NCT07768631
Study Evaluating the Metabolic Effects of pulsENDO Therapy in Adults With Type 2 Diabetes
Not Yet Recruiting · Not Applicable · Endogenex, Inc. · registry updated 2026-08-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This is a prospective, multicenter, randomized, double-blind, sham-controlled, adaptive study evaluating the pulsENDO system in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications (GLMs). The primary objective of this study is to demonstrate that pulsENDO therapy is superior to sham control for improving glycemic control in adults with type 2 diabetes.
Inclusion
- years of age, inclusive.
- T2D diagnosis for at least 6 months.
- HbA1c of 7.5-10.5%, inclusive, for participants on 1-3 GLMs or or if on 4 glucose-lowering medications must have HbA1c between 7.5% - 9.0%, inclusive.
- BMI 27-40 kg/m2, inclusive.
- On 1-4 non-insulin glucose lowering medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit
- If on lipid-lowering medications, the medication stable for at least 12 weeks .
Exclusion
- 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