The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus.
The objective of this study is to evaluate the safety, feasibility and efficacy of pulsed electric field induced duodenal mucosal regeneration (with the Endogenex System en Gen 2 Device) combined with a GLP-1 receptor agonist (Semaglutide, Ozempic) in subjects with insulin-dependent type 2 diabetes mellitus and an adequate beta cell reserve in a randomized sham-controlled study. The aimed effect is an adequate or improved glucose regulation without the need for insulin therapy. Secondary effects include improved cardiovascular, hepatic, and metabolic parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Investigational product.
Already registered medicine for type 2 diabetes
The sham control for the PEF therapy procedure.
Amsterdam UMC
Amsterdam, North Holland, Netherlands
Incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs [safety]
The incidence rate of procedure-related SAEs, UADEs, SADEs, AESIs 24 weeks post PEF therapy procedure.
Time frame: 24 weeks
Percentage of patients off insulin at 24 weeks [efficacy]
Percentage of patients free of insulin at 24 weeks post PEF therapy with an HbA1c ≤ 58 mmol/mol compared to sham.
Time frame: 24 weeks
Secondary safety endpoint 1 - hypoglycemic events
Number of hypoglycemic events
Time frame: Through study completion (1 to 1,5 year)
Secondary safety endpoint 2 - SAEs
All SAEs
Time frame: Through study completion (1 to 1,5 year)
Secondary feasibility endpoint 1 - technical success rate
Technical success rate, defined as percentage of subjects successfully completed the PEF therapy procedure (defined as ≥ 3 ablations).
Time frame: 24 weeks (after cross-over)
Secondary feasibility endpoint 2 - GLP-1RA tolerability
Percentage of subjects adequately using and tolerating GLP-1RA (semaglutide).
Time frame: Through study completion (1 to 1,5 year)
Secondary efficay endpoint 1 - HbA1c 48 weeks
Protocol driven number of subjects free of insulin at 48 weeks, including an HbA1c ≤ 58 mmol/mol.
Time frame: at 48 weeks
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