Clinical trial NCT00986349: Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study
Official title: A Phase II Single-Center, Prospective, Open Label Efficacy Study, of the GI EndoBarrier™ Liner for the Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Weight Loss
GI Dynamics
EndoBarrier
Lead sponsor: Morphic Medical Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Assessment of Glycemic Control (HbA1c) Over Time
timeFrame: Baseline to 12 Months with device implanted
measure: Change in Anti-diabetes Medications
timeFrame: Baseline to 52 weeks
Secondary outcomes:
measure: Total Weight Change (kg) at Week 52 Compared to Baseline Weight
timeFrame: Baseline to 52 weeks
Other outcomes:
measure: Fasting Plasma Glucose Over Time for All Subjects
timeFrame: Baseline to 12 months post Device Explant
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
Study officials:
affiliation: Hospital Alemão Oswaldo Cruz
name: Ricardo Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: