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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT00985114
First received: September 25, 2009
Last updated: August 9, 2016
Last verified: August 2016
  Purpose

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.

Condition Intervention
Type II Diabetes
Device: EndoBarrier
Behavioral: Diet + Lifestyle Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Controlled Study of a Second Generation EndoBarrier™ Liner vs. Diet Control for the Treatment of Type 2 Diabetes

Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: October 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00985114

Locations
Netherlands
Ziekenhuis Rijnstate Arnhem
Arnhem, Netherlands
Medisch Centrum Parkstad
Heerlen, Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Sponsors and Collaborators
GI Dynamics
Investigators
Principal Investigator: Jan Willem Greve, MD University Hospital Masstricht
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT00985114     History of Changes
Other Study ID Numbers: 07-1 
Study First Received: September 25, 2009
Results First Received: March 20, 2016
Last Updated: August 9, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description:

Yes

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


Keywords provided by GI Dynamics:
Type II Diabetes
Obesity

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

ClinicalTrials.gov processed this record on December 02, 2016