Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

This study has been completed.
Information provided by (Responsible Party):
GI Dynamics Identifier:
First received: September 27, 2009
Last updated: May 10, 2013
Last verified: May 2013

The main objective of the study is to demonstrate the safety and efficacy of the Gastrointestinal (GI) EndoBarrier in the glycemic control of diabetes in subjects with Type 2 diabetes.

Condition Intervention
Type 2 Diabetes
Device: EndoBarrier Liner

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • The primary efficacy endpoint is the proportion of the study population that demonstrates an improvement in their diabetic status assessed at 24 weeks post index procedure. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • An assessment of the amount of absolute weight loss [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who demonstrate a reduction in the HbA1C of 0.5% of baseline value or greater assessed at 24 weeks post index procedure [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who demonstrate a decrease in post-prandial excursions as evidenced by a challenge to a standardized meal evaluated at 24 weeks post index procedure. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Safety will be assessed as the incidence and severity of adverse events (device and non-device related). [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: June 2010
Study Completion Date: November 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes Device: EndoBarrier Liner
52 week treatment of EnoBarrier Liner
Other Names:
  • EndoBarrier Gastrointestial Liner
  • GI Sleeve


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects Age > 18 years and ≤ 55 years
  • Male or Female
  • Subjects with Type 2 Diabetes who have been treated for ≤10 years and are on oral diabetic medications
  • Subjects with an HbA1C > 7.5 and ≤ 10.0%
  • Subjects with a BMI > 26 - < 50
  • Subjects willing to comply with study requirements
  • Subjects who have signed an informed consent form
  • Women who are post-menopausal, surgically sterile or on oral contraceptives and agree to remain on oral contraceptives for at least twenty-four (24) weeks after being implanted or the duration of their trial participation and agree not to become pregnant during the trial.

Exclusion Criteria:

  • Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
  • Subjects requiring insulin
  • Subjects with probable insulin production failure (fasting C Peptide serum <1ng/mL)
  • Subjects that have autoimmune disease as evidenced by a positive anti-GAD blood test
  • Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening
  • Subjects requiring prescription anticoagulation therapy
  • Subjects with or a history of iron deficiency and/or iron deficiency anemia
  • Subjects with or a history of abnormalities of the GI tract
  • Subjects with symptomatic gallstones or kidney stones at the time of screening
  • Subjects with a known infection
  • Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
  • Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the Subject a poor candidate for device placement or clinical trial participation
  • Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
  • Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
  • Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
  • Subjects receiving weight loss medications such as Meridia, Xenical, or over the counter weight loss medications
  • Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  • Subjects with active and uncontrolled GERD
  • Subjects with a known history of substance abuse
  • Subjects participating in another ongoing investigational clinical trial
  • Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
  Contacts and Locations
Please refer to this study by its identifier: NCT00986349

Hospital Alemão Oswaldo Cruz
Sao Paulo, Brazil, CEP 01323-903
Sponsors and Collaborators
GI Dynamics
Principal Investigator: Ricardo Cohen, MD Hospital Alemão Oswaldo Cruz
  More Information

No publications provided

Responsible Party: GI Dynamics Identifier: NCT00986349     History of Changes
Other Study ID Numbers: 08-2
Study First Received: September 27, 2009
Last Updated: May 10, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by GI Dynamics:
Weight Loss
GI Dynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on April 17, 2014