Duodenal Mucosal Resurfacing (DMR) for Type 2 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Type 2 DiabetesDuodenal Mucosal Resurfacing (DMR) - Device
Eligibility
21 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is investigating whether a new diabetes treatment is better than a sham treatment at improving glycemic, hepatic, and cardiovascular outcomes for patients with type 2 diabetes who can't control their blood sugar with insulin therapy.

Eligible Conditions
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 Weeks

24 Weeks
The primary endpoint is the percentage of subjects at Week 24 who achieve a HbA1c of </= 7.0% without the need for insulin, DMR vs Sham

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Duodenal Mucosal Resurfacing (DMR)
1 of 2
Duodenal Mucosal Resurfacing Sham (Sham)
1 of 2

Active Control

Non-Treatment Group

560 Total Participants · 2 Treatment Groups

Primary Treatment: Duodenal Mucosal Resurfacing (DMR) · Has Placebo Group · N/A

Duodenal Mucosal Resurfacing Sham (Sham)
Device
ShamComparator Group · 1 Intervention: Duodenal Mucosal Resurfacing (Sham) · Intervention Types: Device
Duodenal Mucosal Resurfacing (DMR)
Device
ActiveComparator Group · 1 Intervention: Duodenal Mucosal Resurfacing (DMR) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Fractyl Laboratories, Inc.Lead Sponsor
5 Previous Clinical Trials
249 Total Patients Enrolled
Fractyl Health, Inc.Lead Sponsor

Eligibility Criteria

Age 21 - 70 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male and non-pregnant, non-lactating females.
You have a body mass index (BMI) of 24 to 40 kg/m2.
You are of child-bearing potential (WOCBP) and you must agree to use two of the established contraceptive methods throughout the study duration.
You are able to sign an informed consent form and comply with study requirements.

Who else is applying?

What state do they live in?
California40.0%
Arizona20.0%
Texas20.0%
Other20.0%
How old are they?
18 - 6566.7%
65+33.3%
What site did they apply to?
Mayo Clinic Arizona33.3%
Mills Peninsula Health Center33.3%
Baylor St. Luke's Medical Center33.3%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%
Why did patients apply to this trial?
  • "I think I need to change my medication. DawnBarrera"
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Most responsive sites:
  1. Baylor St. Luke's Medical Center: < 48 hours
Typically responds via
Email100.0%
Average response time
  • < 2 Days