Type 2 Diabetes Clinical Trial
— REVITALIZE 1Official 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
NCT number | NCT04419779 |
Other study ID # | C-00044 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 8, 2021 |
Est. completion date | January 2026 |
Verified date | May 2024 |
Source | Fractyl Health Inc. |
Contact | Lynn Wilson |
Phone | 781-208-2564 |
lwilson[@]fractyl.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | January 2026 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Belgium | Cliniques Universitaires de Bruxelles Hopital Erasme | Bruxelles | |
France | Bichat-Claude Bernard Hospital | Paris | |
Ireland | University College Dublin | Dublin | |
Italy | Italy Gemelli | Roma | |
Netherlands | Universiteit Van Amsterdam Academisch Medisch Centrum | Amsterdam | |
Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
Switzerland | Inselspital | Bern | |
Switzerland | University Hospital Zurich | Zürich | |
United Kingdom | Cleveland Clinic London | London | England |
United Kingdom | King's College Hospital | London | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | AHN - Avon | Avon | Indiana |
United States | Beth Israel | Boston | Massachusetts |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Investigators Research Group | Brownsburg | Indiana |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Northwestern Unviersity | Evanston | Illinois |
United States | Northeast Research Institute, Llc | Fleming Island | Florida |
United States | AHN- Franklin | Franklin | Indiana |
United States | AHN - Greenfield | Greenfield | Indiana |
United States | Baylor St. Luke's Medical Center | Houston | Texas |
United States | Biopharma Informatic, Llc | Houston | Texas |
United States | Indiana University School of Medicine | Indianapolis | Indiana |
United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
United States | Jefferson City Medical Group | Jefferson City | Missouri |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Endocrine Associates of West Village | Long Island City | New York |
United States | Angel City Research , Inc. | Los Angeles | California |
United States | UCLA Health | Los Angeles | California |
United States | University of Louisville | Louisville | Kentucky |
United States | Alcanza Clinical Research, LLC | Methuen | Massachusetts |
United States | University of Miami | Miami | Florida |
United States | West Virginia University | Morgantown | West Virginia |
United States | AHN - Muncie | Muncie | Indiana |
United States | Yale | New Haven | Connecticut |
United States | Tulane University | New Orleans | Louisiana |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | NYU Langone Gastroenterology Associates | New York | New York |
United States | Synexus Clinical Research, New York | New York | New York |
United States | Weill Cornell Medicine | New York | New York |
United States | Care Access Santa Clarita | Newhall | California |
United States | Hoag Hospital | Newport Beach | California |
United States | West Orange Endocrinology | Ocoee | Florida |
United States | Advent Health Orlando | Orlando | Florida |
United States | Synexus Research | Orlando | Florida |
United States | St. Joseph Medical Center | Paterson | New Jersey |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Helios CR, Inc | Phoenix | Arizona |
United States | Preferred PCP - Pittsburgh | Pittsburgh | Pennsylvania |
United States | Preferred Primary Care Physicians | Pittsburgh | Pennsylvania |
United States | M3 Wake Research | Raleigh | North Carolina |
United States | Stanford University Medical Center | Redwood City | California |
United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
United States | IMA Clinical Research St. Louis | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | AcellaCare Salisbury | Salisbury | North Carolina |
United States | Mills Peninsula Health Center | San Mateo | California |
United States | HonorHealth Research Institute | Scottsdale | Arizona |
United States | Mayo Clinic Arizona | Scottsdale | Arizona |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | AcellaCare Piedmont | Statesville | North Carolina |
United States | Simcare Medical Research, Llc. | Sugar Land | Texas |
United States | Care Access Warwick | Warwick | Rhode Island |
United States | AcellaCare Wilmington | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Fractyl Health Inc. |
United States, Belgium, France, Ireland, Italy, Netherlands, Spain, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Demonstrate superiority of Revita DMR to sham in improving glycemic control | Change from baseline in HbA1c at Week 24 | Baseline to Week 24 | |
Secondary | Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks | The proportion of subjects who achieve an HbA1c of =7.0% at Week 24 | Baseline to Week 24 | |
Secondary | Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks | Change from baseline in fasting plasma glucose (FPG) at Week 24 | Baseline to Week 24 | |
Secondary | Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks | Percentage of total body weight loss (%TBWL) from baseline at Week 24 | Baseline to Week 24 | |
Secondary | Demonstrate superiority of Revita DMR to sham in insulin requirement at 24 weeks | Percentage change from baseline in insulin total daily dose at Week 24 | Baseline to Week 24 | |
Secondary | Demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks | The proportion of subjects who discontinued insulin at Week 24 | Baseline to Week 24 |
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