Trial Outcomes & Findings for Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus (NCT NCT00943917)
NCT ID: NCT00943917
Last Updated: 2015-04-13
Results Overview
Mean change in HbA1c over first 12 weeks (Stage I)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Day 0 and Week 12
Results posted on
2015-04-13
Participant Flow
At Stage II subjects divided into 6 total arms: ITCA 650 20 mcg/day assigned to either ITCA 650 20 mcg/day or ITCA 650 40 mcg/day; ITCA 650 40 mcg/day assigned to ITCA 650 40 mcg/day or ITCA 650 80 mcg/day; Ex Inj assigned to either ITCA 650 40 mcg/day or ITCA 650 60 mcg/day
Participant milestones
| Measure |
ITCA 650 20 mcg/Day- STAGE I
ITCA 650 20 mcg/day continuous exenatide
|
ITCA 650 40 mcg/Day- STAGE I
ITCA 650 40 mcg/day continuous exenatide
|
Exenatide Injection- STAGE I
exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
|
ITCA 650 20/20- STAGE II
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
|
ITCA 650 20/60- STAGE II
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
|
ITCA 650 40/40 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
|
ITCA 650 40/80 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
|
Ex Inj/ITCA 650 40 mcg/Day- STAGE II
Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
|
Ex Inj/ITCA 650 60 mcg/Day- STAGE II
Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
|
ITCA 650 20/20 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
|
ITCA 650 20/40 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/40 Contination
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/80 Continuation
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
|
Ex Inj/ITCA 650 40 Continuation
Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
Ex Inj/ITCA 650 60 Continuation
Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage I
STARTED
|
51
|
51
|
53
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage I
COMPLETED
|
47
|
48
|
47
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage I
NOT COMPLETED
|
4
|
3
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II
STARTED
|
0
|
0
|
0
|
20
|
21
|
23
|
23
|
23
|
21
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II
COMPLETED
|
0
|
0
|
0
|
20
|
21
|
20
|
20
|
23
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II Continuation
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
15
|
13
|
16
|
15
|
12
|
|
Stage II Continuation
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
15
|
11
|
13
|
12
|
8
|
|
Stage II Continuation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
3
|
3
|
4
|
Reasons for withdrawal
| Measure |
ITCA 650 20 mcg/Day- STAGE I
ITCA 650 20 mcg/day continuous exenatide
|
ITCA 650 40 mcg/Day- STAGE I
ITCA 650 40 mcg/day continuous exenatide
|
Exenatide Injection- STAGE I
exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
|
ITCA 650 20/20- STAGE II
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
|
ITCA 650 20/60- STAGE II
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
|
ITCA 650 40/40 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
|
ITCA 650 40/80 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
|
Ex Inj/ITCA 650 40 mcg/Day- STAGE II
Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
|
Ex Inj/ITCA 650 60 mcg/Day- STAGE II
Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
|
ITCA 650 20/20 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
|
ITCA 650 20/40 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/40 Contination
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/80 Continuation
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
|
Ex Inj/ITCA 650 40 Continuation
Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
Ex Inj/ITCA 650 60 Continuation
Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Stage I
Adverse Event
|
1
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage I
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage I
hyperglycemia
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage I
A1C elevation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage I
Withdrawal by Subject
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Stage II Continuation
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
|
Stage II Continuation
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Stage II Continuation
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Stage II Continuation
hypoglycemia
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Stage II Continuation
A1C elevation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
ITCA 650 20 mcg/Day- STAGE I
n=51 Participants
ITCA 650 20 mcg/day continuous exenatide
|
ITCA 650 40 mcg/Day- STAGE I
n=51 Participants
ITCA 650 40 mcg/day continuous exenatide
|
Exenatide Injection- STAGE I
n=53 Participants
exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
|
ITCA 650 20/20- STAGE II
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
|
ITCA 650 20/60- STAGE II
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
|
ITCA 650 40/40 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
|
ITCA 650 40/80 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
|
Ex Inj/ITCA 650 40 mcg/Day- STAGE II
Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
|
Ex Inj/ITCA 650 60 mcg/Day- STAGE II
Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
|
ITCA 650 20/20 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
|
ITCA 650 20/40 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/40 Contination
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/80 Continuation
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
|
Ex Inj/ITCA 650 40 Continuation
Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
|
Ex Inj/ITCA 650 60 Continuation
Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
53.7 years
STANDARD_DEVIATION 8.9 • n=135 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 participants
n=135 Participants
|
|
Age, Customized
Between 18 and 60 years
|
41 participants
n=5 Participants
|
37 participants
n=7 Participants
|
39 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
117 participants
n=135 Participants
|
|
Age, Customized
>=60 years
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
38 participants
n=135 Participants
|
|
Gender
Female
|
26 participants
n=5 Participants
|
28 participants
n=7 Participants
|
24 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
78 participants
n=135 Participants
|
|
Gender
Male
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
29 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
77 participants
n=135 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
51 participants
n=7 Participants
|
53 participants
n=5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
155 participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Week 12Population: Per protocol analysis- Only subjects with values at baseline and Week 12 endpoint are included.
