ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2013
Safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple rising doses of empagliflozin in patients with type 2 diabetes mellitus.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 65 papers, 2 of them syntheses that pooled it.
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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.
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Who cites it
65 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Safety of sodium-glucose cotransporter 2 inhibitors drugs among heart failure patients: a systematic review and meta-analysis.ESC heart failure · 2024Pooled it
- Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis.BMJ open · 2019Pooled it
- Efficacy of empagliflozin as adjunctive therapy to citalopram in major depressive disorder: a randomized double-blind, placebo-controlled clinical trial.BMC psychiatry · 2024Trial
- No Relevant Pharmacokinetic Drug-Drug Interaction Between the Sodium-Glucose Co-Transporter-2 Inhibitor Empagliflozin and Lobeglitazone, a Peroxisome Proliferator-Activated Receptor-γ Agonist, in Healthy Subjects.Drug design, development and therapy · 2021Trial
- Trial
- Trial
- Pharmacokinetic and pharmacodynamic profile of the sodium-glucose co-transporter-2 inhibitor empagliflozin in young people with Type 2 diabetes: a randomized trial.Diabetic medicine : a journal of the British Diabetic Association · 2018Trial
- Pharmacokinetic Evaluation of Empagliflozin in Healthy Egyptian Volunteers Using LC-MS/MS and Comparison with Other Ethnic Populations.Scientific reports · 2017Trial
- SGLT2 Inhibitors and Cardiovascular Risk: Lessons Learned From the EMPA-REG OUTCOME Study.Diabetes care · 2016 · on this mapTrial
- Pharmacokinetics, Pharmacodynamics, and Safety of Luseogliflozin in Japanese Patients with Type 2 Diabetes Mellitus: A Randomized, Single-blind, Placebo-controlled Trial.Advances in therapy · 2015Trial
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- Dapagliflozin Beyond Glucose Lowering: Mechanisms of Renal and Systemic Protection.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026Review
- Effects of empagliflozin and metformin on biofilm formation and pathogenicity factors of urinary Escherichia coli isolates.Folia microbiologica · 2026Article
- Bioequivalence Evaluation of Immediate-Release Empagliflozin/Metformin Fixed-Dose Combination Tablets Under Fed Conditions in Healthy Mexican Subjects and Exploratory Analysis of Metformin Dose Proportionality.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Age-Driven Physiologically Based Pharmacokinetic Modeling of Empagliflozin: Toward Precision Dosing in Youth.ACS pharmacology & translational science · 2026Article
- Bioequivalence of Two Empagliflozin 25 mg Immediate-Release Tablet Formulations Under Fasting Conditions in Healthy Mexican Subjects.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Sex Differences in Antiarrhythmic Effects of Empagliflozin: The EMPA-ICD Trial Subanalysis.JACC. Asia · 2026Article
- Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin.Journal of pharmaceutical sciences · 2025Article
- Comparison of the Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Cardiac Fibroblast Properties.International journal of molecular sciences · 2025Article
- A Human Engineered Heart Tissue-Derived Lipotoxic Diabetic Cardiomyopathy Model Revealed Early Benefits of Empagliflozin.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
5 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis study examined the safety, tolerability, pharmacokinetics, and pharmacodynamics of empagliflozin, a potent and highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes mellitus (T2DM).
methodsA total of 48 patients with T2DM were randomized to receive one of four doses of empagliflozin (2.5, 10, 25, or 100 mg qd) or placebo over 8 days. In every dose group, nine patients received active drug and three received placebo. The primary endpoint was safety and tolerability. Pharmacokinetic and pharmacodynamic parameters were measured as secondary endpoints.
resultsEmpagliflozin was rapidly absorbed, reaching peak levels 1.5-3.0 h after dosing and showed a biphasic decline. The mean terminal elimination half-life ranged from 10 to 19 h. Increases in exposure (area under the plasma concentration-time curve [AUC] and maximum concentration of analyte in plasma [C max]) were approximately proportional with dose. Empagliflozin increased the rate and total amount of glucose excreted in urine compared to placebo. After administration of a single dose of empagliflozin, cumulative amounts of glucose excreted in urine over 24 h ranged from 46.3 to 89.8 g, compared with 5.84 g with placebo. Similar results were seen after multiple doses. Fasting plasma glucose levels decreased by 17.2-25.8% with empagliflozin and by 12.7% with placebo. The frequency of adverse events was 33.3-66.7% with empagliflozin and 41.7% with placebo. There were no changes in urine volume or micturition frequency under the controlled study conditions.
conclusionOverall, pharmacokinetic assessments demonstrated a dose-proportional increase in drug exposure and support once-daily dosing. Elevated urinary glucose excretion was observed with all doses. Multiple once-daily oral doses of empagliflozin (2.5-100 mg) reduced plasma glucose and were well tolerated in patients with T2DM. EudraCT (2007-000654-32).
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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.