Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413567
• Other study ID #: C-20000 A & B
• Status: Completed
• Phase: N/A
• Start date: March 23, 2015
• Est. completion date: September 18, 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 evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 18, 2019
• Est. primary completion date: June 12, 2017
• 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 for less than 10 years

3. HbA1c of 7.5 - 10.0% (59-86 mmol/mol)

4. Body Mass Index (BMI) = 24 and = 40 kg/m2

5. On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry

6. Willing to comply with study requirements and able to understand and comply with informed consent

7. Sign an informed consent form

Exclusion Criteria

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

2. Probable insulin production failure, defined as fasting C Peptide serum <1ng/mL (333pmol/l)

3. Current use of Insulin

4. Use of Glucagon like peptide (GLP)-1 analogues

5. Hypoglycemia unawareness or a history of severe hypoglycemia (at least 1 severe hypoglycemic event, as defined by need for third-party-assistance, in the last year)

6. 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

7. Previous gastrointestinal (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 (clopidrogel, 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 mg/dl

18. Estimated glomerular filtration rate (eGFR) or Modification of Diet in Renal Disease (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. Those who are pregnant, nursing or expect to become pregnant over the course of the study

24. Participating in another ongoing clinical trial

25. 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

Intervention

Device:
• DMR Procedure (Fractyl)
Endoscopic procedure

Locations

Country	Name	City	State
Belgium	Hopital Erasme	Brussels
Belgium	UZ Leuven	Leuven
Chile	Centro Clinico de Obesidad	Santiago
Italy	Università Cattolica del Sacro Cuore, Policlinico A. Gemelli	Rome	Lazio
Netherlands	Academic Medical Center	Amsterdam
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	University College London Hospitals	London

Sponsors (1)

Lead Sponsor	Collaborator
Fractyl Health Inc.

Countries where clinical trial is conducted

Belgium,  Chile,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure		24 weeks post-procedure
Primary	Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)		24 weeks post-procedure