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Trial subjects sought for new diabetes pill

Allison Nimlos, of Minnesota, holds up her U.S. bottle of NovoLog insulin and a Canadian box of NovoRapid, which she picked up at a pharmacy in London, Ontario, Canada., Saturday, June 29, 2019. AP file photo

A new drug in phase three clinical trials could spare Type II diabetics from administering their regular insulin injections.

Insulin has been used to treat diabetes for a century, historically administered through injection because insulin is a large molecule that will not absorb into the body if 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 of insulin that lowers blood sugar, Lucksinger explained.

Velocity has initiated a clinical trial to test new technology developed by Oramed Pharmaceuticals, which allows insulin absorption to occur through a pill, he said.

“When we inject insulin, most of the insulin effect is in muscle tissue, and although that works to lower blood sugar, it increases the risk of hypoglycemic episodes, where the blood sugar drops too low,” Lucksinger said. “The hope is this oral form, in addition to being more convenient, will be safer and will more closely mimic normal physiology, so it will be better for the person all the way around.”

Interested participants must be 18 or older, taking two or three oral medications for Type II diabetes and no injected medicines of any kind, with “less than optimal” blood sugar control determined by slightly elevated hemoglobin A1C (between 7.5-11.0), he said. This study is not for people with Type I diabetes.

Trial enrollment will be open for three to four months. Money is offered for time committed to the study, which involves lab testing, physical exams, blood sugar monitoring and scheduled visits at the clinical research site. Participants will take one pill twice daily.

Studies with “broad representation” of the population will yield the best data, Lucksinger said, stressing the importance of trial participation across ethnic groups, sexes and adult ages.

The oral insulin pill has been tested in people through smaller-scale studies — now scaling up to confirm safety and efficacy before progressing to the U.S. Food and Drug Administration for approval and market release, Lucksinger said. Oramed aims to enroll 675 people across 75 sites worldwide for phase three testing. Lucksinger said he hopes to enroll 20 trial participants in Medford.

Oramed has enrolled more than half of patients planned for the study and projected “topline results” in 2022, according to an Oramed press release.

About 15,000 adults within an hour drive of the Medford research facility have Type II diabetes, Lucksinger estimated. According to Asante, more than 10% of adults in Jackson and Josephine counties have been diagnosed with diabetes, and another 15% have been diagnosed with prediabetes.

If the drug acts as intended, evening dosing could allow people with Type II diabetes to see improved blood sugar control at night and awaken with sound metabolic control, he said.

People interested in participating in the clinical trial can contact Velocity Clinical Research at 541-858-1018 or email info@velocityclinical.com.

Contact Ashland Tidings reporter Allayana Darrow at adarrow@rosebudmedia.com or 541-776-4497.