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Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02413567
Recruitment Status : Active, not recruiting
First Posted : April 10, 2015
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Fractyl Laboratories, Inc.

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus Device: DMR Procedure (Fractyl) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes
Study Start Date : January 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DMR Procedure
Subjects receive the endoscopic DMR procedure in this arm
Device: DMR Procedure (Fractyl)
Endoscopic procedure




Primary Outcome Measures :
  1. mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure [ Time Frame: 24 weeks post-procedure ]
  2. Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 24 weeks post-procedure ]


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Ages Eligible for Study:   28 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413567


Locations
Belgium
Hopital Erasme
Brussels, Belgium, 1070
UZ Leuven
Leuven, Belgium
Chile
Centro Clinico de Obesidad
Santiago, Chile
Italy
Università Cattolica del Sacro Cuore, Policlinico A. Gemelli
Rome, Lazio, Italy, 00168
Netherlands
Academic Medical Center
Amsterdam, Netherlands, 1105
United Kingdom
University College London Hospitals
London, United Kingdom, NW1 2BU
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Fractyl Laboratories, Inc.

Responsible Party: Fractyl Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02413567     History of Changes
Other Study ID Numbers: C-20000 A & B
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases