Novel Therapy for Type 2 Diabetes

(REGENT-1-US Trial)

Not currently recruiting at 2 trial locations

Overseen By Andrew Storm, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endogenex, Inc.

Must be taking: Non-insulin glucose-lowering

Must not be taking: Insulin, Anticoagulants, P2Y12 inhibitors, NSAIDs

Disqualifiers: Type 1 diabetes, Autoimmune disease, GI surgery, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: At the time of procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Endogenex Device, designed to help people with type 2 diabetes manage their blood sugar levels more effectively. It targets individuals who have struggled to control their diabetes despite using 2-3 non-insulin medications. The trial aims to determine if this device can safely regenerate part of the intestine lining to improve blood sugar control. Suitable candidates have had type 2 diabetes for 3 to 10 years, have attempted lifestyle changes without success, and maintain a stable weight. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes research.

Will I have to stop taking my current medications?

The trial requires that you continue taking your current non-insulin glucose-lowering medications without changes for at least 12 weeks before the baseline visit. However, certain medications like anticoagulants, P2Y12 inhibitors, NSAIDs, and some dietary supplements must be stopped for a specified period before and after the procedure.

What prior data suggests that the Endogenex Device is safe for endoscopic duodenal mucosal regeneration in patients with type 2 Diabetes?

Research shows that the Endogenex Device is being tested for treating type 2 diabetes, focusing on its safety and practicality. In earlier studies, patients experienced better insulin sensitivity and improved beta cell function, which are key factors in managing diabetes. Although specific safety information about the Endogenex Device is limited, it is important to note that it is currently in the clinical trial phase. At this stage, researchers closely monitor treatments for any side effects. Participants in these trials report any negative reactions, which helps researchers learn about the treatment's safety. Those considering joining the trial should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Endogenex Device is unique because it offers a new approach to treating Type 2 Diabetes through an endoscopic procedure. Unlike traditional treatments like oral medications or insulin injections, which manage blood sugar levels, this device aims to modify the gastrointestinal tract, potentially altering how the body processes glucose. Researchers are excited about this treatment because it could provide a more lasting solution by addressing the underlying mechanisms of the disease rather than just managing symptoms. This innovative approach could reduce the need for daily medication and improve patients' quality of life.

What evidence suggests that the Endogenex Device is effective for type 2 diabetes?

Research has shown that the Endogenex Device, used in a procedure to regenerate the lining of the small intestine, may help treat type 2 diabetes. In one study, all participants who underwent the procedure experienced success without serious side effects. Another study found that within 12 weeks, participants showed improved insulin sensitivity and better function of insulin-producing cells. These early findings suggest that this device could help people with type 2 diabetes manage their blood sugar levels more effectively. ^{1 3 4 5 6}

Who Is on the Research Team?

Daniel DeMarco, MD

Principal Investigator

Baylor Scott & White

Are You a Good Fit for This Trial?

This trial is for adults aged 22-65 with type 2 diabetes, who have been unable to control their blood sugar levels despite taking 2-3 non-insulin medications. Participants should have a BMI of 24-40 and a stable weight, without any significant gastrointestinal or autoimmune diseases, no recent insulin use (except for gestational diabetes), and not be on certain other medications.

Inclusion Criteria

Weight stability for at least 12 weeks prior to screening

BMI 24-40 kg/m2

Agree not to donate blood during participation

Exclusion Criteria

Presence of certain medical devices or implants

Critically ill or life expectancy <3 years

I cannot have an upper GI endoscopy or be put under general anesthesia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Endogenex procedure for duodenal mucosal regeneration

At the time of procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Regular visits at 4, 12, 24, 36, and 48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The Endogenex Device

Trial Overview The Endogenex Device is being tested in this study. It's an endoscopic tool designed to regenerate the duodenal mucosa in patients whose type 2 diabetes isn't well-controlled by current medications. The study will check how safe it is and if it can feasibly be used as a treatment option.

How Is the Trial Designed?

Group I: Interventional Experimental Treatment 1 Intervention

All eligible patients will receive the endoscopic Endogenex procedure.

Who Is Running the Clinical Trial?

Endogenex, Inc.

Lead Sponsor

Trials

3

Recruited

350+

DyaMX Inc.

Lead Sponsor

Trials

2

Recruited

90+

Citations

1. endogenex.com endogenex.com/endogenex-to-present-data-on-endoscopic-procedure-for-type-2-diabetes-at-american-diabetes-associations-ada-85th-scientific-sessions/

Endogenex to Present Data on Endoscopic Procedure for ... Endogenex to Present Data on Endoscopic Procedure for Type 2 Diabetes at American Diabetes Association's (ADA) 85th Scientific Sessions.

2. endogenex.com endogenex.com/endogenex-announces-first-patient-enrolled-in-the-recet-clinical-study/

Endogenex™ Announces First Patient Enrolled in the ... Therapeutic interventions targeting the upper gastrointestinal tract are demonstrating improved outcomes for patients with type 2 diabetes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06267391

Study Details | NCT06267391 | Safety and Effectiveness of ... This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) ...

4. mayoclinic.org mayoclinic.org/medical-professionals/digestive-diseases/news/researchers-study-novel-endoscopic-therapy-for-type-2-diabetes/mqc-20563134

Researchers study novel endoscopic therapy for type 2 ... The findings presented in the abstract include data from 10 participants and demonstrated a 100% success rate in the procedure, with no serious ...

5. endogenex.com endogenex.com/endogenex-highlights-48-week-regent-1-clinical-study-results-at-digestive-disease-week-2025/

Endogenex Highlights 48-Week REGENT-1 Clinical Study ... The REGENT-1 Australia study results showed significant improvements in insulin sensitivity and beta cell function at 12 weeks.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04725890

Study Details | NCT04725890 | Safety and Feasibility of a ... 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 ...