Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type II Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorEndogenex, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ReCET Treatment
- Sham Procedure
Treatment groups
264 Participants
are divided into 2 treatment groupsLocations
45Australia
Royal Prince Alfred Hospital2006, CamperdownNew South Wales, Australia
The BMI Clinic2028, Double BayNew South Wales, Australia
Royal North Shore Hospital2065, Saint LeonardsNew South Wales, Australia
Eastern Health - Box Hill Hospital3128, Box HillVictoria, Australia
Sponsors and collaborators
Endogenex, Inc.
Lead sponsor
Source ClinicalTrials.gov