Trial Outcomes & Findings for A Study of the GI Sleeve for the Treatment of Type 2 Diabetes (NCT NCT02709577)
NCT ID: NCT02709577
Last Updated: 2016-12-28
Results Overview
Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline. Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline to 24 weeks or 52 weeks
Results posted on
2016-12-28
Participant Flow
Participant milestones
| Measure |
Cohort A: EndoBarrier Gastrointestinal Liner
Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
|
Cohort B:EndoBarrier Gastrointestinal Liner
Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
|
Cohort A Control Sham
Device was not implanted
|
Cohort B Control Sham
Device not implanted.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
6
|
5
|
|
Overall Study
COMPLETED
|
10
|
8
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: EndoBarrier Gastrointestinal Liner
Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
|
Cohort B:EndoBarrier Gastrointestinal Liner
Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
|
Cohort A Control Sham
Device was not implanted
|
Cohort B Control Sham
Device not implanted.
|
|---|---|---|---|---|
|
Overall Study
non-accommodating anatomy
|
0
|
1
|
0
|
0
|
|
Overall Study
procedural complication
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
2
|
0
|
Baseline Characteristics
A Study of the GI Sleeve for the Treatment of Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
EndoBarrier Gastrointestinal Liner
n=18 Participants
Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.
EndoBarrier Gastrointestinal Liner: The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.
|
Sham: Endoscopy and Standard of Care
n=9 Participants
Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.
Sham: endoscopy and standard of care: Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Cohort A
|
44.8 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 16.14 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
|
Age, Continuous
Cohort B
|
41.2 years
STANDARD_DEVIATION 9.28 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 6.25 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 8.36 • n=5 Participants
|
|
Gender
Female
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
18 participants
n=5 Participants
|
9 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeks or 52 weeksCohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline. Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.
Outcome measures
| Measure |
Cohort A: EndoBarrier Gastrointestinal Liner
n=10 Participants
Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
|
Cohort B: EndoBarrier Gastrointestinal Liner
n=8 Participants
Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
|
Cohort A Control Sham: Endoscopy and Standard of Care
n=4 Participants
Subjects received only an upper GI endoscopic examination with no device implantation.
|
Cohort B Control Sham: Endoscopy and Standard of Care
n=5 Participants
Subjects received only an upper GI endoscopic examination with no device implantation.
|
|---|---|---|---|---|
|
Change in HbA1c Values From Baseline Measurement
|
2.4 percentage of HbA1c
Standard Deviation 1.96
|
2.2 percentage of HbA1c
Standard Deviation 1.44
|
0.8 percentage of HbA1c
Standard Deviation 0.81
|
1.6 percentage of HbA1c
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: 24 weeks or 52 weeksOutcome measures
| Measure |
Cohort A: EndoBarrier Gastrointestinal Liner
n=10 Participants
Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
|
Cohort B: EndoBarrier Gastrointestinal Liner
n=8 Participants
Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
|
Cohort A Control Sham: Endoscopy and Standard of Care
n=4 Participants
Subjects received only an upper GI endoscopic examination with no device implantation.
|
Cohort B Control Sham: Endoscopy and Standard of Care
n=5 Participants
Subjects received only an upper GI endoscopic examination with no device implantation.
