Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

The purpose of this protocol is to evaluate the initial safety profile of the Fractyl System and its effect on participants with Type 2 Diabetes. This will be determined through the monitoring of adverse events and outcome measures including Mixed Meal Tolerance Test (MMTT).

Inclusion criteria

• Participants Age > 28 years and ≤ 75 years
• Male or Female
• Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months
• Participants with an HbA1c > 7.5 and ≤ 10.0%
• Participants with a BMI > 24 and < 40
• Participants willing to comply with study requirements and able to understand and comply with informed consent
• Participants who have signed an informed consent form

Exclusion criteria

• Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
• Participants using insulin for more than 12 months
• Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
• Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
• Participants requiring prescription anticoagulation therapy and/or dual anti-platelet therapy including aspirin who cannot discontinue their medication for 14 days before and 14 days after the procedure
• Participants with iron deficiency anemia - either currently or in their history
• Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
• Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
• Participants with symptomatic gallstones or kidney stones at the time of screening
• Participants with a history of pancreatitis
• Participants with an active systemic infection
• Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
• Participants with celiac disease
• Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
• Participants with known active hepatitis or active liver disease
• Participants emotionally unstable or who exhibit psychological characteristics which, in the opinion of the Investigator, make the participant a poor candidate for clinical trial participation
• Participants with previous GI surgery that could affect the ability to treat the duodenum such as participants who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
• Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase
• Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
• Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater
• Participants with active illicit substance abuse or alcoholism
• Participants participating in another ongoing investigational clinical trial
• Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
• Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia