Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study

Type 2 Diabetes Clinical Trial

Official title:

A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986349
• Other study ID #: 08-2
• Status: Completed
• Phase: N/A
• First received: September 27, 2009
• Last updated: May 10, 2013
• Start date: June 2010
• Est. completion date: November 2012

Study information

• Verified date: May 2013
• Source: GI Dynamics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• EndoBarrier Liner
52 week treatment of EnoBarrier Liner

Locations

Country	Name	City	State
Brazil	Hospital Alemão Oswaldo Cruz	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
GI Dynamics

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the proportion of the study population that demonstrates an improvement in their diabetic status assessed at 24 weeks post index procedure.		52 weeks	No
Secondary	An assessment of the amount of absolute weight loss		52 weeks	No
Secondary	Proportion of subjects who demonstrate a reduction in the HbA1C of 0.5% of baseline value or greater assessed at 24 weeks post index procedure		52 weeks	No
Secondary	Proportion of subjects who demonstrate a decrease in post-prandial excursions as evidenced by a challenge to a standardized meal evaluated at 24 weeks post index procedure.		52 weeks	No
Secondary	Safety will be assessed as the incidence and severity of adverse events (device and non-device related).		52 weeks	Yes