Novel procedure-medicine combo eliminates insulin need for type 2 diabetes patients

MedTech & Diagnostics News: A new procedure has shown to eliminate the need for insulin in patients with type 2 diabetes when combined with Novo Nordisk’s Ozempic (semaglutide), according to the first-in-human study presented at Digestive Disease Week (DDW) 2023 over the weekend.

The procedure – a re-cellularisation via electroporation therapy (ReCET) – uses electroporation to ablate the superficial layer of the mucosa in the small intestine, rejuvenating the duodenal lining and reducing insulin resistance. Unlike other ablation methods, ReCET does not use extreme heat or cold to damage the intestinal tissue. The procedure was successful in 100% of patients and was shown to be feasible and safe.

“This is one of the first times that endoscopy has been used to improve glycaemic control in patients with type 2 diabetes,” said Dr Jacques Bergman, principal investigator on the EMINENT study and professor of gastrointestinal endoscopy at Amsterdam University Medical Centre.

“Using a single outpatient procedure combined with semaglutide, we have shown that it may be possible to either reduce or eliminate the need for insulin.”

We have seen stock shortages with Ozempic since last year. However, while stock is currently available in Australia, there is limited and intermittent availability until June 2023.

At 12-month follow-up, the key efficacy results from the Ozempic+ReCET combo study included 86% of patients being able to stay off insulin while maintaining glycaemic control, fasting plasma glucose levels improving from 158 mg/dl to 119 mg/dl, and HbA1c improving from 7.2% to 6.6% (p=0.010). There was also a greater than 50% reduction in liver fat percentage.

“ReCET uses a pulsed electric field, which can be precisely controlled and has a limited depth of penetration,” said Dr Celine Busch, the study’s lead researcher.

“It doesn’t directly physically damage the mucosa. Instead, it disrupts the cellular membrane of the mucosa and superficial submucosa. These cells subsequently die of natural cell death within 24 hours of the procedure. There is no increase in temperature during the procedure, which significantly reduces the chance of complications.”

“One of the biggest advantages is that this treatment is compliance-free. Patients with type 2 diabetes are generally on six to eight different drugs, and many are not taking these drugs correctly,” said Dr Busch.

Due to the single-arm nature of the study, it is difficult to tease out the impact of ReCET and that of Ozempic on glycemic control, but Dr Busch noted that there is reason to believe that the two approaches may be working together.

“In most studies in which patients on long-acting insulin receive a GLP-1 receptor agonist, less than 20% can stop insulin completely,” she said.

“It’s difficult to explain our results based on just the activity of semaglutide. We know that GLP-1 receptor agonists boost the release of endogenous insulin. This acts synergistically with the insulin-sensitising effect of ReCET, as reflected in a 86% success rate at 6, 9 and 12 months follow-up.”

The study was funded by Endogenex, a company founded in partnership with the Mayo Clinic, who owns the technology used for the endoscopic procedure. Due to the single-arm nature of the study, the researchers are planning a randomised controlled trial to confirm their results.

The ReCET procedure is currently only available in Australia through the REGENT-1 clinical study.

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