Trial reportClinical pharmacokinetics2019
The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects.
Trial report in Clinical pharmacokinetics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02304627 (Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects), which is not on this map. Cited by 10 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.
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
Who cites it
10 citing papers in PubMed, 34 citations in OpenAlex.
- A self-unfolding polymer foil loaded with a permeation enhancer Ionogel for superior oral peptide delivery.Drug delivery and translational research · 2026Article
- Impact of sodium caprate dosed as a mini-tablet or suspension on insulin delivery and mucosa histomorphology.Drug delivery and translational research · 2026Article
- Development of 3D-Printed Two-Compartment Capsular Devices for Pulsatile Release of Peptide and Permeation Enhancer.Pharmaceutical research · 2024Article
- Gastrointestinal Permeation Enhancers Beyond Sodium Caprate and SNAC - What is Coming Next?Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2024Review
- Evaluating the oral delivery of GalNAc-conjugated siRNAs in rodents and non-human primates.Nucleic acids research · 2024Article
- Intestinal Absorption of FITC-Dextrans and Macromolecular Model Drugs in the Rat Intestinal Instillation Model.Molecular pharmaceutics · 2022Article
- Impact of Intestinal Concentration and Colloidal Structure on the Permeation-Enhancing Efficiency of Sodium Caprate in the Rat.Molecular pharmaceutics · 2022Article
- Novel Drugs for Diabetes Therapy.Handbook of experimental pharmacology · 2022Review
- Future Perspectives of Oral Delivery of Next Generation Therapies for Treatment of Skin Diseases.Pharmaceutics · 2021Review
- Molecular engineering of safe and efficacious oral basal insulin.Nature communications · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOral insulin 338 is a novel tablet formulation of a long-acting basal insulin. This randomised, open-label, four-period crossover trial investigated the effect of timing of food intake on the single-dose pharmacokinetic properties of oral insulin 338.
methodsAfter an overnight fast, 44 healthy males received single fixed doses of oral insulin 338 administered 0, 30, 60 or 360 min before consuming a standardised meal (500 kcal, 57 energy percent [E%] carbohydrate, 13 E% fat, 30 E% protein). Blood samples for pharmacokinetic assessment were taken up to 288 h post-dose.
resultsTotal exposure (area under the concentration-time curve from time zero to infinity [AUC
conclusionsOral insulin 338 pharmacokinetics are not affected by food intake from 30 min after dosing, implying that patients with diabetes mellitus do not need to wait more than 30 min after a morning dose of oral insulin 338 before having their breakfast. This is considered important for convenience and treatment compliance. CLINICALTRIALS. GOV IDENTIFIER: NCT02304627.
Indexed as
Identifiers
What OpenQuestion holds
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 OpenQuestion graph.