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Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes

Sponsor
Fractyl Laboratories, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02413567
Collaborator
(none)
60
Enrollment
7
Locations
1
Arm
53.9
Actual Duration (Months)
8.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: DMR Procedure (Fractyl)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
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
Actual Study Start Date :
Mar 23, 2015
Actual Primary Completion Date :
Jun 12, 2017
Actual Study Completion Date :
Sep 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: DMR Procedure

Subjects receive the endoscopic DMR procedure in this arm

Device: DMR Procedure (Fractyl)
Endoscopic procedure

Outcome Measures

Primary Outcome Measures

  1. mean reduction in HbA1c (glycated hemoglobin) from baseline at 24 weeks post-procedure [24 weeks post-procedure]

  2. Device or procedure related Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) [24 weeks post-procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
28 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Erasme Brussels Belgium 1070
2 UZ Leuven Leuven Belgium
3 Centro Clinico de Obesidad Santiago Chile
4 Università Cattolica del Sacro Cuore, Policlinico A. Gemelli Rome Lazio Italy 00168
5 Academic Medical Center Amsterdam Netherlands 1105
6 University College London Hospitals London United Kingdom NW1 2BU
7 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS

Sponsors and Collaborators

  • Fractyl Laboratories, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fractyl Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT02413567
Other Study ID Numbers:
  • C-20000 A & B
First Posted:
Apr 10, 2015
Last Update Posted:
Jun 5, 2020
Last Verified:
Jun 1, 2020
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

Study Results

No Results Posted as of Jun 5, 2020