The Centers for Disease Control estimates about 13 percent of people over 20 have diabetes, and an increasing number of children are being diagnosed with Type 2 Diabetes, which was once considered an adult disease.
The new drug is called Exsulin and so far studies show it works for both Type 1 and Type 2 Diabetes.
Alexander Fleming, MD, former US Food and Drug Administration official and Exsulin Corp. Chief Medical Officer, said the goal is to get diabetics off insulin.
“And it does that by causing the cells in the pancreas to develop into insulin-secreting cells,” Fleming said. “This is actually a natural hormone we’re developing as a therapy.”
Fleming said Exsulin has to be injected like insulin, but it doesn’t cause any direct effect on blood sugar. It simply starts to make the pancreas regenerate normal insulin secreting cells.
Fleming said data collected from clinical trials on about 200 patients with both Type 1 and Type 2 Diabetes is promising.
“They show not only the pancreas is starting to bring back insulin secretion but many of the patients actually experienced an improvement in their blood sugar control which is of course important as well,” Fleming said.
Fleming said it will take another three or four years before Exsulin can be approved by the FDA.
If the drug makes it through the process it will be the first time in 80 years people with Type 1 Diabetes will have an option other than insulin.
Fleming said there are oral drugs for Type 2 Diabetes, but he said Exsulin is different from the existing therapies because it could offer better management of blood sugar levels which could lead to better long term health.
Diabetes is the leading cause of heart disease, death from heart disease, blindness, kidney failure, amputations and nerve damage.
Fleming calls it a horrible problem not only for an individual but for the entire health care system.
“It’s such a devastating disease over a long period of time and it becomes increasingly more expensive to care for people with diabetes,” Fleming said.
Fleming said the most common cause of people going on kidney dialysis is diabetes.
“And that happens to be one of the largest line items in our Federal Government budget for health care,” Fleming said. “It’s a huge amount of money for a relatively small amount of people.”
Fleming said soon medical scientists will begin another trial for Exsulin at the Mayo Clinic in Minnesota and McGill University in Canada.
After that, much larger trials will take place throughout the country.
Fleming said so far the only negative side effect of Exsulin has been a rash at the injection site.