Trial Outcomes & Findings for An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects (NCT NCT02793154)
NCT ID: NCT02793154
Last Updated: 2020-10-30
Results Overview
The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for distribution of average power in the bradygastria, normal, tachygastria and duodenal range during pre-WL and 10, 20 and 30 minutes post-WL after treatment with exenatide has been presented. The analysis was performed on Pharmacodynamic Population, which included all Par. who received at least one dose of study medication and had valid data.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
Up to Day 4
Results posted on
2020-10-30
Participant Flow
This study compared effects of repeated doses of albiglutide and exenatide in type 2 diabetes mellitus. This study was conducted in two parts; first cohort of participants (Par.) were planned to receive exenatide (Part A) and second cohort with albiglutide or exenatide (Part B). There were no pre-specified Primary or Secondary endpoints for Part A.
This study was terminated during exploratory Part A due to the difficulty with enrollment and Part B was cancelled. Hence, Par. received only exenatide subcutaneous (SC) injection in Part A. The data was only collected in Part A and no Par. were enrolled in Part B. All the 4 enrolled Par. completed Part A and no Par. was withdrawn from study.
Participant milestones
| Measure |
Part A: Exenatide SC Injection
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Exenatide SC Injection
Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|---|
|
Part A (Single Group-up to 12 Days)
STARTED
|
4
|
0
|
0
|
|
Part A (Single Group-up to 12 Days)
COMPLETED
|
4
|
0
|
0
|
|
Part A (Single Group-up to 12 Days)
NOT COMPLETED
|
0
|
0
|
0
|
|
Part B (Parallel Group-up to 84 Days)
STARTED
|
0
|
0
|
0
|
|
Part B (Parallel Group-up to 84 Days)
COMPLETED
|
0
|
0
|
0
|
|
Part B (Parallel Group-up to 84 Days)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects
Baseline characteristics by cohort
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Exenatide SC Injection
Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.8 Years
STANDARD_DEVIATION 3.30 • n=5 Participants
|
—
|
—
|
56.8 Years
STANDARD_DEVIATION 3.30 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
—
|
—
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White-White/Causasian/European Heritage
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 4Population: Pharmacodynamic Population
The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for distribution of average power in the bradygastria, normal, tachygastria and duodenal range during pre-WL and 10, 20 and 30 minutes post-WL after treatment with exenatide has been presented. The analysis was performed on Pharmacodynamic Population, which included all Par. who received at least one dose of study medication and had valid data.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; Pre-WL; Bradygastria
|
56.15 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; Pre-WL; Normal
|
23.49 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; Pre-WL; Tachygastria
|
17 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; Pre-WL; Duodenal
|
3.35 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria
|
93.97 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Normal
|
2.9 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Tachygastria
|
2.4 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Duodenal
|
0.73 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria
|
57.13 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Normal
|
23.29 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Tachygastria
|
13.17 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Duodenal
|
6.41 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria
|
43.44 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Normal
|
36.16 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Tachygastria
|
17.78 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Duodenal
|
2.62 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; Pre-WL; Bradygastria
|
71.94 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; Pre-WL; Normal
|
13 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; Pre-WL; Tachygastria
|
9.51 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; Pre-WL; Duodenal
|
5.55 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria
|
43.99 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Normal
|
12.94 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Tachygastria
|
28.33 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Duodenal
|
14.74 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria
|
73.87 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Normal
|
10.97 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Tachygastria
|
8.77 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Duodenal
|
6.39 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria
|
48.87 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Normal
|
16.66 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Tachygastria
|
23.16 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Duodenal
|
11.31 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; Pre-WL; Bradygastria
|
67.44 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; Pre-WL; Normal
|
10.67 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; Pre-WL; Tachygastria
|
17.2 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; Pre-WL; Duodenal
|
4.68 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria
|
94.05 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Normal
|
2.46 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Tachygastria
|
2.83 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Duodenal
|
0.67 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria
|
85.64 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Normal
|
11.72 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Tachygastria
|
2.43 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Duodenal
|
0.22 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria
|
77.34 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Normal
|
15.57 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Tachygastria
|
6.23 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Duodenal
|
0.86 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; Pre-WL; Bradygastria
|
43.32 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; Pre-WL; Normal
|
23.82 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; Pre-WL; Tachygastria
|
18.71 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; Pre-WL; Duodenal
|
14.14 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria
|
84.23 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Normal
|
7.93 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Tachygastria
|
6.81 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Duodenal
|
1.02 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria
|
66.32 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Normal
|
19.43 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Tachygastria
|
11.7 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Duodenal
|
2.55 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria
|
73.05 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Normal
|
