Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
Trial Parameters
Brief Summary
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
Eligibility Criteria
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 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. * 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