A study testing whether a one-time procedure can improve blood sugars in patients age 22-70 with Type 2 Diabetes who are not on insulin
Purpose
To test the efficacy of a one-time non-surgical endoscopic procedure on improved glycemic control in patients with type 2 diabetes who are not on insulin.
Could this study be right for you?
Participants are eligible to be included in the study if all of the following criteria apply:
1. 22-70 years of age, inclusive.
2. T2D diagnosis for at least 6 months.
3. HbA1c of 7.5-10.5%, inclusive, determined by central laboratory. If the individual is on four glucose-lowering medications, HbA1c should be between 7.5% and 9.0%.
4. BMI 27-40 kg/m2, inclusive.
5. On 2-4 non-insulin glucose lowering mediations or on monotherapy with either GLP-1, or GLP-1/GIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.
6. Individualized metabolic surgery (IMS) score ≤ 115.
7. Weight stability (defined as a < 5% change in body weight) for at least 12 weeks prior to the screening visit.
8. Agree not to donate blood during participation in the study.
9. Able to comply with study requirements and understand and sign the Informed Consent Form.
10. Women of childbearing potential must be not pregnant and using an acceptable method of contraception throughout the study.
11. Willing and able to comply with study visits and study tasks as required per protocol.