Status:
COMPLETED
Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study
Lead Sponsor:
Morphic Medical Inc.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00986349
Start Date
June 1 2010
End Date
November 1 2012
Last Update
February 17 2017
Active Locations (1)
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1
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil, CEP 01323-903