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Device

Novel Therapy for Type 2 Diabetes (REGENT-1-US Trial)

N/A
Waitlist Available
Research Sponsored by Endogenex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
22-65 years of age
Current diagnosis of T2D
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of procedure
Awards & highlights

REGENT-1-US Trial Summary

This trial will test a new device to help control blood sugar in people with diabetes who are already taking medication.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include those commonly associated with endoscopic procedures such as discomfort, bleeding or infection at the site of intervention. There could also be device-specific reactions that will be monitored during the trial.

REGENT-1-US Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 65 years old.
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I have been diagnosed with type 2 diabetes.
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I am taking 2-3 diabetes medications that don't include insulin.

REGENT-1-US Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4, 12, 24, 36, 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4, 12, 24, 36, 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Safety Endpoint
Secondary outcome measures
Changes in HbA1c
Changes in Weight
Changes in alanine aminotransferase (ALT)
+6 more
Other outcome measures
Procedural Time
Procedural success

REGENT-1-US Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionalExperimental Treatment1 Intervention
All eligible patients will receive the endoscopic Endogenex procedure.

Find a Location

Who is running the clinical trial?

Endogenex, Inc.Lead Sponsor
2 Previous Clinical Trials
324 Total Patients Enrolled
DyaMX Inc.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Daniel DeMarco, MDStudy ChairBaylor Scott & White
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 50 or above eligible to partake in this investigation?

"This medical trial requires individuals to be between 22 and 65 years old. There are 244 trials for minors, whereas seniors have a total of 1217 studies available to them."

Answered by AI

Could I qualify to join this research project?

"This investigation is recruiting 20 individuals that are suffering from endocrine system diseases and between the ages of 22 to 65. The prerequisite criteria for applicants include a history of T2D lasting 3-10 years, HbA1C within 7.5-10%, BMI ranging 24-40 kg/m2, be on two or three glucose lowering medications with one at maximum capacity and another reduced dose, body weight stability (< 5% change) 12 weeks prior to screening visit, an inability to donate blood during participation in research study, compliance with requirements as well as signing informed consent forms."

Answered by AI

Are there any current openings for recruitment in this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this medical study, first published on October 29th 2021 and last updated April 21st 2022, is actively seeking enrolment from 20 potential participants across 3 sites."

Answered by AI

How many people are enrolled in the trial at its maximum capacity?

"Verified. Clinicaltrials.gov displays that this medical experiment, first published on October 29th 2021, is actively recruiting participants. Approximately 20 persons need to be recruited from 3 distinct locations."

Answered by AI

Who else is applying?

What state do they live in?
California
Minnesota
How old are they?
65+
What site did they apply to?
Mayo Clinic
University of Southern California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm currently on 2 medications but they don't seem to be helping my blood sugars hoping this trial will help improve my condition.
PatientReceived 2+ prior treatments
I have tried metformin with no luck, glimepiride, and am currently on semaglutide. I really want my type 2 diabetes cured. I've been dieting and exercising, even losing 60 pounds, but it's been tough.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does first visit take? Is there validation on parking provided? Will this study work around my schedule?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes
2021. "Safety and Feasibility of Novel Therapy for Duodenal Mucosal Regeneration for Type II Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05014204.
All > Diabetes Type 2
~3 spots leftby Oct 2024
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