Intestinal Treatment Plus Ozempic May Help People With Type 2 Diabetes Stop Taking Insulin
Key takeaways:
- A one-hour intestinal procedure, ReCET, may help those with type 2 diabetes to improve blood glucose management.
- A combination therapy of ReCET with Ozempic (semaglutide) may eliminate the need for insulin therapy in type 2 diabetes, according to recently presented study findings.
- The latest: A second trial, EMINENT-2, is currently recruiting and underway.
A new outpatient intestinal procedure could not only help people with type 2 diabetes manage their blood sugar, but it could also help them get off insulin altogether.
That’s the assertion one company, Endogenex, is making based on new results of an early-stage study, EMINENT, recently presented at the United European Gastroenterology annual meeting in Vienna.
ReCET (re-cellularization via electroporation therapy) is a one-time, hour-long endoscopic procedure developed by Endogenex that delivers electric pulses to regenerate cells in the lining of the duodenum. The duodenum is the first part of the small intestine that helps digest food, absorb water, and relay information between the gut and the brain.
In EMINENT, 14 people between the ages 28 and 75 who had type 2 diabetes and were taking long-acting basal insulin successfully underwent ReCET while under sedation with no serious adverse events. They were then put on a calorie-controlled liquid diet for two weeks, and then started on the GLP-1 receptor agonist medication Ozempic (semaglutide) following that, slowly increasing the dose up to 1 mg per week. Researchers then tracked 6-, 12- and 24-month outcomes.
In the study, 12 of the 14 participants, or 86%, were able to come off insulin treatment at six months and remain off insulin treatment for a year following the ReCET procedure combined with the use of Ozempic. The findings showed that the same number and percentage of participants maintained blood sugar control for two years without insulin after the treatment.
According to Dr. Jacques Bergman, principal investigator on the study and an Endogenex advisory board member, the company hopes to improve the ReCET procedure so that it can be used on a large scale for many more people with type 2 diabetes.
“We expect the ReCET procedure to be further simplified [as research continues],” he said.
This process, also known as duodenal mucosal regeneration (DMR), is similar to Fractyl Health’s Revita DMR procedure. But unlike Fractyl Health’s procedure, which Bergman was also involved in studying, ReCET does not use heat or cold to disrupt the intestinal tissue, which may reduce the chance of complications.
While semaglutide on its own sometimes allows people with type 2 diabetes to stop taking insulin, the ReCET procedure may further improve the chances of not needing insulin.
“In most studies in which patients on long-acting insulin receive a GLP-1 receptor agonist, less than 20% can stop insulin completely,” said Celine Busch, the study’s lead researcher and graduate student working towards her PhD at Amsterdam University Medical Center. “It’s difficult to explain our results based on [only the use of] semaglutide.”
After 12 months of follow-up, study results also showed that A1C levels improved from 7.2% to 6.6%; fasting glucose levels improved from 158 mg/dL to 119 mg/dL; liver fat percentage was reduced by more than 50%. Nearly all patients (13 of 14 participants, or 93%) had no adverse side effects from Ozempic, with only one reporting nausea.
The small study has not yet been published or peer-reviewed. Endogenex and Busch have a second trial, EMINENT-2, now underway and currently recruiting, which uses the same methodology but this time comparing the use of a sham procedure or ReCET.
Learn more about type 2 diabetes treatments and trials here: