ArticleBMJ open2021
Rationale and design of the EMPA-ELDERLY trial: a randomised, double-blind, placebo-controlled, 52-week clinical trial of the efficacy and safety of the sodium-glucose cotransporter-2 inhibitor empagliflozin in elderly Japanese patients with type 2 diabetes.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT04531462. Cited by 16 papers, 1 of them a synthesis that pooled it.
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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.
A Randomised, Double-blind, Placebo-controlled, Parallel Group, 52 Weeks Phase IV Trial to Evaluate Efficacy and Safety of Oral, Once Daily Empagliflozin in Elderly Japanese Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Open the trial in the graphWho cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Long-term effects of SGLT2 inhibitors on arrhythmias: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Study Protocol for the TIGHTEN Study Comparing the Effects of Tofogliflozin and Glimepiride on Skeletal Muscle Mass in Patients with Type 2 Diabetes without Obesity: A Prospective, Multicenter, Open-Label, Randomized, Parallel Group Trial in Japan.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026Article
- Low baseline HbA1c and reduced eGFR are associated with relatively unfavorable body recomposition after SGLT2 inhibitor therapy in type 2 diabetes.Frontiers in endocrinology · 2026Observational
- Kidney Disease Aging Research Collaborative (KDARC): Addressing barriers in geriatric nephrology research.Journal of the American Geriatrics Society · 2025Article
- Establishing Research Priorities in Geriatric Nephrology: A Delphi Study of Clinicians and Researchers.American journal of kidney diseases : the official journal of the National Kidney Foundation · 2025Article
- Analysis risk factors of long-term adverse outcomes and a prediction nomogram for coronary artery disease patients underwent fractional flow reserve.International journal of medical sciences · 2025Article
- Benefit and Safety of Sodium-Glucose Co-Transporter 2 Inhibitors in Older Patients with Type 2 Diabetes Mellitus.Diabetes & metabolism journal · 2024Review
- Practical Guidance for the Use of SGLT2 Inhibitors in Heart Failure.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023Review
- Sodium-Glucose Co-transporter Type-2 Inhibitors' Effect on Quality of Life in Older Adult Population.Cureus · 2023Article
- Overall Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitor Luseogliflozin Versus Dipeptidyl-Peptidase 4 Inhibitors: Multicenter, Open-Label, Randomized-Controlled Trial (J-SELECT study).Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023Article
- Functional and Clinical Importance of SGLT2-inhibitors in Frailty: From the Kidney to the Heart.Hypertension (Dallas, Tex. : 1979) · 2023Review
- Immunomodulatory Effects of SGLT2 Inhibitors-Targeting Inflammation and Oxidative Stress in Aging.International journal of environmental research and public health · 2023Review
- Repurposing Drugs for Diabetes Mellitus as Potential Pharmacological Treatments for Sarcopenia - A Narrative Review.Drugs & aging · 2023Review
- The Association Between Sarcopenia and Diabetes: From Pathophysiology Mechanism to Therapeutic Strategy.Diabetes, metabolic syndrome and obesity : targets and therapy · 2023Review
- The role of sodium-glucose co-transporter-2 inhibitors in frail older adults with or without type 2 diabetes mellitus.Age and ageing · 2022Review
- The Intersection of SGLT2 Inhibitors, Cognitive Impairment, and CKD.Frontiers in neurology · 2022Review
Corrections and comments
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Authors and funding
9 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionElderly people (≥65 years) with type 2 diabetes mellitus (T2DM) are becoming increasingly prevalent, notably in Japan. As cardiovascular (CV) risk increases with age and sodium-glucose cotransporter-2 (SGLT2) inhibitors reduce CV risk, elderly patients with T2DM are increasingly likely to be prescribed these glucose-lowering drugs. There is controversy surrounding the effects of SGLT2 inhibitors on muscle mass, particularly in elderly patients for whom loss of muscle is especially undesirable; however, robust evidence on this important issue is lacking. Consequently, we have designed a clinical trial of the SGLT2 inhibitor empagliflozin in elderly Japanese patients with T2DM (Empagliflozin in Elderly T2DM Patients (EMPA-ELDERLY)) to assess its effects on body composition as well as glycaemic control. EMPA-ELDERLY will be the first randomised clinical trial of an SGLT2 inhibitor in elderly patients with T2DM to evaluate effects on skeletal muscle mass, muscle strength and physical performance concurrently. METHODS AND ANALYSIS: EMPA-ELDERLY is a randomised, double-blind, placebo-controlled, parallel-group clinical trial to be conducted in Japan. Patients with T2DM aged ≥65 years are eligible if they are Japanese with a body mass index of ≥22 kg/m ETHICS AND DISSEMINATION: We will submit the trial results to conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04531462.
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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 OpenQuestion graph.