Trial reportCardiovascular diabetology2013
The sodium glucose cotransporter 2 inhibitor empagliflozin does not prolong QT interval in a thorough QT (TQT) study.
Trial report in Cardiovascular diabetology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01195675 (Assessment of the Effect of 25 mg and 200 mg of BI 10773 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Five-period Crossover Phase-I-study With Moxifloxacin as Positive Control), which is not on this map. Cited by 27 papers.
What it found
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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.
Assessment of the Effect of 25 mg and 200 mg of BI 10773 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Five-period Crossover Phase-I-study With Moxifloxacin as Positive Control
Who cites it
27 citing papers in PubMed.
- Evaluation of the effect of empagliflozin on prevention of atrial fibrillation after coronary artery bypass grafting: a double-blind, randomized, placebo-controlled trial.Naunyn-Schmiedeberg's archives of pharmacology · 2024Trial
- Vericiguat: A Randomized, Phase Ib, Placebo-Controlled, Double-Blind, QTc Interval Study in Patients with Chronic Coronary Syndromes.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2023Trial
- Effect of dapagliflozin on ventricular arrhythmias, resuscitated cardiac arrest, or sudden death in DAPA-HF.European heart journal · 2021Trial
- The effect of empagliflozin on arterial stiffness and heart rate variability in subjects with uncomplicated type 1 diabetes mellitus.Cardiovascular diabetology · 2014 · on this mapTrial
- A dual-electropolymerized poly(Xylenol orange)@poly(Euchrysine) sensing interface for sustainable simultaneous electroanalysis of 5-fluorouracil and empagliflozin: density functional theory mechanistic elucidation.Mikrochimica acta · 2026Article
- Comparative study of cardio-protective effect of metformin versus dapagliflozin in experimentally induced myocardial infarction in diabetic rats.BMC pharmacology & toxicology · 2026Article
- The Effects of Sodium-Glucose Cotransporter-2 Inhibitors on Implantable Cardioverter Defibrillator Shocks in Heart Failure Patients Undergoing Diuretic Therapy.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2025Article
- Mechanism of the cardioprotective effect of empagliflozin on diabetic nephropathy mice based on the basis of proteomics.Proteome science · 2024Article
- Effect of Empagliflozin Treatment on Ventricular Repolarization Parameters.Reviews in cardiovascular medicine · 2024Article
- Dapagliflozin Pretreatment Prevents Cardiac Electrophysiological Changes in a Diet and Streptozotocin Induction of Type 2 Diabetes in Rats: A Potential New First-Line?Journal of experimental pharmacology · 2024Article
- Potential favorable action of sodium-glucose cotransporter-2 inhibitors on sudden cardiac death: a brief overview.Frontiers in cardiovascular medicine · 2023Review
- Current gaps in management and timely referral of cardiorenal complications among people with type 2 diabetes mellitus in the Middle East and African countries: Expert recommendations.Journal of diabetes · 2022Review
- Mechanisms Underlying Antiarrhythmic Properties of Cardioprotective Agents Impacting Inflammation and Oxidative Stress.International journal of molecular sciences · 2022Review
- Electrocardiographic changes associated with SGLT2 inhibitors and non-SGLT2 inhibitors: A multi-center retrospective study.Frontiers in cardiovascular medicine · 2022Article
- Absence of QTc Prolongation with Sodium N-(8-[2-Hydroxybenzoyl] Amino) Caprylate (SNAC), an Absorption Enhancer Co-Formulated with the GLP-1 Analogue Semaglutide for Oral Administration.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021Article
- Characteristics of Ventricular Electrophysiological Substrates in Metabolic Mice Treated with Empagliflozin.International journal of molecular sciences · 2021Article
- Placebo-Controlled, Double-Blind Study of Empagliflozin (EMPA) and Implantable Cardioverter-Defibrillator (EMPA-ICD) in Patients with Type 2 Diabetes (T2DM): Rationale and Design.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Article
- Effects of Secretome from Fat Tissues on Ion Currents of Cardiomyocyte Modulated by Sodium-Glucose Transporter 2 Inhibitor.Molecules (Basel, Switzerland) · 2020Article
- Review
- Efficacy and safety of dapagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in diabetes mellitus.Cardiovascular diabetology · 2015 · on this mapReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEmpagliflozin is a potent, selective sodium glucose cotransporter 2 (SGLT2) inhibitor in development as an oral antidiabetic treatment. This QT interval study assessed potential effects of empagliflozin on ventricular repolarisation and other electrocardiogram (ECG) parameters.
methodsA randomised, placebo-controlled, single-dose, double-blind, five-period crossover study incorporating a novel double-placebo period design to reduce sample size, while maintaining full statistical power. TREATMENTS: single empagliflozin doses of 25 mg (therapeutic) and 200 mg (supratherapeutic), matching placebo and open-label moxifloxacin 400 mg (positive control). Triplicate 12-lead ECGs of 10 second duration were recorded at baseline and during the first 24 hours after dosing. The primary endpoint was mean change from baseline (MCfB) in the population heart rate-corrected QT interval (QTcN) between 1-4 hours after dosing.
resultsThirty volunteers (16 male, 14 female, mean [range] age: 34.5 [18-52] years) were randomised. The placebo-corrected MCfB in QTcN 1-4 hours after dosing was 0.6 (90% CI: -0.7, 1.9) ms and -0.2 (-1.4, 0.9) ms for empagliflozin 25 mg and 200 mg, respectively, below the ICH E14 defined threshold of regulatory concern 10 ms. Assay sensitivity was confirmed by a placebo-corrected MCfB in QTcN 2-4 hours post-dose of 12.4 (10.7, 14.1) ms with moxifloxacin 400 mg. Empagliflozin tolerability was good for all volunteers; 23.3% experienced adverse events (AEs) with empagliflozin and 27.6% with placebo. The most frequent AE was nasopharyngitis. CONCLUSIONS/
interpretationSingle doses of empagliflozin 25 mg and 200 mg were not associated with QTcN prolongation and were well tolerated in healthy volunteers.
trial registrationClinicalTrials.gov: NCT01195675.
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