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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 : July 13, 2017
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 : 50 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 : January 2018
Estimated Study Completion Date : January 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. Glycated Hemoglobin [ 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 ]
  3. Number of hypo-glycemic events (blood glucose level of < 56 mg/dL (3.1 mmol/L) or requiring 3rd party assistance) [ Time Frame: 24 weeks ]


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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:

  • 28 -75 years of age
  • Diagnosed with Type 2 Diabetes for less than 10 years
  • HbA1c of 7.5 - 10.0% (59-86 mmol/mol)
  • BMI ≥ 24 and ≤ 40 kg/m2

Exclusion Criteria:

  • Diagnosed with Type 1 Diabetes or with a history of ketoacidosis
  • Probable insulin production failure, defined as fasting C Peptide serum <1 ng/mL (333pmol/l)
  • Current use of Insulin
  • Use of GLP-1 analogues
  • Active and uncontrolled GERD defined as grade III esophagitis or greater
  • Upper gastro-intestinal conditions such as ulcers, gastric varices, strictures, congenital or acquired intestinal telangiectasia

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.

Publications:

Responsible Party: Fractyl Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT02413567     History of Changes
Other Study ID Numbers: C-20000A
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

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