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Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy (REVITALIZE 1)

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ClinicalTrials.gov Identifier: NCT04419779
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Fractyl Health Inc.

Study Description
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Brief Summary:
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 with insulin therapy. 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: Duodenal Mucosal Resurfacing (DMR) Device: Duodenal Mucosal Resurfacing (Sham) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy
Actual Study Start Date : March 8, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Duodenal Mucosal Resurfacing (DMR)
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.
 Device: Duodenal Mucosal Resurfacing (DMR)
The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
Sham Comparator: Duodenal Mucosal Resurfacing Sham (Sham)
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.
 Device: Duodenal Mucosal Resurfacing (Sham)
The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.


Outcome Measures
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Primary Outcome Measures :
  1. Demonstrate superiority of Revita DMR to sham in improving glycemic control [ Time Frame: Baseline to Week 24 ]
    Change from baseline in HbA1c at Week 24


Secondary Outcome Measures :
  1. Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks [ Time Frame: Baseline to Week 24 ]
    The proportion of subjects who achieve an HbA1c of ≤7.0% at Week 24

  2. Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks [ Time Frame: Baseline to Week 24 ]
    Change from baseline in fasting plasma glucose (FPG) at Week 24

  3. Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks [ Time Frame: Baseline to Week 24 ]
    Percentage of total body weight loss (%TBWL) from baseline at Week 24

  4. Demonstrate superiority of Revita DMR to sham in insulin requirement at 24 weeks [ Time Frame: Baseline to Week 24 ]
    Percentage change from baseline in insulin total daily dose at Week 24

  5. Demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks [ Time Frame: Baseline to Week 24 ]
    The proportion of subjects who discontinued insulin at Week 24


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male, and non-pregnant, non-lactating females
  2. Age between 21 and 70 years (both inclusive)

  3. Subjects with type 2 diabetes on stable doses of 20-100 units (both inclusive) of total daily insulin dose of basal insulin or basal insulin combined with short-acting insulin and up to 3 permitted non-insulin antidiabetic agents (ADAs). Permitted non-insulin ADAs include:

    • Metformin,
    • Glucagon-like peptide-1 receptor agonist (GLP-1 RA) including dual peptide agonists and related molecules (e.g., glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA),
    • Dipeptidyl peptidase 4 inhibitor (DPP-4i),
    • Thiazolidinediones (TZD),
    • Sodium-glucose cotransporter 2 inhibitors (SGLT2i),
    • Sulfonylureas (SU),
    • Meglitinides
  4. Glycosylated hemoglobin A1c (HbA1c) of 7.5-10% (both inclusive)
  5. Body mass index (BMI) > 24 to ≤ 40 kg/m^2
  6. Women of childbearing potential (WOCBP) should have a negative urine beta human chorionic gonadotrophin (hCG) pregnancy test and must agree to use two established contraceptive methods throughout the study duration.
  7. Able to sign an informed consent form and comply with study requirements

Exclusion Criteria:

