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Type 2 diabetics might soon be able to take their insulin orally if a new clinical test in San Antonio reaps results.
Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on oral drug delivery systems, is conducting a trial as part of a nationwide study to test whether a pill with a special protective coating can pass through the stomach without dissolving before it reaches the small intestine.
Getting the insulin molecule into the bloodstream is a challenge because insulin can quickly degrade in the stomach due to the high-acid environment, said Dr. Douglas Denham, medical director of Clinical Trials of Texas, one of three local research organizations hosting study participants.
“When you give someone [an insulin injection], the amount of insulin you give them is absorbed in the bloodstream and goes through the body until it gets to the liver,” where it helps regulate blood sugar in the body, Denham said. “To get insulin into the bloodstream in oral form, it takes a carefully protected capsule that will survive through the digestive system.”
Oramed said its oral insulin uses a highly protective pH-sensitive enteric coating that helps protect the capsule through the stomach so it dissolves only when it reaches the small intestine.
“The biggest downfall [for oral insulin] is getting enough absorbed into the system to be able to manage a person’s level of insulin full time,” Denham said. “But people are afraid of needles. When you start talking to patients about insulin therapy and needles, they refuse to do it. They want to take orals.”
Most people with Type 2 diabetes have an assortment of oral medications at their disposal to help the body make enough insulin to convert blood sugar into energy, but many cannot control the amount of sugar in the blood and need insulin to control their symptoms, which previously had only been available as an injection.
“The advancement we’re making in the development of oral insulin is good news for the estimated 30 million Americans with diabetes,” said Nadav Kidron, Oramed’s CEO. “Experts have long said that patients with diabetes would benefit from earlier insulin intervention, but for various reasons, insulin injections are currently the last line of treatment. Our pill would allow for earlier, more effective treatment.”
Kidron told the Rivard Report that San Antonio’s high incidence of Type 2 diabetes made the city an obvious location for its oral insulin study. He said if the trial was successful, the medication could be on the market within three to five years.
In Bexar County, 113,009 residents have been diagnosed with Type 2 diabetes – nearly 12 percent of the population – but doctors and other health experts believe many more have the disease but have not been diagnosed. It’s estimated that more than 14 percent of adults in Bexar County have diabetes. Nationwide, nearly 24 percent of adults with diabetes don’t know they have it, according to a CDC report.
“Oral insulin is geared towards providing a more convenient, effective, and safer method for delivering insulin therapy. Non-compliance to diabetes medications is a major cause of hospitalizations and can lead to serious health complications,” Kidron said. “Compliance rates would likely improve if people could take insulin in a capsule form rather than an injection.”
While compliance might improve, there might still be financial hurdles to overcome. Dr. Curtis Triplitt, assistant professor in the diabetes division at UT Health San Antonio, noted that oral insulin “is going to cost a lot more than injectable insulin,” so it would only benefit those who could afford it.
“The amount of insulin needed when taken orally is much higher than injectable insulin, so in addition to it being more expensive, patients would need more. From an insurance payer standpoint, that might be a big hindrance to [oral insulin] moving forward.”
Triplitt pointed out that in 2016, drug manufacturer Novo Nordisk discontinued a successful oral insulin trial upon realizing the cost of the medication would put it out of reach for most consumers. But the Novo Nordisk trial used analog insulin, a laboratory-grown and genetically altered form that is often much more expensive than human insulin, which is being used in the Oramed trial.
San Antonio trial participants at Clinical Trials of Texas, Discovery Clinical Trials, and Sun Research Institute are taking Oramed’s insulin pill for 90 days, with different groups following different dosing regimens at varying times throughout the day. The study is designed to show the product’s effectiveness at lowering glycated hemoglobin, a determinant of average blood-sugar levels over three months that is considered the gold standard by the Food and Drug Administration when evaluating the drug’s efficacy.
The trial is being conducted as a double-blind study, which means neither the researchers nor the participants know who is receiving the oral insulin pill and who is getting a placebo.
“It will be interesting to see what the total picture looks like [at the end of the trial],” Denham said. “That’s when you could talk about someone tweaking the dose, or ranges they use, to see what is most effective and whether it is something they should potentially take every meal.”
A 2016 double-blind Oramed study evaluating the effectiveness of its oral insulin pill in reducing the average nighttime glucose levels in 180 adult Type 2 diabetic patients successfully achieved its primary objective, according to Kidron.
Other experimental oral insulin pills also are being studied: Capsulin by the company Diabetology and HDV-Insulin by the company Diasome, which was the first oral insulin approved for a third clinical trial by the FDA, according to the company’s website. Oramed is one trial behind Diasome, but Diasome’s insulin pill is for mealtime consumption only, while Oramed’s has no such restrictions.
Kidron said approximately 285 patients are participating in Oramed’s current clinical trial at dozens of sites across the United States. “We expect results [at the end of] 2019,” he said.