Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: Type II Diabetes
• Intervention / Treatment: Device: Fractyl Duodenal Remodeling System

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • INDISA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants Age > 28 years and ≤ 75 years
2. Male or Female
3. Participants with Type 2 Diabetes who are treated for ≤ 10 years and are on stable oral diabetic medications for a minimum of 3 months
4. Participants with an HbA1c > 7.5 and ≤ 10.0%
5. Participants with a BMI > 24 and < 40
6. Participants willing to comply with study requirements and able to understand and comply with informed consent
7. Participants who have signed an informed consent form

Exclusion Criteria:

1. Participants diagnosed with Type I Diabetes or with a history of ketoacidosis
2. Participants using insulin for more than 12 months
3. Participants with probable insulin production failure (defined as fasting C Peptide serum <1ng/mL)
4. Participants that have known autoimmune disease as evidenced by a positive anti glutamic acid decarboxylase (GAD) blood test
5. 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
6. Participants with iron deficiency anemia - either currently or in their history
7. Participants with current symptomatic hypocalcemia or vitamin D deficiency (routine calcium and/or vitamin D supplementation would not be excluded)
8. Participants with or a history of abnormalities of the GI tract preventing endoscopic access to the duodenum,
9. Participants with symptomatic gallstones or kidney stones at the time of screening
10. Participants with a history of pancreatitis
11. Participants with an active systemic infection
12. Participants with or a history of coagulopathy, upper gastro-intestinal bleeding c conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
13. Participants with celiac disease
14. Participants with active malignancy. Those who have had remedial treatment and/or are cancer free for 5 years can be enrolled
15. Participants with known active hepatitis or active liver disease
16. 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
17. 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
18. Participants unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 2 weeks post procedure phase
19. Participants receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
20. Participant with a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
21. Participants with active and uncontrolled gastroesophageal reflux disease (GERD) defined as grade II esophagitis or greater
22. Participants with active illicit substance abuse or alcoholism
23. Participants participating in another ongoing investigational clinical trial
24. Participants taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
25. Participants who are not potential candidates for duodenal exclusion surgery or general anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duodenal Treatment; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fractyl Health Inc.
• Investigators: Principal Investigator: Leonard R Gomez, MD, Centro Clinico De La Obesidad

Publications and helpful links

General Publications

• Rajagopalan H, Cherrington AD, Thompson CC, Kaplan LM, Rubino F, Mingrone G, Becerra P, Rodriguez P, Vignolo P, Caplan J, Rodriguez L, Galvao Neto MP. Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study. Diabetes Care. 2016 Dec;39(12):2254-2261. doi: 10.2337/dc16-0383. Epub 2016 Aug 12.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2013
• Primary Completion (Actual): April 7, 2017
• Study Completion (Actual): March 16, 2018

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimated): August 22, 2013

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: C-10000

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No