Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

NCT02413567 | Completed

• 1 other identifier: C-20000 A & B
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the Fractyl Duodenal Mucosal Resurfacing (DMR) Procedure for the treatment of Type 2 Diabetes.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure

  24 weeks post-procedure

• Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)

  24 weeks post-procedure

Study Arms (1)

DMR Procedure

EXPERIMENTAL

Subjects receive the endoscopic DMR procedure in this arm

Device: DMR Procedure (Fractyl)

Interventions

DMR Procedure (Fractyl) DEVICE

Endoscopic procedure

DMR Procedure

Eligibility Criteria

• Age: 28 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Diagnosed with Type 2 Diabetes for less than 10 years
• HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
• Body Mass Index (BMI) ≥ 24 and ≤ 40 kg/m2
• On a minimum of 1 stable oral anti-diabetic medications with no changes in medication in the previous 3 months prior to study entry
• Willing to comply with study requirements and able to understand and comply with informed consent
• Sign an informed consent form

You may not qualify if:

• Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
• Probable insulin production failure, defined as fasting C Peptide serum \<1ng/mL (333pmol/l)
• Current use of Insulin
• Use of Glucagon like peptide (GLP)-1 analogues
• 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)
• 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
• 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
• History of chronic or acute pancreatitis
• Known active hepatitis or active liver disease
• Symptomatic gallstones or kidney stones, acute cholecystitis or history of duodenal inflammatory diseases including Crohn's Disease and Celiac Disease
• History of coagulopathy, upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia
• Use of anticoagulation therapy (such as Warfarin) which cannot be discontinued for 7 days before and 14 days after the procedure
• 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.
• Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during treatment through 4 weeks post procedure phase
• Taking corticosteroids or drugs known to affect GI motility (e.g. Metoclopramide)

Sponsors & Collaborators

• Fractyl Health Inc.: lead

Study Sites (7)

Hopital Erasme

Brussels, 1070, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Centro Clinico de Obesidad

Santiago, Chile

Location

Università Cattolica del Sacro Cuore, Policlinico A. Gemelli

Rome, Lazio, 00168, Italy

Location

Academic Medical Center

Amsterdam, 1105, Netherlands

Location

University College London Hospitals

London, NW1 2BU, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (3)

• Busch CBE, Meiring S, van Baar ACG, Gastaldelli A, DeFronzo R, Mingrone G, Hagen M, White K, Rajagopalan H, Nieuwdorp M, Bergman JJGHM. Insulin sensitivity and beta cell function after duodenal mucosal resurfacing: an open-label, mechanistic, pilot study. Gastrointest Endosc. 2024 Sep;100(3):473-480.e1. doi: 10.1016/j.gie.2024.01.031. Epub 2024 Jan 25.

  PMID: 38280531 DERIVED

• van Baar ACG, Deviere J, Hopkins D, Crenier L, Holleman F, Galvao Neto MP, Becerra P, Vignolo P, Rodriguez Grunert L, Mingrone G, Costamagna G, Nieuwdorp M, Guidone C, Haidry RJ, Hayee B, Magee C, Carlos Lopez-Talavera J, White K, Bhambhani V, Cozzi E, Rajagopalan H, J G H M Bergman J. Durable metabolic improvements 2 years after duodenal mucosal resurfacing (DMR) in patients with type 2 diabetes (REVITA-1 Study). Diabetes Res Clin Pract. 2022 Feb;184:109194. doi: 10.1016/j.diabres.2022.109194. Epub 2022 Jan 13.

  PMID: 35032562 DERIVED

• van Baar ACG, Holleman F, Crenier L, Haidry R, Magee C, Hopkins D, Rodriguez Grunert L, Galvao Neto M, Vignolo P, Hayee B, Mertens A, Bisschops R, Tijssen J, Nieuwdorp M, Guidone C, Costamagna G, Deviere J, Bergman JJGHM. Endoscopic duodenal mucosal resurfacing for the treatment of type 2 diabetes mellitus: one year results from the first international, open-label, prospective, multicentre study. Gut. 2020 Feb;69(2):295-303. doi: 10.1136/gutjnl-2019-318349. Epub 2019 Jul 22.

  PMID: 31331994 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: March 23, 2015
• Primary Completion: June 12, 2017
• Study Completion: September 18, 2019
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

CL (1); NL (1); GB (2); BE (2); IT (1)