Trial record 8 of 31 for:    gi dynamics

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by GI Dynamics
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01728116
First received: November 13, 2012
Last updated: June 20, 2014
Last verified: June 2014

November 13, 2012
June 20, 2014
December 2012
June 2015   (final data collection date for primary outcome measure)
Improvement in HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01728116 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese
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

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes in Obese Subjects
  • Device: EndoBarrier
  • Procedure: Sham Procedure
  • Experimental: Device (EndoBarrier)
    Device for glycemic control
    Intervention: Device: EndoBarrier
  • Sham Comparator: Sham Procedure
    sham procedure
    Intervention: Procedure: Sham Procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
June 2015   (final data collection date for primary outcome measure)

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)
Both
21 Years to 65 Years
No
Contact: Kelly Woessner kwoessner@gidynamics.com
United States
 
NCT01728116
09-1
Yes
GI Dynamics
GI Dynamics
Not Provided
Study Chair: Lee M Kaplan, MD, PhD Massachusetts General Hospital
Study Director: Keith Gersin, MD Carolinas Medical Center
GI Dynamics
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP