MONTREAL – Investigators at the Jewish General Hospital’s (JGH) Lady Davis Institute and the McGill University Health Centre (MUHC) have begun clinical trials that they say may revolutionize the treatment of Type 1 diabetes.

The therapy, pioneered by Dr. Lawrence Rosenberg, aims to regenerate islet cells in the pancreas, thereby restoring normal insulin secretion.

The treatment combines a peptide-based drug, developed by Minneapolis-based pharmaceutical company Exsulin Corporation, which stimulates the growth of insulin-producing cells, and ustekinumab (marketed under the trademark Stelera), an immunosuppressant drug approved for the treatment of psoriasis.   

The discovery of the INGAP (islet neogenesis-associated protein) peptide is the result of years of research by Rosenberg, a professor of surgery and medicine at McGill University and, since April, president and CEO of the Integrated Health and Social Services University Network for West-Central Montreal, and his collaborator Dr. Aaron Vinik, director of research and Murray Waitzer Endowed Chair for Diabetes Research at the Eastern Virginia Medical School (EVMS). 

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Vinik and his colleagues identified the specific INGAP peptide after Rosenberg demonstrated that islet regeneration can be induced and isolated the islet regeneration activity.

The clinical study is jointly led by Rosenberg and George Tsoukas, senior endocrinologist and associate professor of medicine at the MUHC.

The addition of ustekinumab, an interleukin-12 inhibitor, is based on research by Dr. Jerry Nadler, chair of medicine and vice-dean of research at EVMS, which showed the islet restoring effect of INGAP peptide was enhanced by the addition of another IL-12 inhibitor.

Though less common than Type 2 diabetes, Type 1 diabetes affects over 1.5 million people in North America, and its incidence is growing, the researchers point out.

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.

“While many therapies have been approved for Type 2 diabetes, no treatment has been approved specifically for Type 1 diabetes,” said Rosenberg. “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.”

The study is being conducted at institutions within the McGill network, including the JGH. Exsulin is providing the peptide drug product and some financial and scientific support.

“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,” said Dr. Alexander Fleming, Exsulin’s founder and chair. “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.”