Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Device: EndoBarrier Liner

Registration Number: NCT00986349

Lead Sponsor: Morphic Medical Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 23

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetes	EndoBarrier Liner	Single Arm

Primary Outcome Measures

Name	Time	Method
Assessment of Glycemic Control (HbA1c) Over Time	Baseline to 12 Months with device implanted	HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Change in Anti-diabetes Medications	Baseline to 52 weeks	Medications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."

Secondary Outcome Measures