Mean change in HbA1c over first 12 weeks (Stage I)
Outcome measures
| Measure |
ITCA 650 20 mcg/Day - STAGE I
n=47 Participants
ITCA 650 20 mcg/day through Week 12
|
ITCA 650 40 mcg/Day - STAGE I
n=45 Participants
ITCA 650 40 mcg/day through Week 12
|
Exenatide Injection - STAGE I
n=47 Participants
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
|
ITCA 650 40/80
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 40
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 60
Stage II \& Stage II Continuation
|
|---|---|---|---|---|---|---|
|
Mean Change in HbA1c (Per Protocol)
|
-0.96 percent change
Standard Deviation 0.905
|
-1.04 percent change
Standard Deviation 0.713
|
-0.82 percent change
Standard Deviation 0.870
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Week 12Population: Intent to treat analysis
Mean change in HbA1c through Week 12
Outcome measures
| Measure |
ITCA 650 20 mcg/Day - STAGE I
n=51 Participants
ITCA 650 20 mcg/day through Week 12
|
ITCA 650 40 mcg/Day - STAGE I
n=51 Participants
ITCA 650 40 mcg/day through Week 12
|
Exenatide Injection - STAGE I
n=52 Participants
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
|
ITCA 650 40/80
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 40
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 60
Stage II \& Stage II Continuation
|
|---|---|---|---|---|---|---|
|
Mean Change in HbA1c (ITT)
|
-.93 percent change
Standard Deviation 0.882
|
-0.96 percent change
Standard Deviation 0.724
|
-0.75 percent change
Standard Deviation 0.866
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 to Week 24Population: Per protocol analysis - Only subjects with values at baseline and Week 24 endpoint are included.
Mean change in HbA1c through Week 24
Outcome measures
| Measure |
ITCA 650 20 mcg/Day - STAGE I
n=20 Participants
ITCA 650 20 mcg/day through Week 12
|
ITCA 650 40 mcg/Day - STAGE I
n=21 Participants
ITCA 650 40 mcg/day through Week 12
|
Exenatide Injection - STAGE I
n=19 Participants
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
|
ITCA 650 40/80
n=19 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 40
n=22 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 60
n=20 Participants
Stage II \& Stage II Continuation
|
|---|---|---|---|---|---|---|
|
Mean Change in HbA1c (Per Protocol)
|
-.89 percent change
Standard Deviation .660
|
-1.26 percent change
Standard Deviation .950
|
-0.67 percent change
Standard Deviation .908
|
-1.36 percent change
Standard Deviation 0.664
|
-1.01 percent change
Standard Deviation 0.823
|
-1.51 percent change
Standard Deviation 1.266
|
PRIMARY outcome
Timeframe: Day 0 to Week 24Population: Intent to treat analysis
Mean change in HbA1c through Week 24
Outcome measures
| Measure |
ITCA 650 20 mcg/Day - STAGE I
n=22 Participants
ITCA 650 20 mcg/day through Week 12
|
ITCA 650 40 mcg/Day - STAGE I
n=21 Participants
ITCA 650 40 mcg/day through Week 12
|
Exenatide Injection - STAGE I
n=23 Participants
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
|
ITCA 650 40/80
n=23 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 40
n=22 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 60
n=22 Participants
Stage II \& Stage II Continuation
|
|---|---|---|---|---|---|---|
|
Mean Change in HbA1c (ITT)
|
-0.89 percent change
Standard Deviation 0.660
|
-1.26 percent change
Standard Deviation 0.950
|
-0.70 percent change
Standard Deviation 0.892
|
-1.36 percent change
Standard Deviation 0.664
|
-1.01 percent change
Standard Deviation 0.823
|
-1.51 percent change
Standard Deviation 1.266
|
PRIMARY outcome
Timeframe: Day 0 to Week 48Population: Per protocol - Only subjects with values at baseline and Week 48 endpoint are included.
