Promising results for new type 2 diabetes management procedure
pharmafile | August 12, 2016 | News story | Research and Development, Sales and Marketing | Fractyl, Revita, diabetes, type 2 diabetes
Fractyl Laboratories has revealed data from its first-in-human study of Revita duodenal mucosal resurfacing (Revita DMR), a new 60-minute, non-surgical procedure for the management of type 2 diabetes.
The study focused on 39 hyperglycaemia patients with type 2 diabetes which was poorly controlled on one or more oral antidiabetic agents. It found a significant improvement of HbA1c in type 2 diabetes sufferers following the procedure, with an average reduction of 1.2% at six months, against a group average of 9.5% prior to the study. HbA1c indicates blood sugar levels for the previous two to three months. It is a measure of the amount of glucose that is being carried by red blood cells in the body. An HbA1c of 6.5%is considered the cut off point for diagnosing diabetes.
Francesco Rubino, chair of Bariatric Surgery at King’s College London and consultant surgeon at King’s College Hospital remarked: “Because surgery is not suitable as mass treatment for the hundreds of millions of patients suffering from diabetes, less invasive approaches that harness the mechanisms of major surgery and reproduce some of its beneficial effects could provide a real opportunity for improvement of diabetes care. The early results with Revita DMR are quite encouraging in this regard.”
“This is the first peer-reviewed publication of human clinical data from the proof-of-concept trial,” said Harith Rajagopalan, co-founder and CEO of Fractyl. “This study is part of a growing body of evidence that suggests Revita DMR may address the underlying metabolic complications of insulin resistance and could represent a new treatment for option for patients with type 2 diabetes who are failing oral medications or have evidence of fatty liver disease.”
An international clinical trial of 50 participants is currently underway in patients with type 2 diabetes, in which 40 patients have already been treated across sites in the United Kingdom, Chile, Italy, Netherlands and Belgium.
Matt Fellows
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