Trial reportBMJ open diabetes research & care2021
Comparing the effects of tofogliflozin and pioglitazone in non-alcoholic fatty liver disease patients with type 2 diabetes mellitus (ToPiND study): a randomized prospective open-label controlled trial.
Trial report in BMJ open diabetes research & care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
50 citing papers in PubMed, 9 syntheses or guidelines pooled it, 97 citations in OpenAlex.
- Model-Based Meta-Analysis of the Relationship Between Pioglitazone and Histological Outcomes in Metabolic Dysfunction-Associated Steatohepatitis Patients.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- Pharmacological treatment options for metabolic dysfunction-associated steatotic liver disease in patients with type 2 diabetes mellitus: A systematic review.European journal of clinical investigation · 2025Pooled it
- Efficacy of sodium glucose cotransporter 2 inhibitors on hepatic fibrosis and steatosis in non-alcoholic fatty liver disease: an updated systematic review and meta-analysis.Scientific reports · 2024Pooled it
- Pooled it
- Impact of tofogliflozin on hepatic outcomes: a systematic review.European journal of clinical pharmacology · 2023Pooled it
- The Effects of Sodium-Glucose Cotransporter 2-Inhibitors on Steatosis and Fibrosis in Patients with Non-Alcoholic Fatty Liver Disease or Steatohepatitis and Type 2 Diabetes: A Systematic Review of Randomized Controlled Trials.Medicina (Kaunas, Lithuania) · 2023Pooled it
- New anti-diabetic agents for the treatment of non-alcoholic fatty liver disease: a systematic review and network meta-analysis of randomized controlled trials.Frontiers in endocrinology · 2023Pooled it
- Comparative efficacy of 5 sodium-glucose cotransporter protein-2 (SGLT-2) inhibitor and 4 glucagon-like peptide-1 (GLP-1) receptor agonist drugs in non-alcoholic fatty liver disease: A GRADE-assessed systematic review and network meta-analysis of randomized controlled trials.Frontiers in pharmacology · 2023Pooled it
- Efficacy of Off-Label Therapy for Non-alcoholic Fatty Liver Disease in Improving Non-invasive and Invasive Biomarkers: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials.Frontiers in medicine · 2022Pooled it
- Effect of Empagliflozin and Pioglitazone on left ventricular function in patients with type two diabetes and nonalcoholic fatty liver disease without established cardiovascular disease: a randomized single-blind clinical trial.BMC gastroenterology · 2023Trial
- Combination of tofogliflozin and pioglitazone for NAFLD: Extension to the ToPiND randomized controlled trial.Hepatology communications · 2022Trial
- Selective SGLT2 inhibitors in MASLD/MASH: an outcome-specific systematic review and meta-analysis of hepatic and cardiometabolic outcomes.Acta diabetologica · 2026Review
- Microalgae Oil Attenuates Liver Fat Deposition in NAFLD via Modulation of Anti-Lipogenic Genes and Insulin Signaling Pathways in HFD Mice.Food science & nutrition · 2026Article
- The Metabolic Dysfunction-Associated Steatotic Liver Disease-CKD Axis: Intersecting Pathways and Opportunities for Early Intervention.Kidney international reports · 2026Review
- Comparative Efficacy of SGLT2 Inhibitors in MASLD: Bayesian Network Meta-Analysis of CAP-LSM Outcomes and Time Effects.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
- Tofogliflozin attenuates liver steatosis and fibrosis in non-diabetic non-alcoholic steatohepatitis mice.BMC gastroenterology · 2026Article
- Factors Affecting the Treatment Heterogeneity of PPARγ and Pan-PPAR Agonists in Type 2 Diabetes Mellitus: A Systematic Review and Machine Learning-Based Meta-Regression Analysis.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Comparative effectiveness of antidiabetic therapies on hepatic decompensation in patients with type 2 diabetes: A target trial emulation.JHEP reports : innovation in hepatology · 2025Article
- Effect of GLP-1 RA and SGLT2I on Biomarkers of Oxidative Stress in T2DM: A Systematic Review and Meta-analysis.Journal of the Endocrine Society · 2025Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe treatment of diabetes has a significant impact on the pathogenesis of non-alcoholic fatty liver disease (NAFLD). 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. RESEARCH DESIGN AND
methodsThis open-label, prospective, single-center, randomized clinical trial recruited NAFLD patients with type 2 diabetes mellitus and a hepatic fat fraction of at least 10% as assessed based on the MRI-proton density fat fraction (MRI-PDFF). Eligible patients were stratified according to hemoglobin A1c (HbA1c), alanine transaminase, and MRI-PDFF levels and randomly assigned (1:1) to receive either 20 mg tofogliflozin or 15-30 mg pioglitazone, orally, once daily for 24 weeks. The primary endpoint was an absolute change in MRI-PDFF at 24 weeks. Efficacy and safety was assessed in all treated patients. This trial was registered in the Japan Registry of Clinical Trials.
resultsOverall, 40 eligible patients were randomly assigned to receive tofogliflozin (n=21) or pioglitazone (n=19). Changes in hepatic steatosis after 24 weeks of treatment were evaluated by MRI-PDFF, which showed a significant decrease in both groups (-7.54% (p<0.0001) and -4.12% (p=0.0042) in the pioglitazone and tofogliflozin groups, respectively). Compared with baseline, the body weight decreased by 2.83±2.86 kg (-3.6%, p=0.0443) in the tofogliflozin group and increased by 1.39±2.62 kg (1.7%, p=0.0002) in the pioglitazone group after 24 weeks. No life-threatening events or treatment-related deaths occurred.
conclusionsTofogliflozin was well tolerated, and it reduced the MRI-PDFF levels in NAFLD patients with type 2 diabetes mellitus. TRIAL REGISTRATION NUMBER: jRCTs031180159.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.