Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

January 3, 2017 updated by: GI Dynamics

A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, CEP 01323-903
        • Hospital Alemao Oswaldo Cruz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 12 Months with device implanted
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."
Baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total Weight Change (kg) at Week 52 Compared to Baseline Weight
Time Frame: Baseline to 52 weeks
Baseline to 52 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Fasting Plasma Glucose Over Time for All Subjects
Time Frame: Baseline to 12 months post Device Explant
Baseline to 12 months post Device Explant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GI Dynamics

Investigators

  • Principal Investigator: Ricardo Cohen, MD, Hospital Alemao Oswaldo Cruz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 27, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual patient data is on file at the Sponsor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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