19.64 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Tachygastria
|
6.47 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Duodenal
|
0.84 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; Pre-WL; Bradygastria
|
59.66 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; Pre-WL; Normal
|
9.05 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; Pre-WL; Tachygastria
|
22.39 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; Pre-WL; Duodenal
|
8.91 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria
|
32.73 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Normal
|
11.03 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Tachygastria
|
48.77 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Duodenal
|
7.47 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Bradygastria
|
29.94 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Normal
|
22.84 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Tachygastria
|
39.72 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Duodenal
|
7.5 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Bradygastria
|
16.32 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Normal
|
22.48 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria
|
54.77 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Duodenal
|
6.43 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; Pre-WL; Bradygastria
|
52.85 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; Pre-WL; Normal
|
16.64 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; Pre-WL; Tachygastria
|
13.21 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; Pre-WL; Duodenal
|
17.29 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria
|
64.27 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Normal
|
10.37 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Tachygastria
|
13.26 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Duodenal
|
12.1 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria
|
71.66 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Normal
|
11.11 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Tachygastria
|
9.52 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Duodenal
|
7.72 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria
|
53.97 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Normal
|
8.61 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Tachygastria
|
16.12 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Duodenal
|
21.3 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; Pre-WL; Bradygastria
|
82.47 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; Pre-WL; Normal
|
6.66 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; Pre-WL; Tachygastria
|
7.86 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; Pre-WL; Duodenal
|
3.01 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria
|
81.89 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Normal
|
5.6 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Tachygastria
|
11.63 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Duodenal
|
0.88 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria
|
62.96 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Normal
|
12.84 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Tachygastria
|
17.04 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Duodenal
|
7.17 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria
|
73.64 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Normal
|
12.7 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Tachygastria
|
11.1 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Duodenal
|
2.56 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; Pre-WL; Bradygastria
|
54.98 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; Pre-WL; Normal
|
17.6 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; Pre-WL; Tachygastria
|
22.97 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; Pre-WL; Duodenal
|
4.45 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria
|
83.7 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Normal
|
4.2 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Tachygastria
|
10.69 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Duodenal
|
1.4 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria
|
82.96 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Normal
|
5.92 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Tachygastria
|
10.1 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Duodenal
|
1.02 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Bradygastria
|
39.01 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Normal
|
42.61 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Tachygastria
|
16.77 Percentage of power
|
—
|
|
Part A: Distribution of Average Power by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Duodenal
|
1.62 Percentage of power
|
—
|
PRIMARY outcome
Timeframe: Up to Day 4Population: Pharmacodynamic Population
The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for ratios of average power post- WLT/pre-WLT in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at 10, 20, and 30 minutes post-WL has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 10 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 20 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 1; 30 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 10 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 20 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 1; Day 4; 30 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria
|
0.01 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 10 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria
|
0.04 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Normal
|
0.04 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 20 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria
|
0.01 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Normal
|
0.02 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 1; 30 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria
|
0.03 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Normal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Tachygastria
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 10 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria
|
0.03 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Normal
|
0.02 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Tachygastria
|
0.01 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 20 minutes Post-WL; Duodenal
|
0 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria
|
0.22 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Normal
|
0.11 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Tachygastria
|
0.05 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 2; Day 4; 30 minutes Post-WL; Duodenal
|
0.01 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria
|
0.13 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Normal
|
0.29 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Tachygastria
|
0.52 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 10 minutes Post-WL; Duodenal
|
0.2 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Bradygastria
|
0.2 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Normal
|
0.99 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Tachygastria
|
0.7 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 20 minutes Post-WL; Duodenal
