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

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.

Conditions

• Type I Diabetes

Interventions

DRUG

Placebo GABA and Placebo GAD-alum

Maltodextrin as a placebo formulation for GABA Placebo GAD-alum injection

DRUG

GABA and Placebo GAD-alum

Oral Active GABA with Placebo GAD-alum

DRUG

Active Oral GABA and Active GAD-alum injection

Active Oral GABA and Active GAD-alum injection

Sponsors & Collaborators

• Diamyd Inc

  collaborator INDUSTRY

• NOW Foods

  collaborator OTHER

• Janssen Pharmaceuticals

  collaborator INDUSTRY

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Kenneth McCormick, MD · University of Alabama at Birmingham

• Gail Mick, MD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2021-10-15

Completion

2022-04-15

FDA Drug

Yes

Countries

• United States

Study Locations