|
|---|---|---|---|---|
|
Absolute Weight Change
|
9.9 kg
Standard Deviation 1.7
|
11.3 kg
Standard Deviation 2.0
|
7.9 kg
Standard Deviation 5.4
|
5.4 kg
Standard Deviation 3.7
|
Adverse Events
Cohorts A and B: EndoBarrier Gastrointestinal Liner
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohorts A and B Sham: Endoscopy and Standard of Care
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohorts A and B: EndoBarrier Gastrointestinal Liner
n=25 participants at risk
Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 or 52 weeks and evaluated for study endpoints
|
Cohorts A and B Sham: Endoscopy and Standard of Care
n=11 participants at risk
Subjects randomized to sham and underwent an endoscopy procedure and then received standard of care treatment for their diabetes
|
|---|---|---|
|
Injury, poisoning and procedural complications
Oesophageal injury
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
Other adverse events
| Measure |
Cohorts A and B: EndoBarrier Gastrointestinal Liner
n=25 participants at risk
Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 or 52 weeks and evaluated for study endpoints
|
Cohorts A and B Sham: Endoscopy and Standard of Care
n=11 participants at risk
Subjects randomized to sham and underwent an endoscopy procedure and then received standard of care treatment for their diabetes
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Cardiac disorders
Atrial fibrillation
|
8.0%
2/25 • Number of events 2 • I year
|
0.00%
0/11 • I year
|
|
Gastrointestinal disorders
Abdominal distension
|
40.0%
10/25 • Number of events 10 • I year
|
54.5%
6/11 • Number of events 6 • I year
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Number of events 1 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.0%
2/25 • Number of events 2 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
100.0%
25/25 • Number of events 51 • I year
|
72.7%
8/11 • Number of events 8 • I year
|
|
Gastrointestinal disorders
Constipation
|
28.0%
7/25 • Number of events 7 • I year
|
45.5%
5/11 • Number of events 5 • I year
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
6/25 • Number of events 6 • I year
|
18.2%
2/11 • Number of events 2 • I year
|
|
Gastrointestinal disorders
Erosive duodenitis
|
8.0%
2/25 • Number of events 2 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Gastrointestinal disorders
Flatulence
|
12.0%
3/25 • Number of events 3 • I year
|
0.00%
0/11 • I year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Gastrointestinal disorders
Gastritis
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Gastrointestinal disorders
Nausea
|
44.0%
11/25 • Number of events 11 • I year
|
18.2%
2/11 • Number of events 2 • I year
|
|
Gastrointestinal disorders
Oesophagitis
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Gastrointestinal disorders
Vomiting
|
68.0%
17/25 • Number of events 17 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
General disorders
Non-cardiac chest pain
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
General disorders
Oedema peripheral
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Infections and infestations
Bronchitis
|
8.0%
2/25 • Number of events 2 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Infections and infestations
Folliculitis
|
8.0%
2/25 • Number of events 2 • I year
|
0.00%
0/11 • I year
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Number of events 2 • I year
|
0.00%
0/11 • I year
|
|
Infections and infestations
Tonsillitis
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Infections and infestations
Tooth infection
|
16.0%
4/25 • Number of events 4 • I year
|
0.00%
0/11 • I year
|
|
Infections and infestations
Nail infection
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Injury, poisoning and procedural complications
Airway complication of anaesthesia
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
28.0%
7/25 • Number of events 7 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
28.0%
7/25 • Number of events 7 • I year
|
0.00%
0/11 • I year
|
|
Investigations
Blood cholesterol increased
|
8.0%
2/25 • Number of events 2 • I year
|
0.00%
0/11 • I year
|
|
Investigations
Blood iron decreased
|
16.0%
4/25 • Number of events 4 • I year
|
0.00%
0/11 • I year
|
|
Investigations
High density lipoprotein decreased
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Investigations
Low density lipoprotein decreased
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Investigations
Serum ferritin decreased
|
8.0%
2/25 • Number of events 2 • I year
|
0.00%
0/11 • I year
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
92.0%
23/25 • Number of events 23 • I year
|
45.5%
5/11 • Number of events 5 • I year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Number of events 2 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Psychiatric disorders
Anxiety
|
28.0%
7/25 • Number of events 7 • I year
|
63.6%
7/11 • Number of events 7 • I year
|
|
Psychiatric disorders
Anxiety disorder
|
8.0%
2/25 • Number of events 2 • I year
|
0.00%
0/11 • I year
|
|
Psychiatric disorders
Depression
|
20.0%
5/25 • Number of events 5 • I year
|
36.4%
4/11 • Number of events 4 • I year
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
|
Vascular disorders
Orthostatic hypotension
|
4.0%
1/25 • Number of events 1 • I year
|
0.00%
0/11 • I year
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • I year
|
9.1%
1/11 • Number of events 1 • I year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60