S1. Inclusion and Exclusion Criteria

Supplementary Information

S1. Inclusion and Exclusion Criteria

Inclusion criteria

1.  Informed consent

2.  Body mass index 30-40 kg/m2 inclusive

3.  Duration of diabetes of ≤12 years

4.  Absence of significant DM2 complications, such as history or evidence of retinopathy (by symptoms and history), nephropathy (by abnormal serum creatinine level), neuropathy (by abnormal serum creatinine level), or active coronary artery disease

5.  HbA1c levels between 7% and 10% inclusive

6.  Females or males

·  Females of child-bearing potential: negative pregnancy test at study entrance and within 14 days of implant procedure followed by physician-approved contraceptive regimen for the 60-month period

7.  25-60 years of age inclusive

8.  Failure to respond to diet-exercise program according to investigator’s judgment

9.  Ability to complete all study visits and procedures

Exclusion criteria

1.  Concurrent chronic pancreatic disease

2.  History of Crohn’s disease and/or ulcerative colitis

3.  History of gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy)

4.  History of pulmonary embolism or blood coagulation disorders

5.  Large, clinically significant hiatal hernias known from subject’s medical record

6.  Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery

7.  Treatment with weight-loss drug therapy within the prior three months

8.  Smoking cessation within the prior three months

9.  Known genetic cause of obesity (e.g., Prader-Willi Syndrome)

10.  Reductions of more than 10% of body weight in the previous 12 months

11.  Current type 1 diabetes mellitus (DM) or type 2 DM poorly controlled with oral hypoglycemic agents (subjects with type 2 DM with three or more months of stable oral hypoglycemic treatment with or without supplemental insulin treatment are acceptable)

12.  DM with associated autonomic neuropathy, e.g., diabetes-associated gastroparesis)

13.  Current or recent history (within 12 months) of ongoing binge eating disorder or bulimia, or night eating disorder

14.  Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable)

15.  Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable)

16.  Current treatment for peptic ulcer disease (previous history acceptable)

17.  Chronic treatment with narcotic analgesic drug regimens (treatment with non- steroidal anti-inflammatory drugs acceptable)

18.  Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic antidepressants (stable treatment regimen for prior six months acceptable)

19.  Current medical condition that, in the opinion of the investigator, would make subject unfit for surgery under general anesthesia or that would be exacerbated by intentional weight loss. Some examples include diagnosis of cancer, recent heart attack, recent stroke or recent serious trauma

20.  Presence of permanently implanted electrical powered medical device or implanted gastrointestinal device or prosthesis

21.  Significant psychiatric disorders that, in the opinion of the investigator, may interfere with subject’s ability to follow study procedures and/or instructions

22.  Pre-operative diet with intent to lose weight prior to surgery

23.  Use of insulin, GLP-1 receptor agonists (e.g., exenatide), or DPP-4 inhibitors (e.g., sitagliptin)