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

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ClinicalTrials.gov Identifier: NCT01728116
Recruitment Status : Terminated (Higher than anticipated rate of Hepatic abscess (N=7))
First Posted : November 16, 2012
Results First Posted : December 2, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
Obesity
Interventions: Device: EndoBarrier
Procedure: Sham Procedure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Up to 500 subjects were planned to be randomized into either the EndoBarrier or the sham control arm at a 2:1 ratio, respectively. Due to early termination of the trial, only 325 subjects were randomized with 216 EndoBarrier subjects and 109 sham control subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The mITT population for the primary analyses includes 213 EndoBarrier subjects and 107 sham control subjects. The remaining five (5) subjects (n=3 randomized to device; n=2 randomized to sham) were deemed ineligible before an attempted device placement due to findings identified during the upper endoscopy.

Reporting Groups
  Description
EndoBarrier Group Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
Sham Control Group Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.

Participant Flow:   Overall Study
    EndoBarrier Group   Sham Control Group
STARTED   213 [1]   107 [2] 
COMPLETED   52 [3]   60 [4] 
NOT COMPLETED   161   47 
Sponsor Terminated Study                106                35 
Withdrawal by Subject                16                9 
Adverse Event                13                0 
Procedure/device failure                7                0 
Lost to Follow-up                9                2 
Physician Decision                2                0 
Subject Non-Compliance                2                0 
Inter-current finding at procedure                1                0 
Incorrectly enrolled in Study                0                1 
various not noted previously                5                0 
[1] EndoBarrier mITT Subjects
[2] Sham mITT subjects
[3] Completed to Week 78
[4] Completed to Week 52



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
mITT

Reporting Groups
  Description
EndoBarrier Group Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
Sham Control Group Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
Total Total of all reporting groups

Baseline Measures
   EndoBarrier Group   Sham Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 213   107   320 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 52.9  (8.19)   51.8  (8.21)   52.5  (8.20) 
[1] Age, range 25 to 65 years
Gender [1] 
[Units: Participants]
Count of Participants
     
Female      127  59.6%      69  64.5%      196  61.3% 
Male      86  40.4%      38  35.5%      124  38.8% 
[1] In both arms (Device and Sham) of the mITT population, 61.3% were female and 38.8% were male
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      19   8.9%      14  13.1%      33  10.3% 
Not Hispanic or Latino      194  91.1%      93  86.9%      287  89.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
     
American Indian or Alaska Native   6   3   9 
Asian   1   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   44   22   66 
White   165   80   245 
More than one race   1   1   2 
Unknown or Not Reported   1   1   2 
[1] Subjects were allowed to select more than one race.
Baseline Weight (lbs) 
[Units: Lbs]
Mean (Standard Deviation)
 245.0  (47.46)   245.6  (44.20)   245.2  (46.32) 
Baseline BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 38.4  (5.74)   38.3  (5.33)   38.4  (5.60) 
HbA1c (%) fasting bloodwork 
[Units: Percent]
Mean (Standard Deviation)
 8.8  (0.92)   8.9  (0.89)   8.8  (0.91) 


  Outcome Measures

1.  Primary:   Primary Efficacy Endpoint: Improvement in HbA1c   [ Time Frame: Baseline and12 months ]

2.  Primary:   Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE   [ Time Frame: Baseline and 12 Months ]

3.  Secondary:   Assessment of Total Cholesterol Change at 12 Months Compared to Baseline   [ Time Frame: Baseline and 12 Months ]

4.  Secondary:   Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months   [ Time Frame: Baseline and 12 Months ]

5.  Secondary:   LDL Change From Baseline   [ Time Frame: Baseline and 12 Months ]

6.  Secondary:   Triglycerides Change From Baseline   [ Time Frame: Baseline and 12 Months ]

7.  Secondary:   Fasting Glucose Change From Baseline   [ Time Frame: Baseline and 12 Months ]

8.  Secondary:   Systolic BP Change From Baseline   [ Time Frame: Baseline and 12 Months ]

9.  Secondary:   Diastolic BP Change From Baseline   [ Time Frame: Baseline and 12 Months ]

10.  Secondary:   Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months   [ Time Frame: Baseline and 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The ENDO Trial was stopped early due to a higher than anticipated rate of hepatic abscess (n=7).


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Brian Callahan
Organization: GI Dynamics, Inc
phone: 781.357.3302
e-mail: bcallahan@gidynamics.com



Responsible Party: GI Dynamics
ClinicalTrials.gov Identifier: NCT01728116     History of Changes
Other Study ID Numbers: 09-1
First Submitted: November 13, 2012
First Posted: November 16, 2012
Results First Submitted: June 22, 2016
Results First Posted: December 2, 2016
Last Update Posted: February 1, 2017