Trial Outcomes & Findings for Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study (NCT NCT00986349)
NCT ID: NCT00986349
Last Updated: 2017-02-17
Results Overview
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline to 12 Months with device implanted
Results posted on
2017-02-17
Participant Flow
Participant milestones
| Measure |
EndoBarrier Liner Device
Enrolled Subjects
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
Successful Implant Procedure
|
20
|
|
Overall Study
Early Explant
|
4
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
EndoBarrier Liner Device
Enrolled Subjects
|
|---|---|
|
Overall Study
Unsuccessful implant procedure
|
3
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
device migration
|
1
|
Baseline Characteristics
Study of EndoBarrier Liner for Treatment of Type 2 Diabetes Study
Baseline characteristics by cohort
| Measure |
EndoBarrier Liner Device
n=20 Participants
EndoBarrier Liner: 52 week treatment of EndoBarrier Liner
|
|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 6.69 • n=99 Participants
|
|
Gender
Female
|
7 Participants
n=99 Participants
|
|
Gender
Male
|
13 Participants
n=99 Participants
|
|
Region of Enrollment
Brazil
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 Months with device implantedPopulation: 20 subjects with a successfully implanted device were analyzed at Baseline. 1 subject removed at day 75 due to non-compliance with attending required visits. 1 subject removed at 175 due to device rotation, 2 subjects removed at day 203 and 313 due to abdominal pain AE
HbA1c (%) at Baseline, Month 3, Month 6, Month 9, and Month 12
Outcome measures
| Measure |
EndoBarrier Liner Device at Baseline
n=20 Participants
HbA1c %
|
EndoBarrier Liner Device at 3 Months
n=19 Participants
HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
|
EndoBarrier Liner Device % at 6 Months
n=19 Participants
HbA1c
|
EndoBarrier Liner Device % at 9 Months
n=17 Participants
HbA1c
|
EndoBarrier Liner Device % at 52 Weeks
n=16 Participants
HbA1c
|
|---|---|---|---|---|---|
|
Assessment of Glycemic Control (HbA1c) Over Time
|
8.7 HbA1c %
Interval 7.4 to 10.2
|
6.7 HbA1c %
Interval 5.7 to 9.4
|
6.9 HbA1c %
Interval 5.8 to 8.9
|
6.9 HbA1c %
Interval 5.9 to 9.3
|
6.8 HbA1c %
Interval 5.9 to 11.0
|
PRIMARY outcome
Timeframe: Baseline to 52 weeksMedications were classified as "increased" if the dose of one or more oral agents was higher or an additional glucose-lowering agent was utilized at the time of treatment completion after EndoBarrier implantation in comparison with baseline. Medications were classified as "decreased" if the dose of one or more oral agents was lowered or one or more agents were discontinued at the time of treatment completion in comparison with baseline. For subjects in which the dose of one oral glucose-lowering agent was increased and another agent decreased, the change in medications was classified as "not assessable."
