Vildagliptin 50mg / Metformin 1g tablets

INTRODUCTION: The management of type 2 diabetes with metformin as the first-line therapy has long been established. However, combination therapy of metformin and other oral antidiabetics became necessary to achieve optimal glycemic targets. Recently, the rising cost of these combinations poses a challenge for the healthcare system and patients, particularly in low- and middle-income settings, highlighting the need to balance clinical benefits with economic considerations to ensure access to treatment while maintaining sustainability in patient care. This review aims to compare the efficacy, safety, and cost-effectiveness of DPP-4 inhibitors with metformin/metformin with other combinations and metformin alone. METHODS: A literature search was performed through databases including PubMed, Scopus, Cochrane, clinicaltrials.gov, and Google Scholar using specific keywords on "type 2 diabetes mellitus management," "metformin," "DPP-4 inhibitors," "safety," and "efficacy." The retrieved studies were screened and selected according to eligibility criteria, followed by data extraction and critical appraisal. The extracted data were synthesized and reported according to the PRISMA guidelines. RESULTS: Thirty-five eligible studies were included in the review. From the studies, oral antidiabetic options apart from DPP-4 inhibitors commonly combined with metformin, either as free or fixed-dose combinations, include SGLT-2 inhibitors, sulfonylureas, GLP-1 receptor agonists, insulin, and thiazolidinediones (TZDs). The efficacy of this drug combination is comparable to that of metformin monotherapy, which is more cost-effective, especially at the beginning of treatment. Where metformin monotherapy fails, the efficacy of an add-on therapy as a second line depends on the specific target and individual patient differences, and even triple therapy may be recommended for some individuals. The cost-effectiveness of each combination depended on the cost-effectiveness model used in the assessment and the nature of the healthcare setting. DISCUSSION: DPP-4 inhibitors/metformin demonstrate significant HbA1c reduction, but their low cost-effectiveness hinders patient adherence compared to metformin monotherapy, free drugs, or other combinations. For that, initiating therapy with cost-effective metformin alone is recommended. Manufacturer-funded trials highlight a potential bias, necessitating independent research validations.

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Dipeptidyl peptidase 4 inhibitors (DPP-4 inhibitors) are used as second-line drugs in the treatment of type 2 diabetes mellitus (T2DM) patients. They act by preventing the breakdown of incretin hormones, which enhance insulin secretion and reduce glucagon secretion. Vildagliptin and sitagliptin are more commonly used DPP-4 inhibitors. In recent years, the use of DPP-4 inhibitors has been increasing; hence, it is important to evaluate the comparative efficacy and safety of this medication with available evidence. Moreover, this systematic review will evaluate to look for any specific superiority or safety advantage of using Vildagliptin over other DPP-4 inhibitors. In accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we conducted a systematic review search with Cochrane and PubMed databases. Two independent reviewers examined randomized controlled trial (RCT) studies against the inclusion criteria. Excluded studies involve type 1 diabetes, gestational diabetes, and severe acute diabetic complications. Finally, five RCT studies were chosen, involving 296 participants overall. Baseline and outcome values with p-values and intergroup differences with their p-value from original studies were gathered to evaluate the significance of using vildagliptin over DPP-4 inhibitors, and findings were provided in a narrative way with available evidence. All five RCT studies have demonstrated a significant reduction in HbA1c from baseline, ranging from -0.3 to -1.34 with p-value <0.05 in the vildagliptin group and -0.1 to -1.07 with p-value >0.05 in other DPP-4 inhibitors, with no significant intergroup differences indicating comparable efficacy between vildagliptin and other DPP-4 inhibitors. Similarly, no significant intergroup differences were observed between vildagliptin and comparator agents in reducing fasting plasma glucose and postprandial glucose. Notably, one study reported a significant reduction favoring vildagliptin, while another showed a greater reduction of FPG with alogliptin; however, intergroup comparisons were not statistically significant. In addition, vildagliptin did not show consistent improvement in lipid profile across the involved studies. Vildagliptin showed a low incidence of hypoglycemic events in comparison with other DPP-4 inhibitors. Overall, this systematic review found no significant superiority of vildagliptin over other DPP-4 inhibitors such as sitagliptin and alogliptin in the management of type 2 diabetes mellitus, whether used as monotherapy or in combination therapy.

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BACKGROUND: Prediabetes refers to the transitional stage from normal glucose metabolism to diabetes. The International Diabetes Federation guidelines reported that, as of 2024, approximately 1.12 billion people globally were in the prediabetes stage. Without intervention, individuals with prediabetes are highly likely to progress to type 2 diabetes mellitus. It can be seen that prediabetes is posing a threat to human health and life and leads to a significant global public health concern. METHODS: PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov were searched before March 29, 2025. Eligible randomized controlled trials (RCTs) enrolled adults with prediabetes, compared the efficacy and safety of placebo and anti-prediabetic drugs (e.g., metformin, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor agonists, and thiazolidinedione) with a follow-up duration of at least 12 weeks. Bayesian network meta-analysis was employed in statistical analysis. RESULTS: ). Specifically, 2.4 mg of semaglutide SC demonstrated the most optimal efficacy in WL (MD - 13.59 kg; 95% confidence interval (CI) - 17.30 to - 9.91) and favorable efficacy in lowering HbA1c (MD - 0.39%; 95% CI - 0.55 to - 0.25); 15 mg of tirzepatide showed significant efficacy in lowering FPG (MD - 9.58 mg/dL; 95% CI - 12.00 to - 7.15), and potent efficacy in lowering BMI. Thirty milligrams of pioglitazone showed excellent efficacy in lowering lipid and FPG. Among the interventions, there was no significant difference in the incidence of adverse events (AEs), while 100 mg of sitagliptin demonstrated higher incidence of serious adverse events (SAEs). CONCLUSIONS: Among all the included interventions, GLP-1RAs, GIP/GLP-1RAs, and TZDs demonstrated favorable anti-prediabetic efficacy and acceptable safety. 2.4 mg of semaglutide SC and 15 mg of tirzepatide were the best option among the included interventions considering favorable glucose and BMI control. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42025636991.

