Treatment diabetes
Conditions
Interventions
Sponsors
Fractyl Laboratories, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Screening Visit (Pre-Medication Run-In, Visit 1) 1. 28 -75 years of age 2. Diagnosed with Type 2 Diabetes for less than 10 years 3. HbA1c of 7.5 - 10.0% (59-86 mmol/mol) 4. BMI * 24 and * 40 kg/m2 5. On a minimum of 1 stable oral anti-diabetic medication with no changes in medication in the previous 3 months prior to study entry 6. Willing to comply with study requirements and able to understand and comply with informed consent 7. Sign an informed consent form
Exclusion criteria
Exclusion criteria: Screening Visit (Pre-Medication Run-In, Visit 1) 1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis 2. Probable insulin production failure, defined as fasting C Peptide serum 10.0% (86 mmol/mol) 2. Hypoglycemic event defined as a plasma glucose level of 15 mmol/L (270 mg/dL) or non-fasting blood glucose measurements >20 mmol/L (360 mg/dL) or any combination of the two. Fasting glucose hyperglycemia is not an exclusion if measured at the actual baseline visit (Visit 2) blood analysis test.;Procedure (Visit 3) 1. Active and uncontrolled GERD defined as grade III esophagitis or greater 2. Abnormalities of the GI tract preve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study endpoints Feasibility endpoints: The feasibility endpoints (device performance) are assessed using the following criteria: 1. Successful Completion of Submucosal Expansion 2. Successful Completion of Ablation Safety Endpoint: The safety endpoint is the incidence rate of the following events at 24 weeks and at 36 months post-procedure: 1. All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) 2. All Procedure and device-related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) 3. Number of hypo-glycemic events (blood glucose level of | — |
Secondary
| Measure | Time frame |
|---|---|
| - | — |
Countries
Netherlands
Outcome results
None listed