Every day, Central New Yorkers with diabetes either have to inject insulin or have a pump to maintain their blood sugar levels. This routine is typically seen as the final option in the treatment pathway for diabetes patients. But what if they could take an insulin pill instead?
Clinical trials taking place in Syracuse and elsewhere could put the drug on a path to final approval.
The quest to create an insulin pill goes back about a century, but has never been successful. That might be about to change. Dr. Ramachandra Naik is professor of medicine in the division of endocrinology and diabetes at Upstate Medical University.
“The oral insulin formulation, supposedly the holy grail in diabetes therapy, has been tried by other companies that could not succeed. Currently, the data available at this point seems encouraging.”
Naik also an investigator for the three month clinical trial that includes about 300 patients at 37 sites across the country. Naik says they’re trying to see how the pill performs compared to placebo for certain patients.
“They have not yet begun the insulin therapy. They are taking the oral agents for treatment of diabetes, but they are not controlled. In a standard-of-care scenario, they would could qualify to go on to take injectable insulin. In lieu of that, we are trying the oral formulation of insulin to see if it can get their sugars under control.”
But how does it work? Previous attempts have proven elusive. Nadav Kidron is CEO of Oramed Pharmaceuticals, which is developing the oral insulin involved in the clinical trial.
“From the first time insulin was discovered, they tried to administer it orally. But the challenge of that when you try to administer it, it gets degraded, and because of the size, it doesn’t get into the bloodstream,” he said. "A few years ago if you went to medical school, you would see a big sign that says ‘peptides cannot be administered orally.’ Today, we know it’s possible.”
Peptides are small proteins. Kidron says Oramed has been able to overcome some of the technological barriers that allow peptides to be delivered intact, orally. He says unlike an insulin injection into the bloodstream, this pill goes to the liver.
“Because the liver is the organ that regulates the secretion of insulin into the blood, mimicking the physiological way the body works is the right way to treat diabetes. Therefore, it can result in a longer period of time that those patients will be much more balanced.”
So, imagine if those with diabetes who had to start taking insulin had the option of a pill versus an injection? Upstate Medical endocrinologist Dr. Ramachandra Naik says he’s always been a believer of early initiation of insulin, even though it’s typically introduced much later.
“One of the things preventing patients from taking insulin is the phobia of injection and inertia by physicians to start insulin.”
He says studies have shown that the sooner you introduce it, the better it is for the patient. A pill will make acceptance that much easier.
“It’s not the last thing to be used in the treatment pathway. One could use insulin anytime. The sooner we introduce it, the better it is in terms of outcomes. This will facilitate earlier introduction.”
He says oral insulin could also be a game changer for the roughly 1.7 million New Yorkers already injecting or pumping the drug, who might struggle with compliance.
“People who are on insulin, including type-1, sometimes get burned out, they get fed-up and stop insulin. Not just for financial reasons, but because of burn out, the lack of convenience of carrying the pens, however sophisticated they are. We see several patients getting admitted to Upstate University Hospital with complications of diabetes, many times from missing insulin doses. This is a major barrier for successful insulin therapy.”
Naik says at this point, the clinical trial is targeting those with type-2 diabetes. If proven effective, they’ll move on to type-1. The current trial should be completed by late this year. Oramed CEO Nadav Kidron says if the results are positive, it moves to the final phase. After that, it can be registered as a drug in the United States. But he says it could be made available in China and other countries even sooner.
