Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

Inclusion criteria

• 28 -75 years of age
• Diagnosed with Type 2 Diabetes for less than 10 years
• HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
• Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
• On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry
• Willing to comply with study requirements and able to understand and comply with informed consent
• Sign an informed consent form

Exclusion criteria

• Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
• Probable insulin production failure, defined as fasting C Peptide serum <1ng/mL (333pmol/l)
• Current use of Insulin
• Use of Glucagon like peptide (GLP)-1 analogues
• Hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
• Known autoimmune disease, as evidenced by a positive anti glutamic acid decarboxylase (GAD) test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Previous gastrointestinal (GI) surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
• History of chronic or acute pancreatitis
• Known active hepatitis or active liver disease
• Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
• History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
• Use of anticoagulation therapy (such as Warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
• Use of P2Y12 inhibitors (clopidrogel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed.
• Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
• Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)
• Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
• Persistent Anemia, defined as Hgb < 10 mg/dl
• Estimated glomerular filtration rate (eGFR) or Modification of Diet in Renal Disease (MDRD) <30 ml/min/1,73m^2
• Active systemic infection
• Active malignancy within the last 5 years
• Not potential candidates for surgery or general anesthesia
• Active illicit substance abuse or alcoholism
• Those who are pregnant, nursing or expect to become pregnant over the course of the study
• Participating in another ongoing clinical trial
• Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation