Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of the Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879383
• Other study ID #: C-30000
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2024
• Source: Fractyl Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal mucosal resurfacing (DMR) Procedure using the Revita System compared to a sham procedure for the treatment of uncontrolled type 2 diabetes.

Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham treatment arm will cross over to receive the DMR treatment at 24 weeks with background medications held constant from 24-48 weeks of follow up.

Description:

The study is a multi-center, randomized, prospective, double-blinded (subject and endocrinologist) trial of type 2 diabetes patients sub-optimally controlled on 1 or more oral anti-diabetic medications comparing the Fractyl DMR procedure to sham procedure. Randomization will be 1:1 DMR treatment to sham. All subjects will participate in a 4 week oral anti-diabetic medication run-in period before the index procedure to confirm lack of blood glucose control in conjunction with medication compliance and nutritional counseling. The Sham treatment arm will cross-over to receive the DMR treatment at 24 weeks with background medications held constant 24weeks of follow up after the cross-over DMR procedure. The DMR treatment arm will be managed according to current diabetes standard of care.

Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. The Sham treatment arm will cross over to receive the DMR treatment at 24 weeks with background medications held constant from 24-48 weeks of follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 28-75 years of age

2. Diagnosed with Type 2 Diabetes and evidence of preserved insulin secretion. Fasting insulin > 7 µU/ mL.

3. Glycated Hemoglobin (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

Exclusion Criteria:

1. Diagnosed with Type 1 Diabetes or with a history of ketoacidosis

2. Current use of Insulin

3. Current use of Glucagon-like peptide-1 (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- Glutamic Acid Decarboxylase (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 and re-testing verifies the condition has resolved.)

7. Previous GI surgery that could affect the ability to treat the duodenum such as subjects who have had a Bilroth 2, Roux-en-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 anti-inflammatory 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. Estimated Glomerular Filtration Rate (eGFR) or Modified of Diet in Renal Diseae (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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Noninsulin-Dependent Diabetes Mellitus

Intervention

Procedure:
• DMR Procedure
The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
• Sham Procedure
The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Brussels
Belgium	UZ Leuven	Leuven
Brazil	Hospital das Clinicas da Faculdade de medicina da Universidade de São Paulo	Sao Paulo
Brazil	ABC Hospital	São Paulo
Italy	Humanitas Research Hospital & Humanitas University Via Manzoni 56, Rozzano	Milano
Italy	Policlinico Gemelli (Sacro Cuore)	Rome	Lazio
Netherlands	Amsterdam University Medical Center	Amsterdam
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	King's College, Denmark Hill	London
United Kingdom	University College London Hospitals	London
United Kingdom	Queens Medical Centre campus, Nottingham University Hospitals NHS Trust, Derby Road	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Fractyl Health Inc.

Countries where clinical trial is conducted

Belgium,  Brazil,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham.	The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham	Baseline and 24 Weeks post-procedure
Primary	Change From Baseline at 12 Weeks in MR-PDFF, DMR vs Sham	The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF > 5% , DMR vs Sham	Baseline and 12 Weeks post-procedure