Diabetes type2STEP-1NCT04101669
The RESET System Pivotal Clinical Trial (Protocol Revision K)
A study testing RESET Liner in people with Diabetes type2 and Obesity, run by Morphic Medical Inc. at 27 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Diabetes type2, Obesity
- What is being tested?
- RESET Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 27 sitesUnited States
- Study dates
- 9 Sep 2019to 30 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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)
- Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide
- Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
- Active or recent (less than 12 months) gastroesophageal reflux disease (GERD), unless treated with H2Ras not PPI.
- 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)
- 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
- 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
- Active H. pylori
- History of Crohn's disease, atresias or untreated stenoses
- Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization
- Patients may be disqualified for study inclusion for any condition determined by the PI that places patient at undue risk.
- Poor dentition not allowing complete chewing of food
- Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)
- Residing in a location without ready access to study site medical resources
- Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
- Positive Fecal Immunochemical Test (FIT)
- History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan
- No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary
- 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
- Any condition that increases red cell turnover, such as thalassemia
- Existence of (>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K36. A known sensitivity to nickel or titanium
- 37. Do not meet the screening criteria for Fibroscan (i.e., Fibroscan unsafe, or Fibroscan conditional but not appropriate for the region of interest 38. History of myocardial infarction, stroke, or hospitalization for heart failure 39. History Afib and/or cardiac arrythmias 40. History of unstable angina 41.History of new or worsening signs or symptoms of CAD within the last 3 months 42.Any contraindication to general anesthesia or high risk for general anesthesia as determined by anesthesiologist (e.g., ASA score 4 or higher)
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 27 recruiting
- Recruiting
Michigan Medicine, Division of Gastroenterology and Hepatology
Ann Arbor, Michigan, 48109
Spring Stonebraker, 734-615-6258, sprstone@med.umich.edu
Allison R Schulman, MD
- Recruiting
Elevate Clinical Research, Atascocita
Atascocita, Texas, 77346
Shalina Wells, 4693401433, Shalina.Wells@elevateclinical.com
Maria Berdayes, MD
- Recruiting
Denali Health Atlanta
Atlanta, Georgia, 30083
Maryam Bintumar, (404) 999-2734, maryam@denali-health.com
Maria Johnson
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Delaney Mahan, MS, 617-525-8266, dmanahan@bwh.harvard.edu
Christopher C Thompson, MD
- Recruiting
Imagine Research
Boynton Beach, Florida, 33435
Zachary M Weiss, Zachary@imagineresearch.com
Aaron Cohen, MD
- Recruiting
M3 Wake Research
Dallas, Texas, 75224
Vicki Martinez, vmartinez@wakeresearch.com
Carlos Arauz-Pacheco, MD
- Recruiting
Epic Medical Research
DeSoto, Texas, 75115
Josie Propheter, 9302324376, jquemado@epicmedresearch.com
Haresh Boghara, MD
- Recruiting
Care United Research
Forney, Texas, 75126
Caroline Woodruff, 972-564-0044, caroline.woodruff@careunitedresearch.com
Shilpi Mittal, MD
- Recruiting
Banner Health
Gilbert, Arizona, 85234
Bethany Kerr, (480) 649-6600, Bethany.Kerr2@bannerhealth.com
Neil Sharma, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Haydee Rochits, 713-798-0950, BCM-RESET@bcm.edu
Wasif M Abidi, MD
- Recruiting
Elevate Clinical Research, Houston
Houston, Texas, 78504
Jennifer Keane, (832) 240-9765, jennifer.keane@elevateclinical.com
Joe Pouzar, MD
- Recruiting
Elevate Clinical Research, Lake Charles
Lake Charles, Louisiana, 70605
Ashley Pennington, 4693401433, ashley.pennington@elevateclinical.com
Francisco Marrero, MD
- Recruiting
Drug Studies America
Marietta, Georgia, 30060
Tanya Astorga, 470-535-9379, tastorga@drugstudies.net
Glenn Gatipon, MD
- Recruiting
HCA Health Research Institute
Miami, Florida, 33140
Ana Portela, 786-457-7672, ana.portela@hcahealthcare.com
Nestor De La Cruz, MD
- Recruiting
UMiami
Miami, Florida, 33143
Giana Ilarraza, 305-689-1910, gni4@med.miami.edu
Robert Cubas
- Recruiting
Quantum Clinical Trials
Miami Beach, Florida, 33140
Nicole Burgos, 955-375-2235, nicole@qctrials.com
George Azar, MD
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Veronika Solomon, ves4012@med.cornell.edu
Reem Sharaiha, MD
- Recruiting
Optimal Research Sites
Orange City, Florida, 32763
Claxton Copeland, (386) 218-5911, claxton.copeland@optimalresearchsites.net
Kristyna Paradis, MD
- Recruiting
Orlando Health
Orlando, Florida, 32806
Leticia Morales, 321-843-8910, Leticia.Morales@orlandohealth.com
Andre Texeira, MD
- Recruiting
Denali Health Plant City
Plant City, Florida, 33563