  1. FPG >270 mg/dL
  2. Known case of absolute insulin deficiency as indicated by clinical assessment a fasting plasma C-peptide of <0.6 ng/ml
  3. Subjects on any other class of glucose-lowering agents other than GLAs listed in inclusion criteria
  4. Any drugs or concomitant medications (e.g., psychoactive drugs such as carbamazepine, phenobarbital, sympathomimetics such as ephedrine, corticosteroids, anabolic steroids, and male sex hormones such as testosterone) that can interfere with glucose metabolism
  5. Recurrent or severe urinary tract or genital mycotic infections or history of genitourinary infection within 4 weeks prior to informed consent
  6. ALT or AST >3 times upper limit normal values
  7. Use of an investigational drug within 1 month or 5 half-lives (whichever is longer) before the screening
  8. Diagnosed with type 1 diabetes or with a recent history of ketoacidosis
  9. Ketosis-prone T2D
  10. Known diabetes related non-healing diabetic ulcers or amputations
  11. History of more than 1 severe hypoglycemia episode or hypoglycemia unawareness within past 6 months
  12. Clinically significant hypoglycemia occurring during the run-in period, defined as a) 2 or more glucose alert values of ≤70 mg/dL (3.9 mmol/L) unless a clear correctable precipitating factor can be identified; b) clinically significant hypoglycemia with self-monitored or laboratory plasma glucose level <54 mg/dL (3.0 mmol/L); c) severe hypoglycemic episode requiring third party assistance
  13. Known intestinal autoimmune disease, including celiac disease, ulcerative colitis, Crohn's disease, lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder, which affects the small intestine
  14. Secondary hypothyroidism or inadequately controlled primary hypothyroidism (thyroid stimulating hormone [TSH] value outside the normal range at screening)
  15. Known history of thyroid cancer or hyperthyroidism with treatment within the past 12 months or inadequately controlled hyperthyroidism
  16. An uncontrolled endocrine condition such as multiple endocrine neoplasia (except T2D)
  17. Known history of a structural or functional disorder of the esophagus, including any swallowing disorder, esophageal chest pain disorders, drug-refractory esophageal reflux symptoms, or active and uncontrolled gastroesophageal reflux disease (GERD) (grade 3 esophagitis or greater)
  18. Known structural or functional disorder of the stomach including gastric ulcer, chronic gastritis, gastric varices, hiatal hernia (a large hiatal hernia or type II and higher paraoesophageal hernia), cancer, or any other disorder of the stomach
  19. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Billroth 2, Roux-en-Y gastric bypass, gastric sleeve or other similar procedures or conditions
  20. Known history of chronic pancreatitis or a recent history of acute pancreatitis within the past year
  21. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis; hepatic decompensation/acute liver disease during the last 6 months; or alcoholic or autoimmune chronic hepatitis
  22. Symptomatic gallstones, symptomatic kidney stones, or acute cholecystitis
  23. Clinically active systemic infection
  24. Known immunocompromised status including but not limited to individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months; have clinically significant leukopenia; are positive for the human immunodeficiency virus (HIV); are on potential immunosuppressants; or individuals whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator
  25. Known active malignancy or partial remission from clinically significant malignancy within the past 5 years (except basal or squamous cell skin cancer, carcinoma in situ, those who received curative treatment and are in complete remission for 5 years, or if the subject is confirmed as cancer free)
  26. Known active coagulopathy or current upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, or congenital or acquired intestinal telangiectasia
  27. Known cases of anemia, thalassemia, or conditions that affect red blood cell (RBC) turnover such as a recent blood transfusion within 90 days
  28. Use of anticoagulation therapy (e.g., warfarin, coumadin, or novel oral anticoagulants such as NOAC) or anti-platelet agents (e.g., thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure
  29. Use of systemic glucocorticoids (excluding topical or ophthalmic applications or inhaled forms) for more than 10 consecutive days within 90 days prior to the screening visit
  30. Use of non-GLA drugs known to affect GI motility (e.g., metoclopramide)
  31. Known moderate to severe chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73m2 (estimated by Modification of Diet in Renal Disease [MDRD]), end-stage renal failure, or on dialysis
  32. History of myocardial infarction, stroke, transient ischemic attack, coronary artery intervention, CHF exacerbation, or a major event requiring hospitalization within the last 6 months prior to screening
  33. History of new or worsening signs or symptoms of coronary heart disease (CHD) within the last 3 months
  34. Known case of severe peripheral vascular disease, disease, defined as AMA Criteria Class 1 or greater
  35. Known case of symptomatic heart failure with reduced ejection fraction (NYHA Class II-IV) requiring pharmacologic therapy to control symptoms
  36. Clinically significant electrocardiogram (ECG) findings such as new clinically significant arrhythmia, ST segment changes, or other conduction disturbances that increase risk of heart disease and require intervention as determined by the investigator
  37. Subjects who are at risk of pancreatitis, particularly those with a recent fasting triglyceride value of >600 mg/dL within the past 3 months
  38. Actively participating in a weight-loss program and currently not in the maintenance phase
  39. General contraindications to deep or conscious sedation, general anesthesia, high risk as determined by anesthesiologist (e.g., ASA score 4 or higher), or contraindications to upper GI endoscopy
  40. History of substance use disorder based on the DSM-5 criteria within the last 12 months.
  41. Use of weight loss medication such as Meridia, Xenical, over-the-counter weight-loss medications, or other prescribed medications used specifically for the purpose of weight loss
  42. Use of dietary supplements or herbal preparations that may have unknown effects on glycemic control or risk of bleeding
  43. Participating in another ongoing clinical trial of an investigational drug or device
  44. History of non-adherence to treatment in the previous 6 months, as determined by the investigator based on patient history, HbA1c value, or drug accountability
  45. Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical-trial participation
  46. Unwilling or unable to perform SMBG, complete the subject glycemia diary, or comply with study visits and other study procedures as required per protocol
  47. Recovered from severe COVID-19 infection (requiring hospitalization) but with persistent long COVID-19 symptoms (i.e., the individual has not recovered for several weeks or months since the start of symptoms that were suggestive of COVID-19, irrespective if the individual is tested or not)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419779


Contacts
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Contact: Lynn Wilson 781-208-2564 lwilson@fractyl.com
Contact: Kelly White kwhite@fractyl.com

Locations
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Sponsors and Collaborators
Fractyl Health Inc.
More Information
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Responsible Party: Fractyl Health Inc.
ClinicalTrials.gov Identifier: NCT04419779    
Other Study ID Numbers: C-00044
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Fractyl Health Inc.:
Type 2 Diabetes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Revita System
Duodenal Mucosal Resurfacing
Insulin-Dependent Diabetes Mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases