Tofogliflozin clinical trials. 0 International License, which permits .

Tofogliflozin clinical trials Mar 6, 2017 · The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. The protocol and any information supplied to gain informed consent were approved by a qualified Institutional Review Board/Independent Ethics Committee of Download scientific diagram | Time course of clinical parameters after the start of tofogliflozin treatment. , Tokyo, Japan 2 CPC Clinical Trial Hospital, Medipolis Medical Research Institute, Kagoshima, Japan 3 PurposeMedical Co. Methods: Individual-level data on 775 T2D patients in TOFO Phase 3 trials were analysed. Diastolic dysfunction has attracted much concern, diabetes, hypertension, and gender (female) are attributed to its pathophysiology. Pemafibrate in combination with tofogliflozin under development for the treatment of non-alcoholic steatohepatitis (NASH). A large-scale, non-commercial, investigator-initiated study is needed to explore safety and Jun 22, 2023 · In this prospective observational 2-year extension study of the UTOPIA trial, we aimed to assess the long-term effects of tofogliflozin on the progression of atherosclerosis and major clinical parameters in patients with type 2 diabetes mellitus without an apparent history of cardiovascular disease. This trial was registered in the Japan Registry of Clinical Trials. The patients were divided into two groups: one receiving tofogliflozin, the shortest half‐life, without salt restriction, and the other receiving both tofogliflozin and dietary salt restriction. The adverse events (AEs) of tofogliflozin observed in the clinical trials were hyperketonemia, dry mouth and pollakiuria, which are known as class effects of SGLT2 inhibitors11. Tofogliflozin is a selective oral inhibitor of sodium-glucose co-transporter 2 for treatment of type 2 diabetes mellitus. DrugBank TOFOGLIFLOZIN is a small molecule drug with a maximum clinical trial phase of IV (across all indications) that was first approved in 2014 and has 2 investigational indications. The protocol and any information supplied to gain informed consent were approved by a qualified Institutional Review Board/Independent Ethics Committee of Jun 1, 2014 · The efficacy and safety of tofogliflozin have been demonstrated in mono-and combination therapies with other OADs and/or insulin in the clinical trials [14][15][16][17] , and among the elderly in Nov 5, 2022 · In a multinational, double-blind, randomized, controlled trial, we assigned patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia (triglyceride level, 200 to 499 mg per deciliter Mar 28, 2014 · Efficacy and safety of monotherapy with the novel sodium/glucose cotransporter-2 inhibitor tofogliflozin in Japanese patients with type 2 diabetes mellitus: a combined Phase 2 and 3 randomized, placebo-controlled, double-blind, parallel-group comparative study Tofogliflozin, a highly selective SGLT2 inhibitor, has been approved in Japan for the treatment of T2DM. This study analysis had some limitations. EndNote 21 software managed the references and Methods and results: The TOP-HFPEF trial (Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus) is a multicenter, double-arm, open-label, confirmatory, investigator-initiated clinical study to investigate the effect of SGLT2 inhibitor on May 25, 2023 · The research adhered to the principles of the Declaration of Helsinki and the ethical guidelines for clinical research established by the Ministry of Health, Labour and Welfare. NCT01289990 EMPA-REG EXTEND MONO (extension of NCT01177813) Empa 10 mg Empa 25 mg Placebo Sita 100 mg: 224 224 228 223: No background therapy: 76 † 7. baseline data. The study design, study schedule, and outcomes of the original UTOPIA trial have been described in detail previously [22, 23]. However, the clinical data on Tofogliflozin from both clinical and real-world studies remain sparse and much less abundant than the other main 3 SGLT-2 inhibitors, thus calling for caution and underscoring the need for further research. Increases in urinary glucose excretion from baseline at week 12 ranged from 217. Even in cases when tofogliflozin was added to oral antidiabetic agents, the efficacy and safety were consistent regardless of the background therapy10. Pemafibrate + tofogliflozin overview. Jul 27, 2022 · Methods A literature search in PubMed, Science Direct and Cochrane Central Register of Controlled Trials was conducted for randomised clinical trials of tofogliflozin by applying predetermined We aimed to combine tofogliflozin and pioglitazone treatment for hepatic steatosis in patients with NAFLD and T2DM. K. The EU Clinical Trials Register currently displays 44286 clinical trials with a EudraCT protocol, of which 7351 are clinical trials conducted with subjects less than 18 years old. 6 μU/mL, group medium (M): 5. DrugBank TOFOGLIFLOZIN ANHYDROUS is a small molecule drug with a maximum clinical trial phase of IV (across all indications) that was first approved in 2014 and has 2 investigational indications. Glossary. To assess the safety of tofogl been registered in the Japan Registry of Clinical Trials (jRCTs031180159). Tofogliflozin Alternative Names: tofogliflozin, csg452 Latest Update: 2025-01-07 Latest Update Note: Clinical Trial Update Aug 25, 2020 · Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus treated in real‐world clinical practice: Results of J‐STEP/LT, a 36‐month post‐marketing Mar 1, 2020 · This trial was registered in the Japan Registry of Clinical Trials (jRCTs, s031180159). Jul 18, 2023 · Purpose Studies have demonstrated a high prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients. This is an open-access journal distributed under the terms of the Creative Commons Attribution-NonCommercial 4. 3 Kansai Electric Power Hospital, Osaka, Japan. Jun 17, 2022 · Clinical trials have not demonstrated any benefit to treating PH due to LHD with therapies approved for pulmonary arterial hypertension . Results Overall, 40 eligible patients were randomly assigned to receive tofogliflozin (n=21) or pioglitazone (n=19). ClinicalTrials. Efficacy of Tofogliflozin. Explore 4,000+ rare diseases, orphan drugs & condition pairs Jun 7, 2021 · The included randomized controlled trials (RCTs) were SGLT-2i in T2D patients. The common adverse events (AEs) of tofogliflozin observed in the clinical trials were increase in blood ketone body level, hyperketonemia, thirst and pollakiuria, which are known as class effects of SGLT2 inhibitors 10. The trial results have been reported in accordance with the Consolidated Standards of Reporting Trials 2010 guidelines. Apr 29, 2019 · Even in cases when tofogliflozin was added to oral antidiabetic agents, the efficacy and safety were consistent regardless of the background therapy 10. , Nagoya, Japan) is an SGLT2 inhibitor that was approved in Japan in 2014 for the treatment of type 2 diabetes mellitus 14, 15. Aug 8, 2024 · Therefore, tofogliflozin, for which no large-scale clinical trials targeting cardiovascular events have been conducted, is expected to show similar results. 9 mmol/24 h ( P < 0. 9 mmol/L Dec 19, 2022 · Unique ID issued by UMIN: UMIN000049753: Receipt number: R000056549: Scientific Title: A study to verify the efficacy of the selective SGLT2 inhibitor tofogliflozin hydrate in reducing nocturia Primary Objectives: To assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (HbA1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus. 72. 12 Clinical trials have shown that tofogliflozin, when used as monotherapy or in combination with oral antidiabetic agents, significantly decreases glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and systolic and This multicenter, open‐label, randomized, parallel‐group trial included 80 subjects with type 2 diabetes and nocturia. We analyzed data from long‐term tofogliflozin monotherapy in an open‐label, randomized controlled trial in Japanese patients with type 2 diabetes mellitus. Veeva Search CTV Jun 1, 2019 · The EMPA-REG OUTCOME trial revealed that cardiovascular diseases were improved in patients administered empagliflozin (Zinman et al. The register also displays information on 18700 older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006). This clinical trial is focused on studying a liver condition called Nonalcoholic Steatohepatitis (NASH), which is a type #1 Clinical Trials Search in Europe Select region: Empagliflozin (BI 10773) is a potent and selective SGLT2 inhibitor being developed by Boehringer Ingelheim and Eli Lilly pharmaceuticals as a treatment for T2DM [109]. Methods A literature search in PubMed, Science Direct and Cochrane Central Register of Controlled Trials was conducted for randomised clinical trials of tofogliflozin Jul 8, 2019 · However, those findings are mainly based on clinical trials with a limited number and range of patients and study durations. We recruited 11 institutes in Japan at the start of the study. Adult patients with NAFLD and type 2 diabetes mellitus Mar 19, 2014 · The common adverse events (AEs) of tofogliflozin observed in the clinical trials were increase in blood ketone body level, hyperketonemia, thirst and pollakiuria, which are known as class effects This trial was registered in the Japan Registry of Clinical Trials (jRCTs, s031180159). [2] It is an inhibitor of subtype 2 sodium-glucose transport protein ( SGLT2 ), which is responsible for at least 90% of the glucose reabsorption in the Jul 13, 2017 · Tofogliflozin, a highly selective SGLT2 inhibitor, has been approved in Japan for the treatment of T2DM. Dec 30, 2024 · Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The protocol was approved by the Kanazawa University Certified Review Board, Ishikawa, Japan (CRB4180005). 88: Merker et al. In this open-label, prospective, single-center, randomized clinical trial, patients with NAFLD with T2DM and a hepatic fat fraction of ≥10% were assessed based on magnetic resonance imaging proton density fat fraction. 6. Jun 29, 2020 · Tofogliflozin (Apleway ®, Deberza ®) is a SGLT2 inhibitor that was approved in Japan in 2014. 05 vs. Introduction The treatment of diabetes has a significant impact on the pathogenesis of non-alcoholic fatty liver disease (NAFLD). Jul 5, 2022 · Renal protective effects of tofogliflozin and changes in clinical parameters affecting renal function in patients with type 2 diabetes: Date of disclosure of the study information: 2022/07/05: Last modified on: 2024/01/09 13:52:25 Therefore, tofogliflozin, for which no large-scale clinical trials targeting cardiovascular events have been conducted, is expected to show similar results. 01 for all doses), compared with 16. The safety and effectiveness of tofogliflozin have been shown in previous clinical trials and studies 16, 17, 18, 19. Jul 18, 2023 · for randomised clinical trials of tofogliflozin by applying predetermined inclusion and ex clusion criteria. Research design and methods This open-label, prospective, single-center Tofogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been developed for the treatment of diabetes mellitus based on the outcomes of preclinical studies and clinical trials [113,114]. In this open‐label, prospective, single‐center, randomized clinical trial, patients with NAFLD with T2DM and a hepatic fat fraction of ≥10% were assessed based on magnetic resonance imaging proton density fat fraction. We compared the effectiveness of tofogliflozin, a selective sodium-glucose cotransporter 2 inhibitor, and pioglitazone for the treatment of NAFLD patients with type 2 diabetes mellitus. Clinical treatment effects are a combination of drug and time, and the confounding factor of duration of drug action cannot be ruled out; the clinical effects of interventions may be magnified by longer dosing times. baseline Aug 14, 2024 · 2 Yutaka Seino Distinguished Center for Diabetes Research, Kansai Electric Power Medical Research Institute, Kyoto, Japan. 0001) and bodyweight (−3. Results A total number of four randomised clinical trials, including 226 subjects, were Phase 3 extension trials: patients continued previous treatment as randomized in 24-week trials: Roden et al. Clinical trials have shown that tofogliflozin can be effective in several ways: Glycemic Control: It helps reduce HbA1c levels, which is a measure of average blood sugar over the past 2-3 months. 44% to -0. 68%, P < 0. Eligibility for the trial was determined at screening using standard blood tests, clinical history (including written confirmation of drug history, where necessary), and physical examination Nov 12, 2024 · Clinical relevance: Tofogliflozin reduced the severity of sleep apnea in patients with HF, T2DM, and OSA, likely due to a decrease in body water content. 5–40 mg once daily produced significant, dose-dependent increases in urinary glucose excretion in patients with T2DM (n = 398) . Such differences could include mo re careful selection of people with type 2 diabetes for treatment with SGLT2 inhibitors in Jul 27, 2022 · This trial was registered with ClinicalTrials. 99% throughout clinical studies, and it is well tolerated with a low rate of drug-related adverse events. The aim was to review the effect of tofogliflozin on hepatic outcomes in T2DM patients. Treatment with tofogliflozin for 24 weeks was effective in improving hepatic steatosis to low-dose pioglitazone without statistical significance. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels. 9 to 402. 05, vs. Dec 31, 2019 · Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease patients with type 2 diabetes mellitus: A randomized, open-label pilot study (ToPiND study) Contemp Clin Trials Commun . 4 Department of Diabetes, Endocrinology and Metabolism and Department of Rheumatology and Clinical Immunology, Gifu University Graduate School of Medicine, Gifu, Japan. In both trials, patients were randomly assigned to receive tofogliflozin 20 or 40 mg once daily orally for 52 weeks. 6< insulin ≤10 μU/mL and group high (H): insulin >10 μU/mL. Search for terms The “Using TOfogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA)” was a randomized clinical trial that investigated the preventive effects of tofogliflozin on the progression of atherosclerosis in subjects with T2DM; its primary study outcome was the change in intima–media thickness A recently reported 3‐year post‐marketing surveillance (PMS) study in Japan confirmed the safety and effectiveness of tofogliflozin in clinical use 15, but that study was carried out by a drug development company as an extension of their clinical trial. gov number NCT02649465 and the Japan Registry of Clinical Trials (jRCTs041180132) from UMIN 000020544. A large‐scale, non‐commercial, investigator‐initiated study is needed to explore May 10, 2024 · Download Citation | Rationale and Design of Prospective, Multicenter, Double-Arm Clinical Trial to Investigate the Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients Tofogliflozin is the most selective SGLT2 inhibitor, with HbA1c reductions ranging from -0. In the present study, the clinical effects of tofogliflozin and empagliflozin were compared via analysis of 24-h Glossary. 0001) over a period of 36 months in the context of real‐world clinical practice broadly reflect those observed in shorter clinical trials (≤52 weeks), in which reductions in HbA1c and In these trials, tofogliflozin was well‐tolerated and most adverse drug reactions (ADRs) were mild or moderate in severity. Mar 30, 2017 · Tofogliflozin, a highly selective SGLT2 inhibitor, has been approved in Japan for the treatment of T2DM. The study protocol was approved by the Minami Osaka Hospital Ethics Committee (no. Jul 15, 2022 · This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD). It was the first SGLT2 inhibitor to get approval for marketing as oral tablets in 2014. The mechanism seems to be a class effect, not a drug effect. biomedcentral. b Body weights (kg), *p < 0. NCT01289990 EMPA-REG EXTEND MET (extension of NCT01159600) Empa 10 An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus. May 16, 2022 · We aimed to combine tofogliflozin and pioglitazone treatment for hepatic steatosis in patients with NAFLD and T2DM. Feb 1, 2021 · This trial was registered in the Japan Registry of Clinical Trials. iflozin and pioglitazone treatment for hepatic steatosis in patients with NAFLD and T2DM. , 2015); however, a large-scale clinical trial using tofogliflozin has not yet been performed. The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001. Patients were divided into tertiles by baseline insulin level: group low (L): insulin ≤5. Search for terms Jun 23, 2023 · Background: This study aimed to assess the long-term effects of tofogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on atherosclerosis progression and major clinical parameters in patients with type 2 diabetes lacking an apparent history of cardiovascular disease. We need further confirmation through long-term larger-scale clinical trials of SGLT2 inhibitors. Histological analysis revealed Tofogliflozin or combination therapy group markedly suppressed ER-TR7 (fibroblast) and ballooning degeneration. In a pre-clinical study, empagliflozin had the highest selectivity for SGLT2 over SGLT1 (> 2500-fold), followed by tofogliflozin (>1875-fold), dapagliflozin (>1200 fold), ipragliflozin (>550-fold) and canagliflozin (>250-fold) [110]. The content of this site is intended for health care professionals. J-STEP/LT is an observational study conducted . Therefore, Jan 20, 2017 · The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. The study was registered with the Japan Registry of Clinical Trials (jRCTs031180440) and the University Hospital Medical Information Network (UMIN-CRT) (UMIN000028634). Sodium-glucose cotransporter 2 (SGLT2) inhibitors (SGLT2i) are oral anti-diabetic drugs that act to promote urinary glucose excretion and improve glucose metabolism [7] . This potent selectivity might have contributed to relatively few AEs in this clinical trial. 6. The adverse events (AEs) of tofogliflozin observed in the clinical trials were hyperketonemia, dry mouth and pollakiuria, which are known as class effects of SGLT2 inhibitors 11. in a real-world clinical pr actice. 