|
0.33 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Bradygastria
|
0.15 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Normal
|
1.38 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria
|
1.36 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 1; 30 minutes Post-WL; Duodenal
|
0.4 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria
|
0.16 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Normal
|
0.08 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Tachygastria
|
0.13 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 10 minutes Post-WL; Duodenal
|
0.09 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria
|
0.2 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Normal
|
0.1 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Tachygastria
|
0.11 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 20 minutes Post-WL; Duodenal
|
0.07 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria
|
0.16 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Normal
|
0.08 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Tachygastria
|
0.19 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 3; Day 4; 30 minutes Post-WL; Duodenal
|
0.19 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria
|
2.6 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Normal
|
2.21 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Tachygastria
|
3.88 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 10 minutes Post-WL; Duodenal
|
0.76 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria
|
0.89 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Normal
|
2.24 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Tachygastria
|
2.52 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 20 minutes Post-WL; Duodenal
|
2.76 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria
|
1.54 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Normal
|
3.29 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Tachygastria
|
2.44 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 1; 30 minutes Post-WL; Duodenal
|
1.47 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria
|
4.7 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Normal
|
0.74 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Tachygastria
|
1.44 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 10 minutes Post-WL; Duodenal
|
0.97 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria
|
10.24 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Normal
|
2.28 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Tachygastria
|
2.98 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 20 minutes Post-WL; Duodenal
|
1.55 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Bradygastria
|
3.4 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Normal
|
11.6 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Tachygastria
|
3.5 Ratio
|
—
|
|
Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region
Par. 4; Day 4; 30 minutes Post-WL; Duodenal
|
1.74 Ratio
|
—
|
PRIMARY outcome
Timeframe: Up to Day 4Population: Pharmacodynamic Population
The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for dominant EGG frequencies including bradygastria, normal, tachygastria and duodenal at pre-WL and after treatment with exenatide at pre-WL and 10, 20, 30 minutes post-WL has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; Pre-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; Pre-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 20 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 30 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 30 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 1; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; Pre-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; Pre-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 20 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 30 minutes Post-WL; Normal
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 30 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 2; Day 4; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; Pre-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; Pre-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 20 minutes Post-WL; Bradygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 20 minutes Post-WL; Normal
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 30 minutes Post-WL; Bradygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 30 minutes Post-WL; Normal
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 1; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; Pre-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; Pre-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 20 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 30 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 30 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 3; Day 4; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; Pre-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; Pre-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 20 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 30 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 30 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 1; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; Pre-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; Pre-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 20 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 30 minutes Post-WL; Bradygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 30 minutes Post-WL; Normal
|
80 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 30 minutes Post-WL; Tachygastria
|
20 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 4; Day 4; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; Pre-WL; Bradygastria
|
80 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; Pre-WL; Normal
|
20 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 20 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 30 minutes Post-WL; Normal
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 30 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 1; 30 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; Pre-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; Pre-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; Pre-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; Pre-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 10 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 10 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 10 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria
|
100 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 20 minutes Post-WL; Normal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 20 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 20 minutes Post-WL; Duodenal
|
0 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 30 minutes Post-WL; Normal
|
50 Percentage of time
|
—
|
|
Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal
Par. 1; Day 4; 30 minutes Post-WL; Tachygastria
|
0 Percentage of time
|
—
|
PRIMARY outcome
Timeframe: Up to 12 daysPopulation: Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.
EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 12 daysPopulation: Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.
EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Day 4Population: Pharmacodynamic Population
The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for average dominant frequency in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at Pre-WL and 10, 20, 30 minutes post-WL has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Average Dominant Frequency
Par. 1; Day 1; Pre-WL; Bradygastria
|
1.5 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 1; Day 1; 10 minutes Post-WL; Bradygastria
|
0.75 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 1; Day 1; 20 minutes Post-WL; Bradygastria
|
1.25 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 1; Day 1; 30 minutes Post-WL; Bradygastria
|
2.19 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 1; Day 4; Pre-WL; Bradygastria
|
1.05 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 1; Day 4; 10 minutes Post-WL; Bradygastria
|
0.96 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 1; Day 4; 20 minutes Post-WL; Bradygastria
|
1.25 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 1; Day 4; 30 minutes Post-WL; Bradygastria
|
2.38 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 1; Pre-WL; Bradygastria
|
1 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 1; 10 minutes Post-WL; Bradygastria
|
1 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 1; 20 minutes Post-WL; Bradygastria
|
1.5 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 1; 30 minutes Post-WL; Bradygastria
|
1.75 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 4; Pre-WL; Bradygastria
|
0.75 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 4; 10 minutes Post-WL; Bradygastria
|
1.38 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 4; 20 minutes Post-WL; Bradygastria
|
1 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 2; Day 4; 30 minutes Post-WL; Bradygastria
|
2.42 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 1; Pre-WL; Bradygastria
|
0.96 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 1; 10 minutes Post-WL; Bradygastria
|
1.83 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 1; 20 minutes Post-WL; Normal
|
3 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 1; 30 minutes Post-WL; Tachygastria
|
4.13 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 4; Pre-WL; Bradygastria
|
1.2 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 4; 10 minutes Post-WL; Bradygastria
|
1.5 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 4; 20 minutes Post-WL; Bradygastria
|
0.94 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 3; Day 4; 30 minutes Post-WL; Bradygastria
|
1.5 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 1; Pre-WL; Bradygastria
|
0.86 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 1; 10 minutes Post-WL; Bradygastria
|
1.88 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 1; 20 minutes Post-WL; Bradygastria
|
1.7 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 1; 30 minutes Post-WL; Bradygastria
|
1.19 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 4; Pre-WL; Bradygastria
|
1.2 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 4; 10 minutes Post-WL; Bradygastria
|
0.94 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 4; 20 minutes Post-WL; Bradygastria
|
1.29 Cycles per minute
|
—
|
|
Part A: Average Dominant Frequency
Par. 4; Day 4; 30 minutes Post-WL; Normal
|
2.9 Cycles per minute
|
—
|
PRIMARY outcome
Timeframe: Day 4Population: Pharmacodynamic Population
The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces nausea in Par. allowing the assessment of gastric myoelectrical activity during the episodes of nausea. The intensity of upper gastrointestinal symptom of nausea was measured using VAS ranging from 0 (no nausea) to 100 (severe nausea) immediately before (pre-WL) and 10, 20, 30 minutes post-WL. Individual Par. responses to VAS score scale has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 1; Day 4; Pre-WL
|
4 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 1; Day 4; 10 minutes Post-WL
|
2 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 1; Day 4; 20 minutes Post-WL
|
4 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 1; Day 4; 30 minutes Post-WL
|
3 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 2; Day 4; Pre-WL
|
3 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 2; Day 4; 10 minutes Post-WL
|
4 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 2; Day 4; 20 minutes Post-WL
|
4 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 2; Day 4; 30 minutes Post-WL
|
24 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 3; Day 4; Pre-WL
|
1 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 3; Day 4; 10 minutes Post-WL
|
0 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 3; Day 4; 20 minutes Post-WL
|
0 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 3; Day 4; 30 minutes Post-WL
|
0 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 4; Day 4; Pre-WL
|
4 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 4; Day 4; 10 minutes Post-WL
|
5 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 4; Day 4; 20 minutes Post-WL
|
3 Scores on a scale
|
—
|
|
Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score
Par. 4; Day 4; 30 minutes Post-WL
|
4 Scores on a scale
|
—
|
PRIMARY outcome
Timeframe: Up to Day 5Population: Pharmacodynamic Population
Breath samples were collected to assess the time to half gastric emptying using gastric emptying breath test (GEBT) containing 13 Carbon (13C)-Spirulina pre-meal and post GEBT meal. The GEBT method was used to measure GE of solid food. The time to half gastric emptying for individual Par. has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Time to Half-gastric Emptying
Par. 1; Day -1
|
87.2 Minutes
|
—
|
|
Part A: Time to Half-gastric Emptying
Par. 1; Day 5
|
226.5 Minutes
|
—
|
|
Part A: Time to Half-gastric Emptying
Par. 2; Day -1
|
73.0 Minutes
|
—
|
|
Part A: Time to Half-gastric Emptying