Mean change in HbA1c through Week 48
Outcome measures
| Measure |
ITCA 650 20 mcg/Day - STAGE I
n=13 Participants
ITCA 650 20 mcg/day through Week 12
|
ITCA 650 40 mcg/Day - STAGE I
n=14 Participants
ITCA 650 40 mcg/day through Week 12
|
Exenatide Injection - STAGE I
n=11 Participants
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
|
ITCA 650 40/80
n=13 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 40
n=11 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 60
n=8 Participants
Stage II \& Stage II Continuation
|
|---|---|---|---|---|---|---|
|
Mean Change in HbA1c (Per Protocol)
|
-1.00 percent change
Standard Deviation 0.493
|
-1.23 percent change
Standard Deviation 0.908
|
-0.69 percent change
Standard Deviation 1.182
|
-1.37 percent change
Standard Deviation 0.837
|
-1.45 percent change
Standard Deviation 0.895
|
-1.88 percent change
Standard Deviation 1.212
|
PRIMARY outcome
Timeframe: Day 0 to Week 48Population: Intent to treat analysis
Mean change in HbA1c through Week 48
Outcome measures
| Measure |
ITCA 650 20 mcg/Day - STAGE I
n=15 Participants
ITCA 650 20 mcg/day through Week 12
|
ITCA 650 40 mcg/Day - STAGE I
n=15 Participants
ITCA 650 40 mcg/day through Week 12
|
Exenatide Injection - STAGE I
n=13 Participants
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
|
ITCA 650 40/80
n=16 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 40
n=15 Participants
Stage II \& Stage II Continuation
|
Ex Inj/ITCA 650 60
n=12 Participants
Stage II \& Stage II Continuation
|
|---|---|---|---|---|---|---|
|
Mean Change in HbA1c (ITT)
|
-1.13 percent change
Standard Deviation 0.651
|
-1.25 percent change
Standard Deviation 0.880
|
-0.48 percent change
Standard Deviation 1.555
|
-1.40 percent change
Standard Deviation 0.803
|
-1.16 percent change
Standard Deviation 0.988
|
-1.84 percent change
Standard Deviation 1.570
|
Adverse Events
ITCA 650 20 mcg/Day
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
ITCA 650 40 mcg/Day
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Exenatide Injection
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
ITCA 650 20/20
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
ITCA 650 20/60
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
ITCA 650 40/40
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
ITCA 650 40/80
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Ex Inj/ITCA 650 40
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Ex Inj/ITCA 650 60
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
ITCA 650 20/20 Continuation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
ITCA 650 20/60 Continuation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
ITCA 650 40/40 Continuation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
ITCA 650 40/80 Continuation
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Ex Inj/ITCA 40 Continuation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ex Inj/ITCA 650 60 Continutation
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ITCA 650 20 mcg/Day
n=51 participants at risk
ITCA 650 20 mcg/day continuous exenatide
|
ITCA 650 40 mcg/Day
n=51 participants at risk
ITCA 650 40 mcg/day continuous exenatide
|
Exenatide Injection
n=53 participants at risk
exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
|
ITCA 650 20/20
n=20 participants at risk
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
|
ITCA 650 20/60
n=21 participants at risk
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
|
ITCA 650 40/40
n=23 participants at risk
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
|
ITCA 650 40/80
n=23 participants at risk
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
|
Ex Inj/ITCA 650 40
n=23 participants at risk
Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
|
Ex Inj/ITCA 650 60
n=21 participants at risk
Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
|
ITCA 650 20/20 Continuation
n=15 participants at risk
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
|
ITCA 650 20/60 Continuation
n=15 participants at risk
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
|
ITCA 650 40/40 Continuation
n=13 participants at risk
ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/80 Continuation
n=16 participants at risk
ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
|
Ex Inj/ITCA 40 Continuation
n=15 participants at risk
Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
|
Ex Inj/ITCA 650 60 Continutation
n=12 participants at risk
Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
cholecyctitis acute
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/19 • 48 weeks
|
0.00%
0/19 • 48 weeks
|
0.00%
0/22 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Blood and lymphatic system disorders
leukopenia
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/19 • 48 weeks
|
5.3%
