Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes

The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal Remodeling System for the treatment of patients with poorly controlled 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:

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

Exclusion Criteria:

1. Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
2. Participants using insulin for more than 12 months
3. Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
4. Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
5. 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
6. Participants with iron deficiency anemia - either currently or in their history
7. Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
8. Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
9. Participants with symptomatic gallstones or kidney stones at the time of screening
10. Participants with a history of pancreatitis
11. Participants with an active systemic infection
12. Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
13. Participants with celiac disease
14. Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
15. Participants with known active hepatitis or active liver disease
16. 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
17. 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
18. Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase
19. Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
20. Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
21. Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater
22. Participants with active illicit substance abuse or alcoholism
23. Participants participating in another ongoing investigational clinical trial
24. Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
25. Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia