Trial Outcomes & Findings for Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner (NCT NCT01114438)
NCT ID: NCT01114438
Last Updated: 2017-04-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
12 months
Results posted on
2017-04-24
Participant Flow
Participant milestones
| Measure |
EndoBarrier Gastrointestinal Liner
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
EndoBarrier Gastrointestinal Liner
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
concomitant medication
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner
Baseline characteristics by cohort
| Measure |
EndoBarrier Gastrointestinal Liner
n=45 Participants
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
45 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
45 participants
n=5 Participants
|
|
Weight (kg)
|
115 kg
STANDARD_DEVIATION 21.02 • n=5 Participants
|
|
BMI
|
40.0 kg/m2
STANDARD_DEVIATION 5.79 • n=5 Participants
|
|
Duration of Diabetes
|
4.6 years
STANDARD_DEVIATION 2.79 • n=5 Participants
|
|
Baseline HbA1c
|
8.5 %
STANDARD_DEVIATION 0.85 • n=5 Participants
|
|
Baseline glucose
|
9.5 mmol/L
STANDARD_DEVIATION 2.95 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for analysis of HbA1c at the defined 12 month (week 52) endpoint.
Outcome measures
| Measure |
EndoBarrier Liner Device
n=29 Participants
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
Increase in Glucose-Lowering Meds at Week 52
Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
|
No Change in Glucose-Lowering Meds at Week 52
Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
|
|---|---|---|---|
|
HbA1c (%) Measured at Week 52
|
7.3 % glycated hemoglobin
Interval 5.8 to 11.5
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis was conducted on the Full Analysis Set (FAS) defined as all subjects enrolled and implanted with the EndoBarrier, There were 29 subjects' data available for weight loss analysis at the defined 12 month endpoint.
Total weight change at 12 months (kg) compared to baseline
Outcome measures
| Measure |
EndoBarrier Liner Device
n=29 Participants
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
Increase in Glucose-Lowering Meds at Week 52
Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
|
No Change in Glucose-Lowering Meds at Week 52
Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
|
|---|---|---|---|
|
Total Weight Change From Baseline to Week 52
|
-12.1 kg
Standard Deviation 7.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Analysis was conducted on subjects with a device
number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)
Outcome measures
| Measure |
EndoBarrier Liner Device
n=45 Participants
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
Increase in Glucose-Lowering Meds at Week 52
n=45 Participants
Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
|
No Change in Glucose-Lowering Meds at Week 52
n=45 Participants
Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
|
|---|---|---|---|
|
Changes in Diabetic Medications at Treatment Completion Compared to Baseline
|
23 Participants
|
4 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)Population: The number of participants analyzed reflects all participants who received the implant and were assessed for QoL at the respective time points.
Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.
Outcome measures
| Measure |
EndoBarrier Liner Device
n=35 Participants
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
Increase in Glucose-Lowering Meds at Week 52
n=25 Participants
Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
|
No Change in Glucose-Lowering Meds at Week 52
Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
|
|---|---|---|---|
|
Change From Baseline in SF 36v2 Quality of Life Assessment
MCS-Change from Baseline
|
3.0 units on a scale
Standard Deviation 9.66
|
-0.5 units on a scale
Standard Deviation 14.12
|
—
|
|
Change From Baseline in SF 36v2 Quality of Life Assessment
PCS-Change from Baseline
|
1.0 units on a scale
Standard Deviation 9.49
|
1.0 units on a scale
Standard Deviation 8.33
|
—
|
Adverse Events
Device
Serious events: 13 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device
n=45 participants at risk
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
|---|---|
|
Cardiac disorders
Atrial Flutter
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
General disorders
Chest pain
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
Gout
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.2%
1/45 • Number of events 1 • 12 months
|
|
Vascular disorders
Gastrointestinal hemorrhage
|
2.2%
1/45 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Device
n=45 participants at risk
EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.9%
4/45 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
40.0%
18/45 • Number of events 22 • 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
9/45 • Number of events 10 • 12 months
|
|
Gastrointestinal disorders
Nausea
|
17.8%
8/45 • Number of events 8 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
17.8%
8/45 • Number of events 10 • 12 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
15.6%
7/45 • Number of events 7 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
15.6%
7/45 • Number of events 7 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
13.3%
6/45 • Number of events 6 • 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
5/45 • Number of events 5 • 12 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
General disorders
Fatigue
|
8.9%
4/45 • Number of events 4 • 12 months
|
|
General disorders
Chest pain
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
General disorders
Edema peripheral
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
17.8%
8/45 • Number of events 8 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
8.9%
4/45 • Number of events 4 • 12 months
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
31.1%
14/45 • Number of events 15 • 12 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
8.9%
4/45 • Number of events 6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
10/45 • Number of events 10 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
6/45 • Number of events 6 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
3/45 • Number of events 3 • 12 months
|
|
Psychiatric disorders
Depression
|
11.1%
5/45 • Number of events 5 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.7%
3/45 • Number of events 3 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60