Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity

August 9, 2016 updated by: GI Dynamics

An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes

The purpose of this study is to evaluate the safety and efficacy of a second generation EndoBarrier Liner compared to a study diet to treat Subjects with Type 2 Diabetes.

This is a randomized, controlled study which will enroll approximately 70 Subjects with Type 2 Diabetes. Randomization will be one to one with approximately 35 EndoBarrier device Subjects and approximately 35 study diet Subjects. Subjects randomized as diet Subjects will be offered the EndoBarrier device after 12 months on study at the investigator's discretion if treatment of the device subjects indicates adequate efficacy. This study will be conducted at three (3) investigational sites.

The primary efficacy endpoint is:

  • Assessment of the percent (%) of Subjects who achieve a ≥ 0.5% reduction in HbA1C at 24 weeks or last visit from baseline between the two groups.

Secondary endpoints are:

  • Percent (%) of Subjects who achieve a HbA1C of 7.0% or lower at week 24 or last visit from baseline.
  • Percent (%) of Subjects who have their diabetic medication(s) dosage decreased or discontinued at week 24 or last visit from baseline.
  • Percent (%) of Subjects who achieve a decrease in post-prandial excursions as evidenced by challenge to a standardized meal tolerance test (MTT) at week 24 or last visit from baseline.
  • Assessment of absolute weight loss (Kg) at week 24 or last visit from baseline.
  • Percent (%) of Subjects who maintain a HbA1c lower than their baseline assessment at 12 months.
  • Compare physical component summary (PCS), mental component summary (MCS) and quality adjusted life years (QALYs)via analysis of the SF-36v2 QOL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Utilization of the EndoBarrier Gastrointestinal Liner in obese subjects with T2DM demonstrated an acceptable safety profile with clinically significant improvements in glycemic control and body weight when compared to a similar diet controlled group of subjects.

Study Type

Interventional

Enrollment (Actual)

77

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

  • Netherlands
      • Arnhem, Netherlands
        • Ziekenhuis Rijnstate Arnhem
      • Heerlen, Netherlands
        • Medisch Centrum Parkstad
      • Maastricht, Netherlands
        • University Hospital Maastricht

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years and < 65 years
  • Male or Female
  • Subjects with Type 2 Diabetes who have been treated for ≤10 years
  • BMI> 30 - < 50
  • Subjects with an HbA1c level > 7.5 and ≤ 10.0%
  • Subjects taking a combination of metformin and sulfonylureas and/or insulin (other than pre-mixed long and short acting insulins, ie. NovoMix 30)
  • Patients willing to comply with study requirements
  • Patients who have signed an informed consent form

Exclusion Criteria:

  • Subjects taking oral medications to control their diabetes other than sulfonylureas and metformin
  • Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
  • Subjects on insulin > 10 years
  • Subjects requiring insulin > 70 units per day
  • Subjects on pre-mixed insulin (ie. NovoMix 30)

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device
EndoBarrier implanted for 6 months. Subject followed for 6 months after device was explanted.
Device: EndoBarrier
EndoBarrier implant
Behavioral: Diet + Lifestyle Counseling
Multidisciplinary lifestyle and nutritional counseling
Active Comparator: Diet + Lifestyle counseling
Multidisciplinary lifestyle and nutritional counseling for 12 months
Behavioral: Diet + Lifestyle Counseling
Multidisciplinary lifestyle and nutritional counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

GI Dynamics

Investigators

  • Principal Investigator: Jan Willem Greve, MD, University Hospital Masstricht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2009

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 3, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Yes

De-identified individual subject 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.

Clinical Trials on Type II Diabetes

Clinical Trials on EndoBarrier

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe