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Long-term gamma-aminobutyric acid (GABA) treatment fails to regain beta-cell function in longstanding type 1 diabetes in a randomized trial.

  • 2025-04-04
  • Scientific reports 15(1)
    • Henrik Hill
    • Per Lundkvist
    • Georgios Tsatsaris
    • Bryndis Birnir
    • Daniel Espes
    • Per-Ola Carlsson

Study Design

Type
Randomized Controlled Trial (RCT)
Population
35 male subjects with T1D (≥ 5 years)
Methods
Phase I/II randomized controlled trial, three arms receiving study drug(s) once daily for 6 months: GABA 200 mg (Arm 1), GABA 600 mg (Arm 2) and GABA 600 mg + alprazolam 0.5 mg for 3 months followed by GABA 600 mg alone for 3 months (Arm 3)
Duration
6 months
  • Rigorous Journal
Gamma-amino butyric acid (GABA) has in experimental studies been found to promote beta-cell proliferation, enhance insulin secretion and reduce inflammation, positioning it as a candidate drug for type 1 diabetes (T1D) therapy. This phase I/II randomized controlled trial assessed the safety and efficacy of long-term treatment with Remygen® (Diamyd Medical), a controlled-release oral GABA formulation, as a potential beta-cell regenerative therapy in adults with long-standing T1D. Thirty-five male subjects with T1D (≥ 5 years) were randomized into three arms receiving the study drug(s) once daily for 6 months: GABA 200 mg (Arm 1), GABA 600 mg (Arm 2) and GABA 600 mg + alprazolam 0.5 mg for 3 months followed by GABA 600 mg alone for 3 months (Arm 3). Safety measures, hormonal counter-regulation during hypoglycemic clamps, fasting- and stimulated C-peptide levels, were assessed at multiple timepoints. Safety concerns included elevated aspartate aminotransferase (AST) in nine subjects, leading to the withdrawal of two subjects. Most elevations were, however, transient with no dose-differences. No effects were observed on fasting- or stimulated C-peptide levels, CGM metrics or HbA1c. Hypoglycemic hormonal counter-regulation was unaltered. To conclude, we found no clinical evidence of a beta-cell regenerative effect of GABA, but side effects were commonly observed.

Research Insights

Adverse Events Reported

  • Gamma-Aminobutyric Acid→Overall tolerability

    Most elevations were, however, transient with no dose-differences.

    Finding
    Reported
  • Gamma-Aminobutyric Acid→elevated aspartate aminotransferase

    Safety concerns included elevated aspartate aminotransferase (AST) in nine subjects, leading to the withdrawal of two subjects.

    Finding
    Reported
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