It might be tricky to pronounce at first, but a human monoclonal antibody, called golimumab (gō-lim-yü-mab), can help kids and young adults with newly diagnosed type 1 diabetes, according to new research. The fact that golimumab has been approved to treat a number of autoimmune conditions in both the adult and pediatric populations, led to curiosity over whether the drug could help patients with type 1 diabetes. The small proof of concept study strongly suggests that golimumab can indeed reduce the amount of injected insulin required by children and youth with newly diagnosed type 1 diabetes by preserving their ability to produce insulin on their own, called endogenous insulin.
The study is the culmination of decades of work conducted at the University at Buffalo in New York State and at the Diabetes Center at UBMD Pediatrics and Children’s Hospital. The main goal of the study was to see if golimumab could preserve beta-cell function in newly diagnosed patients, which it does, for as it seems at least a year after diagnosis.
Beta cells are unique cells in the pancreas that produce and secrete hormones directly into the bloodstream to regulate levels of glucose. When blood glucose levels start to rise (e.g., during digestion), beta cells quickly respond by secreting some of their stored insulin. This quick response to a spike in blood glucose usually takes about ten minutes. In people with diabetes, however, these cells are either attacked and destroyed by the immune system or are unable to produce enough insulin needed for blood sugar control.
In addition to insulin, beta cells also secrete the hormone Amylin and so called C-peptide, a byproduct of insulin production. Amylin slows the rate of glucose entering the bloodstream, making it a more short-term regulator of blood glucose levels. C-peptide is a molecule that helps to prevent neuropathy and other vascular complications by assisting in the repair of the muscular layers of the arteries.
The most important finding in the recent study is that golimumab is a potential disease-modifying agent for newly diagnosed type 1 diabetes. The team determined that beta-cell function was preserved based on the amount of C-peptide in patients’ blood during a four-hour mixed meal tolerance test. Because C-peptide reflects only insulin made by the body and not injected insulin, C-peptide levels reveal how well the pancreas is producing insulin.
The findings represent a major step forward in the effort to find ways to preserve the insulin-making capabilities of children and young adults with type 1 diabetes. Patients newly diagnosed with type 1 diabetes don’t stop making insulin all of a sudden. During the period just after diagnosis, called partial remission or the honeymoon period, patients are still able to make some insulin on their own. That is the period the scientists targeted with this study of golimumab.
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Although none of the patients were able to stop taking insulin entirely, the results have important clinical implications. The need for less injected insulin is a major quality of life improvement and carries advantages, including lower rates of hypoglycemia. The scientists believe that the golimumab results represent another tangible step towards achieving the ultimate goal of developing therapies that will one day prevent and reverse type 1 diabetes. “People want a cure, but the fact is, a cure is not available yet. But this is an intermediate step towards a cure” according to one of the lead authors.
Based on these promising results, the research team have planned future studies seeking to determine if golimumab can be given even earlier in the disease process to more effectively prevent or delay type 1 diabetes in high risk patients. So, stay tuned for some more exciting news to come.