13 kg, P < 0. Luseogliflozin. Aug 6, 2021 · The “Using TOfogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA)” was a randomized clinical trial that investigated the preventive effects of tofogliflozin on the progression of atherosclerosis in subjects with T2DM; its primary study outcome was the change in intima–media thickness 1 Translational Clinical Research Science and Strategy Department, Chugai Pharmaceutical Co. Eligible patients received either 20 mg tofogliflozin or 15–30 mg pioglitazone Sep 5, 2019 · Tofogliflozin hydrate (Apleway ®; Sanofi K. Mar 3, 2020 · Journal of Clinical Medicine Research, monthly, ISSN 1918-3003 (print), 1918-3011 (online), published by Elmer Press Inc. 1. Feb 5, 2022 · ntrolled trial was conducted to investigate the preventive effects of tofogliflozin, an SGLT2 inhibitor, on the progression of carotid intima-media thickness (IMT) in patients with apparent CVD-free T2DM, and found that there were no significant differences in the progression of IMT between the tofogliflozin treatment and conventional treatment Jul 1, 2018 · While Tofogliflozin or Pemafibrate treatment markedly decreased blood glucose and triglyceride levels, the combination therapy showed the synergistic effect compared to mono-therapy groups. This randomized prospective open-label controlled trial is the first report to investigate the efficacy of tofogliflozin in NAFLD patients with T2DM. Trial results were reported in accordance with the guidelines provided by the Consolidated Standards of Reporting Trials Feb 8, 2020 · In these trials, tofogliflozin was well-tolerated and most adverse drug reactions (ADRs) were mild or moderate in severity. LTA, Souseikai Sumida Hospital, Tokyo, Japan 4 Clinical Science and Strategy Department, Chugai Pharmaceuti- Jan 4, 2021 · Study design. Mar 6, 2019 · However, as there is only limited information from clinical trials on SGLT2 inhibitors in Japanese patients, and clinical experience with long‐term treatment using SGLT2 inhibitors is limited as compared with existing glucose‐lowering agents, further information on the long‐term safety and efficacy of tofogliflozin in a large number of May 22, 2014 · In a phase II clinical trial (NCT00800176), tofogliflozin 2. Tofogliflozin has been used in trials studying the treatment and prevention of Diabetes Mellitus Type 2. SGLT-2i such as dapagliflozin, canagliflozin, empagliflozin, tofogliflozin, ertugliflozin, luseogliflozin, and bexagliflozin were compared with placebo or other active hypoglycemic drugs to explore malignancy incidence in patients during follow-up. Adjusted changes in variables during 52 weeks of TOFO therapy were Tofogliflozin (INN, [1]: 88 USAN, codenamed CSG452) is an experimental drug for the treatment of diabetes mellitus and is being developed by Chugai Pharma in collaboration with Kowa and Sanofi. Methods: A literature search in PubMed, Science Direct and Cochrane Central Register of Controlled Trials was conducted for randomised clinical trials of tofogliflozin by applying predetermined inclusion and exclusion criteria. Methods A literature search in PubMed, Science Direct and Cochrane Central Register of Controlled Trials was conducted for randomised clinical trials of tofogliflozin by applying predetermined inclusion and exclusion criteria. 12 Clinical trials have shown that tofogliflozin, when used as monotherapy or in combination with oral antidiabetic agents, significantly decreases glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and systolic and Aims: To evaluate the long-term safety and efficacy of tofogliflozin as an add-on treatment to insulin over 52 weeks. Three studies were conducted: single-ascending dose study (10-640 … Mar 28, 2014 · Tofogliflozin is a SGLT2 inhibitor, with 2,900-fold greater selectivity for SGLT2 than SGLT1, and has the highest selectivity of all clinically developed inhibitors . (PubMed, J Diabetes Res) - "Subgroup analyses were based on type of medication (GLP-1 RA: liraglutide and exenatide; SGLT2i: empagliflozin, ipragliflozin, tofogliflozin, and dapagliflozin), randomized clinical trials (RCTs), and diabetic patients. Heart failure (HF) is a common and serious comorbidity in patients with type 2 diabetes, and its prevention is crucial 1. Aug 14, 2019 · Introduction. Dec 13, 2024 · OBJECTIVE: Tofogliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor widely used to treat T2DM, but it also exhibits