Outcome measures
| Measure |
EndoBarrier Liner Device at Baseline
n=16 Participants
HbA1c %
|
EndoBarrier Liner Device at 3 Months
n=16 Participants
HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
|
EndoBarrier Liner Device % at 6 Months
n=16 Participants
HbA1c
|
EndoBarrier Liner Device % at 9 Months
HbA1c
|
EndoBarrier Liner Device % at 52 Weeks
HbA1c
|
|---|---|---|---|---|---|
|
Change in Anti-diabetes Medications
|
9 Participants
|
0 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 52 weeksOutcome measures
| Measure |
EndoBarrier Liner Device at Baseline
n=16 Participants
HbA1c %
|
EndoBarrier Liner Device at 3 Months
HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
|
EndoBarrier Liner Device % at 6 Months
HbA1c
|
EndoBarrier Liner Device % at 9 Months
HbA1c
|
EndoBarrier Liner Device % at 52 Weeks
HbA1c
|
|---|---|---|---|---|---|
|
Total Weight Change (kg) at Week 52 Compared to Baseline Weight
|
-6.3 kg
Standard Deviation 4.05
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 months post Device ExplantPopulation: Subjects with a Successful Device Implant Procedure
Outcome measures
| Measure |
EndoBarrier Liner Device at Baseline
n=20 Participants
HbA1c %
|
EndoBarrier Liner Device at 3 Months
HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
|
EndoBarrier Liner Device % at 6 Months
HbA1c
|
EndoBarrier Liner Device % at 9 Months
HbA1c
|
EndoBarrier Liner Device % at 52 Weeks
HbA1c
|
|---|---|---|---|---|---|
|
Fasting Plasma Glucose Over Time for All Subjects
Baseline
|
10.9 mmol/L
Interval 5.8 to 16.6
|
—
|
—
|
—
|
—
|
|
Fasting Plasma Glucose Over Time for All Subjects
Month 3
|
7.3 mmol/L
Interval 3.7 to 13.2
|
—
|
—
|
—
|
—
|
|
Fasting Plasma Glucose Over Time for All Subjects
Month 6
|
7.5 mmol/L
Interval 5.4 to 11.9
|
—
|
—
|
—
|
—
|
|
Fasting Plasma Glucose Over Time for All Subjects
Month 9
|
7.6 mmol/L
Interval 5.5 to 11.4
|
—
|
—
|
—
|
—
|
|
Fasting Plasma Glucose Over Time for All Subjects
Month 12
|
7.6 mmol/L
Interval 4.9 to 14.0
|
—
|
—
|
—
|
—
|
|
Fasting Plasma Glucose Over Time for All Subjects
3 Months Post-Explant
|
7.4 mmol/L
Interval 3.3 to 10.9
|
—
|
—
|
—
|
—
|
|
Fasting Plasma Glucose Over Time for All Subjects
6 Months Post-Explant
|
8.3 mmol/L
Interval 5.2 to 13.6
|
—
|
—
|
—
|
—
|
|
Fasting Plasma Glucose Over Time for All Subjects
12 Months Post-Explant
|
8.9 mmol/L
Interval 5.8 to 16.6
|
—
|
—
|
—
|
—
|
Adverse Events
EndoBarrier Liner Device
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EndoBarrier Liner Device
n=23 participants at risk
All subjects who had a device attempted to be implanted. N = 23
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
56.5%
13/23 • Number of events 26
|
|
Gastrointestinal disorders
Abdominal pain upper
|
56.5%
13/23 • Number of events 36
|
|
Gastrointestinal disorders
Abdominal pain lower
|
39.1%
9/23 • Number of events 17
|
|
Gastrointestinal disorders
Abdominal distension
|
34.8%
8/23 • Number of events 10
|
|
Gastrointestinal disorders
Diarrhea
|
34.8%
8/23 • Number of events 14
|
|
Gastrointestinal disorders
Nausea
|
34.8%
8/23 • Number of events 10
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
7/23 • Number of events 8
|
|
Gastrointestinal disorders
Flatulence
|
13.0%
3/23 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Fatigue
|
21.7%
5/23 • Number of events 5
|
|
General disorders
Asthenia
|
13.0%
3/23 • Number of events 3
|
|
Immune system disorders
Hypersensitivity
|
8.7%
2/23 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
13.0%
3/23 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
21.7%
5/23 • Number of events 6
|
|
Infections and infestations
Influenza
|
8.7%
2/23 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
8.7%
2/23 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
8.7%
2/23 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
73.9%
17/23 • Number of events 173
|
|
Metabolism and nutrition disorders
Iron deficiency
|
65.2%
15/23 • Number of events 29
|
|
Nervous system disorders
Headache
|
21.7%
5/23 • Number of events 6
|
|
Nervous system disorders
Somnolence
|
8.7%
2/23 • Number of events 2
|
|
Psychiatric disorders
Depression
|
13.0%
3/23 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.7%
2/23 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.0%
3/23 • Number of events 3
|
|
Vascular disorders
Hypertension
|
8.7%
2/23 • Number of events 4
|
|
Vascular disorders
Ischemic limb pain
|
8.7%
2/23 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place