Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes

NCT04725890 | Completed Results FDA Device

• 1 other identifier: 196
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open-label study to assess the safety and feasibility of the DyaMX device for endoscopic duodenal mucosal regeneration in individuals with type 2 diabetes inadequately controlled on glucose-lowering medications.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Device- or Procedure-related Serious Adverse Events (SAE)

  Number of participants experiencing one or more device- or procedure-related serious adverse events at 12 weeks post procedure

  At 12 weeks post procedure

Secondary Outcomes (3)

• HbA1c by Post Procedure Follow-up Visit

  Follow up at 12, 24, and 48 weeks post procedure

• Fasting Plasma Glucose by Visit

  Baseline, 12, 24, and 48 weeks

• Weight by Visit

  Baseline, 12, 24, and 48 weeks

Other Outcomes (2)

• Procedural Success

  At the time of the Index Procedure

• Procedural Time

  Time of Procedure

Study Arms (1)

Intervention

EXPERIMENTAL

All eligible participants will receive the DyaMX procedure.

Device: The DyaMX Device

Interventions

The DyaMX Device DEVICE

The DyaMX device is designed to induce duodenal mucosal regeneration using pulsed electric field. The DyaMX procedure is a non-surgical, endoscopic procedure.

Also known as: Duodenal Mucosal Regeneration

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Current diagnosis of T2D
• History of T2D for less than or equal to 10 years, or use insulin for less or equal to 10 years
• HbA1C of 7.5-11.0%
• BMI 24-40 kg/m2
• If treated with non-insulin glucose lowering mediations, the medications (1-4 medications) should be stable for at least 12 weeks prior to baseline visit. If treated with basal insulin, the daily insulin dose should be within 20-60 IU.
• Agree not to donate blood during participation in the study.
• If treated with non-insulin glucose lowering medications, participant should have weight stability (defined as a \< 5% change in body weight) for at least 12 weeks prior to the screening visit
• Able to comply with study requirements and understand and sign the Informed Consent Form
• Women of childbearing potential must be using an acceptable method of contraception throughout the study
• Willing and able to perform self-monitoring blood glucose and comply with study visits and study tasks as required per protocol.

You may not qualify if:

• Diagnosed with type 1 diabetes
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Probable insulin production failure, defined as overnight fasting C-peptide serum \<1 ng/mL (333pmol/l).
• Previous use of any types of insulin for \>1 month (at any time, except for treatment of gestational diabetes) in last 2 years for those on non-insulin medications.
• Current use of multiple daily dose insulin or insulin pump
• Hypoglycemia unawareness
• History of ≥1 severe hypoglycemia (defined by needing for third-party assistance), unless a clear correctable precipitating factor can be identified, in past 6 months from the screening visit
• Known autoimmune disease, as evidenced by a positive anti-glutamic acid decarboxylase (GAD) test, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
• Previous GI surgery that has changed GI anatomy or could limit treatment of the duodenum, such as Billroth 2, Roux-en-Y gastric bypass, gastric band or other similar procedures or conditions.
• Known history of a structural or functional disorder of the upper GI tract that may impede passage of the device through the upper GI tract or increase risk of tissue damage during an endoscopic procedure, including esophagitis, stricture/stenosis, varices, diverticula, or other disorder of the esophagus, stomach and duodenum.
• Active H. pylori infection (Participants with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
• History of, or gastrointestinal symptoms suggestive of gastroparesis.
• Acute gastrointestinal illness in the previous 7 days
• Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease and Celiac disease
• History of chronic or acute pancreatitis.

Sponsors & Collaborators

• Endogenex, Inc.: lead

Study Sites (2)

The BMI Clinic

Sydney, New South Wales, 2028, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, VIC 3065, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

This pilot study was performed to provide an early assessment of safety of the Endogenex device in participants with Type 2 Diabetes. Due to the small sample size, formal hypothesis testing was not performed and data may be limited to descriptive statistics, including mean and standard deviations.

Results Point of Contact

• Title: Lian Cunningham, MD, PhD
• Organization: Endogenex, Inc.

lcunningham@endogenex.com

(763) 251-6820

Study Officials

• Adrian Sartoretto, MD

  The BMI Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 27, 2021
• Study Start: April 20, 2021
• Primary Completion: March 1, 2024
• Study Completion: December 22, 2024
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)