Trial reportBMJ open diabetes research & care2021
GABA induces a hormonal counter-regulatory response in subjects with long-standing type 1 diabetes.
Trial report in BMJ open diabetes research & care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03635437 (A Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients), which is not on this map. Cited by 20 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 Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients
Who cites it
20 citing papers in PubMed, 28 citations in OpenAlex.
- Trial
- Abnormally Elevated PKCδ Delays Diabetic Wound Healing by Inhibiting the GAD1-GABA Pathway.Diabetes & metabolism journal · 2026Article
- Gamma-aminobutyric acid supplementation combined with gonadotropin-releasing hormone analog therapy versus gonadotropin-releasing hormone analog therapy alone for linear growth in children with growth retardation: a retrospective cohort study.Translational pediatrics · 2026Article
- Paracrine inhibition via G protein inwardly rectifying potassium channels regulates glucagon secretion from human pancreatic alpha cells.Cell reports · 2026Article
- Liver-pancreas communication in disease and drug development.Acta pharmaceutica Sinica. B · 2026Review
- Intestinal-related substances in obesity regulation: A comprehensive review.World journal of gastrointestinal pharmacology and therapeutics · 2025Review
- Benchmarking porcine pancreatic ductal organoids for drug screening applications.EMBO molecular medicine · 2025Article
- Nutrient-Enriched Germinated Brown Rice Alters the Intestinal Ecological Network by Regulating Lipid Metabolism in Rats.International journal of molecular sciences · 2025Article
- Targeting GABA signaling in type 1 diabetes and its complications- an update on the state of the art.Pharmacological reports : PR · 2025Review
- Role of γ-Aminobutyric Acid (GABA) as an Inhibitory Neurotransmitter in Diabetes Management: Mechanisms and Therapeutic Implications.Biomolecules · 2025Review
- Comparative Evaluation of Responsiveness of Insulin Counter-Regulatory Hormones and Insulin Resistance to Hypoglycemia in Newly Diagnosed Type 1 Diabetes Mellitus Man.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025Article
- GABA-mediated inhibition of human CD4EBioMedicine · 2024Article
- Gamma-aminobutyric acid for delaying type 1 diabetes mellitus: an update.Annals of pediatric endocrinology & metabolism · 2024Article
- The role of GABA in type 1 diabetes.Frontiers in endocrinology · 2024Review
- Experimental pharmacological approaches to reverse impaired awareness of hypoglycemia-a review.Frontiers in pharmacology · 2024Review
- Review
- Current and future therapies to treat impaired awareness of hypoglycemia.Frontiers in pharmacology · 2023Review
- GABA signalling in human pancreatic islets.Frontiers in endocrinology · 2023Review
- Therapeutic Strategies Targeting Pancreatic Islet β-Cell Proliferation, Regeneration, and Replacement.Endocrinology · 2022Article
- Endogenous Levels of Gamma Amino-Butyric Acid Are Correlated to Glutamic-Acid Decarboxylase Antibody Levels in Type 1 Diabetes.Biomedicines · 2021Article
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 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionExperimentally, gamma-aminobutyric acid (GABA) has been found to exert immune-modulatory effects and induce beta-cell regeneration, which make it a highly interesting substance candidate for the treatment of type 1 diabetes (T1D). In many countries, including those in the European Union, GABA is considered a pharmaceutical drug. We have therefore conducted a safety and dose escalation trial with the first controlled-release formulation of GABA, Remygen (Diamyd Medical). RESEARCH DESIGN AND
methodsSix adult male subjects with long-standing T1D (age 24.8±1.5 years, disease duration 14.7±2.2 years) were enrolled in an 11-day dose escalation trial with a controlled-release formulation of GABA, Remygen. Pharmacokinetics, glucose control and hormonal counter-regulatory response during hypoglycemic clamps were evaluated at every dose increase (200 mg, 600 mg and 1200 mg).
resultsDuring the trial there were no serious and only a few, transient, adverse events reported. Without treatment, the counter-regulatory hormone response to hypoglycemia was severely blunted. Intake of 600 mg GABA more than doubled the glucagon, epinephrine, growth hormone and cortisol responses to hypoglycemia.
conclusionsWe find that the GABA treatment was well tolerated and established a counter-regulatory response to hypoglycemia in long-standing T1D. Further studies regarding not only the clinical potential of Remygen for beta-cell regeneration but also its potential use as hypoglycemic prophylaxis are warranted. TRAIL REGISTRATION NUMBER: NCT03635437 and EudraCT2018-001115-73.
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.