1/19 • Number of events 1 • 48 weeks
|
0.00%
0/22 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
General disorders
pyrexia
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Infections and infestations
meningitis cryptococcal
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/19 • 48 weeks
|
5.3%
1/19 • Number of events 1 • 48 weeks
|
0.00%
0/22 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Pregnancy, puerperium and perinatal conditions
abortion, spontaneous
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
5.3%
1/19 • Number of events 1 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Reproductive system and breast disorders
prostatomegaly
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
skin ulcer
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
6.2%
1/16 • Number of events 1 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Infections and infestations
labyrinthitis
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
rectal cancer
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
7.7%
1/13 • Number of events 1 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Vascular disorders
subclavian artery stenosis
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/19 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
6.2%
1/16 • Number of events 1 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Gastrointestinal disorders
abdominal pain upper
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
Other adverse events
| Measure |
ITCA 650 20 mcg/Day
n=51 participants at risk
ITCA 650 20 mcg/day continuous exenatide
|
ITCA 650 40 mcg/Day
n=51 participants at risk
ITCA 650 40 mcg/day continuous exenatide
|
Exenatide Injection
n=53 participants at risk
exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
|
ITCA 650 20/20
n=20 participants at risk
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
|
ITCA 650 20/60
n=21 participants at risk
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
|
ITCA 650 40/40
n=23 participants at risk
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
|
ITCA 650 40/80
n=23 participants at risk
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
|
Ex Inj/ITCA 650 40
n=23 participants at risk
Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
|
Ex Inj/ITCA 650 60
n=21 participants at risk
Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
|
ITCA 650 20/20 Continuation
n=15 participants at risk
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
|
ITCA 650 20/60 Continuation
n=15 participants at risk
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
|
ITCA 650 40/40 Continuation
n=13 participants at risk
ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
|
ITCA 650 40/80 Continuation
n=16 participants at risk
ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
|
Ex Inj/ITCA 40 Continuation
n=15 participants at risk
Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
|
Ex Inj/ITCA 650 60 Continutation
n=12 participants at risk
Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
decreased appetite
|
11.8%
6/51 • Number of events 6 • 48 weeks
|
13.7%
7/51 • Number of events 7 • 48 weeks
|
9.4%
5/53 • Number of events 5 • 48 weeks
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Nervous system disorders
headache
|
3.9%
2/51 • Number of events 2 • 48 weeks
|
11.8%
6/51 • Number of events 6 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
6.2%
1/16 • Number of events 1 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Injury, poisoning and procedural complications
incision site pain
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
15.0%
3/20 • Number of events 3 • 48 weeks
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
21.7%
5/23 • Number of events 6 • 48 weeks
|
13.0%
3/23 • Number of events 3 • 48 weeks
|
13.0%
3/23 • Number of events 3 • 48 weeks
|
9.5%
2/21 • Number of events 3 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
18.8%
3/16 • Number of events 3 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
8.3%
1/12 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
incision site erythema
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
10.0%
2/20 • Number of events 3 • 48 weeks
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
7.7%
1/13 • Number of events 1 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
8.3%
1/12 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
incision site complication
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
5.0%
1/20 • Number of events 2 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
6.2%
1/16 • Number of events 2 • 48 weeks
|
6.7%
1/15 • Number of events 1 • 48 weeks
|
16.7%
2/12 • Number of events 2 • 48 weeks
|
|
General disorders
fatigue
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
13.0%
3/23 • Number of events 3 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
