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

GI Dynamics

Status

Completed

Conditions

Obesity

Type 2 Diabetes

Treatments

Device: EndoBarrier Gastrointestinal Liner

Study type

Interventional

Funder types

Industry

Identifiers

NCT01114438

10-1

Details and patient eligibility

About

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.

Full description

Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods. EndoBarrier is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality

Enrollment

45 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 Inhibitors of dipeptidyl peptidase 4 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 gastroesophageal reflux disease (GERD)
Subjects with severe liver or kidney failure (serum creatinine >180mmol/l)
Subjects with poor dentition who can not adequately chew their food