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Procedure

DMR for Type 2 Diabetes (REVITALIZE 1 Trial)

N/A
Recruiting
Research Sponsored by Fractyl Laboratories, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male, and non-pregnant, non-lactating females
Age between 21 and 70 years (both inclusive)
Must not have
Known case of absolute insulin deficiency as indicated by clinical assessment, a history of type 1 diabetes, and a fasting plasma C-peptide of <0.6 ng/ml
Subjects who are on any other class of antidiabetic drug agents other than permitted non-insulin baseline ADAs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include discomfort at the procedure site, digestive issues such as nausea or bloating, risks associated with sedation used during the procedure like allergic reactions or breathing difficulties, bleeding from where tissue was treated, and possible infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man or a woman not pregnant or breastfeeding.
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I am between 21 and 70 years old.
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I have type 2 diabetes, take metformin and up to 2 other diabetes medications, and need 20-60 units of insulin daily.
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I am a woman who can have children, not pregnant, and agree to use two forms of birth control during the study.
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I am a man or a woman not pregnant or breastfeeding.
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I am between 21 and 70 years old.
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I have type 2 diabetes and take 20-100 units of insulin daily, along with up to 3 other diabetes medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have type 1 diabetes with very low C-peptide levels.
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I am not on any diabetes medication except for non-insulin ones.
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I haven't taken any experimental drugs recently.
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I have type 1 diabetes or recently had ketoacidosis.
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I have had non-healing diabetic ulcers or amputations.
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I have an autoimmune disease that affects my small intestine.
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My thyroid is underactive or not well-controlled.
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I have an uncontrolled hormone-related condition, but not type 2 diabetes.
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I have a serious condition affecting my esophagus or severe, uncontrolled acid reflux.
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I have a known stomach condition such as an ulcer, hernia, or cancer.
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I have had stomach surgery that might affect treatment near my small intestine.
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I have a history of chronic pancreatitis or had acute pancreatitis in the last year.
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I do not have active hepatitis B or C, cirrhosis, recent severe liver disease, or chronic hepatitis from alcohol or autoimmune disease.
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I have painful gallstones, kidney stones, or inflammation of the gallbladder.
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I currently have an active infection in my body.
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I have a bleeding disorder or active bleeding in my upper GI tract.
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I am not taking medications that affect stomach movement.
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I have severe kidney disease or am on dialysis.
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I have severe issues with blood flow in my limbs.
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I have heart failure that needs medication to manage symptoms.
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I am currently in a weight-loss program and not just maintaining my weight.
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I am currently using medication to help me lose weight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Demonstrate superiority of Revita DMR to sham in improving glycemic control
Secondary study objectives
Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks
Demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks
Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks
+2 more

Trial Design

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 type 2 diabetes on insulin.
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 type 2 diabetes on insulin.

Find a Location

Who is running the clinical trial?

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

Media Library

Duodenal Mucosal Resurfacing (DMR) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04419779 — N/A
Type 2 Diabetes Research Study Groups: Duodenal Mucosal Resurfacing (DMR), Duodenal Mucosal Resurfacing Sham (Sham)
Type 2 Diabetes Clinical Trial 2023: Duodenal Mucosal Resurfacing (DMR) Highlights & Side Effects. Trial Name: NCT04419779 — N/A
Duodenal Mucosal Resurfacing (DMR) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419779 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04419779 — N/A
~69 spots leftby Nov 2025