Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.

Detailed Description
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The purpose of this protocol is to evaluate the initial safety profile of the Fractyl System and its effect on participants with Type 2 Diabetes. This will be determined through the monitoring of adverse events and outcome measures including Mixed Meal Tolerance Test (MMTT).

Official Title
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Evaluation of the Fractyl Duodenal Remodeling System for the Treatment of Type 2 Diabetes

Conditions
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Type II Diabetes

Intervention / Treatment
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* Device: Fractyl Duodenal Remodeling System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants Age > 28 years and ≤ 75 years Male or Female Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months Participants with an HbA1c > 7.5 and ≤ 10.0% Participants with a BMI > 24 and < 40 Participants willing to comply with study requirements and able to understand and comply with informed consent Participants who have signed an informed consent form Exclusion Criteria: Participants diagnosed with Type I Diabetes or with a history of ketoacidosis Participants using insulin for more than 12 months Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL) Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test Participants requiring prescription anticoagulation therapy and/or dual anti-platelet therapy including aspirin who cannot discontinue their medication for 14 days before and 14 days after the procedure Participants with iron deficiency anemia - either currently or in their history Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded) Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum, Participants with symptomatic gallstones or kidney stones at the time of screening Participants with a history of pancreatitis Participants with an active systemic infection Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia Participants with celiac disease Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled Participants with known active hepatitis or active liver disease Participants emotionally unstable or who exhibit psychological characteristics which, in the opinion of the Investigator, make the participant a poor candidate for clinical trial participation Participants with previous GI surgery that could affect the ability to treat the duodenum such as participants who have had a Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater Participants with active illicit substance abuse or alcoholism Participants participating in another ongoing investigational clinical trial Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan) Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duodenal Treatment<br>The Duodenal Remodeling procedure utilizes both a trans-oral over the wire and endoscopic approach to minimally invasively ablating and remodeling the duodenum. | Device: Fractyl Duodenal Remodeling System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changed in Mixed Meal Tolerance From Baseline to 3 Months | Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months | 3 months |