Trial Outcomes & Findings for Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes (NCT NCT01798264)
NCT ID: NCT01798264
Last Updated: 2013-05-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
4 weeks
Results posted on
2013-05-17
Participant Flow
Initiated February 2009 completed 15 May 2009
Participant milestones
| Measure |
10 Mcg/Day
ITCA 650 (exenatide in DUROS)
|
20 Mcg/Day
ITCA 650 (exenatide in DUROS)
|
40 Mcg/Day
ITCA 650 (exenatide in DUROS)
|
80 Mcg/Day
ITCA 650 (exenatide in DUROS)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
10 Mcg/Day
n=12 Participants
ITCA 650 (exenatide in DUROS)
|
20 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
40 Mcg/Day
n=10 Participants
ITCA 650 (exenatide in DUROS)
|
80 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
56.3 years
STANDARD_DEVIATION 6.74 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 6.10 • n=7 Participants
|
52.6 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 4.84 • n=4 Participants
|
55.7 years
STANDARD_DEVIATION 6.92 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
44 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Number of subjects reporting study drug-related adverse events
Outcome measures
| Measure |
10 Mcg/Day
n=12 Participants
ITCA 650 (exenatide in DUROS)
|
20 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
40 Mcg/Day
n=10 Participants
ITCA 650 (exenatide in DUROS)
|
80 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
|---|---|---|---|---|
|
Number of Subjects With Study Drug-Related Adverse Events
|
9 participants
|
11 participants
|
9 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 4 weeksChange in HbA1c from baseline
Outcome measures
| Measure |
10 Mcg/Day
n=12 Participants
ITCA 650 (exenatide in DUROS)
|
20 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
40 Mcg/Day
n=10 Participants
ITCA 650 (exenatide in DUROS)
|
80 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
|---|---|---|---|---|
|
To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
|
-0.5 percentage
Standard Deviation 0.39
|
-0.6 percentage
Standard Deviation 0.31
|
-0.5 percentage
Standard Deviation 0.31
|
-0.7 percentage
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
10 Mcg/Day
n=12 Participants
ITCA 650 (exenatide in DUROS)
|
20 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
40 Mcg/Day
n=10 Participants
ITCA 650 (exenatide in DUROS)
|
80 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
|---|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline
|
-5.6 mg/dL
Standard Deviation 34.33
|
-31.2 mg/dL
Standard Deviation 24.2
|
-42.0 mg/dL
Standard Deviation 33.16
|
-28.8 mg/dL
Standard Deviation 33.5
|
SECONDARY outcome
Timeframe: 4 weeksOutcome measures
| Measure |
10 Mcg/Day
n=12 Participants
ITCA 650 (exenatide in DUROS)
|
20 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
40 Mcg/Day
n=10 Participants
ITCA 650 (exenatide in DUROS)
|
80 Mcg/Day
n=11 Participants
ITCA 650 (exenatide in DUROS)
|
|---|---|---|---|---|
|
Change in Weight From Baseline to 4 Weeks
|
-0.3 kg
Standard Deviation 0.91
|
-0.3 kg
Standard Deviation 1.51
|
-1.1 kg
Standard Deviation 1.6
|
-3.1 kg
Standard Deviation 2.13
|
Adverse Events
10 Mcg/Day
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
20 Mcg/Day
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
40 Mcg/Day
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
80 Mcg/Day
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 Mcg/Day
n=12 participants at risk
ITCA 650 (exenatide in DUROS)
|
20 Mcg/Day
n=11 participants at risk
ITCA 650 (exenatide in DUROS)
|
40 Mcg/Day
n=10 participants at risk
ITCA 650 (exenatide in DUROS)
|
80 Mcg/Day
n=11 participants at risk
ITCA 650 (exenatide in DUROS)
|
|---|---|---|---|---|
|
Eye disorders
eye swelling
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Eye disorders
photophobia
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Gastrointestinal disorders
nausea
|
8.3%
1/12 • Number of events 1 • 4 weeks
|
27.3%
3/11 • Number of events 3 • 4 weeks
|
60.0%
6/10 • Number of events 9 • 4 weeks
|
72.7%
8/11 • Number of events 23 • 4 weeks
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/12 • 4 weeks
|
27.3%
3/11 • Number of events 6 • 4 weeks
|
10.0%
1/10 • Number of events 5 • 4 weeks
|
81.8%
9/11 • Number of events 23 • 4 weeks
|
|
General disorders
dyspepsia
|
0.00%
0/12 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
