Trial Outcomes & Findings for Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity (NCT NCT00985114)
NCT ID: NCT00985114
Last Updated: 2016-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
6 months
Results posted on
2016-10-03
Participant Flow
Participant milestones
| Measure |
EndoBarrier Device
EndoBarrier
EndoBarrier: EndoBarrier implant
|
Diet + Lifestyle Counseling
Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
39
|
|
Overall Study
Diet + Lifestyle Counseling Cross-over
|
0
|
28
|
|
Overall Study
COMPLETED
|
33
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
EndoBarrier Device
EndoBarrier
EndoBarrier: EndoBarrier implant
|
Diet + Lifestyle Counseling
Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Safety and Efficacy Study of EndoBarrier in Subjects With Type II Diabetes and Obesity
Baseline characteristics by cohort
| Measure |
Device
n=34 Participants
EndoBarrier
EndoBarrier: EndoBarrier implant
|
Diet + Lifestyle Counseling
n=39 Participants
Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 9.1 • n=39 Participants
|
49.3 years
STANDARD_DEVIATION 7.8 • n=41 Participants
|
49.3 years
STANDARD_DEVIATION 8.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Region of Enrollment
Netherlands
|
34 participants
n=39 Participants
|
39 participants
n=41 Participants
|
73 participants
n=35 Participants
|
|
Baseline weight
|
110.1 kg
STANDARD_DEVIATION 19.5 • n=39 Participants
|
113.5 kg
STANDARD_DEVIATION 19.3 • n=41 Participants
|
111.9 kg
STANDARD_DEVIATION 19.3 • n=35 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Device
n=33 Participants
EndoBarrier
EndoBarrier: EndoBarrier implant
|
Diet + Lifestyle Counseling
n=36 Participants
Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
|
|---|---|---|
|
Percent (%) of Subjects Who Achieve a ≥ 0.5% Reduction in HbA1C at 24 Weeks or Last Visit From Baseline.
|
81.8 % of participants
|
61.1 % of participants
|
Adverse Events
Device and Cross Over
Serious events: 18 serious events
Other events: 55 other events
Deaths: 0 deaths
Diet + Lifestyle Counseling
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device and Cross Over
n=66 participants at risk
EndoBarrier
EndoBarrier: EndoBarrier implant
|
Diet + Lifestyle Counseling
n=39 participants at risk
Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
1.5%
1/66 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.6%
5/66 • Number of events 5
|
0.00%
0/39
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney carcinoma
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.5%
1/66 • Number of events 1
|
2.6%
1/39 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Scapula fracture
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Acute hernia
|
0.00%
0/66
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain lower
|
6.1%
4/66 • Number of events 4
|
0.00%
0/39
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Gastrointestinal disorders
Diverticulitis
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Gastrointestinal disorders
Melena
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Gastrointestinal disorders
Pylorospasm
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
3.0%
2/66 • Number of events 2
|
0.00%
0/39
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
3.0%
2/66 • Number of events 2
|
0.00%
0/39
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
1.5%
1/66 • Number of events 1
|
0.00%
0/39
|
Other adverse events
| Measure |
Device and Cross Over
n=66 participants at risk
EndoBarrier
EndoBarrier: EndoBarrier implant
|
Diet + Lifestyle Counseling
n=39 participants at risk
Multidisciplinary lifestyle and nutritional counseling
Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
47.0%
31/66 • Number of events 47
|
10.3%
4/39 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.1%
4/66 • Number of events 4
|
0.00%
0/39
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
11/66 • Number of events 15
|
0.00%
0/39
|
|
Gastrointestinal disorders
Abdominal pain lower
|
19.7%
13/66 • Number of events 20
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
21.2%
14/66 • Number of events 15
|
10.3%
4/39 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
4/66 • Number of events 4
|
7.7%
3/39 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
21.2%
14/66 • Number of events 21
|
15.4%
6/39 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
8/66 • Number of events 11
|
10.3%
4/39 • Number of events 4
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
25.8%
17/66 • Number of events 18
|
0.00%
0/39
|
|
Gastrointestinal disorders
Procedural vomiting
|
12.1%
8/66 • Number of events 8
|
2.6%
1/39 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
21.2%
14/66 • Number of events 48
|
28.2%
11/39 • Number of events 11
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
6.1%
4/66 • Number of events 4
|
0.00%
0/39
|
|
Metabolism and nutrition disorders
Iron deficiency
|
27.3%
18/66 • Number of events 22
|
25.6%
10/39 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
4/66 • Number of events 5
|
7.7%
3/39 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
4/66 • Number of events 6
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Headache
|
6.1%
4/66 • Number of events 4
|
2.6%
1/39 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/66
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
3/66 • Number of events 3
|
7.7%
3/39 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
1.5%
1/66 • Number of events 2
|
5.1%
2/39 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/66
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/66
|
7.7%
3/39 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place