Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
264 participants
INTERVENTIONAL
2019-09-09
2026-12-01
Brief Summary
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A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).
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Detailed Description
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Specific objectives of this study are:
1. To determine if the RESET System significantly improves glycemic control
2. To determine that the RESET System can be safely used to improve glycemic control
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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RESET
Patients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner
RESET Liner
The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.
Sham
Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner.
Sham
Patient receives upper endoscopy but no treatment
Interventions
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RESET Liner
The RESET System is provided as a single-use, sterile device and consists of an RESET Liner preloaded, packaged and sterilized within the RESET Delivery System. The RESET Delivery System is utilized to deliver the RESET Liner to the proximal small intestine. The RESET Liner is removed using the RESET Retrieval System. The RESET System incorporates no pharmacological, biological tissue or blood products.
Sham
Patient receives upper endoscopy but no treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have understood and signed the approved informed consent form
3. Diagnosis of type 2 diabetes
4. HbA1c ≥ 7.5% and ≤10%
5. BMI ≥30kg/m2 and ≤ 50kg/m2
6. Willing and able to comply with study requirements
7. Documented negative pregnancy test in women of childbearing potential
8. Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 1 form of birth-control to prevent unwanted pregnancies
9. At least one year of medical records available, including detailed medical therapy and dosing information
10. Failed to achieve adequate HbA1c reduction (\<7.5%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin, SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.
Exclusion Criteria
2. Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner
3. Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance
4. Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)
5. eGFR of less than 45 ml/min/1.73 m2
6. Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
7. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
8. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
9. Fasting C-peptide \< 1.0 ng/mL
10. Triglyceride level \> 600 mg/dL
11. Vitamin D deficiency (\<20ng/ml)
12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
13. Height \< 5 feet (152.4 cm)
14. Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
15. History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)
16. Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide
17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
18. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI.
19. Uncontrolled thyroid disease, including a history of thyroid cancer, hyperthyroidism, or taking thyroid hormone for any reason other than primary hypothyroidism (TSH level must be between 0.4-4)
20. Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 9 months post implant procedure
21. Currently taking the following medications (within 30 days prior to randomization) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure:
Restricted Medications/Supplements Systemic corticosteroids Proton Pump Inhibitor (PPI) Drugs known to affect GI motility (e.g.metoclopramide) Prescription or over-the-counter weight loss medication(s) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and other anti-inflammatory medication for study duration Medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
Supplements that are known or suspected to increase bleeding risk including but not limited to:
Gingko biloba Ginseng Vitamins C \& E Turmeric St. John's wort Evening primrose oil Feverfew Green Tea Extract
22. Active H. pylori
23. History of Crohn's disease, atresias or untreated stenoses
24. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization
25. Patients may be disqualified for study inclusion for any condition determined by the PI that places the patient at undue risk
26. Poor dentition not allowing complete chewing of food
27. Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)
28. Residing in a location without ready access to study site medical resources
29. Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
30. Positive Fecal Immunochemical Test (FIT) at time of screening
31. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan
32. No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary
33. Having donated blood or received a blood transfusion in the 90 days prior to baseline labs. Patients should agree not to donate blood during the study
34. Any condition that increases red cell turnover, such as thalassemia
35. Existence of (\>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K2
36. A known sensitivity to nickel or titanium
37. Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI conditional but not appropriate for the region of interest)
38. Patients with history or suspicion of coronary artery disease
22 Years
65 Years
ALL
No
Sponsors
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Biostatistical Consulting, Inc.
OTHER
Morphic Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher C Thompson, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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MedStar Health Research Institute
Washington D.C., District of Columbia, United States
University of Miami Hospital
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Michigan Medicine, Division of Gastroenterology and Hepatology
Ann Arbor, Michigan, United States
Weill Cornell Medicine
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.
Rodbard D. Interpretation of continuous glucose monitoring data: glycemic variability and quality of glycemic control. Diabetes Technol Ther. 2009 Jun;11 Suppl 1:S55-67. doi: 10.1089/dia.2008.0132.
Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.
Ford ES, Li C, Little RR, Mokdad AH. Trends in A1C concentrations among U.S. adults with diagnosed diabetes from 1999 to 2004. Diabetes Care. 2008 Jan;31(1):102-4. doi: 10.2337/dc07-0565. Epub 2007 Oct 12. No abstract available.
Detournay B, Cros S, Charbonnel B, Grimaldi A, Liard F, Cogneau J, Fagnani F, Eschwege E. Managing type 2 diabetes in France: the ECODIA survey. Diabetes Metab. 2000 Nov;26(5):363-9.
Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, Marks JS. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003 Jan 1;289(1):76-9. doi: 10.1001/jama.289.1.76.
Torquati A, Lutfi R, Abumrad N, Richards WO. Is Roux-en-Y gastric bypass surgery the most effective treatment for type 2 diabetes mellitus in morbidly obese patients? J Gastrointest Surg. 2005 Nov;9(8):1112-6; discussion 1117-8. doi: 10.1016/j.gassur.2005.07.016.
Rubino F, Gagner M. Potential of surgery for curing type 2 diabetes mellitus. Ann Surg. 2002 Nov;236(5):554-9. doi: 10.1097/00000658-200211000-00003.
Colditz GA, Willett WC, Rotnitzky A, Manson JE. Weight gain as a risk factor for clinical diabetes mellitus in women. Ann Intern Med. 1995 Apr 1;122(7):481-6. doi: 10.7326/0003-4819-122-7-199504010-00001.
Koh-Banerjee P, Wang Y, Hu FB, Spiegelman D, Willett WC, Rimm EB. Changes in body weight and body fat distribution as risk factors for clinical diabetes in US men. Am J Epidemiol. 2004 Jun 15;159(12):1150-9. doi: 10.1093/aje/kwh167.
Ritz E. Limitations and future treatment options in type 2 diabetes with renal impairment. Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S330-4. doi: 10.2337/dc11-s242. No abstract available.
Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703.
Bennett MC, Badillo R, Sullivan S. Endoscopic Management. Gastroenterol Clin North Am. 2016 Dec;45(4):673-688. doi: 10.1016/j.gtc.2016.07.005.
Brethauer SA, Chang J, Galvao Neto M, Greve JW. Gastrointestinal devices for the treatment of type 2 diabetes. Surg Obes Relat Dis. 2016 Jul;12(6):1256-61. doi: 10.1016/j.soard.2016.02.031. Epub 2016 Mar 2.
Frattini F, Borroni G, Lavazza M, Liu X, Kim HY, Liu R, Anuwong A, Rausei S, Dionigi G. New endoscopic procedures for diabetes mellitus type 2 and obesity treatment. Gland Surg. 2016 Oct;5(5):458-464. doi: 10.21037/gs.2016.10.03.
Laubner K, Riedel N, Fink K, Holl RW, Welp R, Kempe HP, Lautenbach A, Schlensak M, Stengel R, Eberl T, Dederichs F, Schwacha H, Seufert J, Aberle J. Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study. Diabetes Obes Metab. 2018 Aug;20(8):1868-1877. doi: 10.1111/dom.13300. Epub 2018 Apr 23.
Related Links
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Merck \& Co. I. Prescribing information: Januvia (sitagliptin) tablets. 2011:1-23.
Other Identifiers
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18-1
Identifier Type: -
Identifier Source: org_study_id
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