Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Revita System, Duodenal Mucosal Resurfacing, Insulin-Dependent Diabetes Mellitus
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.
Interventions
The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
DEVICEDuodenal Mucosal Resurfacing (Sham)
The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 48 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
Sponsors
Fractyl Health Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria for inclusion in the study: 1. Males and non-pregnant non-lactating females 2. Age between 21 and 70 years (both inclusive) 3. Subjects on at least one glucose lowering agent (GLA) with no changes in GLA medications or dosing for at least 12 weeks prior to the screening visit Permitted GLAs include: * Metformin, * GLP-1 RA including dual peptide agonists and related molecules (e.g., GLP-1/GIP RA), * DPP-4i, * TZDs, * SGLT2is, * SUs, * Meglitinides, * Insulin (basal or basal combined with short-acting), up to a total of 100 units daily 4. HbA1c of 7.5%-10% (both inclusive) 5. BMI \>24 to ≤40 kg/m2 6. WOCBP should have a negative urine beta hCG pregnancy test and must agree to use two of the established contraceptive methods throughout the study duration 7. Able to sign an ICF and comply with study requirements
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate superiority of Revita DMR to sham in improving glycemic control | Baseline to Week 24 | Change from baseline in HbA1c at Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Belgium, Ireland, Italy, Netherlands, Switzerland, United Kingdom, United States
Outcome results
None listed