MOREHEAD CITY — With nearly one in 10 adults in North Carolina diagnosed with diabetes, a local medical practice is at the forefront of testing a new medicine that could help treat the disease.
Lucas Research in Morehead City is participating in the nation’s first trial of oral insulin on humans. The trials are being spearheaded by Oramed Pharmaceuticals under the direction of the U.S. Food and Drug Administration at 37 research centers across the country involving about 300 patients.
Insulin is usually administered by needle, but Oramed developed a pill containing the medicine. The company expects results from the trial to be available by the end of this year and, if the pill proves successful, it could be on the market in the next three to five years.
Dr. K. Jean Lucas, principal investigator at Lucas Research, said her practice was tapped to participate in the trial because it is a clinical research site focusing on diseases of the endocrine system, including diabetes. She said about 30 people have participated in the study through her office, so far, and about 15 more are signed up.
“We were one of 37 sites that were picked all over the country to do this oral insulin study,” Dr. Lucas said at her office in Morehead City recently. “We do a lot of other studies, we do diabetes studies and liver studies and a lot of other kind of studies, but this was a pretty interesting.”
Dr. Lucas explained insulin is a hormone made by the pancreas that helps keep blood sugar levels stable. Diabetics struggle with producing insulin naturally, so as the disease progresses, they often have to get the chemical by artificial means.
Insulin is traditionally administered as a shot, which Dr. Lucas said puts some people off to receiving the medication. According to Oramed, as many as a quarter of Americans are afraid of needles, which keeps some diabetics from taking insulin medications.
“Insulin is given by injections, but nobody wants to be on shots, shots are bad, people are afraid of needles,” Dr. Lucas said.
The new medicine being trialed is an oral form of insulin that can be taken as a pill. Dr. Lucas said insulin has traditionally been injected because stomach acid breaks the molecule down when it is ingested. However, the new pill has a coating that helps it withstand the destructive effects of stomach acid.
“The way you have to make an oral insulin work is to make it protected from the stomach acid,” Dr. Lucas said. “So if you swallow a pill with insulin in it, the pill itself has to be sort of armor protecting the insulin”
Dr. Lucas said the pill has a coating that does not dissolve until it passes through the stomach and into the intestine, allowing the medication to be absorbed by the intestine.
“It’s just like if you were eating insulin or drinking insulin,” Dr. Lucas said.
An added benefit of the pill is it takes a more direct route than a shot of insulin to the liver, the key organ in balancing blood sugar levels.
“If you take a shot it has to get absorbed in your skin, go into your bloodstream, go all around your body and then finally go to your liver, so it doesn’t work as quick,” Dr. Lucas said. “…By going to the liver first, it counteracts a lot of that problem, it helps the sugar quicker. It’s a better product than the shot because it mimics what the pancreas is actually doing.”
Dr. Lucas said although the study is ongoing and results won’t be released until later this year, the new medication seems to be a success for some of her patients. The company is testing the pill on diabetes patients who have out-of-control symptoms, such as major blood sugar spikes or dips. The study is double-blind, meaning neither the patient nor Dr. Lucas knows whether they are receiving the actual pill or a placebo.
“It’s very interesting because some of these people are way out of control and they get more controlled during these studies, so whether they’re on the insulin or not, we’ll find out,” she said. “…We won’t know what they’re on, but when they analyze the data that’s when they’ll figure out if it’s effective.”
Dr. Lucas said many of her patients have said they prefer taking the insulin pills over shots, so far.
According to Oramed, diabetes is a growing worldwide concern. The company said an estimated 425 million adults globally have the disease, a number expected to reach 629 million by 2045.
Dr. Lucas said you may be predisposed to diabetes if you have a family member with the disease. She said a healthy diet low on sugar and carbs and regular exercise can help prevent or treat the disease. Early intervention, including insulin treatments, can also help.
“The advancement we’re making in the development of oral insulin is good news for the estimated 30 million Americans with diabetes,” Oramed CEO Nadav Kidron said. “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.”
Dr. Lucas said the trials are focused on treating type 2 diabetes, but the medication may eventually be able to treat type 1 cases, as well.
There will likely be additional studies on oral insulin before the FDA approves the new drug, but Dr. Lucas said she feels confident it will prove successful. Additionally, the cost of the pill hasn’t been determined yet, but she expects it will be less than insulin injections because it costs less to manufacture.
Dr. Lucas said her research center participates in a number of studies focused on diseases of the endocrine system, especially the liver. Her office is currently in the process of moving to a new, larger building near the existing office on N. 35th Street.
The new office opened and began accepting patients Monday. Dr. Lucas started the research center in 2004 and has grown to a team of 25 employees with multiple locations in the area.
Contact Elise Clouser at firstname.lastname@example.org; by phone at 252-726-7081 ext. 229; or follow on Twitter @eliseccnt.