10.0%
1/10 • Number of events 2 • 4 weeks
|
36.4%
4/11 • Number of events 5 • 4 weeks
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
27.3%
3/11 • Number of events 4 • 4 weeks
|
|
Gastrointestinal disorders
eructation
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
0.00%
0/10 • 4 weeks
|
27.3%
3/11 • Number of events 4 • 4 weeks
|
|
Gastrointestinal disorders
abdominal disomfort
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
GERD
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
0.00%
0/10 • 4 weeks
|
18.2%
2/11 • Number of events 2 • 4 weeks
|
|
General disorders
early satiety
|
16.7%
2/12 • Number of events 2 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
|
General disorders
chills
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
General disorders
feeling hot
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Injury, poisoning and procedural complications
incision site erythema
|
33.3%
4/12 • Number of events 6 • 4 weeks
|
54.5%
6/11 • Number of events 9 • 4 weeks
|
60.0%
6/10 • Number of events 16 • 4 weeks
|
45.5%
5/11 • Number of events 11 • 4 weeks
|
|
Injury, poisoning and procedural complications
incision site complication
|
50.0%
6/12 • Number of events 8 • 4 weeks
|
63.6%
7/11 • Number of events 8 • 4 weeks
|
70.0%
7/10 • Number of events 16 • 4 weeks
|
45.5%
5/11 • Number of events 8 • 4 weeks
|
|
Injury, poisoning and procedural complications
incision site hemmorhage
|
25.0%
3/12 • Number of events 4 • 4 weeks
|
45.5%
5/11 • Number of events 6 • 4 weeks
|
20.0%
2/10 • Number of events 4 • 4 weeks
|
27.3%
3/11 • Number of events 4 • 4 weeks
|
|
Injury, poisoning and procedural complications
incision site pain
|
33.3%
4/12 • Number of events 5 • 4 weeks
|
9.1%
1/11 • Number of events 3 • 4 weeks
|
20.0%
2/10 • Number of events 3 • 4 weeks
|
45.5%
5/11 • Number of events 6 • 4 weeks
|
|
Injury, poisoning and procedural complications
incision site blister
|
0.00%
0/12 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
40.0%
4/10 • Number of events 6 • 4 weeks
|
18.2%
2/11 • Number of events 2 • 4 weeks
|
|
Injury, poisoning and procedural complications
incision site edema
|
8.3%
1/12 • Number of events 1 • 4 weeks
|
18.2%
2/11 • Number of events 2 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
27.3%
3/11 • Number of events 3 • 4 weeks
|
|
Metabolism and nutrition disorders
decreased appetite
|
33.3%
4/12 • Number of events 4 • 4 weeks
|
36.4%
4/11 • Number of events 4 • 4 weeks
|
30.0%
3/10 • Number of events 3 • 4 weeks
|
54.5%
6/11 • Number of events 6 • 4 weeks
|
|
Metabolism and nutrition disorders
hyperlipasaemia
|
0.00%
0/12 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
hyperamylasemia
|
0.00%
0/12 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Metabolism and nutrition disorders
hypoglycemia
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
8.3%
1/12 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
headache
|
8.3%
1/12 • Number of events 2 • 4 weeks
|
9.1%
1/11 • Number of events 1 • 4 weeks
|
20.0%
2/10 • Number of events 2 • 4 weeks
|
18.2%
2/11 • Number of events 5 • 4 weeks
|
|
Nervous system disorders
dizziness
|
16.7%
2/12 • Number of events 2 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
20.0%
2/10 • Number of events 2 • 4 weeks
|
18.2%
2/11 • Number of events 3 • 4 weeks
|
|
Nervous system disorders
paresthesia
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
0.00%
0/10 • 4 weeks
|
18.2%
2/11 • Number of events 2 • 4 weeks
|
|
Nervous system disorders
dizziness extertional
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Nervous system disorders
lethargy
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Nervous system disorders
syncope vasovagal
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Psychiatric disorders
anxiety
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Psychiatric disorders
libido decreased
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Reproductive system and breast disorders
vulvovaginal dryness
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
|
Vascular disorders
orthostatic hypotension
|
0.00%
0/12 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
10.0%
1/10 • Number of events 1 • 4 weeks
|
0.00%
0/11 • 4 weeks
|
Additional Information
Michelle Braon
Intarcia
Phone: 510-782-7800
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60