Par. 2; Day 5
|
75.5 Minutes
|
—
|
|
Part A: Time to Half-gastric Emptying
Par. 3; Day -1
|
57.6 Minutes
|
—
|
|
Part A: Time to Half-gastric Emptying
Par. 3; Day 5
|
174.0 Minutes
|
—
|
|
Part A: Time to Half-gastric Emptying
Par. 4; Day -1
|
52.9 Minutes
|
—
|
|
Part A: Time to Half-gastric Emptying
Par. 4; Day 5
|
103.8 Minutes
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: Pharmacodynamic Population
The effect of exenatide on gastric emptying was be assessed by calculating the percent dose excreted of 13C in breath multiplied by 1000 (kPCD). Breath samples were collected at the indicated time points. Individual Par. data at pre-meal and 45, 90, 120, 150, 180 and 240 minutes post-meal has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 1; Day 5; Pre-Meal
|
0 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 1; Day 5; 45 Minutes Post-Meal
|
1.8 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 1; Day 5; 90 Minutes Post-Meal
|
3.3 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 1; Day 5; 120 Minutes Post-Meal
|
3.1 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 1; Day 5; 150 Minutes Post-Meal
|
3.3 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 1; Day 5; 180 Minutes Post-Meal
|
7.4 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 1; Day 5; 240 Minutes Post-Meal
|
21.1 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 2; Day 5; Pre-Meal
|
0 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 2; Day 5; 45 Minutes Post-Meal
|
22.2 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 2; Day 5; 90 Minutes Post-Meal
|
42.5 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 2; Day 5; 120 Minutes Post-Meal
|
66.5 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 2; Day 5; 150 Minutes Post-Meal
|
82.3 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 2; Day 5; 180 Minutes Post-Meal
|
84.7 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 2; Day 5; 240 Minutes Post-Meal
|
75.8 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 3; Day 5; Pre-Meal
|
0 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 3; Day 5; 45 Minutes Post-Meal
|
1 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 3; Day 5; 90 Minutes Post-Meal
|
2.3 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 3; Day 5; 120 Minutes Post-Meal
|
6.5 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 3; Day 5; 150 Minutes Post-Meal
|
16.4 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 3; Day 5; 180 Minutes Post-Meal
|
28.2 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 3; Day 5; 240 Minutes Post-Meal
|
56.3 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 4; Day 5; Pre-Meal
|
0 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 4; Day 5; 45 Minutes Post-Meal
|
11.3 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 4; Day 5; 90 Minutes Post-Meal
|
27.8 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 4; Day 5; 120 Minutes Post-Meal
|
39.6 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 4; Day 5; 150 Minutes Post-Meal
|
51.1 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 4; Day 5; 180 Minutes Post-Meal
|
59.8 kPCD per minute
|
—
|
|
Part A: Rate of [13]C Dose Excreted in Breath
Par. 4; Day 5; 240 Minutes Post-Meal
|
61.6 kPCD per minute
|
—
|
PRIMARY outcome
Timeframe: Up to Day 5Population: All Subjects Population
GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: episodes (epi) of vomiting, epi of retching, nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe),to 5 (very severe). Individual Par. data has been presented. All Subjects Population was used which consisted of all Par. who received at least one dose of study medication.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day-1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day 1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day 4; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day 5; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day -1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day 1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day 4; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 1; Day 5; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Nausea
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Nausea
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Excessively full after meals
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Excessively full after meals
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Excessively full after meals
|
5 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Excessively full after meals
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Bloating
|
5 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Unable to finish normal-sized meal
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Unable to finish normal-sized meal
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Unable to finish normal-sized meal
|
5 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Unable to finish normal-sized meal
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Retching
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Retching
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Stomach fullness
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Stomach fullness
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Stomach fullness
|
5 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Stomach fullness
|
5 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Loss of appetite
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Loss of appetite
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Loss of appetite
|
2 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Upper abdominal pain
|
3 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Upper abdominal discomfort
|
