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
Morphic Medical Inc.
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).
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%). 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
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥22 years and ≤ 65 years 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 place…
Interventions
- DeviceRESET 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.
- OtherSham
Patient receives upper endoscopy but no treatment
Locations (7)
- MedStar Health Research InstituteWashington D.C., District of Columbia
- University of Miami HospitalMiami, Florida
- Brigham and Women's HospitalBoston, Massachusetts
- Michigan Medicine, Division of Gastroenterology and HepatologyAnn Arbor, Michigan
- Weill Cornell MedicineNew York, New York
- Cleveland ClinicCleveland, Ohio