The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.
Diagnosed with Type 2 Diabetes.
Age ≥ 18 to ≤ 75 years.
Insulin naïve patients who are on stable dose (maximally approved or tolerated dose) of 2 or more glucose lowering drugs, including metformin, sulphonylurea (SU), (sodium-glucose cotransporter-2) inhibitors (SGLT-2i), Glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase 4 inhibitor (DPP-4i) and/or, thiazolidinedionderivaten (TZD) for at least 12 weeks.
BMI ≥ 24 and ≤ 40 kg/m2
Uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15.0 mmol/L) after an overnight 8-hour fasting at the end of run-in and confirmed by a second measurement on the consecutive day.
Subjects who are using insuline.
Known case of absolute insulin deficiency as indicated by a fasting plasma C-peptide value of <0.6 ng/ml (<0,2 nmol/L).
Diagnosis of autoimmune diabetes/Type 1 diabetes mellitus, monogenic (neonatal or maturity onset diabetes of the young (MODY)) diabetes or Type 1 diabetes in adults/latent autoimmune diabetes of adults (LADA).
Crossover
Revita® DMR Treatment
DeviceThe Revita® System is an endoscopic treatment consisting of a single catheter and console designed to lift the duodenal mucosa with saline followed by controlled circumferential hydrothermal ablation of the mucosa. For this study Revita® DMR procedure will be conducted as follows: DMR Treatment Paradigm 1- After initial 2 Lift and Ablate step, remaining Lift: Ablate steps will be conducted in 1:1 manner.
Sham procedure
Other interventionThe sham control for the Revita DMR procedure.
Safety endpoint
Safety endpoint is evaluated 12 weeks post DMR and 12 weeks post retreatment with DMR \- Number (percentage) of patients experienced device and procedure-related Serious Adverse Events (SAEs), Unanticipated Device Effects (UADEs), Serious Adverse Device Effects (SADEs), Suspected Unexpected Serious Adverse Reaction (SUSARs)
Feasibility endpoint 1
Feasibility endpoint is evaluated during and after the procedure: \- Number of ablations, whether a DMR was successful (\>3 ablations)
Feasibility endpoint 2
Feasibility endpoint is evaluated during and after the procedure: \- Procedure time, defined as time between catheter in and catheter out.
Efficacy endpoint 1
Efficacy is evaluated at 24 weeks compared to baseline and sham: \- Mean change in Fasting Plasma Glucose (FPG)/Flash Glucose Monitoring (FGM)
Secondary safety endpoint
Secondary safety endpoint is evaluated during follow-up and compared to baseline and sham at week 24 and compared to baseline and 12 weeks after (re)-DMR for all patients: incidences and event rates of hypoglycemic events during complete study period
Efficacy endpoint 1: mean change in HbA1c
Efficacy endpoint 1: mean change in HbA1c
Efficacy endpoint 2: mean Change in Fasting Glucose
Efficacy endpoint 2: mean Change in Fasting Glucose
Efficacy endpoint 2: mean Change in Time in Range (TIR)
Efficacy endpoint 2: mean Change in Time in Range
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Fractyl Health Inc.
Collaborator