cardio-protective effects. Tofogliflozin. See full list on cardiab. Written informed consent for participation in the study will be obtained from all participants. Jan 24, 2024 · Two studies 24,37 used empagliflozin as the SGLT-2 inhibitor while the other two trials 39,41 received tofogliflozin, Five clinical trials 27,28,30,34,41 provided data on the liver proton Glossary. Apr 14, 2019 · The trial was sponsored by Janssen Research and Development as a collaboration between the sponsor, an academic-led steering committee, and an academic research organization, George Clinical, with Oct 21, 2024 · As with SGLT2is, in cases where the efficacy cannot be easily evaluated but an appropriate pharmacodynamic marker was assessed in early clinical trials, similar approaches for other drug classes Jul 9, 2020 · First, although many clinical trials of antilipidemic and antidiabetic agents have used the carotid IMT as a surrogate clinical endpoint for cardiovascular events [17–24], there is no sufficient evidence whether the progression of carotid IMT reflects an increased risk of subsequent cardiovascular events. Aug 13, 2012 · Subsequent chemical examination combined with computational modeling resulted in the identification of the clinical candidate 16d (CSG452, tofogliflozin), which is currently under phase III We would like to show you a description here but the site won’t allow us. All participants were briefed on the study outline before their participation, and they provided written informed consent. This trial was registered with ClinicalTrials. The trial consisted of a 48 week treatment period. In this open-label, prospective, single-center, randomized clinical trial Nov 16, 2023 · Second, to maximise the availability of the data, we searched various Clinical Trial Registry websites and specialised journals (Additional file 1: Table S3) for ongoing and unpublished trials and potential trials; relevant systematic reviews and guideline references were also considered. Results A total number of four randomised clinical trials, including 226 subjects, were included in the review. Nov 16, 2023 · So far, we have done all we can to enrich our research within the limits of control, but we should still consider some limitations. Tofogliflozin Clinical Trials Clinical Trials. We compared the effectiveness of tofogliflozin, a selective sodium-glucose cotransporter 2 inhibitor, and pioglitazone for the treatment of NAFLD patients with type 2 diabetes mellitus. Dec 31, 2019 · This trial was registered in the Japan Registry of Clinical Trials (jRCTs, s031180159). The in vitro SGLT2 potencies are similar for these compounds; all exhibit good selectivity over SGLT1 [15,17,19,21,23,26,27], except LX-4211, which is being positioned as a dual SGLT1 and SGLT2 inhibitor [16,26]. . Thus, to date, long‐term data on tofogliflozin in a large number of Japanese patients with type 2 diabetes mellitus in a real‐world setting are scarce. Therefore, tofogliflozin, for which no large-scale clinical trials targeting cardiovascular events have been conducted, is expected to show similar results. The pharmacokinetics, pharmacodynamics, and safety of tofogliflozin were investigated in healthy male subjects. May 10, 2024 · TOP-HFPEF trial (Efficacy of Tofogliflozin on Left Ventricular Diastolic Dysfunction in Patients with Heart Failure with Preserved Ejection Fraction and Type 2 Diabetes Mellitus) is a phase 4, open-label, confirmatory, investigator-initiated clinical study of pharmaceuticals. Jun 1, 2019 · Request PDF | Clinical comparison of tofogliflozin and empagliflozin based on an analysis of 24-h accumulated urine in Japanese patients with type 2 diabetes mellitus | Aim In Japan, six sodium Thus, we investigated the impact of daily sodium intake on the estimated glomerular filtration rate (eGFR) via an SGLT2i, tofogliflozin (TOFO), in patients with type 2 diabetes (T2D). Clinical Trial & Rare Diseases Add-on Data Package. Sep 1, 2022 · The hepatic expression of the genes involved in energy metabolism, inflammation, and fibrosis was well correlated with liver histological changes and rescued by tofogliflozin. a HbA1c (%), *p < 0. Metaregression showed that IMT change correlated with baseline IMT, whereas it did not correlate Jan 31, 2019 · outcome clinical trial of tofogliflozin. The common adverse events (AEs) of tofogliflozin observed in the clinical trials were increase in blood ketone body level, hyperketonemia, thirst and pollakiuria, which are known as class effects of SGLT2 inhibitors10. 