RecruitingType 2 Diabetes MellitusType2diabetesDiabetes Mellitus, Type 2

Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes

Eligible age

22–70 yrs

Accepts

All genders

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: Endogenex, Inc.

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.