Sitagliptin 50mg / Metformin 850mg tablets

BACKGROUND: Type 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. METHODS: Following 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. RESULTS: Eleven 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. CONCLUSIONS: In 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 REGISTRATION: PROSPERO ID: CRD420251152360.

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BACKGROUND: Triple 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). METHODS: Following 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 < 7%, and adverse events (AEs). Pooled standardized mean differences (SMDs) and risk ratios (RRs) were calculated using random-effects models. RESULTS: Eight 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 < .0001). Weight reduction was modest, with an SMD: -0.14 (95% CI: -0.22 to -0.07; P = .0002). No significant differences were found in total AEs (RR = 0.97; P = .69) or hypoglycemia (RR = 1.32; P = .32), although there was higher discontinuation due to AEs (RR = 2.62; P = .03). CONCLUSION: Triple therapy offers superior glycemic control over dual therapy without major safety trade-offs, though tolerability may affect long-term adherence.

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INTRODUCTION: A slower adoption rate of fixed dose combinations (FDC) in diabetes management is partly due to insufficient data. This study evaluates the safety and efficacy of an FDC of dapagliflozin + sitagliptin + metformin hydrochloride extended release (XR), compared to a dual FDC of sitagliptin + metformin hydrochloride XR among patients with type 2 diabetes mellitus (T2DM) with poor glycemic control when treated with metformin monotherapy. METHODS: A total of 274 patients with T2DM were randomized (1:1) to either arm X, receiving FDC of dapagliflozin (10 mg) + sitagliptin (100 mg) + metformin hydrochloride XR (1000 mg) (Dapa + Sita + Met) tablets, or arm Y, receiving sitagliptin phosphate (100 mg) + metformin hydrochloride XR (1000 mg) (Sita + Met) tablets, and treated for 16 weeks. The outcome measures included changes in hemoglobin A1c (HbA1c)(%), fasting plasma glucose (FPG), 2-h post-prandial glucose (PPG), weight, and the proportion of patients achieving target HbA1c levels of < 7.0% by week 16 of the study period. RESULTS: The reduction in HbA1c at week 16 was significantly higher in arm X than in arm Y [estimated treatment difference (ETD), - 0.65% (95% CI - 0.76 to - 0.53; P < 0.0001)]. Arm X showed a marked decrease in FPG [ETD - 15.42 mg/dl; 95% CI (17.63, 13.22; P < 0.0001)], PPG [ETD - 30.39 mg/dl; 95% CI (35.59, 25.19; P < 0.0001)], and weight [ETD - 1.47 kg; 95% CI (1.59, 1.28; P < 0.0001)] after 16 weeks. In arm X, 54% of patients reached HbA1c < 7.0% compared to 29.9% in arm Y. The incidence of adverse events was comparable [13.14% (arm X) vs 12.4% (arm Y)]. There was no severe hypoglycemia-led treatment discontinuation. CONCLUSION: Among patients with T2DM who have poor glycemic control with metformin monotherapy, triple FDC (Dapa + Sita + Met) effectively helped achieve better glycemic response compared to dual FDC (Sita + Met), with a comparable safety and tolerability profile. TRIAL REGISTRATION: CTRI/2022/01/039857.

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BACKGROUND: Due to the progressive decline in β-cell function, it is often necessary to utilize multiple agents with complementary mechanisms of action to address various facets and achieve glycemic control. Thus, this study aimed to evaluate the efficacy and safety of a fixed-dose combination (FDC) of metformin/sitagliptin/pioglitazone (MSP) therapy vs. metformin/sitagliptin (MS) in type 2 diabetes mellitus (T2DM). METHODS: In this phase 3, multicenter, double-blind study, patients with T2DM who exhibited inadequate glycemic control with HbA1c of 8.0-11.0% while taking ≥1500 mg/day metformin for at least 6 weeks were randomized to receive either FDC of MSP (1000/100/15 mg) or MS (1000/100 mg) per day for 24 weeks. The primary outcome measure was the change in HbA1c, and secondary outcomes included changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and body weight from baseline to 24 weeks along with safety and tolerability. RESULTS: Among the 236 patients randomized, 207 (87.71%) successfully completed the study. All baseline characteristics were comparable between the FDC of MSP and MS groups. There was a subsequent significant reduction of HbA1c in FDC of MSP (- 1.64) vs. MS (- 1.32); between groups was [- 0.32% (95% CI, - 0.59, - 0.05)], P = 0.0208. Similar reductions were found in FPG [- 13.2 mg/dL (95% CI, - 22.86, - 3.71)], P = 0.0068, and PPG [- 20.83 mg/dL (95% CI, - 34.11, - 7.55)], P = 0.0023. There were no significant changes in body weight. A total of 27 adverse effects (AEs) and one severe AE were reported, none of which were related to the study drug. CONCLUSION: The FDC of MSP demonstrated significant efficacy in managing glycemic indices and could serve as a valuable tool for physicians in the management of Indian patients with T2DM. TRIAL REGISTRATION: Clinical Trials Registry of India, CTRI/2021/10/037461.

