Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes

Inclusion Criteria

• Men and non-pregnant women 28-65 years of age
• Diagnosed with T2D for at least 3 years
• A1C of 7.5 - 9.5% (59-80 mmol/mol)
• BMI ≥ 28 and ≤ 40 kg/m2
• On two to three oral OADs (metformin plus one to two additional OADs) with two (see note below) at least at half maximum labeled dose (or highest tolerated) with no changes in medication in the 12 weeks prior to the Screening Visit (Visit 1) (Refer to ADA Standard of Medical Care in Diabetes 2018, Table 8.3 for the maximum approved daily dose of non-insulin glucose lowering agents) (43). Note: For subjects on sulfonylurea (SU) glucose-lowering drugs for diabetes, the only SUs permitted in the study will be glipizide or glimepiride, and their doses below half maximum labeled dosing will not be an exclusion for study entry. Patients unwilling to reduce the dose of SU at the time of the DMR procedure as described by protocol will be excluded.
• Agree to use an additional glucose-lowering treatment (eg, liraglutide, other OAD with the exception of glyburide) if recommended by the study investigator in case of persistent hyperglycemia.
• Agree not to donate blood during their participation in the study
• Able to comply with study requirements and understand and sign the Informed Consent Form
• Women of childbearing potential (WOCBP) must be using two acceptable methods of contraception throughout the study
• Women must not be breastfeeding

Exclusion Criteria

• Diagnosed with Type 1 Diabetes (T1D)
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Probable insulin production failure, defined as fasting C Peptide serum 1 month (at any time, except for treatment of gestational diabetes)
• Current use of injectable medications for diabetes (insulin, GLP-1RA)
• Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes
• Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
• Known autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Previous GI surgery that could limit treatment of the duodenum such as Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
• History of chronic or acute pancreatitis
• History of diabetic gastroparesis
• Known active hepatitis or active liver disease
• Acute gastrointestinal illness in the previous 7 days
• Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
• Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus
• Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
• Known history of a structural or functional disorder of the stomach including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach
• Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety
• Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bow