Test Subjects Wanted For New Diabetes Pill – Medford News, Weather, Sports, Breaking News
Allison Nimlos of Minnesota holds up her U.S. bottle of NovoLog insulin and a Canadian box of NovoRapid that she picked up at a pharmacy in London, Ontario, Canada on Saturday, June 29, 2019. AP file photo file
A new drug in phase 3 clinical trials could save type II diabetics from having their regular insulin injections.
Insulin has been used to treat diabetes for a century and has historically been given by injection because insulin is a large molecule that is not absorbed by the body when taken orally, said Dr. Gregg Lucksinger, Medical Director at Velocity Clinical Research in Medford.
People with type II diabetes, the most common form, still produce insulin but have developed resistance to the element insulin, which lowers blood sugar levels, Lucksinger explained.
Velocity has initiated a clinical trial to test a new technology developed by Oramed Pharmaceuticals that enables insulin to be absorbed through a pill, he said.
“When we inject insulin, most of the insulin action takes place in the muscle tissue, and while this helps lower blood sugar, it increases the risk of hypoglycemic episodes, where blood sugar drops too low,” Lucksinger said. “The hope is that this oral form is not only more convenient, but also safer and better mimicking normal physiology so that it is better for the person all round.”
Interested participants must be at least 18 years of age, be taking two or three oral medications for type II diabetes, and not taking any injected medication. This study is not suitable for people with type I diabetes.
The trial registration is open for three to four months. Money will be offered for the time allocated for the study, which includes laboratory tests, physical exams, blood glucose monitoring, and scheduled visits to the clinical research site. Participants take one tablet twice a day.
Studies with “broad representation” of the population will provide the best data, Lucksinger said, emphasizing the importance of study participation across ethnic groups, genders and adulthood.
The oral insulin pill has been tested in people in smaller studies – now it’s scaling up to confirm safety and effectiveness before being sent to the U.S. Food and Drug Administration for approval and market release, Lucksinger said. Velocity is committed to enrolling 675 people in 75 locations worldwide for Phase III testing. Lucksinger said he hopes to enroll 20 study participants at Medford.
According to a press release from Oramed, Oramed has enrolled more than half of the patients planned for the study and forecast “top-line results” for 2022.
About 15,000 adults within an hour’s drive of the Medford research facility have type II diabetes, according to Lucksinger. Asante said, more than 10% of adults in Jackson and Josephine Counties were diagnosed with diabetes and an additional 15% were diagnosed with prediabetes.
If the drug works as intended, the evening dosage could allow people with type II diabetes to see improved blood sugar control at night and wake up with healthy metabolic control, he said.
Individuals interested in participating in the clinical trial can contact Velocity Clinical Research at 541-858-1018 or email [email protected]
Contact Ashland Tidings reporter Allayana Darrow at [email protected] or 541-776-4497.