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

Condition Intervention
Type 2 Diabetes
Obesity
Device: EndoBarrier
Procedure: Sham Procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by GI Dynamics:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 325
Study Start Date: December 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device (EndoBarrier)
Device for glycemic control
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)
Sham Comparator: Sham Procedure
sham procedure
Procedure: Sham Procedure
Endoscopic evaluation but no device placement

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

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728116

  Show 25 Study Locations
Sponsors and Collaborators
GI Dynamics
Investigators
Study Chair: Lee M Kaplan, MD, PhD Massachusetts General Hospital
Study Director: Keith Gersin, MD Carolinas Medical Center
  More Information

Additional Information:
Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT01728116     History of Changes
Other Study ID Numbers: 09-1 
Study First Received: November 13, 2012
Results First Received: June 22, 2016
Last Updated: October 10, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by GI Dynamics:
glycemic control, type 2 diabetes, device, obese

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on December 08, 2016