Trial reportClinical pharmacokinetics2005
Steady-state pharmacokinetics of a novel extended-release metformin formulation.
Trial report in Clinical pharmacokinetics, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03477162 (Metformin Pharmacology in Human Cancers), which is not on this map. Cited by 45 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.
Metformin Pharmacology in Human Cancers
Who cites it
45 citing papers in PubMed, 121 citations in OpenAlex.
- Pharmacokinetic comparison between fixed-dose combination and loose combination of enavogliflozin 0.3 mg and metformin HCl 1000 mg in healthy subjects under fasting and fed conditions.Naunyn-Schmiedeberg's archives of pharmacology · 2026Trial
- Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19.The New England journal of medicine · 2022Trial
- Trial
- Metformin extended-release versus immediate-release: An international, randomized, double-blind, head-to-head trial in pharmacotherapy-naïve patients with type 2 diabetes.Diabetes, obesity & metabolism · 2018Trial
- Metformin and daclatasvir: absence of a pharmacokinetic-pharmacodynamic drug interaction in healthy volunteers.British journal of clinical pharmacology · 2017 · on this mapTrial
- Effects of metformin extended release compared to immediate release formula on glycemic control and glycemic variability in patients with type 2 diabetes.Drug design, development and therapy · 2017Trial
- The effect of dipyridamole on the pharmacokinetics of metformin: a randomized crossover study in healthy volunteers.European journal of clinical pharmacology · 2016Trial
- Bioequivalence of saxagliptin/metformin extended-release (XR) fixed-dose combination tablets and single-component saxagliptin and metformin XR tablets in healthy adult Chinese subjects.Clinical drug investigation · 2014Trial
- 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
- Metformin promotes mitochondrial integrity through AMPK-signaling in Leber's hereditary optic neuropathy.FEBS open bio · 2026Article
- Reduced Metformin Concentrations in Obese Women With Human Immunodeficiency Virus Treated With Dolutegravir.The Journal of infectious diseases · 2025Observational
- Effect of in utero metformin exposure in gestational diabetes mellitus on infant mesenchymal stem cell metabolism.American journal of physiology. Endocrinology and metabolism · 2025Article
- Non-Linear Dose-Response Relationship for Metformin in Japanese Patients With Type 2 Diabetes: Analysis of Irregular Longitudinal Data by Interpretable Machine Learning Models.Pharmacology research & perspectives · 2025Article
- Intranasal delivery of metformin using metal-organic framework (MOF)-74-Mg nanocarriers.Advanced composites and hybrid materials · 2025Article
- The Impact of Paediatric Obesity on Drug Pharmacokinetics: A Virtual Clinical Trials Case Study with Amlodipine.Pharmaceutics · 2024Article
- Repurposing Metformin for the Treatment of Atrial Fibrillation: Current Insights.Vascular health and risk management · 2024Review
- Improving Type 2 Diabetes Care with Extended-Release Metformin: Real-Life Insights from a Physician Educational Program.Endocrine, metabolic & immune disorders drug targets · 2024Article
- Significant impact of time-of-day variation on metformin pharmacokinetics.Diabetologia · 2023Article
- The development and benefits of metformin in various diseases.Frontiers of medicine · 2023Review
- PGC-1α Is a Master Regulator of Mitochondrial Lifecycle and ROS Stress Response.Antioxidants (Basel, Switzerland) · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveMetformin is an effective treatment for type 2 diabetes mellitus. The pharmacokinetic characteristics of the conventional immediate-release (IR) formulation of metformin (Glucophage), however, necessitate two- or three-times-daily dosing. Development of a novel extended-release (XR) formulation of metformin (Glucophage XR) using GelShield Diffusion System technology provides a once-daily dosing option. The objective of this study was to assess the steady-state pharmacokinetics of metformin XR tablets. STUDY
designThis was an open-label, multiple-dose, five-regimen, two-sequence clinical study lasting 5 weeks.
methodsSubjects were 16 healthy volunteers aged 18-40 years. Three 1-week regimens of metformin XR (500, 1000 and 1500 mg once daily) were administered sequentially. Subjects were alternately given either metformin XR 2000 mg once daily or metformin IR 1000 mg twice daily during weeks 4 and 5. The pharmacokinetic properties of metformin XR were assessed on two separate days at steady state and compared with those of metformin IR.
resultsAbsorption of metformin XR was slower than that of metformin IR (time to maximum plasma concentration = 7 versus 3 hours). Maximum plasma concentrations (Cmax) following the administration of metformin XR 2000 mg once daily was 36% higher than that following the evening dose of metformin IR 1000 mg twice daily. The extent of absorption, determined by area under the plasma concentration-time curve (AUC), was equivalent for both formulations. The mean accumulation ratio of metformin XR was 1.0, indicating no accumulation with multiple-dose administration. Intrasubject variabilities in Cmax and AUC of metformin were comparable between metformin XR and metformin IR. This novel formulation of metformin XR was well tolerated at single doses up to 2000 mg once daily for 7 days, and adverse events were similar to those reported with metformin IR.
conclusionThe pharmacokinetic parameters of metformin XR tablet using GelShield Diffusion System technology were similar to those of metformin IR. Metformin XR was well tolerated at single doses up to 2000 mg once daily.
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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.