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BACKGROUND: Alpha-glucosidase inhibitors or dipeptidyl peptidase-4 inhibitors are both hypoglycemia agents that specifically impact on postprandial hyperglycemia. We compared the effects of acarbose and sitagliptin add on to metformin on time in range (TIR) and glycemic variability (GV) in Chinese patients with type 2 diabetes mellitus through continuous glucose monitoring (CGM). METHODS: This study was a randomized, open-label, active-con-trolled, parallel-group trial conducted at 15 centers in China from January 2020 to August 2022. We recruited patients with type 2 diabetes aged 18-65 years with body mass index (BMI) within 19-40 kg/m 2 and hemoglobin A1c (HbA1c) between 6.5% and 9.0%. Eligible patients were randomized to receive either metformin combined with acarbose 100 mg three times daily or metformin combined with sitagliptin 100 mg once daily for 28 days. After the first 14-day treatment period, patients wore CGM and entered another 14-day treatment period. The primary outcome was the level of TIR after treatment between groups. We also performed time series decomposition, dimensionality reduction, and clustering using the CGM data. RESULTS: A total of 701 participants received either acarbose or sitagliptin treatment in combination with metformin. There was no statistically significant difference in TIR between the two groups. Time below range (TBR) and coefficient of variation (CV) levels in acarbose users were significantly lower than those in sitagliptin users. Median (25th percentile, 75th percentile) of TBR below target level <3.9 mmol/L (TBR 3.9 ): Acarbose: 0.45% (0, 2.13%) vs . Sitagliptin: 0.78% (0, 3.12%), P = 0.042; Median (25th percentile, 75th percentile) of TBR below target level <3.0 mmol/L (TBR 3.0 ): Acarbose: 0 (0, 0.22%) vs . Sitagliptin: 0 (0, 0.63%), P = 0.033; CV: Acarbose: 22.44 ± 5.08% vs . Sitagliptin: 23.96 ± 5.19%, P <0.001. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV (group with small wave, moderate wave and big wave). No significant difference was found in the complexity of glucose time series index (CGI) between acarbose users and sitagliptin users. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV. CONCLUSIONS: Acarbose had slight advantages over sitagliptin in improving GV and reducing the risk of hypoglycemia. Time series analysis of CGM data may predict GV and the risk of hypoglycemia. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2000039424.

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Objective: To compare the efficacy and safety and profile of empagliflozin and sitagliptin as an add on therapy to metformin in T2DM patients. Study Design: Randomized Controlled Trial. Period: January to March 2024. Setting: Sheikh Zayed Medical College &amp; Hospital, Rahim Yar Khan. Methods: A total of 280 T2DM patients with inadequate glycemic control on metformin were randomly assigned to receive either empagliflozin or sitagliptin. The primary outcomes included changes in body weight (BW), body mass index (BMI), fasting blood glucose (FBG), HbA1c, systolic and diastolic blood pressure (SBP, DBP), and lipid profile. Secondary outcomes involved monitoring adverse effects throughout the study. Results: After 12 weeks, both groups showed significant reductions in BW and BMI, with empagliflozin showing greater improvements (BW: 92.5±13.5 to 79±14.5 kg, BMI: 29.4±4.2 to 27.5±3.8) compared to sitagliptin (BW: 89±16.6 to 81±12.5 kg, BMI: 28.5±5.6 to 27.3±4.2). Similarly, empagliflozin more effectively reduced FBG (240±60.5 to 130±35.5 mg/dL) and HbA1c (8.35±1.9% to 7.2±1.6%) compared to sitagliptin. Both drugs were well-tolerated with no major adverse effects. Conclusion: Empagliflozin demonstrated superior efficacy and safety compared to sitagliptin as an add-on therapy to metformin in T2DM management.

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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.

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Type 2 diabetes mellitus is a progressive disease associated with significant morbidity and mortality. There is good evidence showing that intensive glycemic control reduces the development and progression of complications. In order to achieve glycemic targets, patients often require a combination of oral therapy and/or insulin in addition to lifestyle modification. Unfortunately, many of the traditional therapies for type 2 diabetes are associated with weight gain and hypoglycemia, resulting in poor compliance and subsequent worsening of glycemic control. The dipeptidyl peptidase-4 inhibitor sitagliptin is a therapy for type 2 diabetes and is available as a fixed-dose combination with metformin. Phase III clinical trials have demonstrated beneficial effects on glycemic control and minimal untoward effects with this combination. In this article, we provide an overview of the pharmacology, efficacy, and safety and examine the role of this combination within current practice.

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Type 2 diabetes mellitus is an increasingly prevalent condition worldwide. The complications of this disease are known to significantly increase the morbidity and mortality of those affected, resulting in substantial direct and indirect costs. Although good glycemic control has been shown to reduce the incidence and progression of diabetes-related microvascular complications, blood glucose levels are not adequately controlled in most individuals with diabetes. The reasons for this are many, and include issues such as poor adherence to complex medication regimes; costs of prescribed therapies; and the failure of traditionally prescribed medications to preserve beta cell function over time. However, our armamentarium of glucose-lowering drugs has expanded recently with the development of medications that act via the incretin pathway. Sitagliptin, the first commercially available dipeptidyl peptidase-4 inhibitor, inhibits the metabolism and inactivation of the incretin hormones GLP-1 and GIP. The subsequent elevation in levels of these hormones and associated prolongation of their actions has been shown to increase insulin secretion and suppress glucagon secretion in a glucose-appropriate fashion. Sitagliptin therapy in individuals with type 2 diabetes has been found to lower significantly hemoglobin A1c (Hb1c) levels with a minimum of adverse side effects such as weight gain or hypoglycemia. Use of sitagliptin in conjunction with the insulin-sensitizing medication metformin has been shown to decrease HbAlc levels more significantly than does either drug alone. This combination of medications is generally well tolerated, with no adverse effects on weight and a very low likelihood of treatment-related hypoglycemia. Use of both drugs will positively affect many of the underlying metabolic abnormalities associated with type 2 diabetes, including the disordered secretion of insulin and glucagon as well as impaired sensitivity to insulin which are known to accompany this disease. Animal studies also suggest that dipeptidyl peptidase-4 inhibitor treatment may help to preserve beta cell mass; however, it is unclear at present whether or not this will prove to be the case in humans.

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