Clinical trial NCT01728116: Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese
Official title: A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Obesity
Keywords: glycemic control, type 2 diabetes, device, obese
Lead sponsor: Morphic Medical Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 325
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

Detailed description: This is a randomized, double blinded, prospective study. Subjects will be evaluated and randomized to either the device or sham treatment group if they qualify for the study. A comparison of glycemic control between the two groups will be assessed as the primary outcome measurement as well as the safety profile of the device.

Eligibility criteria: Inclusion Criteria:

* Males/females aged ≥ 21 years and ≤ 65 years
* Diagnosis of Type 2 Diabetes for ≤ 20 years
* Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2)
* Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i or TZD)
* Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%.
* Subjects willing to comply with study requirements
* Subjects who have signed an informed consent form

Exclusion Criteria:

* Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
* C-peptide \< 1.0 ng/mL
* Triglyceride level \> 400 mg/dL
* Vitamin D deficiency (\<20 ng/mL)
* Male subjects with serum Creatinine \>1.5 mg/dl or female subjects with Creatinine \>1.4 mg/dL
* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
* Height \< 5 feet (152.4 cm)
* Current alcohol or drug addiction
* Symptomatic kidney stones or gallstones within 6 months prior to randomization
* Chronic pancreatitis or acute pancreatitis within 12 months of randomization
* Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
* Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus, scleroderma)
* Active gastroesophageal reflux disease \[GERD\] uncontrolled with a Proton Pump Inhibitor (PPI)
* Thyroid disease unless controlled with medication
* Currently taking Non-Steroidal Anti-Inflammatory Drugs \[NSAIDs\] (e.g., aspirin, ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or expected use of these agents during the trial 12 months post index procedure
* Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 12 months post index procedure
* Currently taking systemic corticosteroids, drugs known to affect GI motility, prescription/over-the-counter weight loss medications, or medications known to cause significant weight gain or weight loss within 30 days prior to randomization and/or there is a need or expected need to use these medications during the trial 12 months post index procedure
* Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or insulin) within 3 months of screening
* Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers
* Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any equivalent antibiotics
* Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing 2 weeks of antibiotic treatment without re-screening)
* Previous GI surgery or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier device, liner or affect the function of the liner
* Abnormal pathologies or conditions of the gastrointestinal tract, including current ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper gastrointestinal bleeding conditions within 3 months of randomization
* Any condition or major illness that places the subject at undue risk by participating in the study
* Poor dentition not allowing complete chewing of food
* Enrolled in another investigational study within 3 months of screening for this study (Enrollment in observational studies is permitted)
* Residing in a location without ready access to study site medical resources
* Documented weight loss of \>10 pounds anytime during the 3 months preceding randomization
* Positive stool guaiac at time of screening

Primary outcomes:
measure: Primary Efficacy Endpoint: Improvement in HbA1c
timeFrame: Baseline and12 months
measure: Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
timeFrame: Baseline and 12 Months
Secondary outcomes:
measure: Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
timeFrame: Baseline and 12 Months
measure: Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months
timeFrame: Baseline and 12 Months
measure: LDL Change From Baseline
timeFrame: Baseline and 12 Months
measure: Triglycerides Change From Baseline
timeFrame: Baseline and 12 Months
measure: Fasting Glucose Change From Baseline
timeFrame: Baseline and 12 Months
measure: Systolic BP Change From Baseline
timeFrame: Baseline and 12 Months
measure: Diastolic BP Change From Baseline
timeFrame: Baseline and 12 Months
measure: Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months
timeFrame: Baseline and 12 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Little Rock
country: United States
facility: Little Rock Diagnostic Center (LRDC)
state: Arkansas
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado/ Anschutz Health & Wellness Center
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
city: St Louis
country: United States
facility: Washington University
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Legacy Research Institute
state: Oregon
city: Knoxville
country: United States
facility: Endocrinology Consultants of East Tennessee & Gastrointestinal Associates
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Lee M Kaplan, MD, PhD
role: STUDY_CHAIR
affiliation: Carolinas Medical Center
name: Keith Gersin, MD
role: STUDY_DIRECTOR
References: