Landmark clinical trial under way for type 1 diabetes treatment

For the first time, patients with long-standing type 1 diabetes are undergoing a clinical trial for a therapeutic approach that combines an agent for stimulating the growth of insulin-secreting cells in the pancreas, along with a drug to prevent the autoimmune system from rejecting the newly formed cells. The trial is being conducted at the JGH and the McGill University Health Centre.

Dr. Lawrence Rosenberg, President and CEO of the Integrated Health and Social Services University Network for West-Central Montreal, along with his colleagues, was responsible for the pioneering research that discovered the INGAP (islet neogeneis-associated protein) peptide (Exsulin^TM) that stimulates the growth of the particular islets that secrete insulin in a normally functioning pancreas.

Separate research revealed that ustekinumab (Stelera^TM), a drug approved for treating psoriasis, helps to prevent the body from rejecting these newly formed cells, while enhancing the positive effects of the peptide.

Diabetes is a life-threatening condition that has become a global public health crisis. Though less common than type 2 diabetes, type 1 affects over 1.5 million North Americans, and its prevalence is also growing. Type 1 diabetes develops when the body’s immune system destroys the beta cells within the pancreatic islets. Beta cells make insulin, the key hormone responsible for controlling blood sugar levels. All people with type 1 diabetes require insulin therapy to survive. People with type 2 diabetes have insulin resistance and insufficient insulin secretion, which often can require insulin therapy as the disease progresses.

Poorly controlled diabetes can lead to serious complications, including heart disease, blindness, kidney failure and death. While many therapies have been approved for type 2 diabetes, no treatment has been approved specifically for type 1 diabetes. The higher risks of serious hypoglycemia and long term complications associated with type 1 diabetes, which often begins in childhood, reflect one of the highest unmet needs for an effective therapy among all chronic diseases.

“I am very gratified that my institution is hosting this very important study,” says Dr. Rosenberg. “My colleagues and I have invested our careers in demonstrating the potential for and means of restoring normal insulin secretion in people with diabetes. Though our study is small, we know that the return of significant insulin secretion in just one person with this combination could represent a major finding.”
“This really is a landmark study,” says Dr. G. Alexander Fleming, founder and Chairman of Exsulin Corporation. “Most efforts at developing type 1 diabetes treatments have focused on controlling the autoimmune attack, which by itself cannot restore insulin secretion. A few therapies have been tested in humans for islet regeneration activity, but only INGAP Peptide has been specifically developed and tested in patients for this purpose. It is clear that both kinds of treatment will be required to cure type 1 diabetes.”

Funding for this clinical trial was provided, in part, by a generous donation from long-standing JGH benefactor, the Polachek family.

Individuals, corporations and foundations interested in furthering the work of Dr. Rosenberg or other vital clinical research efforts are invited to support the expansion of the Shirley & Max Konigsberg Clinical Research Unit of the Segal Cancer Centre.

The projected 75-per-cent increase in space will allow the Unit to provide more patients with access to cutting-edge treatments. Greater support will also be provided to other clinical trials.

For more information or to make a donation, please visit the JGH Foundation online or call 514-340-8251.