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: December 2, 2016

Last verified: December 2016

History of Changes

Results First Received: June 22, 2016

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

Participant Flow

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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.

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

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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%

Race/Ethnicity, Customized ^[1]
[Units: Participants]

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

165

245

More than one race

Unknown or Not Reported

^[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

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1. Primary:

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

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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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 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: PI to provide to Sponsor for review at least sixty (60) days in advance of submission for publication. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.

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
Study First Received:	November 13, 2012
Results First Received:	June 22, 2016
Last Updated:	December 2, 2016

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