17.4%
4/23 • Number of events 4 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
13.3%
2/15 • Number of events 3 • 48 weeks
|
13.3%
2/15 • Number of events 3 • 48 weeks
|
7.7%
1/13 • Number of events 1 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
13.3%
2/15 • Number of events 2 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/51 • 48 weeks
|
0.00%
0/51 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Gastrointestinal disorders
nausea
|
33.3%
17/51 • Number of events 19 • 48 weeks
|
47.1%
24/51 • Number of events 24 • 48 weeks
|
35.8%
19/53 • Number of events 20 • 48 weeks
|
10.0%
2/20 • Number of events 2 • 48 weeks
|
33.3%
7/21 • Number of events 8 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
26.1%
6/23 • Number of events 7 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
38.1%
8/21 • Number of events 9 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Gastrointestinal disorders
vomiting
|
11.8%
6/51 • Number of events 6 • 48 weeks
|
17.6%
9/51 • Number of events 11 • 48 weeks
|
7.5%
4/53 • Number of events 4 • 48 weeks
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
21.7%
5/23 • Number of events 7 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
23.8%
5/21 • Number of events 6 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Gastrointestinal disorders
diarrhea
|
3.9%
2/51 • Number of events 2 • 48 weeks
|
15.7%
8/51 • Number of events 8 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
5.0%
1/20 • Number of events 2 • 48 weeks
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
4.3%
1/23 • Number of events 1 • 48 weeks
|
13.0%
3/23 • Number of events 3 • 48 weeks
|
17.4%
4/23 • Number of events 6 • 48 weeks
|
19.0%
4/21 • Number of events 5 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Gastrointestinal disorders
gastroesophageal reflux disease (GERD)
|
7.8%
4/51 • Number of events 4 • 48 weeks
|
7.8%
4/51 • Number of events 4 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Gastrointestinal disorders
constipation
|
5.9%
3/51 • Number of events 3 • 48 weeks
|
7.8%
4/51 • Number of events 4 • 48 weeks
|
1.9%
1/53 • Number of events 1 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
13.0%
3/23 • Number of events 3 • 48 weeks
|
19.0%
4/21 • Number of events 5 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Gastrointestinal disorders
dyspepsia
|
7.8%
4/51 • Number of events 4 • 48 weeks
|
2.0%
1/51 • Number of events 1 • 48 weeks
|
5.7%
3/53 • Number of events 3 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
General disorders
early satiety
|
3.9%
2/51 • Number of events 2 • 48 weeks
|
5.9%
3/51 • Number of events 3 • 48 weeks
|
7.5%
4/53 • Number of events 4 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/23 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Injury, poisoning and procedural complications
incision site hematoma
|
15.7%
8/51 • Number of events 8 • 48 weeks
|
15.7%
8/51 • Number of events 8 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
25.0%
5/20 • Number of events 5 • 48 weeks
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
13.0%
3/23 • Number of events 3 • 48 weeks
|
13.0%
3/23 • Number of events 4 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
23.8%
5/21 • Number of events 5 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Injury, poisoning and procedural complications
incision site pruritis
|
5.9%
3/51 • Number of events 3 • 48 weeks
|
13.7%
7/51 • Number of events 7 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
0.00%
0/20 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
0.00%
0/21 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
7.7%
1/13 • Number of events 1 • 48 weeks
|
0.00%
0/16 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
|
Injury, poisoning and procedural complications
incision site hemorrhage
|
5.9%
3/51 • Number of events 3 • 48 weeks
|
9.8%
5/51 • Number of events 5 • 48 weeks
|
0.00%
0/53 • 48 weeks
|
5.0%
1/20 • Number of events 1 • 48 weeks
|
9.5%
2/21 • Number of events 2 • 48 weeks
|
13.0%
3/23 • Number of events 4 • 48 weeks
|
13.0%
3/23 • Number of events 5 • 48 weeks
|
8.7%
2/23 • Number of events 2 • 48 weeks
|
4.8%
1/21 • Number of events 1 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/13 • 48 weeks
|
6.2%
1/16 • Number of events 1 • 48 weeks
|
0.00%
0/15 • 48 weeks
|
0.00%
0/12 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right to submit multicenter results within 12 months after completion of the study. Thereafter, PI may publish the results of its data after submitting advance copy of the planned publication to sponsor. PI to agree to sponsor changes regarding deletion of confidential information, reasonable changes, or a delay of up to 90 days for patent purposes.
- Publication restrictions are in place
Restriction type: OTHER