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DiabetesREGENT-1-USNCT05014204

Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes

A study testing The Endogenex Device in people with Diabetes and Diabetes Type 2, run by Endogenex, Inc. at 3 sites in United States.

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 a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin glucose-lowering medications. Read more about this study

Who is it for?
Ages 22 to 65 years
What is being tested?
The Endogenex Device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesUnited States
Study dates
29 Oct 2021to 29 May 2025
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 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 22- 65 years of age
  • Current diagnosis of T2D
  • History of T2D for at least 3 years and less than or equal to 10 years
  • HbA1C of 7.5-10.0%, inclusive
  • BMI 24-40 kg/m2, inclusive
  • On two to three non-insulin glucose lowering mediations, with one at maximum tolerated dose and another at half-maximum dose at least, with no changes in medication for at least 12 weeks prior to baseline visit prior to baseline visit
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  • History of failed attempt to reach glycemic goal by lifestyle modifications
  • Weight stability (defined as a < 5% change in body weight) for at least 12 weeks prior to the screening visit
  • Agree not to donate blood during participation in the study.
  • 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 use CGM for the duration of the study and comply with study visits and study tasks as required per protocol.
  • Proof of COVID 19 vaccination.

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.
  • Current use of insulin
  • Hypoglycemia unawareness
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  • History of ≥1 severe hypoglycemia episode (defined by needing for third-party assistance) 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. (Participants with adequately controlled primary hypothyroidism may be included).
  • 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 of 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 Meridia, Xenical, Phentermine or over-the-counter weight loss medications (prescription medication)
  • Currently taking, or unable to stop taking dietary supplements or herbal agents, including vitamin C or multivitamins containing vitamin C at >500 mg per day, multivitamins containing biotin (vitamin B7), and supplements for hair, skin, and nail growth. Multivitamins not containing biotin are permitted.
  • Persistent anemia, defined as hemoglobin <10 g/dL.
  • Known history of hemoglobinopathy.
  • Known history of blood donation or transfusion within 3 months prior to the Screening Visit.
  • Known history of cardiac arrythmia
  • 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) ≤ 60 ml/min/1.73m2 (estimated by MDRD).
  • 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.
  • History of secondary hypothyroidism or inadequately controlled primary hypothyroidism (TSH value outside the normal range at screening)
  • 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 breastfeeding
  • 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 > 10% at baseline visit
  • Any severe hypoglycemic event since the screening visit
  • CGM readings <54 mg/dl in more than 1% of time by CGM since the screening visit
  • CGM readings > 360 mg/dL in more than 1% of time
  • 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
  • LA Grade C 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

3 sites in 1 country.

United States3 sites

  • Cuyuna Regional Medical Center

    Crosby, Minnesota, 56441

  • University of Southern California

    Los Angeles, California, 90033

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

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 a multi-center, open-label study to assess the feasibility and preliminary safety of the Endogenex Device for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes inadequately controlled on 2-3 non-insulin 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 Endogenex procedure and followed up for 48 weeks.

Being tested
The Endogenex Device
Keywords
Endoscopy, type 2 diabetes
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases

What participants receive

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

  • The Endogenex DeviceDevice

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

Study groups in NCT05014204
Study groupRoleWhat they receive
InterventionalExperimentalAll eligible patients will receive the endoscopic Endogenex procedure.
Receives: Device: The Endogenex Device

What is being measured

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

  1. Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE)

    Number of participants experiencing device- or procedure-related serious adverse events (SAE)

    Measured: 12 weeks post-procedure

Secondary outcomes (3)

  1. Mean HbA1c by Follow-up Visit

    Mean HbA1c by Post Procedure Follow-up Visits

    Measured: at 4,12, 24, and 48 Weeks Post Procedure

  2. Mean Fasting Plasma Glucose (FPG) by Visit

    Mean Fasting Plasma Glucose (FPG) at Post Procedure Follow-up Visit

    Measured: Follow-up at 4,12, 24, 36, and 48 weeks post procedure

  3. Mean Weight by Follow-up Visit

    Mean weight by Post Procedure Follow-up Visit

    Measured: Follow-up at 4,12, 24, 36, and 48 weeks post procedure

Timeline

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

  1. First posted20 Aug 2021
  2. Study start29 Oct 2021
  3. Primary completion29 May 2024
  4. Study completion29 May 2025

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05014204
Sponsor's protocol ID
346
Acronym
REGENT-1-US
Status last verified
Oct 2025
First submitted
13 Aug 2021
Last updated
22 Dec 2025
Data monitoring committee
Yes
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 Endogenex Device in people with Diabetes and Diabetes Type 2, run by Endogenex, Inc. at 3 sites in United States.

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 13 inclusion and 52 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 Dec 2025). 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?

Participants Experiencing Device- or Procedure-Related Serious Adverse Events (SAE) (time frame: 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 NCT05014204.

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 Dec 2025.

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