DMR for Type 2 Diabetes
(REVITALIZE 1 Trial)
Trial Summary
What is the purpose of this trial?
The Revita® system is being investigated to assess the efficacy of DMR versus Sham on improvement in Glycemic, Hepatic and Cardiovascular endpoints for patients with Type 2 Diabetes who are inadequately controlled on one or more glucose lowering agents. The purpose of this study is to demonstrate the efficacy and safety of the Fractyl DMR Procedure using the Revita® System compared to a sham. Subjects randomized to the DMR procedure will be followed per protocol till 48 weeks post treatment. Subjects in the Sham treatment arm will be offered cross over to receive the DMR treatment at 48 weeks and will be followed per protocol for 48 weeks post treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, you must be on at least one glucose-lowering agent without changes for at least 12 weeks before screening. Some medications that interfere with glucose metabolism are prohibited.
What data supports the idea that DMR for Type 2 Diabetes is an effective treatment?
The available research does not provide any data supporting the effectiveness of DMR for Type 2 Diabetes. Instead, the studies focus on a different drug, dimethyl fumarate (DMF), which is used for treating multiple sclerosis and has shown some potential in preventing autoimmune diabetes in mice. However, this is not related to DMR for Type 2 Diabetes.12345
What safety data is available for Duodenal Mucosal Resurfacing (DMR) for Type 2 Diabetes?
Is Duodenal Mucosal Resurfacing (DMR) a promising treatment for Type 2 Diabetes?
Eligibility Criteria
Adults aged 21-70 with Type 2 Diabetes, using insulin and certain other diabetes medications, who have a BMI of >24 to ≤40 kg/m^2. Participants should not be pregnant or breastfeeding and must use reliable contraception. They cannot have stomach disorders, severe kidney disease, recent heart issues, uncontrolled thyroid conditions, or a history of significant alcohol/substance abuse.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Duodenal Mucosal Resurfacing (DMR)
- Duodenal Mucosal Resurfacing (Sham)
Duodenal Mucosal Resurfacing (DMR) is already approved in European Union, United Kingdom for the following indications:
- Type 2 Diabetes
- Type 2 Diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fractyl Laboratories, Inc.
Lead Sponsor
Fractyl Health Inc.
Lead Sponsor
Fractyl Health, Inc.
Lead Sponsor