Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes

Inclusion Criteria

• 22- 65 years of age
• Current diagnosis of T2D
• History of T2D for at least 3 years and less than or equal to 10 years
• HbA1C of 7.5-10.0%, inclusive
• BMI 24-40 kg/m2, inclusive
• On two to three non-insulin glucose lowering mediations, with one at maximum tolerated dose and another at half-maximum dose at least, with no changes in medication for at least 12 weeks prior to baseline visit prior to baseline visit
• History of failed attempt to reach glycemic goal by lifestyle modifications
• Weight stability (defined as a 1 month (at any time, except for treatment of gestational diabetes) in last 2 years.
• Current use of insulin
• Hypoglycemia unawareness
• History of ≥1 severe hypoglycemia episode (defined by needing for third-party assistance) in past 6 months from the screening visit
• Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder. (Participants with adequately controlled primary hypothyroidism may be included).
• Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
• Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
• Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
• History of, or gastrointestinal symptoms suggestive of gastroparesis.
• Acute gastrointestinal illness in the previous 7 days
• Known history of irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease
• History of chronic or acute pancreatitis.
• Known active hepatitis or active liver disease other than NASH/NAFLD.
• Alcoholic liver disease, as indicated by ANI > 0
• Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.
• Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.
• Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
• Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
• Use of drugs known to affect GI motility (e.g. Metoclopramide)
• Use of weight loss medications such as Meridia, Xenical, Phentermine or over-the-counter weight loss medications (prescription medication)
• Currently taking, or unable to stop taking dietary supplements or herbal agents, including vitamin C or multivitamins containing vitamin C at >500 mg per day, multivitamins containing biotin (vitamin B7), and supplements for hair, skin, and nail growth. Multivitamins not containing biotin are permitted.
• Persistent anemia, defined as hemoglobin 2 drinks/day regularly)
• Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
• Women breastfeeding
• Participating in another ongoing clinical trial of an investigational drug or device.
• Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
• Critically ill or has a life expectancy 10% at baseline visit