Maryam Bintumar, (217) 933-2108, maryam.bintumar@orlandohealth.com
Luis Aponte, MD
- Recruiting
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Cassandra Bravo, 954-372-2209, cassandra@floridacrc.com
Howard Koch, MD
- Recruiting
VAST Clinical Research
Prosper, Texas, 75078
Bukola Adaramola, bukolaa@vastclinicalresearch.com
Uchenna Ozuah
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Abigail Stromme, (507) 284-2511, Stromme.Abigail@mayo.edu
Dan Maselli, MD
- Recruiting
EBGS Clinical Research
Snellville, Georgia, 30078
Cheyenne Head, cheyenne@esbariatricandgeneralsurgery.com
Aliu Sanni, MD
- Recruiting
M3 Wake Research
Tucson, Arizona, 85710
Namrata Oza, 520-230-1372, noza@wakeresearch.com
David Alster, MD
- Recruiting
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Temesgen Atew, 202-877-5819, Temesgen.A.Atew@medstar.net
John Brebbia, MD
- Not yet recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
Michael Maresca, mmaresca@hscresearch.com
Robert Dudley, MD
About this study
Official title: 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
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).
Read the detailed description
The objective of this study is to evaluate the safety and effectiveness of the RESET System when used with moderate intensity lifestyle and dietary counseling and medical management, in patients with baseline HbA1c ≥ 7.5% and ≤10%, and BMI ≥ 30 kg/m2 and ≤ 50kg/m2, whose diabetes medications consist of at least dual therapy for 3 months, yet have not achieved adequate HbA1c control (<7.5%).
Specific objectives of this study are:
- To determine if the RESET System significantly improves glycemic control
- To determine that the RESET System can be safely used to improve glycemic control
- Conditions
- Diabetes type2, Obesity
- Being tested
- RESET Liner, Sham
- Keywords
- Type 2 Diabetes, Obesity
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESET LinerDevice
Also called RESET Sleeve, Duodenal-jejunal Bypass Liner (DJBL), EndoBarrier
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.
ShamOther
Patient receives upper endoscopy but no treatment
| Study group | Role | What they receive |
|---|---|---|
| RESET Treatment Arm | Experimental | Patients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner Receives: Device: RESET Liner |
| Sham Control Arm | Sham comparator | Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Change in HbA1c value from baseline to 9 months.
Measured: 9 Months
SAE Rate
Incidence of serious adverse events
Measured: 9 months
Secondary outcomes (7)
HbA1c Reduction
Proportion of patients who achieve an HbA1c reduction ≥0.5%
Measured: 9 and 21 months
Weight Loss
Proportion of patients who achieve percent total body weight loss ≥ 5% from baseline
Measured: 9 and 21 months
Insulin use
Reduction in percentage insulin units per day
Measured: 9 and 21 months
Fasting blood glucose level
Reduction in fasting blood glucose values
Measured: 9 and 21 months
Diabetes Treatment Satisfaction Questionnaire
Change from baseline in treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire (DTSQ) (0-6, 0=Very dissatified, 6=Very satisfied)
Measured: 9 and 21 months
Impact of Weight on Quality of Life
Impact of weight on quality of life (IWQOL) questionnaire change from baseline (0-100, 0=Worst, 100=Best quality of life)
Measured: 9 and 21 months
EQ-5D
Change from baseline in treatment satisfaction using EuroQol-5D (1-5, 1=No problem, 5=Extreme problems)
Measured: 9 and 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start9 Sep 2019
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diabetes type2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morphic Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biostatistical Consulting, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher C Thompson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101669
- Sponsor's protocol ID
- 18-1
- Acronym
- STEP-1
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2019
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 18784090Rodbard 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.
PubMed 19469679Stratton 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.
PubMed 10938048Effect 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.
PubMed 9742977Ford 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.
PubMed 17934146Detournay 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.
PubMed 11119015Mokdad 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.
PubMed 12503980Torquati 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.
PubMed 16269382Rubino 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.
PubMed 12409659Colditz 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.
PubMed 7872581Koh-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.
PubMed 15191932Ritz 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.
PubMed 21525478Aschner 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.
PubMed 17130196Bennett 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.
PubMed 27837781Brethauer 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.
PubMed 27568475