Novel Therapy for Type 2 Diabetes

(REGENT-1-US Trial)

Recruiting at 2 trial locations

Overseen By Andrew Storm, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endogenex, Inc.

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new procedure using the Endogenex Device to help regenerate the lining of the small intestine. It targets patients with type 2 Diabetes who are not well-controlled on their current medications. The goal is to improve how their bodies process sugar and manage blood sugar levels better.

Research Team

Daniel DeMarco, MD

Principal Investigator

Baylor Scott & White

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+