2018-16) and registered in the University Hospital Medical Information Network Clinical Trial Registry (no. com Jan 18, 2018 · We used flash glucose monitoring (FGM) to identify the differences between tofogliflozin and ipragliflozin in terms of efficacy in reducing glycemic variability and mitigate hypoglycemia risk. Weight Loss: Many patients experience a reduction in body weight while taking tofogliflozin. Surprisingly, the results indicated that this dosage was effective without increasing the likelihood of Clinical Research published by the Ministry of Health, Labour, and Welfare of Japan. 12 Clinical trials have shown that tofogliflozin, when used as monotherapy or in combina-tion with oral antidiabetic agents, significantly decreases glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight and The clinical status, SGLT2 potency and selectivity over SGLT1, and dose ranges of inhibitors in the Phase II and Phase III clinical trials are also listed in Table 1. 0 International License, which permits Roche conducted three phase I clinical trials along with a three-month multinational phase II clinical trial on around 400 patients with T2DM. Materials and methods: This 52-week, multicentre, Phase 4 study consisted of a 16-week, randomized, double-blind, placebo-controlled phase and a 36-week open label extension phase (NCT02201004). Japan also developed luseogliflozin (Lusefi), a selective SGLT2 inhibitor. Feb 11, 2014 · Research design and methods: The single-agent trial included patients with inadequate glycemic control on diet and exercise, whereas the add-on trial included those uncontrolled with any of the oral antidiabetic agents. Besides, tofogliflozin exhibited suppressive effects on the development of colorectal neoplastic lesions, while the administration of Aug 14, 2024 · A recently reported 3-year post-marketing surveillance (PMS) study in Japan confirmed the safety and effectiveness of tofogliflozin in clinical use 15, but that study was carried out by a drug development company as an extension of their clinical trial. Clinical trials of tofogliflozin as monotherapy or add‐on therapy to oral antidiabetic drugs for 52 weeks in Japanese patients with type 2 diabetes mellitus showed that tofogliflozin improved glycemic control and reduced bodyweight. UMIN000037158). The protocol and any information supplied to gain informed consent were approved by a qualified Institutional Review Board/Independent Ethics Committee of Aug 1, 2023 · In a major clinical research testing the efficacy of empagliflozin in patients with chronic renal disease, the daily dose of empagliflozin delivered to the treatment group was 25 mg, which is much higher than the recommended amount of 10 mg. In brief, the UTOPIA trial was a prospective, randomized, open-label, multicenter, parallel-group comparative study to evaluate the efficacy of tofogliflozin in preventing the progression of atherosclerosis over a 2-year intervention period in patients Apr 29, 2019 · Even in cases when tofogliflozin was added to oral antidiabetic agents, the efficacy and safety were consistent regardless of the background therapy 10. In these trials, tofogliflozin was well‐tolerated and most adverse drug reactions (ADRs) were mild or moderate in severity. In this prospective observational 2-year extension study of the UTOPIA trial, we aimed to assess the long-term effects of tofogliflozin on the progression of atherosclerosis and major clinical parameters in patients with type 2 diabetes mellitus without an apparent history of cardiovascular disease. Aug 14, 2024 · differences between clinical trials and routine clinical practice. , Ltd. Recent findings from the large clinical trials showed a significant reduction in hospitalization for HF in patients receiving a sodium–glucose cotransporter 2 (SGLT2) inhibitor compared with those receiving a placebo 2, 3. Clinical trials showed its effectiveness when used in combination with other oral drugs or insulin, and that it was well tolerated with few serious adverse events (AEs) 21-24. Aug 25, 2020 · As for the effectiveness of tofogliflozin, the significant reductions from baseline in HbA1c (−0. Search for terms The aim was to review the effect of tofogliflozin on hepatic outcomes in T2DM patients. , Tokyo, Japan; and Deberza ®; Kowa Company, Ltd. Study record managers: refer to the Data Element Definitions if submitting registration or results information. fejst gypnrq pmjn sdbrifm osq mrzvqpkl uxdcgrv lsfwq ptfgpyz adflg rnmjxdu xhjzio splsiif pwzksf htp