320 Participants Needed

DMR for Type 2 Diabetes

(REVITALIZE 1 Trial)

Recruiting at 66 trial locations
JV
JM
AM
VA
PK
MN
AP
AT
Overseen ByAdarsh Thaker
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

The provided research does not contain any safety data related to Duodenal Mucosal Resurfacing (DMR) for Type 2 Diabetes. The studies focus on rheumatoid arthritis treatments and do not mention DMR or its associated names.678910

Is Duodenal Mucosal Resurfacing (DMR) a promising treatment for Type 2 Diabetes?

The information provided does not include any details about Duodenal Mucosal Resurfacing (DMR) or its effectiveness for Type 2 Diabetes. Therefore, I cannot determine if it is a promising treatment based on the given data.1112131415

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

My fasting blood sugar is between 180 and 270 mg/dL after not eating overnight and stopping my usual diabetes medication for 24-36 hours.
My HbA1c level is between 7.5% and 9.5% after a stable period.
Your weight is within a certain range based on your height.
See 14 more

Exclusion Criteria

I have had severe or repeated urinary or genital infections recently.
I have an autoimmune disease that affects my small intestine.
My thyroid is underactive or not well-controlled.
See 42 more

Treatment Details

Interventions

  • Duodenal Mucosal Resurfacing (DMR)
  • Duodenal Mucosal Resurfacing (Sham)
Trial OverviewThe trial is testing the Revita® System's Duodenal Mucosal Resurfacing (DMR) procedure against a sham (fake) procedure to see if it improves blood sugar control and heart health in those whose diabetes isn't well-managed by insulin alone. Participants will either receive DMR or the sham treatment and be monitored for up to 48 weeks.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Duodenal Mucosal Resurfacing (DMR)Active Control1 Intervention
Duodenal Mucosal Resurfacing (DMR) treatment will include hydrothermal ablation of the duodenal muscosa in an upper endoscopic procedure in patients with inadequately controlled type 2 diabetes.
Group II: Duodenal Mucosal Resurfacing Sham (Sham)Placebo Group1 Intervention
Duodenal Mucosal Resurfacing Sham (Sham) treatment will include an upper endoscopic procedure similar to DMR treatment without hydrothermal ablation of the duodenal mucosa in patients with inadequately controlled type 2 diabetes.

Duodenal Mucosal Resurfacing (DMR) is already approved in European Union, United Kingdom for the following indications:

🇪🇺
Approved in European Union as Revita for:
  • Type 2 Diabetes
🇬🇧
Approved in United Kingdom as Revita for:
  • Type 2 Diabetes

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fractyl Laboratories, Inc.

Lead Sponsor

Trials
6
Recruited
570+

Fractyl Health Inc.

Lead Sponsor

Trials
9
Recruited
1,000+

Fractyl Health, Inc.

Lead Sponsor

Trials
2
Recruited
340+

Findings from Research

In a 24-week phase 3 study involving 225 patients, including 142 East Asians, delayed-release dimethyl fumarate (DMF) significantly reduced the number of new gadolinium-enhancing lesions by 84% compared to placebo, demonstrating strong efficacy in treating relapsing-remitting multiple sclerosis (RRMS).
The safety profile of DMF was consistent across the study population, with flushing and gastrointestinal events noted as common side effects, indicating that DMF is a viable treatment option for East Asian patients with RRMS, similar to its effects in predominantly white populations.
A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries.Saida, T., Yamamura, T., Kondo, T., et al.[2022]
A consensus among North American clinicians identified effective strategies for managing gastrointestinal adverse events (AEs) associated with delayed-release dimethyl fumarate (DMF) in multiple sclerosis patients.
Recommended management strategies include taking DMF with food, gradually increasing the dose, reducing the dose if necessary, and using symptomatic therapies to improve tolerability.
Consensus Management of Gastrointestinal Events Associated with Delayed-Release Dimethyl Fumarate: A Delphi Study.Theodore Phillips, J., Erwin, AA., Agrella, S., et al.[2022]
Dimethyl fumarate (DMF) has shown significant efficacy in treating relapsing-remitting multiple sclerosis (RRMS), with a 44%-53% reduction in annualized relapse rates and a 71%-90% reduction in new MRI lesions based on two phase III trials.
While DMF is generally well-tolerated, with no increased risk of opportunistic infections, it can cause gastrointestinal symptoms and skin flushing, particularly at the start of treatment, necessitating regular safety monitoring of blood counts.
Dimethyl fumarate for relapsing MS.Serra, A., Fox, RJ.[2020]

References

A randomized placebo-controlled trial of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis from East Asia and other countries. [2022]
Consensus Management of Gastrointestinal Events Associated with Delayed-Release Dimethyl Fumarate: A Delphi Study. [2022]
Dimethyl fumarate for relapsing MS. [2020]
Dimethyl fumarate protects against intestinal ischemia/reperfusion lesion: Participation of Nrf2/HO-1, GSK-3β and Wnt/β-catenin pathway. [2021]
Prevention of Autoimmune Diabetes in NOD Mice by Dimethyl Fumarate. [2021]
Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients. [2021]
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. [2021]
Safety of combination therapy with two bDMARDs in patients with rheumatoid arthritis: A systematic review and meta-analysis. [2020]
[DMARDs (disease-modifying antirheumatic drugs)]. [2013]
Factors associated with radiographic progression in rheumatoid arthritis starting biological diseases modifying anti-rheumatic drugs (bDMARDs). [2023]
Mechanisms underlying DMARD inefficacy in difficult-to-treat rheumatoid arthritis: a narrative review with systematic literature search. [2022]
Patient-reported outcomes in RA patients treated with tofacitinib or bDMARDs in real-life conditions in two Latin American countries. [2023]
The impact of seropositivity on the effectiveness of biologic anti-rheumatic agents: results from a collaboration of 16 registries. [2021]
Examining patient preferences in the treatment of rheumatoid arthritis using a discrete-choice approach. [2022]
15.United Statespubmed.ncbi.nlm.nih.gov
Not all moderate disease is the same - Identification of disability trajectories among patients with rheumatoid arthritis and moderate disease activity. [2020]