Dapagliflozin 5mg / Metformin 850mg tablets

BACKGRUOUND: This study investigates the long-term efficacy and safety of evogliptin add-on therapy in patients with inadequately controlled type 2 diabetes mellitus (T2DM) previously received dapagliflozin and metformin (DAPA/MET) combination. METHODS: In this multicenter randomized placebo-controlled phase 3 trial, patients with glycosylated hemoglobin (HbA1c) levels 7.0% to 10.5% (n=283) previously used DAPA 10 mg plus MET (≥1,000 mg) were randomly assigned to the evogliptin 5 mg once daily or placebo group (1:1). The primary endpoint was the difference in the HbA1c level from baseline at week 24, and exploratory endpoints included the efficacy and safety of evogliptin over 52 weeks (trial registration: ClinicalTrials.gov NCT04170998). RESULTS: Evogliptin add-on to DAPA/MET therapy was superior in HbA1c reduction compared to placebo at weeks 24 and 52 (least square [LS] mean difference, -0.65% and -0.55%; 95% confidence interval [CI], -0.79 to -0.51 and -0.71 to -0.39; P<0.0001). The proportion of patients achieving HbA1c <7% was higher in the triple combination group at week 52 (32.14% vs. 8.51% in placebo; odds ratio, 5.62; P<0.0001). Evogliptin significantly reduced the fasting glucose levels and mean daily glucose levels with improvement in homeostatic model assessment of β-cell function (LS mean difference, 9.04; 95% CI, 1.86 to 16.21; P=0.0138). Adverse events were similar between the groups, and no serious adverse drug reactions were reported in the evogliptin group. CONCLUSION: Long-term triple combination with evogliptin added to DAPA/MET showed superior HbA1c reduction and glycemic control compared to placebo at 52 weeks and was well tolerated.

Abstract licence: CC BY-NC

Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and progressive β-cell dysfunction, necessitating effective pharmacological interventions to achieve optimal glycemic control. While metformin is the first-line therapy, adjunct agents such as sodium-glucose co-transporter-2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors are increasingly utilized. Dapagliflozin, an SGLT2 inhibitor, has demonstrated glycemic benefits along with weight loss, whereas sitagliptin, a DPP-4 inhibitor, primarily enhances insulin secretion. Limited data exist comparing these two regimens in newly diagnosed T2DM patients, particularly in the Pakistani population. Objective: To compare the efficacy and safety of dapagliflozin plus metformin versus sitagliptin plus metformin in newly diagnosed T2DM patients, focusing on glycemic control, weight loss, and adverse effects. Methods: This randomized controlled trial was conducted at the Endocrinology Department of Nishtar Hospital, Multan, from March 2023 to August 2023. A total of 130 newly diagnosed T2DM patients aged 18–65 years with HbA1c between 7.0–10.0% and BMI 25–40 kg/m² were randomized 1:1 to receive either dapagliflozin (10 mg) plus metformin (500 mg twice daily) or sitagliptin (100 mg) plus metformin (500 mg twice daily) for 12 weeks. Primary outcome was the change in HbA1c, while secondary outcomes included fasting blood glucose (FBG), postprandial blood glucose (PPG), weight loss, lipid profile, and safety assessments. Statistical analysis was performed using SPSS version 26.0, with a p-value &lt;0.05 considered statistically significant. Results: The dapagliflozin-metformin group demonstrated significantly greater reductions in FBG (128.4 ± 18.5 mg/dL vs. 145.2 ± 21.4 mg/dL, p = 0.001), PPG (179.5 ± 24.7 mg/dL vs. 202.1 ± 26.2 mg/dL, p = 0.004), and HbA1c (7.4 ± 1.0% vs. 8.2 ± 1.2%, p = 0.001) compared to the sitagliptin-metformin group. Weight loss was also significantly greater in the dapagliflozin group (4.2 ± 1.5 kg vs. 1.8 ± 1.2 kg, p &lt; 0.001). The incidence of urinary tract infections was higher in the dapagliflozin group (10.8% vs. 3.1%, p = 0.048), while other adverse effects were comparable between groups. Conclusion: Dapagliflozin plus metformin was superior to sitagliptin plus metformin in improving glycemic control and promoting weight loss in newly diagnosed T2DM patients. These findings suggest that dapagliflozin may be a more effective early-stage treatment option, particularly for individuals requiring weight management. Further long-term studies are warranted to confirm these benefits and assess their durability over time.

