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

This study has been terminated.
(Higher than anticipated rate of Hepatic abscess (N=7))
Sponsor:
Information provided by (Responsible Party):
GI Dynamics
ClinicalTrials.gov Identifier:
NCT01728116
First received: November 13, 2012
Last updated: October 10, 2016
Last verified: October 2016

November 13, 2012
October 10, 2016
December 2012
February 2016   (final data collection date for primary outcome measure)
  • Primary Efficacy Endpoint: Improvement in HbA1c [ Time Frame: Baseline and12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: Yes ]
    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.
Improvement in HbA1c [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01728116 on ClinicalTrials.gov Archive Site
  • Assessment of Total Cholesterol Change at 12 Months Compared to Baseline [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • LDL Change From Baseline [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Triglycerides Change From Baseline [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Fasting Glucose Change From Baseline [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Systolic BP Change From Baseline [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Diastolic BP Change From Baseline [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Weight Loss [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Improvements in select cardiovascular risk factors, such as cholesterol [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese
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
To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Obesity
  • Device: EndoBarrier
    Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point
    Other Name: Duodenal-jejunal bypass liner (DJBL)
  • Procedure: Sham Procedure
    Endoscopic evaluation but no device placement
  • Experimental: Device (EndoBarrier)
    Device for glycemic control
    Intervention: Device: EndoBarrier
  • Sham Comparator: Sham Procedure
    sham procedure
    Intervention: Procedure: Sham Procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
325
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
21 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01728116
09-1
Yes
Yes
Not Provided
GI Dynamics
GI Dynamics
Not Provided
Study Chair: Lee M Kaplan, MD, PhD Massachusetts General Hospital
Study Director: Keith Gersin, MD Carolinas Medical Center
GI Dynamics
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP