Randomised, Double-Blind, Placebo-Controlled Study to Investigate GNbAC1 in Patients with Onset of Type 1 Diabetes Within 4 Years

Project type/s Clinical trial, Cohort study
Project status Currently underway

Diabetes is a condition that occurs when the body is unable to regulate the amount of glucose (“blood sugar”) in the blood. Insulin is a hormone produced by the pancreas which keeps the glucose at healthy levels between meals. There are two types of diabetes, Type 1 and Type 2 (more common). With type 1 diabetes, the pancreas cannot make enough insulin and this causes glucose levels in the blood to rise. Most cases of type 1 diabetes are caused when the body’s own immune system attacks part of its own pancreas. This attack is known as "autoimmune" disease and the cause is unknown. People with type 1 diabetes need to inject insulin under the skin to treat the condition. If left untreated, high levels of blood glucose can cause complications, including damage to eyes, kidneys, nerves, and the heart.
The drug to be used in this clinical trial is what’s commonly called a "biologic drug". Scientific studies indicate that the study drug (GNbAC1) could inactivate a toxic substance found in the pancreas of people with diabetes and potentially delay progression of the disease. People who enrol in this trial will be randomly assigned to receive either the study drug, or the placebo (which is inactive). Trial participants will receive 6 consecutive administrations of study drug or placebo at 4-week intervals for 20 weeks. At the conclusion of the first phase of the trial after 20 weeks, all participants will then be given the option to receive the study drug for a further 24 weeks.

Team Members

  • Trisha O'Moore-Sullivan - Team Role: Principal Investigator
  • Adam Morton - Team Role: Co-Investigator
  • Dr Helen Barrett - Team Role: Co-Investigator
  • Janelle Nisbet - Team Role: Co-Investigator
  • Stephanie Teasdale - Team Role: Co-Investigator
  • Margaret Haughton - Team Role: Project Coordinator