‘Positive results’ from new DMR therapy
A trial testing a new duodenal resurfacing procedural therapy has produced significant changes in blood sugar for people with type 2, it has been announced.
Fractyl’s Revita™ Duodenal Mucosal Resurfacing™ (DMR) System was designed to directly treat the digestive causes of insulin resistance in people with uncontrolled type 2 diabetes.
The proof-of-concept study, of which 39 people took part, has shown similar results which are often created using more invasive bariatric surgery procedures.
The findings were presented during the 3rd World Congress on Interventional Therapies for type 2 Diabetes and 2nd Diabetes Surgery Summit in London.
With this study, we continue to see evidence that the biology of the intestine plays a very important role in type 2 diabetes
Alan D. Cherrington, PhD, Professor of Medicine and Molecular Physiology and Biophysics at Vanderbilt University, said: “Patients in this study had poorly controlled type 2 diabetes, despite medication use.
“They experienced a significant improvement in HbA1c after this minimally invasive procedure, as well as some weight loss.
Safety and reduction
“With this study, we continue to see evidence that the biology of the intestine plays a very important role in type 2 diabetes pathology, and that altering it can meaningfully improve blood sugar control.”
In the proof-of-concept study, 39 patients with poorly controlled type 2 diabetes (HbA1c > 7.5 per cent on at least 1 oral anti-diabetic agent) received DMR on a long-segment (> 9 cm; LS-DMR; n=28) or a short segment (< 6 cm; SS-DMR; n=11) of the duodenum.
The primary endpoints were safety and reduction in HbA1c, assessed over a follow-up period of six months. Baseline mean HbA1c (9.5 per cent) was reduced more by LS-DMR than SS-DMR at three months post-procedure, suggesting a dose-dependent treatment effect from DMR (p
In LS-DMR patients with baseline HbA1c of 7.5 to 10 per cent and stable concomitant anti-diabetic medications, HbA1c after LS-DMR decreased from 8.5 per cent to 7.1 per cent (p<0.05) at six months, accompanied by a modest weight reduction of 2.3 kg.
There was no apparent correlation between degree of weight loss and magnitude of HbA1c improvement. Three patients experienced duodenal stenosis that required endoscopic balloon dilation, all with good resolution.