3 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day -1; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 1; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 4; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par 1; Day 5; Overall severity of gastroparesis
|
4 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2 Day 1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Stomach fullness
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day -1; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 1; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 4; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 2; Day 5; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day -1; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 1; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 4; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 3; Day 5; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Epi of vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Epi of retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Nausea
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Excessively full after meals
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Excessively full after meals
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Excessively full after meals
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Bloating
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Bloating
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par.4; Day -1; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par.4; Day 1; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par.4; Day 4; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par.4; Day 5; Unable to finish normal-sized meal
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Retching
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Vomiting
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Stomach or belly visibly larger
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Stomach fullness
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Stomach fullness
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Stomach fullness
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Loss of appetite
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Upper abdominal pain
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Upper abdominal discomfort
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day -1; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 1; Overall severity of gastroparesis
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 4; Overall severity of gastroparesis
|
1 Scores on GCSI-DD scale
|
—
|
|
Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score
Par. 4; Day 5; Overall severity of gastroparesis
|
0 Scores on GCSI-DD scale
|
—
|
PRIMARY outcome
Timeframe: Up to Day 4Population: Pharmacodynamic Population
The volume of water consumed by Par. at indicated time points after treatment with exenatide during EGG with WLT was determined. An EGG with WLT is a standardized test to induce gastric distention. Individual Par. data has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: The Volume of Water Ingested During EGG
Par. 4; Day 1
|
1000 Milliliter
|
—
|
|
Part A: The Volume of Water Ingested During EGG
Par. 4; Day 4
|
1000 Milliliter
|
—
|
|
Part A: The Volume of Water Ingested During EGG
Par. 1; Day 1
|
430 Milliliter
|
—
|
|
Part A: The Volume of Water Ingested During EGG
Par. 1; Day 4
|
360 Milliliter
|
—
|
|
Part A: The Volume of Water Ingested During EGG
Par. 2; Day 1
|
2160 Milliliter
|
—
|
|
Part A: The Volume of Water Ingested During EGG
Par. 2; Day 4
|
1980 Milliliter
|
—
|
|
Part A: The Volume of Water Ingested During EGG
Par. 3; Day 1
|
900 Milliliter
|
—
|
|
Part A: The Volume of Water Ingested During EGG
Par. 3; Day 4
|
1080 Milliliter
|
—
|
PRIMARY outcome
Timeframe: Day 4Population: Pharmacodynamic Population
The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. The intensity of upper gastrointestinal symptoms was measured using VAS scores ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). Individual Par. responses to VAS has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; Pre-WL; Stomach fullness
|
3 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 10 minutes Post-WL;Stomach fullness
|
43 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Stomach fullness;Day 4; 20 minutes Post-WL
|
50 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 30 minutes Post-WL;Stomach fullness
|
9 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; Pre-WL;Stomach fullness
|
11 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 10 minutes Post-WL;Stomach fullness
|
94 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 20 minutes Post-WL;Stomach fullness
|
92 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 30 minutes Post-WL;Stomach fullness
|
85 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; Pre-WL; Stomach fullness
|
10 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 10 minutes Post-WL;Stomach fullness
|
89 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 20 minutes Post-WL;Stomach fullness
|
82 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 30 minutes Post-WL;Stomach fullness
|
75 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; Pre-WL;Stomach fullness
|
28 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 10 minutes Post-WL;Stomach fullness
|
34 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 20 minutes Post-WL;Stomach fullness
|
38 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 30 minutes Post-WL;Stomach fullness
|
35 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; Pre-WL; Bloating
|
4 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 10 minutes Post-WL;Bloating
|
27 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 20 minutes Post-WL;Bloating
|
46 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 30 minutes Post-WL; Bloating
|
45 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; Pre-WL;Bloating
|
3 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 10 minutes Post-WL;Bloating
