Evaluation of the Efficacy and Safety of DMR Using the Revita® in Subjects With Inadequately Controlled Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT04419779
- Lead Sponsor
- Fractyl Health Inc.
- Brief Summary
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 on one or more glucose lowering agents. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Demonstrate superiority of Revita DMR to sham in improving glycemic control Baseline to Week 24 Change from baseline in HbA1c at Week 24
- Secondary Outcome Measures
Name Time Method Demonstrate superiority of Revita DMR to sham in weight loss at 24 weeks Baseline to Week 24 Percentage of total body weight loss (%TBWL) from baseline at Week 24
Demonstrate superiority of Revita DMR to sham in achieving target HbA1c at 24 weeks Baseline to Week 24 The proportion of subjects who achieve an HbA1c of ≤7.0% at Week 24
To demonstrate superiority of Revita DMR to sham in elimination of insulin use at 24 weeks in those subjects on insulin at baseline Baseline to Week 24 4. The proportion of subjects who discontinued insulin at Week 24 in those subjects on insulin at baseline
Demonstrate superiority of Revita DMR to sham in fasting glucose at 24 weeks Baseline to Week 24 Change from baseline in fasting plasma glucose (FPG) at Week 24
Trial Locations
- Locations (58)
Helios CR, Inc
🇺🇸Phoenix, Arizona, United States
HonorHealth Research Institute
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Angel City Research , Inc.
🇺🇸Los Angeles, California, United States
UCLA Health
🇺🇸Los Angeles, California, United States
Care Access Santa Clarita
🇺🇸Newhall, California, United States
Hoag Hospital
🇺🇸Newport Beach, California, United States
Stanford University Medical Center
🇺🇸Redwood City, California, United States
Mills Peninsula Health Center
🇺🇸San Mateo, California, United States
Northeast Research Institute, Llc
🇺🇸Fleming Island, Florida, United States
Scroll for more (48 remaining)Helios CR, Inc🇺🇸Phoenix, Arizona, United States