| Eligibility |
Inclusion Criteria:
- 22- 70 years of age, inclusive.
- T2D diagnosis for at least 6 months.
- HbA1C of 7.5-10.5%, inclusive, determined by the central laboratory.
- BMI 27-40 kg/m2, inclusive.
- On 2-4 non-insulin glucose lowering mediations, with no changes in medication or
dosing for at least 12 weeks prior to the baseline visit.
- Individualized metabolic surgery (IMS) score = 95.
- Weight stability (=5% weight change) for at least 12 weeks prior to the screening
visit.
- Agree not to donate blood during participation in the study.
- Able to comply with study requirements and understand and sign the Informed Consent
Form.
- Women of childbearing potential must be not pregnant and using an acceptable method of
contraception throughout the study.
- Willing and able to comply with study visits and study tasks as required per protocol.
Exclusion Criteria:
- Diagnosed with type 1 diabetes.
- History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
- Fasting serum C-peptide <1 ng/mL (333pmol/l).
- Current use of insulin, or previous use of any types of insulin for >1 month at any
time (except for treatment of gestational diabetes) in last 2 years.
- Hypoglycemic unawareness.
- History of =1 severe hypoglycemia episode in past 6 months
- Discontinuation of a GLP-1RA or a GLP-1/GIP dual-agonist within 6 months of the
screening visit following at least one month of treatment.
- Known autoimmune disease, including but not limited to, celiac disease, or
pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune
connective tissue disorder, or as evidenced by a positive anti-glutamic acid
decarboxylase (GAD) test.
- 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 eosinophilic esophagitis,
stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach
and duodenum.
- History of gastroparesis.
- Acute gastrointestinal illness in the last 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.
- Active hepatitis or active liver disease, or alanine aminotransferase (ALT) level >3.0
times the upper limit of normal (ULN) for the reference range, as determined by the
central laboratory at screening visit. Patients with NAFLD are eligible if their ALT
level is =3.0 times the ULN.
- Current use of anticoagulation therapy (such as warfarin) that cannot be safely
discontinued periprocedurally.
- Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be
discontinued for 7 days before the procedure.
- Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) from treatment
through 4 weeks following the procedure. Alternative 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
screening visit.
- Use of medications known to affect GI motility (e.g. metoclopramide/ Reglan)
- Current use of weight loss medications such as Saxenda [liraglutide ], Xenical®
[orlistat], Acutrim® [phenylpropanolamine], Sanorex® [mazindol], Adipex®
[phentermine], BELVIQ® [lorcaserin], Qsymia® [phentermine/topiramate combination],
Contrave® [naltrexone/bupropion], or other weight loss medications including
over-the-counter [OTC] medications [for example, Alli®]) or have discontinued weight
loss medications within 6 months.
- Participation in any structured weight loss program or endoscopic weight loss
intervention within 6 months of the screen visit.
- Persistent anemia, defined as hemoglobin <10 g/dL.
- Known history of hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any
other traits of hemoglobin abnormalities known to interfere with the measurement of
HbA1c.
- History of blood donation or transfusion within 3 months prior to the Screening Visit.
- Unstable or paroxysmal cardiac arrhythmia.
- Any of the following cardiovascular conditions within 6-months prior to screening
visit: acute myocardial infarction, cerebrovascular accident (stroke), hospitalization
due to congestive heart failure.
- History of valvular heart disease or chronic heart failure (NYHA III or IV).
- Estimated glomerular filtration rate (eGFR) = 45 ml/min/1.73m2 calculated by CKD-EPI
Creatinine Equation as determined by the central laboratory.
- Known immunocompromised status, including but not limited to individuals who have
undergone organ transplantation, chemotherapy, or radiotherapy within the past 12
months, who have clinically significant leukopenia, who are positive for the human
immunodeficiency virus (HIV) or whose immune status makes the participant a poor
candidate for clinical trial participation in the opinion of the investigator.
- History of secondary hypothyroidism or inadequately controlled primary hypothyroidism
(TSH value outside the normal range at screening).
- Presence of any implanted electronic devices that cannot be turned off during the
procedure
- Presence of duodenal or biliary stents.
- Not a candidate for upper GI endoscopy or general anesthesia.
- Active illicit substance abuse or alcoholism (>2 drinks/day regularly).
- Active malignancy within the last 5 years (excluding non-melanoma skin cancers).
- Women who are breastfeeding.
- Participating in another ongoing clinical trial of an investigational drug or device.
- Binge eating disorder, or 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 <5 years.
- Are investigator site personnel directly affiliated with this study and/or their
immediate family member. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
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