Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00986349
Recruitment Status : Completed
First Posted : September 29, 2009
Results First Posted : January 2, 2017
Last Update Posted : February 17, 2017
Information provided by (Responsible Party):
GI Dynamics

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Device: EndoBarrier Liner Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Diabetes
Single Arm
Device: EndoBarrier Liner
52 week treatment of EnoBarrier Liner
Other Names:
  • EndoBarrier Gastrointestial Liner
  • GI Sleeve

Primary Outcome Measures :
  1. Assessment of Glycemic Control (HbA1c) Over Time [ Time Frame: Baseline to 12 Months with device implanted ]
    HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12

  2. Change in Anti-diabetes Medications [ Time Frame: Baseline to 52 weeks ]
    Medications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."

Secondary Outcome Measures :
  1. Total Weight Change (kg) at Week 52 Compared to Baseline Weight [ Time Frame: Baseline to 52 weeks ]

Other Outcome Measures:
  1. Fasting Plasma Glucose Over Time for All Subjects [ Time Frame: Baseline to 12 months post Device Explant ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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)

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 identifier (NCT number): 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

Responsible Party: GI Dynamics Identifier: NCT00986349     History of Changes
Other Study ID Numbers: 08-2
First Posted: September 29, 2009    Key Record Dates
Results First Posted: January 2, 2017
Last Update Posted: February 17, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data is on file at the Sponsor

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