Medical devices maker GI Dynamics has recruited the first patient in the US STEP-1 clinical trial of EndoBarrier at Michigan Medicine, which is one of the five sites for the study.
The site is monitored by principal investigator Allison Schulman, an assistant professor of gastroenterology and internal medicine.
EndoBarrier is claimed to be the first endoscopically-delivered medical device to treat type 2 diabetes and obesity.
Schulman said: “This groundbreaking trial is the first of its kind to measure the primary endpoint of type 2 diabetes combined with reductions in weight, cardiovascular risk, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and chronic kidney disease (CKD).”
STEP-1 trial will assess safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication
The STEP-1 randomised controlled, the double-blinded pivotal trial will evaluate the efficacy and safety of EndoBarrier in conjunction with lifestyle therapy and diabetes medication to treat type 2 diabetes and obesity.
The company aims to enrol 67 patients in stage 1 of the trial. All patients will be given identical diabetes medication monitoring and counselling across the two-year study period, irrespective of what treatment arm the patient is randomised into the trial.
GI Dynamics intends to complete full recruitment of the 67 patients by the end of 2020.
The firm will use the results from the STEP-1 trial to submit a pre-market approval application for EndoBarrier to the US Food and Drug Administration (FDA).
EndoBarrier, which is not yet secured approval for sale, is restricted by federal law to investigational use only.
Christopher Thompson is the principal investigator of the STEP-1 trial. The trial’s five sites comprise of Brigham and Women’s Hospital, Michigan Medicine, Baylor College of Medicine, Thomas Jefferson University and Surgical Specialists of Louisiana.
Thompson said: “EndoBarrier is a unique device in that it has been shown to produce a clinically and statistically significant impact on type 2 diabetes and obesity as well as on a host of metabolic comorbidities. It is a treatment option that clearly addresses an unmet need for this disease state.”
Earlier this month, a research team from Pohang University of Science and Technology (POSTECH) developed a smart light-emitting diode (LED) contact lens and a wearable medical device for diabetics.
