Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes

Completed · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. At 24 weeks, subjects randomized to the DMR procedure be continued to be followed per protocol till 48 Weeks and the Sham treatment arm will be offered to cross over to receive the DMR treatment and will be followed per protocol for 24 weeks post treatment.

Key facts

Study ID

NCT03653091

Run by

Fractyl Health Inc.

People needed

9

Starts

2018-09-28

Expected to finish

2020-08-10

Last updated by the study team

2024-02-14

Who can join

Age: 28 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and non-pregnant women 28-65 years of age
• Diagnosed with T2D for at least 3 years
• A1C of 7.5 - 9.5% (59-80 mmol/mol)
• BMI ≥ 28 and ≤ 40 kg/m2
• On two to three oral OADs (metformin plus one to two additional OADs) with two (see note below) at least at half maximum labeled dose (or highest tolerated) with no changes in medication in the 12 weeks prior to the Screening Visit (Visit 1) (Refer to ADA Standard of Medical Care in Diabetes 2018, Table 8.3 for the maximum approved daily dose of non-insulin glucose lowering agents) (43). Note: For subjects on sulfonylurea (SU) glucose-lowering drugs for diabetes, the only SUs permitted in the study will be glipizide or glimepiride, and their doses below half maximum labeled dosing will not be an exclusion for study entry. Patients unwilling to reduce the dose of SU at the time of the DMR procedure as described by protocol will be excluded.
• Agree to use an additional glucose-lowering treatment (eg, liraglutide, other OAD with the exception of glyburide) if recommended by the study investigator in case of persistent hyperglycemia.
• Agree not to donate blood during their participation in the study
• Able to comply with study requirements and understand and sign the Informed Consent Form
• Women of childbearing potential (WOCBP) must be using two acceptable methods of contraception throughout the study
• Women must not be breastfeeding

You may not qualify if…

• Diagnosed with Type 1 Diabetes (T1D)
• History of diabetic ketoacidosis or hyperosmolar nonketotic coma
• Probable insulin production failure, defined as fasting C Peptide serum <1 ng/mL (333pmol/l)
• Previous use of any types of insulin for >1 month (at any time, except for treatment of gestational diabetes)
• Current use of injectable medications for diabetes (insulin, GLP-1RA)
• Current use of glyburide, a sulfonylurea (SU) glucose-lowering drug for diabetes
• Hypoglycemia unawareness or a history of severe hypoglycemia (more than 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)
• Known autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Previous GI surgery that could limit treatment of the duodenum such as Bilroth 2, Roux-en-Y gastric bypass, or other similar procedures or conditions
• History of chronic or acute pancreatitis
• History of diabetic gastroparesis
• Known active hepatitis or active liver disease
• Acute gastrointestinal illness in the previous 7 days
• Known history irritable bowel syndrome, radiation enteritis or other inflammatory bowel disease, such as Crohn's disease
• Known history of a structural or functional disorder of the esophagus that may impede passage of the device through the gastrointestinal tract or increase risk of esophageal damage during an endoscopic procedure, including Barrett's esophagus, esophagitis, dysphagia, achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, or any other disorder of the esophagus
• Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, or drug refractory esophageal reflux symptoms
• Known history of a structural or functional disorder of the stomach including gastroparesis, gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (> 2 cm), cancer or any other disorder of the stomach
• Known history of chronic symptoms suggestive of a structural or functional disorder of the stomach, including any symptoms of chronic upper abdominal pain, chronic nausea, chronic vomiting, chronic dyspepsia or symptoms suggestive of gastroparesis, including post-prandial fullness or pain, post-prandial nausea or vomiting or early satiety
• Known history of duodenal ulcer, intestinal diverticula (diverticulitis), intestinal varices, intestinal stricture/stenosis, small bowel obstruction, or any other obstructive disorder of the GI tract
• Currently have ongoing symptoms suggestive of intermittent small bowel obstruction, such as recurrent bouts of post-prandial abdominal pain, nausea or vomiting
• Active H. pylori infection (Subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen)
• History of coagulopathy, upper gastrointestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
• Current use of anticoagulation therapy (such as warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
• Current use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor) which cannot be discontinued for 14 days before and 14 days after the procedure.
• Unable to discontinue non-steroidal anti-inflammatory drugs (NSAIDs) during treatment through 4 weeks following the procedure. Use of low dose aspirin is allowed.

Where it is running

• Florida Hospital / TRANSLATIONAL RESEARCH INSTITUTE FOR METABOLISM AND DIABETES (TRI) — Orlando, Florida, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• University of Pennsylvania - Penn Metabolic Medicine — Philadelphia, Pennsylvania, United States
• UTHealth — Houston, Texas, United States
• Texas Diabetes Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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