Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01114438
First received: April 29, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.


Condition Intervention
Type 2 Diabetes
Obesity
Device: EndoBarrier Gastrointestinal Liner

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner

Resource links provided by NLM:


Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: October 2010
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Device: EndoBarrier Gastrointestinal Liner
EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.

  Eligibility

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

Inclusion Criteria:

  • Subjects Age > 18 years and ≤65 years - Male or Female
  • Subjects with Type 2 Diabetes > 1 and ≤ 10 years in duration
  • Subjects with an Hb A1c level > 7.5 and ≤ 10.0
  • Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required.
  • Subjects with a BMI > 30 and< 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 contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.

Exclusion Criteria:

  • Subjects taking DPP4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide)
  • Subjects requiring insulin >150 units per day

    • Subjects with probable insulin production failure (fasting C Peptide serum <1.0 ng/mL)

  • Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
  • Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period
  • 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 study participation
  • Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
  • Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.)
  • 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 severe liver or kidney failure (serum creatinine >180mmol/l)
  • Subjects with poor dentition who can not adequately chew their food
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114438

Locations
United Kingdom
Imperial College/St. Mary's Hospital
London, United Kingdom
Trafford General Hospital/NOSC
Manchester, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Sponsors and Collaborators
GI Dynamics
  More Information

No publications provided

Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT01114438     History of Changes
Other Study ID Numbers: 10-1
Study First Received: April 29, 2010
Last Updated: March 28, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014