Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese

Not Applicable

Terminated

Conditions: Type 2 Diabetes
Obesity

Registration Number: NCT01728116

Lead Sponsor: Morphic Medical Inc.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 325

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint: Improvement in HbA1c	Baseline and12 months	Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE	Baseline and 12 Months	Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.

Secondary Outcome Measures

Name	Time	Method
Assessment of Total Cholesterol Change at 12 Months Compared to Baseline	Baseline and 12 Months
Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months	Baseline and 12 Months
Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months	Baseline and 12 Months
Triglycerides Change From Baseline	Baseline and 12 Months
Diastolic BP Change From Baseline	Baseline and 12 Months
LDL Change From Baseline	Baseline and 12 Months
Fasting Glucose Change From Baseline	Baseline and 12 Months
Systolic BP Change From Baseline	Baseline and 12 Months

Trial Locations

Locations (25): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Mayo Clinic Arizona
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Scottsdale, Arizona, United States
Little Rock Diagnostic Center (LRDC)
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Little Rock, Arkansas, United States
Cedars-Sinai Medical Center
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Los Angeles, California, United States
Stanford University School of Medicine
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Stanford, California, United States
University of Colorado/ Anschutz Health & Wellness Center
🇺🇸
Aurora, Colorado, United States
Emory University
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Atlanta, Georgia, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Kentucky Research Group
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Louisville, Kentucky, United States
Tulane University Health Sciences Center
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New Orleans, Louisiana, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States