drugset / Trial / NCT02002130

The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes

NCT02002130

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Type I Diabetes is an auto immune disease in which the body's immune system attacks and destroys the insulin-producing beta cells of the pancreas. Therefore, children affected by this condition present with high blood sugars. This condition affects 1:400/500 persons worldwide.Type I Diabetes, previously known as Juvenile Diabetes,usually strikes in childhood, adolescence, or young adulthood, but lasts for a lifetime. To date, there has been no treatments that can arrest, or reverse the ongoing beta cell destruction. We hypothesize that GABA, a naturally occurring substance, has the potential to reduce the inflammation and protect the pancreatic beta cells from autoimmune destruction. GAD-alum may contribute to the preservation of residual insulin secretion in patients with recent onset, Type I Diabetes.

Timeline

Start
2015-01
Primary completion
2021-10-15
Completion
2022-04-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gamma-Aminobutyric Acid Small molecule 250 mg Oral
Comparator Glutamic Acid Decarboxylase Protein / enzyme biologic Other