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Type 2 DiabetesREGENT-1NCT04725890

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

A study testing The DyaMX Device in people with Type 2 Diabetes, run by Endogenex, Inc. at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
The DyaMX Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesAustralia
Study dates
20 Apr 2021to 22 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 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.
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  • 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.

Who cannot join

  • 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
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  • 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.
  • Known active hepatitis or active liver disease other than NASH/NAFLD.
  • Alcoholic liver disease, as indicated by ANI >0
  • Current use of anticoagulation therapy (such as warfarin) that cannot be discontinued for 7 days before and 14 days after the procedure.
  • Current use of P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) that cannot be discontinued for 14 days before and 14 days after the procedure.
  • Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of acetaminophen and low dose aspirin is allowed.
  • Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 12 weeks prior to the baseline visit.
  • Use of drugs known to affect GI motility (e.g. Metoclopramide)
  • Use of weight loss medications such as Phentermine, Meridia, Xenical, or over-the-counter weight loss medications (prescription medication)
  • Persistent anemia, defined as hemoglobin <10 g/dL.
  • Known history of blood donation or transfusion within 3 months prior to the Screening Visit.
  • Known history of cardiac arrhythmia
  • Significant cardiovascular disease, including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack, or stroke within 6 months prior to the Screening Visit.
  • Estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m2.
  • Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the participant a poor candidate for clinical trial participation in the opinion of the investigator.
  • With any implanted electronic devices or duodenal metallic implants
  • Not a candidate for upper GI endoscopy or general anesthesia.
  • Active illicit substance abuse or alcoholism (> 2 drinks/day regularly).
  • Active malignancy within the last 5 years (excluding non-melanoma skin cancers)
  • Women breast feeding
  • Participating in another ongoing clinical trial of an investigational drug or device.
  • Any other mental or physical condition which, in the opinion of the study investigator, makes the participant a poor candidate for clinical trial participation.
  • Critically ill or has a life expectancy <3 years
  • Additional exclusion criteria to be confirmed during the screening process:
  • HbA1c < 7.5% or > 11% at baseline visit
  • Any severe hypoglycemic event since the screening visit
  • Glucose level <54 mg/dl (3.0 mmol/l) in more than 1% of time by CGM since the screening visit
  • Uncontrolled hyperglycemia with a glucose level >270 mg/dl (>15 mmol/L) after an overnight fast or >360 mg/dl (>20 mmol/l) in a randomly performed measurement that is confirmed by a second measurement (not on the same day) since screening visit
  • Mean of 3 separate blood pressure measurements >180 mmHg (systolic) or >100 mmHg (diastolic)
  • Women of child-bearing potential with a positive urine pregnancy test at baseline visit
  • Grade III or greater esophagitis on endoscopy
  • Abnormalities of the GI tract preventing endoscopic access to the duodenum
  • Anatomic abnormalities in the duodenum that would preclude the completion of the treatment procedure, including tortuous anatomy
  • Endoscopic observation of upper gastrointestinal abnormality such as ulcers, polyps, varices, strictures, congenital or intestinal telangiectasia
  • Any other anatomical or endoscopic abnormalities/characteristics that, in the opinion of the investigator, would preclude safe use of the investigational device or procedure.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, VIC 3065

  • The BMI Clinic

    Sydney, New South Wales, 2028

Other trials in Australia

About this study

Official title: Safety and Feasibility of Endoscopic Application of a Novel Therapy for Duodenal Mucosal Regeneration in the Treatment of Type II Diabetes

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.

Read the detailed description

Individuals who sign the informed consent will be screened for study eligibility. Eligible participants will be treated with the DyaMX procedure and followed up for 48 weeks.

Conditions
Type 2 Diabetes
Being tested
The DyaMX Device
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The DyaMX DeviceDevice

    Also called Duodenal Mucosal Regeneration

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

Study groups in NCT04725890
Study groupRoleWhat they receive
InterventionExperimentalAll eligible participants will receive the DyaMX procedure.
Receives: Device: The DyaMX Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 12 weeks post procedure

Secondary outcomes (3)

  1. HbA1c by Post Procedure Follow-up Visit

    Mean HbA1c (%) by Post Procedure Follow-up Visit. The unit of measure for HbA1c is %.

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

  2. Fasting Plasma Glucose by Visit

    Mean Fasting Plasma Glucose by Visit

    Measured: Baseline, 12, 24, and 48 weeks

  3. Weight by Visit

    Mean Weight by Visit

    Measured: Baseline, 12, 24, and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2021
  2. Study start20 Apr 2021
  3. Primary completion1 Mar 2024
  4. Study completion22 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04725890
Sponsor's protocol ID
196
Acronym
REGENT-1
Status last verified
Mar 2025
First submitted
18 Jan 2021
Last updated
22 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The DyaMX Device in people with Type 2 Diabetes, run by Endogenex, Inc. at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Device- or Procedure-related Serious Adverse Events (SAE) (time frame: At 12 weeks post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04725890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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