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New research from a first-in-human study of a novel procedure involving electroporation of the superficial layer of the mucosa in the small intestine could help eliminate need for insulin in some people with type 2 diabetes.
New data from an early-stage study presented at Digestive Disease Week (DDW) 2023 suggests a single, one-hour endoscopic procedure could eliminate need for insulin use in people with type 2 diabetes when coupled with pharmacologic therapy.
Results of the study indicate the treatment approach, which consisted of recellularization via electroporation therapy and GLP-1 receptor agonist use, was associated with a significant improvement in glycemic control, with 86% of participants becoming free of insulin use at 6 months.1
“While drug therapy is ‘disease-controlling,’ it only reduces high blood sugar as long as the patient continues taking the medication,” said principal investigator Jacques Bergman, MD, PhD, professor of gastrointestinal endoscopy at Amsterdam University Medical Center, who also serves on the advisory board of Endogenex.2 “This one procedure is ‘disease-modifying’ in that it reverses the body’s resistance to its own insulin, the root cause of the Type-2 diabetes.”
A first-in-human study fully funded by Endogenex, a Minnesota-based company who owns the technology used in the procedure, the EMINENT study was launched with the intent of examining whether a novel endoscopic procedure might help mitigate the need for insulin without negatively impact glucose control in people with type 2 diabetes. Called Re-Cellularization via Electroporation Therapy (ReCET),the uses electroporation to ablate the superficial layer of the mucosa in the small intestine to induce cell apoptosis without compromising tissue structure.1
The primary feasibility endpoints of interest for the study were procedure time, technical success rate, and percent of patients tolerating GLP-1 receptor agonist. Of note, procedure time was defined as time from catheter-in to catheter-out. The primary efficacy endpoint of interest was the number of subjects not reporting insulin use at 6 months with an HbA1c of 7.5% or less and the primary safety endpoints of interest included incidence of serious adverse events and hypoglycemic events.1
For inclusion in the single-center trial, patients needed to be between 28-75 years of age, have a BMI of 24-40 kg/m2, an HbA1c of 8.0% or less, . Per study protocol, patients were discharged on the same day as the procedure and put on a calorie-controlled liquid diet for 2 weeks. After 2 weeks, patients began titrating up to 1 mg a week of semaglutide.1
The 14-patient cohort had a median age of 62 (IQR, 54-67) years and 57% were male. Further analysis of baseline characteristics indicated the study cohort had a median BMI of 28.8 kg/m2 (IQR, 25.1-31.2), median HbA1c of 7.2% (IQR, 7.0-7.4), median time in range of 72% (IQR, 46-85),and median daily insulin units used was 26 (IQR, 22-33).1
Upon analysis, results indicated the ReCET procedure had a technical success rate of 100%, with a median axial treatment length of 12 (IQR, 10-14) centimeters and a median procedure time of 58 (IQR, 49-79) minutes. Results also indicated no device-related serious adverse events were observed in the study. A single patient reported a hypoglycemic event, but investigators pointed out this event did not require third party assistance.1
In the primary efficacy analysis, results indicated 12 of the 14 subjects (86%) were free from insulin use. Further analysis indicated the median HbA1c was reduced from 7.2% at baseline to 6.6% (IQR, 5.8-6.9) at 6 months and median time in range increased from 72% to 91% (IQR, 62-96) at 6 months. Investigators also highlighted a greater than 50% reduction the amount of liver fat observed among participants.1,3
“The potential for controlling diabetes with a single endoscopic treatment is spectacular,” said lead investigator Celine Busch, a PhD candidate in gastroenterology at Amsterdam University Medical Center.2 “One of the biggest advantages of this treatment is that a single outpatient endoscopic procedure provides glycemic control, a potential improvement over drug treatment, which depends on patients taking their medication day in, day out.”