Trial reportPloS one2013
Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled type 1 diabetes: a pilot study.
Trial report in PloS one, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00867594 (A Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.
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 Single Blind, Open-Label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral Insulin Formulation in Type 1 Subjects
Who cites it
38 citing papers in PubMed, 1 synthesis or guideline pooled it, 91 citations in OpenAlex.
- Efficacy and safety of oral insulin compared to subcutaneous insulin: a systematic review and meta-analysis.Journal of endocrinological investigation · 2016Pooled it
- Re-engineering insulin for oral delivery: structural modifications, advanced formulation strategies, and future directions.Drug delivery · 2026Review
- A self-triggering and fully sustainable gastric device enabling long-acting oral delivery of macromolecules.Science advances · 2026Article
- Small Intestine-Targeted Long-Acting Oral Insulin Formulation Based on Engineered Milk Protein Nanoparticles.ACS applied bio materials · 2026Article
- Insulin Analogs and the Mode of Insulin Delivery: Recent Advances and Challenges.Current pharmaceutical biotechnology · 2025Review
- Oral nanotherapeutic formulation of insulin with reduced episodes of hypoglycaemia.Nature nanotechnology · 2024Article
- Recent advances in oral insulin delivery technologies.Journal of controlled release : official journal of the Controlled Release Society · 2024Article
- Effect of Gegen Qinlian Decoction on the regulation of gut microbiota and metabolites in type II diabetic rats.Frontiers in microbiology · 2024Article
- Oral Insulin Alleviates Liver Fibrosis and Reduces Liver Steatosis in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes: Results of Phase II Randomized, Placebo-controlled Feasibility Clinical Trial.Gastro hep advances · 2024Article
- Impact of Peptide Structure on Colonic Stability and Tissue Permeability.Pharmaceutics · 2023Article
- Insulin: evolution of insulin formulations and their application in clinical practice over 100 years.Acta diabetologica · 2022Review
- Versatile Oral Insulin Delivery Nanosystems: From Materials to Nanostructures.International journal of molecular sciences · 2022Review
- Therapeutic peptides: current applications and future directions.Signal transduction and targeted therapy · 2022Review
- Oral delivery of protein and peptide drugs: from non-specific formulation approaches to intestinal cell targeting strategies.Theranostics · 2022Review
- The combined effect of permeation enhancement and proteolysis inhibition on the systemic exposure of orally administrated peptides: Salcaprozate sodium, soybean trypsin inhibitor, and teriparatide study in pigs.International journal of pharmaceutics: X · 2021Article
- Development of an orally delivered GLP-1 receptor agonist through peptide engineering and drug delivery to treat chronic disease.Scientific reports · 2021Article
- A Century of Progress in Diabetes Care with Insulin: A History of Innovations and Foundation for the Future.Diabetes & metabolism journal · 2021Review
- Oral delivery of proteins and peptides: Challenges, status quo and future perspectives.Acta pharmaceutica Sinica. B · 2021Review
- Trends in peptide drug discovery.Nature reviews. Drug discovery · 2021Article
- Advances in Subcutaneous Delivery Systems of Biomacromolecular Agents for Diabetes Treatment.International journal of nanomedicine · 2021Review
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 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledThe unpredictable behavior of uncontrolled type 1 diabetes often involves frequent swings in blood glucose levels that impact maintenance of a daily routine. An intensified insulin regimen is often unsuccessful, while other therapeutic options, such as amylin analog injections, use of continuous glucose sensors, and islet or pancreas transplantation are of limited clinical use. In efforts to provide patients with a more compliable treatment method, Oramed Pharmaceuticals tested the capacity of its oral insulin capsule (ORMD-0801, 8 mg insulin) in addressing this resistant clinical state. Eight Type I diabetes patients with uncontrolled diabetes (HbA1c: 7.5-10%) were monitored throughout the 15-day study period by means of a blind continuous glucose monitoring device. Baseline patient blood glucose behavior was monitored and recorded over a five-day pretreatment screening period. During the ensuing ten-day treatment phase, patients were asked to conduct themselves as usual and to self-administer an oral insulin capsule three times daily, just prior to meal intake. CGM data sufficient for pharmacodynamics analyses were obtained from 6 of the 8 subjects. Treatment with ORMD-0801 was associated with a significant 24.4% reduction in the frequencies of glucose readings >200 mg/dL (60.1 ± 7.9% pretreatment vs. 45.4 ± 4.9% during ORMD-0801 treatment; p = 0.023) and a significant mean 16.6% decrease in glucose area under the curve (AUC) (66055 ± 5547 mg/dL/24 hours vs. 55060 ± 3068 mg/dL/24 hours, p = 0.023), with a greater decrease during the early evening hours. In conclusion, ORMD-0801 oral insulin capsules in conjunction with subcutaneous insulin injections, well tolerated and effectively reduced glycemia throughout the day.
trial registrationClinicaltrials.gov NCT00867594.
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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 OpenQuestion graph.