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BACKGROUND: The present study aimed to investigate the effects of vildagliptin, a dipeptidyl peptidase 4 inhibitor, on insulin resistance and weight reduction through advanced glycation end-product modulation in patients newly diagnosed with type 2 diabetes mellitus. METHODS: This study was designed as a 12-week, randomized, controlled, parallel trial. A total of 120 patients with type 2 diabetes were selected and divided into two distinct groups: group I, patients who received gliclazide in combination with metformin, and group II, patients who received vildagliptin in combination with metformin. The percentage change in body weight was estimated along with serum advanced glycated end-product levels, glycated hemoglobin (HbA1c), and insulin resistance. RESULTS: Upon completing the study period, when vildagliptin was added to metformin instead of gliclazide, the results demonstrated a significant improvement in insulin resistance, a downregulation of serum levels of advanced glycation end products, glycated hemoglobin, and a decrease in body weight. CONCLUSION: Vildagliptin showed a promising effect on improving type 2 diabetes mellitus-related complications by reducing advanced glycated end-product levels and insulin resistance. Additionally, vildagliptin reveals a favorable impact on weight reduction and glycated hemoglobin values.

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Metformin-associated lactic acidosis (MALA) and euglycemic diabetic ketoacidosis (euDKA) are distinct causes of high anion gap metabolic acidosis, but their simultaneous occurrence is rare and may be overlooked when severe hyperlactatemia dominates the presentation. We report the case of a 68-year-old man with type 2 diabetes mellitus treated with basal-bolus insulin, metformin, and linagliptin who presented with vomiting, confusion, fatigue, hypotension, and reduced level of consciousness. Initial evaluation revealed profound acidemia (arterial pH 6.75), severe high anion gap metabolic acidosis (anion gap 51 mEq/L, bicarbonate <2 mEq/L), marked hyperlactatemia (19 mmol/L), significant ketonemia (beta-hydroxybutyrate >9.60 mmol/L), near-normal glucose (9.1 mmol/L), hyperkalemia (6.5 mEq/L), and severe acute kidney injury (creatinine 516 µmol/L). Ongoing metformin exposure in the setting of acute kidney injury supported MALA, while marked ketonemia with near-normal glucose supported concurrent euDKA, likely precipitated by vomiting and reduced oral intake. The patient was treated with intravenous fluids, vasopressors, sodium bicarbonate, insulin with concurrent dextrose, and sustained low-efficiency dialysis, with subsequent hemodynamic, metabolic, and renal recovery. This case emphasizes that marked hyperlactatemia does not exclude a concurrent ketotic process and that early ketone measurement can materially change management in metformin-treated patients with persistent high anion gap acidosis.

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Background: Vildagliptin/Metformin (EquMet) and imeglimin (Twymeeg) are effective oral hypoglycemic agents (OHAs) for patients with type 2 diabetes (T2D). Case Presentation: The patient was a 68-year-old male with T2D and fatty liver for several years. In November 2022, his HbA1c had increased to 8.2%, and he was started on Twymeeg, followed by EquMet. Results: Over the course of four months, the patient’s HbA1c value successfully decreased from 8.2% to 6.7%, and he did not experience any gastrointestinal adverse effects (GIAEs). Discussion and Conclusion: The combined treatment of EquMet and Twymeeg demonstrated clinical efficacy without any adverse effects. The Trials of IMeglimin for Efficacy and Safety (TIMES) provided various evidence of imeglimin’s effectiveness.

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Abstract Aim Vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn ® ) is being developed for the treatment of type 2 diabetes mellitus. An open label, crossover, bioequivalence study (phase I) was conducted to assess the bioequivalence between Sensityn ® Film Coated Tablets (Test Product/Alpha Pharma Industries, a subsidiary of Cigalah Healthcare LLC, KAEC, Saudi Arabia) and Galvusmet ® Film Coated Tablets (Reference product/Novartis Pharma, Switzerland), in healthy adults under fed conditions. Safety and tolerance were evaluated as secondary endpoints. Materials and methods A randomized study with two treatments, two periods, crossover, open-label, laboratory-blind, single dose, with a washout period of seven days under fed conditions in 36 healthy male subjects. These were administered medicinal drug product (Sensityn ® ) or the reference medicinal product (Galvusmet ® ); both as a single 50 mg/1000 mg oral dose, under fed conditions. Blood samples were collected for pharmacokinetic analysis before treatment and until 24.00h post-dosing in each study period. ANOVA analysis (test sequence, subjects’ nested within sequence, product and period effect) was performed using a 5% significance level for logarithmic and untransformed data for C max AUC 0-t and AUC 0-∞ and for untransformed data for T max , K elimination (λz) and half-life. Results The results showed that C max , AUC 0-t , and AUC 0-∞ have passed the 90% CI acceptance limits of 80.00%–125.00% for vildagliptin and metformin. Consequently, the bioequivalence of Sensityn ® and Galvusmet ® film coated tablets was demonstrated under fed conditions. Treatment emergent adverse events were reported by 3 subjects and 1 subject following the administration of Sensityn ® and the Galvusmet ® , respectively. Conclusion The present findings confirmed that Sensityn ® , the test medicinal product is bioequivalent to Galvusmet ® , the reference medicinal product, in the rate and extent of absorption. Also, it has comparable safety profile. These findings support the continued development of vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn ® ) for use in patients with type 2 diabetes mellitus.

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