Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (ENDO)

This study is currently recruiting participants.
Verified March 2014 by GI Dynamics
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01728116
First received: November 13, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes


Condition Intervention
Type 2 Diabetes in Obese Subjects
Device: EndoBarrier
Procedure: Sham Procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents

Resource links provided by NLM:


Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Improvement in HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight Loss [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Improvements in select cardiovascular risk factors, such as cholesterol [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2012
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device (EndoBarrier)
Device for glycemic control
Device: EndoBarrier
Sham Comparator: Sham Procedure
sham procedure
Procedure: Sham Procedure

Detailed Description:

This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to a treatment group if they qualify for the study. Subjects will receive either a device or sham procedure. Throughout the study glycemic control and various laboratory tests will be evaluated. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1c ≥ 7.5% and ≤ 10%
  • BMI ≥ 30 and ≤ 55

Exclusion Criteria:

  • Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
  • C-peptide < 1.0 ng/mL
  • Previous GI surgery or abnormal GI anatomical finding
  • Prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728116

Contacts
Contact: Kelly Woessner kwoessner@gidynamics.com

  Show 22 Study Locations
Sponsors and Collaborators
GI Dynamics
Investigators
Study Chair: Lee M Kaplan, MD, PhD Massachusetts General Hospital
Study Director: Keith Gersin, MD Carolinas Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT01728116     History of Changes
Other Study ID Numbers: 09-1
Study First Received: November 13, 2012
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GI Dynamics:
glycemic control, type 2 diabetes, device, obese

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 21, 2014