Evaluation of the effect of Duodenal Mucosal Resurfacing (DMR) using the Revita System in the treatment of Type 2 diabetes (T2D)
- Conditions
- Diabetes Type 2T2D10012653
- Registration Number
- NL-OMON48696
- Lead Sponsor
- Fractyl Laboratories Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. 28-75 years of age
2. Diagnosed with Type 2 Diabetes and evidence of preserved insulin secretion.
Fasting insulin > 7.0 µU/ mL.
3. HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
4. Body Mass Index (BMI) >= 24 and <= 40 kg/m2
5. Currently taking one or more oral glucose lowering medications, of which one
must be Metformin, with no changes in dose or medication in the previous 12
Weeks prior to study entry.
6. Able to comply with study requirements and understand and sign the informed
consent
1. Diagnosed with Type 1 Diabetes or with a history of
ketoacidosis
2. Current use of Insulin
3. Current use of GLP-1 analogues
4. Hypoglycemia unawareness or a history of severe
hypoglycemia (more than 1 severe hypoglycemic event, as
defined by need for third-party-assistance, in the last year)
5. Known autoimmune disease, as evidenced by a positive Anti-
GAD test, including Celiac disease, or pre-existing symptoms
of systemic lupus erythematosus, scleroderma or other
autoimmune connective tissue disorder
6. Active H. pylori infection (Participants with active H. pylori may
continue with the screening process if they are treated via
medication.)
7. Previous GI surgery that could affect the ability to treat the
duodenum such as subjects who have had a Bilroth 2, Rouxen-
Y gastric bypass, or other similar procedures or conditions
8. History of chronic or acute pancreatitis
9. Known active hepatitis or active liver disease
10. Symptomatic gallstones or kidney stones, acute cholecystitis
or history of duodenal inflammatory diseases including
Crohn*s Disease and Celiac Disease
11. History of coagulopathy, upper gastro-intestinal bleeding
conditions such as ulcers, gastric varices, strictures,
congenital or acquired intestinal telangiectasia
12. Use of anticoagulation therapy (such as warfarin) which
cannot be discontinued for 7 days before and 14 days after
the procedure
13. Use of P2Y12 inhibitors (clopidogrel, pasugrel, ticagrelor)
which cannot be discontinued for 14 days before and 14 days
after the procedure. Use of aspirin is allowed.
14. Unable to discontinue NSAIDs (non-steroidal antiinflammatory
drugs) during treatment through 4 weeks post
procedure phase
15. Taking corticosteroids or drugs known to affect GI motility
(e.g. Metoclopramide)
16. Receiving weight loss medications such as Meridia, Xenical,
or over the counter weight loss medications
17. Persistent Anemia, defined as Hgb<10 g/dl
18. eGFR or MDRD <30 ml/min/1.73m^2
19. Active systemic infection
20. Active malignancy within the last 5 years
21. Not potential candidates for surgery or general anesthesia
22. Active illicit substance abuse or alcoholism
23. Participating in another ongoing clinical trial of an
investigational drug or device
24. Any other mental or physical condition which, in the opinion of
the Investigator, makes the subject a poor candidate for
clinical trial participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Endpoint:<br /><br>The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c,<br /><br>DMR vs Sham and the absolute change at 12 weeks in MR-PDFF In patients with<br /><br>baseline MR-PDFF > 5%, DMR vs Sham<br /><br><br /><br>Primary Safety Endpoint:<br /><br>The primary safety endpoint is incidence rates of device or procedure related<br /><br>SAEs, UADEs and AESIs DMR vs Sham through 24 Weeks post procedure.</p><br>
- Secondary Outcome Measures
Name Time Method