20 Participants Needed

Novel Therapy for Type 2 Diabetes

(REGENT-1-US Trial)

Recruiting at 2 trial locations
MT
MS
JL
AS
Overseen ByAndrew Storm, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

DD

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
See 10 more

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.
See 22 more

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?
1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Endogenex, Inc.

Lead Sponsor

Trials
3
Recruited
350+

DyaMX Inc.

Lead Sponsor

Trials
2
Recruited
90+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security