If we can improve insulin sensitivity and insulin production at the same time, it could substantially improve the treatment of type 2 diabetes – and, possibly, prevent the onset of clinical complications.
Pittsburgh, PA (PRWEB) December 15, 2015
Could a drug initially developed to treat chronic obstructive pulmonary disease (COPD) be useful in treating type 2 diabetes? Allegheny Health Network’s Institute of Cellular Therapeutics has received a $2.2 million grant from the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS) to explore that possibility.
AHN will use the grant, distributed as part of the NCATS’s New Therapeutic Uses program, to fund a two-year clinical trial in 42 type 2 diabetics who are overweight and have problems controlling their blood sugar. The goal of the trial is to see if this new drug – used in combination with currently approved medications for type 2 diabetes – will help the body create more insulin and improve insulin sensitivity while also suppressing inflammation. Almost all overweight type 2 patients have poor insulin sensitivity. Even though their body can make insulin, a hormone that causes blood sugar to be taken up and used by mainly muscle and the liver, these patients respond poorly to the hormone’s actions. Despite significant advances in drugs that make the body produce more insulin, improved sensitivity has remained rather elusive. Emerging data demonstrate that an underlying chronic inflammation characteristic of overweight people who become diabetic is largely responsible for making the body insensitive to the actions of insulin.
“The problem is that we need to get to a point where the body can control insulin sensitivity naturally,” said Nick Giannoukakis, PhD, who wrote the grant application and will serve as AHN’s lead researcher on the trial. “To do that, we have to break the back of the inflammation.”
The drug being studied by Dr. Giannoukakis and his team was designed by AstraZeneca to short circuit inflammation. In experimental animal studies, when researchers interfered with inflammation at precisely the pressure point on which the drug acts, it not only prevented type 2 diabetes but also significantly improved insulin sensitivity as well as insulin production.
“This suggests there could be a similar effect in diabetic humans,” added Dr. Giannoukakis. “If we can improve insulin sensitivity and insulin production at the same time, it could substantially improve the treatment of type 2 diabetes – and, possibly, prevent the onset of clinical complications.”
Launched three years ago, the NCATS’s New Therapeutic Uses program strengthens the research pipeline by using an innovative strategy to identify new uses for drugs that have undergone significant research and development by the drug industry, including safety testing in humans.
“When companies like AstraZeneca provide access to drugs that already have cleared key development hurdles, it allows researchers to explore new uses for those drugs on a faster track,” said Christine Colvis, Director of the NCATS’s New Therapeutic Uses program. “This increases the odds of getting a new treatment to patients more quickly.”
The drug had a favorable safety profile when AstraZeneca initially tested it several years ago. As AHN’s randomized, double-blinded trial will be a placebo-controlled crossover study, all participants will receive the actual drug at some point during the study. AHN researchers hope to have the results by the end of 2017.
While the study will be focused on improving insulin sensitivity for type 2 diabetics, it is also possible the drug could eventually be shown to be effective in treating a variety of autoimmune diseases such as lupus, rheumatoid arthritis, juvenile diabetes and Chrohn’s disease.
“During the trial with type 2 diabetes patients, we’ll also be gathering information on the drug’s effect on specific white blood cells,” explained Dr. Giannoukakis. “This information can help us determine the drug’s potential for preventing and treating autoimmunity.”
A new and better treatment for type 2 diabetes would also have a significant impact on the enormous cost of treating the disease, Dr. Giannoukakis said. About one in five healthcare dollars in the U.S. is spent on the treatment of diabetes and its complications. Developing novel therapies to treat diseases is also a costly, complex and time-consuming process, with a 14-year average length of time from target discovery to approval of a new drug at a cost of upwards of $2 billion. The failure rate during the drug development process is more than 95 percent.
“But, just as numerous inventions for things we use every day were actually accidental discoveries, we hope to have a similar experience with this trial in the repurposing of an existing drug that was deemed safe but not effective for its original intention,” said Massimo Trucco, MD, Director of AHN’s Institute of Cellular Therapeutics.
The other physicians participating in leading the clinical arm of the trial are Patricia Bononi, MD, and Jennifer Holst, MD, of AHN, as well as Fred Toledo, MD, and Mary Korytkowski, MD, of the University of Pittsburgh School of Medicine.
For more information about AHN’s type 2 diabetes clinical study, please contact the trial team at ahnict(at)ahn.org or call 412-578-5681. To view a short video highlighting the concept of the trial at the NIH’s NCATS website, visit https://ncats.nih.gov/ntu/projects/2015#diabetes.
About Allegheny Health Network
Allegheny Health Network, part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network composes eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; a research institute; Health + Wellness Pavilions; an employed physician organization, home and community based health services and a group purchasing organization. The Network employs approximately 17,500 people and has more than 2,100 physicians on its medical staff. The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.