Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00986349
First received: September 27, 2009
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986349

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

No publications provided

Responsible Party: GI Dynamics
ClinicalTrials.gov 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:
Diabetes
Weight Loss
GI Dynamics
EndoBarrier

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

ClinicalTrials.gov processed this record on October 21, 2014