Trial reportBMC pharmacology & toxicology2013
First human dose-escalation study with remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2 (SGLT2), in healthy subjects and in subjects with type 2 diabetes mellitus.
Trial report in BMC pharmacology & toxicology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01571661 (A Double Blind, Randomized, Placebo Controlled, Single-dose Escalation, First-time-in-human Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GSK189075A in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus), which is not on this map. Cited by 23 papers.
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.
A Double Blind, Randomized, Placebo Controlled, Single-dose Escalation, First-time-in-human Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GSK189075A in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
Who cites it
23 citing papers in PubMed, 51 citations in OpenAlex.
- Assessment of safety and tolerability of remogliflozin etabonate (GSK189075) when administered with total daily dose of 2000 mg of metformin.BMC pharmacology & toxicology · 2021Trial
- Trial
- An Open-Label, Single-Period, Two-Stage, Single Oral Dose Pharmacokinetic Study of Remogliflozin Etabonate Tablet 100 and 250 mg in Healthy Asian Indian Male Subjects Under Fasting and Fed Conditions.Clinical pharmacokinetics · 2020Trial
- Safety, pharmacokinetics and pharmacodynamics of remogliflozin etabonate, a novel SGLT2 inhibitor, and metformin when co-administered in subjects with type 2 diabetes mellitus.BMC pharmacology & toxicology · 2013Trial
- Safety and Efficacy of Remogliflozin in People With Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.Cureus · 2024Review
- Efficacy and Safety of Vildagliptin and Remogliflozin as Add-on Therapy to Metformin in Patients of Type 2 Diabetes Mellitus: An open-label comparative study.Sultan Qaboos University medical journal · 2024Article
- SGLT5 is the renal transporter for 1,5-anhydroglucitol, a major player in two rare forms of neutropenia.Cellular and molecular life sciences : CMLS · 2023Article
- Treatment of the Neutropenia Associated with GSD1b and G6PC3 Deficiency with SGLT2 Inhibitors.Diagnostics (Basel, Switzerland) · 2023Review
- Sex-Specific Computational Models of Kidney Function in Patients With Diabetes.Frontiers in physiology · 2022Article
- Remogliflozin: the new low cost SGLT-2 inhibitor for type 2 diabetes mellitus.Diabetology international · 2021Review
- Development and Validation of Green UV Derivative Spectrophotometric Methods for Simultaneous Determination Metformin and Remogliflozin from Formulation: Evaluation of Greenness.International journal of environmental research and public health · 2021Article
- Effect of dapagliflozin alone and in combination with insulin in a rat model of type 1 diabetes.The Journal of veterinary medical science · 2020Article
- Remogliflozin Etabonate in the Treatment of Type 2 Diabetes: Design, Development, and Place in Therapy.Drug design, development and therapy · 2020Review
- Remogliflozin Etabonate: First Global Approval.Drugs · 2019Review
- Obesity: Current and potential pharmacotherapeutics and targets.Pharmacology & therapeutics · 2017Review
- Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors from Natural Products: Discovery of Next-Generation Antihyperglycemic Agents.Molecules (Basel, Switzerland) · 2016Review
- Remogliflozin Etabonate Improves Fatty Liver Disease in Diet-Induced Obese Male Mice.Journal of clinical and experimental hepatology · 2015Article
- Pharmacokinetics, Pharmacodynamics and Clinical Use of SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease.Clinical pharmacokinetics · 2015Review
- Clinical implications of canagliflozin treatment in patients with type 2 diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2015Article
- Glucose Control and Cardiovascular Outcomes in Clinical Trials of Sodium Glucose Co-transporter 2 Inhibitor Treatments in Type 2 Diabetes.European endocrinology · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundRemogliflozin etabonate (RE) is the prodrug of remogliflozin, a selective inhibitor of the renal sodium-dependent glucose transporter 2 (SGLT2), which could increase urine glucose excretion (UGE) and lower plasma glucose in humans.
methodsThis double-blind, randomized, placebo-controlled, single-dose, dose-escalation, crossover study is the first human trial designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RE. All subjects received single oral doses of either RE or placebo separated by approximately 2 week intervals. In Part A, 10 healthy subjects participated in 5 dosing periods where they received RE (20 mg, 50 mg, 150 mg, 500 mg, or 1000 mg) or placebo (4:1 active to placebo ratio per treatment period). In Part B, 6 subjects with type 2 diabetes mellitus (T2DM) participated in 3 dose periods where they received RE (50 mg and 500 mg) or placebo (2:1 active to placebo per treatment period). The study protocol was registered with the NIH clinical trials data base with identifier NCT01571661.
resultsRE was generally well-tolerated; there were no serious adverse events. In both populations, RE was rapidly absorbed and converted to remogliflozin (time to maximum plasma concentration [Cmax;Tmax] approximately 1 h). Generally, exposure to remogliflozin was proportional to the administered dose. RE was rapidly eliminated (mean T½ of ~25 min; mean plasma T½ for remogliflozin was 120 min) and was independent of dose. All subjects showed dose-dependent increases in 24-hour UGE, which plateaued at approximately 200 to 250 mmol glucose with RE doses ≥150 mg. In T2DM subjects, increased plasma glucose following OGTT was attenuated by RE in a drug-dependent fashion, but there were no clear trends in plasma insulin. There were no apparent effects of treatment on plasma or urine electrolytes.
conclusionsThe results support progression of RE as a potential treatment for T2DM.
trial registrationClinicalTrials.gov NCT01571661.
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Registered trials
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.