Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

GI Dynamics

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Device: EndoBarrier Liner

Study type

Interventional

Funder types

Industry

Identifiers

NCT00986349

08-2

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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)