Abstract licence: CC BY-NC-ND

Introduction The primary aim of this study is to compare the efficacy of three short-term glucose-lowering interventions (exercise, metformin and dapagliflozin) on glycaemic variability in overweight or obese men and women with elevated diabetes risk (ie, prediabetes, defined as haemoglobin A 1c (HbA 1c )39–47 mmol/mol / 5.7%–6.4%). The secondary aims are to investigate the effects of the interventions on body composition and cardiometabolic risk factors. Methods and analysis The Pre-D Trial is an investigator-initiated, randomised, controlled, parallel, open-label, superiority trial. The study aims to assign 120 participants in a 1:1:1:1 ratio to receive one of four interventions for 13 weeks: (1) dapagliflozin (10 mg once daily); (2) metformin (850 mg twice daily); (3) exercise (interval training, 5 days a week, 30 min per session); or (4) control (lifestyle advice). After the 13 weeks of intervention, a follow-up period of 13 weeks will follow to study the long-term effects of the interventions. The primary endpoint is reduction from baseline to end-of treatment (13 weeks) in mean amplitude of glycaemic excursions measured by continuous glucose monitoring. The secondary endpoints include concomitant changes in various measures of glucose metabolism, body weight, cardiorespiratory fitness, blood pressure, plasma lipids, objectively measured physical activity and dietary intake. Ethics and dissemination The study protocol has been approved by the Ethics Committee of the Capital Region and the Danish Medicines Agency. Approval of data and biobank storage has been obtained from the Danish Data Protection Board. The study will be carried out according to the Declaration of Helsinki and to the regulations for good clinical practice. The results from this trial will allow a number of research questions concerning the effect of exercise versus dapagliflozin or metformin in HbA 1c -defined prediabetes to be addressed. Trial registration NCT02695810

Abstract licence: CC BY-NC

PURPOSE: The purpose of this review article is to provide guidance to health care providers regarding the use of dapagliflozin-metformin XR (extended release) as a therapeutic option for the treatment of patients with type 2 diabetes mellitus (T2DM). METHODS: The PubMed database was searched through August 2015 to identify clinical trials and meta-analyses evaluating the use of the sodium-glucose cotransporter type 2 inhibitor dapagliflozin administered as monotherapy or in combination with metformin. RESULTS: Fourteen studies were included for this review, six of which evaluated dapagliflozin in combination with metformin, one of which evaluated dapagliflozin monotherapy, and four of which evaluated dapagliflozin as an add-on therapy to other antidiabetic agents. The combination of dapagliflozin and metformin resulted in an A1C decrease of up to 2%, weight loss of 2-3 kg, and modest systolic blood pressure decrease of 3-5 mmHg. However, long-term effects on cancer and cardiovascular health are still being investigated. Providing patients with a fixed-dose combination therapy such as dapagliflozin-metformin XR can increase medication adherence and patient satisfaction, and improve glycemic control. Dapagliflozin-metformin XR is ideal because it can be administered orally once a day, is associated with a low risk of hypoglycemia, and provides the added benefit of weight reduction and modest blood pressure lowering. CONCLUSION: The unique combined mechanism of action and favorable efficacy and safety profile of dapagliflozin-metformin XR support consideration of this fixed-dose combination as a treatment option for patients with T2DM.

Abstract licence: CC BY-NC

In type 2 diabetes (T2D), early combination therapy using agents that target a number of the underlying pathophysiologic defects contributing to hyperglycemia may improve patient outcomes. For many patients, the combination of metformin with a sodium-glucose cotransporter-2 (SGLT-2) inhibitor may be a good option because these agents have complementary mechanisms of action, neutral-to-positive effects on body weight, and a low risk of hypoglycemia. This review focuses on the combination of metformin with dapagliflozin, a member of the SGLT-2 inhibitor class of antidiabetes agents. In clinical trials, the combination of dapagliflozin with metformin produced significant and sustained reductions in glycated hemoglobin and body weight in a broad range of adult patients with T2D, including those initiating pharmacotherapy and those with more advanced disease. These reductions were accompanied by modest decreases in blood pressure. Dapagliflozin as add-on therapy to metformin was well tolerated and associated with low rates of hypoglycemia. Genital infections and, in some studies, urinary tract infections were more frequent with dapagliflozin than with placebo. Early combination therapy with dapagliflozin and metformin may be a safe and appropriate treatment option that enables patients with T2D to achieve individualized glycemic goals as either initial combination therapy in treatment-naïve patients or as dapagliflozin add-on in patients inadequately controlled with metformin therapy.

Abstract licence: CC BY-NC