ODTs. Other safety outcomes (e.g., urinary tract infections) were comparable between SGLT-2i plus metformin and other ODTs.ConclusionCompared with other ODTs, SGLT-2i plus metformin exhibited overall comparable efficacy and safety, with a lower risk of hypoglycaemia and greater weight reduction at Week 52.

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BackgroundEmpagliflozin, a sodium-glucose cotransporter 2 inhibitor, performs a reduction in the all-cause mortality and cardiovascular mortality in type 2 diabetes mellitus (T2DM) patients compared to dapagliflozin, which has been included in the national volume-based procurement in China. The objective of this study is to evaluate the long-term cost-utility of the addition of empagliflozin (10 mg or 25 mg) versus dapagliflozin (10 mg) in T2DM patients with insufficient control by metformin monotherapy from the perspective of Chinese health care payers.MethodsThe IQVIA CORE diabetes model was used for cost-utility analysis to compare the long-term economics of empagliflozin (10 or 25 mg) versus dapagliflozin (10 mg) respectively. In the two independent analyses, the discount rate was 5% per year, and the utility value was derived from the published literatures. The baseline demographic and biochemical data, as well as treatment efficacy data were obtained from the EMPA-REG MET clinical trial and network meta-analysis, respectively.ResultsCompared with dapagliflozin 10 mg, empagliflozin 10 mg and empagliflozin 25 mg improved the life expectancy by 0.011 and 0.02 years, and improved the quality adjusted life years (QALYs) by 0.011 and 0.02 years, respectively. The total cost of empagliflozin group (10 mg) was 279 Chinese Yuan lower than that of the dapagliflozin group (10 mg), making it an absolutely economical choice. The total cost of empagliflozin (25 mg) was expected to be 1,601 Chinese Yuan higher than dapagliflozin, with an incremental cost-utility ratio (ICUR) of 80,052 Chinese Yuan per QALY, below the set ‌willingness to pay (WTP) threshold of 85,698 Chinese Yuan per QALY.ConclusionFor T2DM patients with insufficient control by metformin monotherapy, the addition of empagliflozin 10 mg showed better efficacy and lower cost compared to dapagliflozin 10 mg, making it an absolutely economical choice. Based on the set WTP threshold, empagliflozin 25 mg was also a more cost-effective treatment option than dapagliflozin from the perspective of Chinese healthcare payers.

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The dramatic rise in the prevalence of obesity and diabetes is associated with increased morbidity, mortality, and public health care costs worldwide. The need for new, effective, and long-lasting drugs is urgent. Recent research has focused on the role of the inhibitors of sodium– glucose co-transporter 2 (SGLT-2). Clinical trials have shown that SGLT-2 inhibitors have glycemic efficacy and weight-lowering potential. Dual drug therapy is a recommended therapy for patients with new-onset type 2 diabetes who need significant glycemic control. Fixed-dose combination therapy represents a particularly attractive option as it may reduce pill burden and improve adherence. The combination of metformin and empagliflozin was approved by the US Food and Drug Administration in 2014 and represents a safe and effective means to combat glycemic control and weight gain. The purpose of this systematic review is to summarize the background of the SGLT-2 inhibitors, particularly empagliflozin, and focus on the safety and efficacy of the fixed-dose combination of empagliflozin and metformin.

Abstract licence: CC BY-NC 3.0