RESET System Pivotal Trial (Rev F)

NCT04101669 | Recruiting DMC FDA Device

• 1 other identifier: 18-1
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 7

Brief Summary

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. 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).

Conditions

Diabetes type2; Obesity

Keywords

Type 2 Diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change in HbA1c value from baseline to 9 months.

  9 Months

Secondary Outcomes (16)

• HbA1c value

  9 and 21 months

• Weight Loss

  9 and 21 months

• Insulin use

  9 and 21 months

• LDL cholesterol

  9 and 21 months

• Triglycerides

  9 and 21 months

Study Arms (2)

RESET

EXPERIMENTAL

Patients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner

Device: RESET Liner

Sham

SHAM COMPARATOR

Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner.

Other: Sham

Interventions

RESET Liner DEVICE

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.

Also known as: RESET Sleeve, Duodenal-jejunal Bypass Liner (DJBL), EndoBarrier

RESET

Sham OTHER

Patient receives upper endoscopy but no treatment

Sham

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥22 years and ≤ 65 years
• Have understood and signed the approved informed consent form
• Diagnosis of type 2 diabetes
• HbA1c ≥ 7.5% and ≤10%
• BMI ≥30kg/m2 and ≤ 50kg/m2
• Willing and able to comply with study requirements
• Documented negative pregnancy test in women of childbearing potential
• 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
• At least one year of medical records available, including detailed medical therapy and dosing information
• 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.

You may not qualify if:

• Previous treatment with the RESET System
• 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
• Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance
• 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)
• eGFR of less than 45 ml/min/1.73 m2
• Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
• Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
• Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
• Fasting C-peptide \< 1.0 ng/mL
• Triglyceride level \> 600 mg/dL
• Vitamin D deficiency (\<20ng/ml)
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
• Height \< 5 feet (152.4 cm)
• Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
• History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)

Sponsors & Collaborators

• Morphic Medical Inc.: lead
• Biostatistical Consulting, Inc.: collaborator

Study Sites (7)

MedStar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Miami Hospital

Miami, Florida, 33166, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Michigan Medicine, Division of Gastroenterology and Hepatology

Ann Arbor, Michigan, 48109, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 18784090 BACKGROUND

• 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.

  PMID: 19469679 BACKGROUND

• 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.

  PMID: 10938048 BACKGROUND

• 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.

  PMID: 9742977 BACKGROUND

• 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.

  PMID: 17934146 BACKGROUND

• 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.

  PMID: 11119015 BACKGROUND

• 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.

  PMID: 12503980 BACKGROUND

• 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.

  PMID: 16269382 BACKGROUND

• 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.

  PMID: 12409659 BACKGROUND

• 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.

  PMID: 7872581 BACKGROUND

• 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.

  PMID: 15191932 BACKGROUND

• 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.

  PMID: 21525478 BACKGROUND

• 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.

  PMID: 17130196 BACKGROUND

• 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.

  PMID: 27837781 BACKGROUND

• 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.

  PMID: 27568475 BACKGROUND

• 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.

  PMID: 27867859 BACKGROUND

• 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.

  PMID: 29569313 BACKGROUND

Related Links

• Statistics on ASMBS 2016
• Merck \& Co. I. Prescribing information: Januvia (sitagliptin) tablets. 2011:1-23.

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christopher C Thompson, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen J Linhares, BS

CONTACT

774-454-3259; slinhares@gidynamics.com

Aoife Devery, BS

CONTACT

617-528-8880; adevery@gidynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The Investigators include interventional gastroenterologists (GI) and endocrinologists. The GI team: MD, PA and site coordinator, as well as radiology personnel will not be masked, while the endocrinologist team: the MDs, PAs, site coordinators and nutritionists, will be masked. The patient is also masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System. Patients will be randomized 3 (RESET):1 (Sham).

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: September 9, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)