Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.

Official Title
-----------------
Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2, Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: DMR Procedure (Fractyl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 28 -75 years of age Diagnosed with Type 2 Diabetes for less than 10 years HbA1c of 7.5 - 10.0% (59-86 mmol/mol) Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2 On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry Willing to comply with study requirements and able to understand and comply with informed consent Sign an informed consent form Exclusion Criteria Diagnosed with Type 1 Diabetes or with a history of ketoacidosis Probable insulin production failure, defined as fasting C Peptide serum <1ng/mL (333pmol/l) Current use of Insulin Use of Glucagon like peptide (GLP)-1 analogues Hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year) Known autoimmune disease, as evidenced by a positive anti glutamic acid decarboxylase (GAD) test, including Celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder Previous gastrointestinal (GI) surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions History of chronic or acute pancreatitis Known active hepatitis or active liver disease Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia Use of anticoagulation therapy (such as Warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure Use of P2Y12 inhibitors (clopidrogel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure. Use of aspirin is allowed. Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide) Receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications Persistent Anemia, defined as Hgb < 10 mg/dl Estimated glomerular filtration rate (eGFR) or Modification of Diet in Renal Disease (MDRD) <30 ml/min/1,73m^2 Active systemic infection Active malignancy within the last 5 years Not potential candidates for surgery or general anesthesia Active illicit substance abuse or alcoholism Those who are pregnant, nursing or expect to become pregnant over the course of the study Participating in another ongoing clinical trial Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMR Procedure<br>Subjects receive the endoscopic DMR procedure in this arm | Device: DMR Procedure (Fractyl)<br>* Endoscopic procedure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure |  | 24 weeks post-procedure | 
| Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) |  | 24 weeks post-procedure |