|
5 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 20 minutes Post-WL;Bloating
|
6 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 30 minutes Post-WL;Bloating
|
26 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Bloating; Day 4; Pre-WL;Bloating
|
1 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 10 minutes Post-WL;Bloating
|
0 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 20 minutes Post-WL;Bloating
|
0 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 30 minutes Post-WL;Bloating
|
1 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; Pre-WL; Bloating
|
3 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 10 minutes Post-WL;Bloating
|
22 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 20 minutes Post-WL; Bloating
|
42 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Bloating; Day 4; 30 minutes Post-WL
|
35 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; Pre-WL; Abdominal pain
|
3 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 10 minutes Post-WL; Abdominal pain
|
4 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 20 minutes Post-WL; Abdominal pain
|
3 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 30 minutes Post-WL;Abdominal pain
|
3 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; Pre-WL; Abdominal pain
|
4 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 10 minutes Post-WL; Abdominal pain
|
4 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 20 minutes Post-WL; Abdominal pain
|
7 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 30 minutes Post-WL;Abdominal pain
|
6 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; Pre-WL; Abdominal pain
|
0 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3;Day 4; 10 minutes Post-WL; Abdominal pain
|
0 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 20 minutes Post-WL; Abdominal pain
|
0 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 30 minutes Post-WL; Abdominal pain
|
0 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; Pre-WL; Abdominal pain
|
4 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 10 minutes Post-WL;Abdominal pain
|
4 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 20 minutes Post-WL; Abdominal pain
|
5 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 30 minutes Post-WL; Abdominal pain
|
5 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; Pre-WL; Hunger
|
88 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 10 minutes Post-WL; Hunger
|
79 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1; Day 4; 20 minutes Post-WL;Hunger
|
85 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 1;Day 4; 30 minutes Post-WL;Hunger
|
84 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; Pre-WL;Hunger
|
32 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 10 minutes Post-WL; Hunger
|
16 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 20 minutes Post-WL; Hunger
|
19 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 2; Day 4; 30 minutes Post-WL; Hunger
|
27 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; Pre-WL; Hunger
|
21 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 10 minutes Post-WL; Hunger
|
3 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 20 minutes Post-WL; Hunger
|
6 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 3; Day 4; 30 minutes Post-WL;Hunger
|
17 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; Pre-WL;Hunger
|
19 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 10 minutes Post-WL; Hunger
|
16 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 20 minutes Post-WL; Hunger
|
29 Scores on VAS scale
|
—
|
|
Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score
Par. 4; Day 4; 30 minutes Post-WL;Hunger
|
37 Scores on VAS scale
|
—
|
PRIMARY outcome
Timeframe: Up to 12 daysPopulation: All Subjects Population
SBP and DBP was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for SBP and DBP up to follow-up (up to 12 days) has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day -1; SBP
|
126 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day 1; SBP
|
121 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day 4; SBP
|
124 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day 5; SBP
|
112 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Follow-up; SBP
|
125 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day -1; DBP
|
71 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day 1; DBP
|
61 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day 4; DBP
|
69 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Day 5; DBP
|
67 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 1; Follow-up; DBP
|
72 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day -1; SBP
|
105 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day 1; SBP
|
109 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day 4; SBP
|
119 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day 5; SBP
|
121 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Follow-up; SBP
|
124 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day -1; DBP
|
61 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day 1; DBP
|
68 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day 4; DBP
|
71 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Day 5; DBP
|
68 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 2; Follow-up; DBP
|
75 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day -1; SBP
|
131 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day 1; SBP
|
131 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day 4; SBP
|
132 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day 5; SBP
|
112 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Follow-up; SBP
|
126 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day -1; DBP
|
86 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day 1; DBP
|
82 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day 4; DBP
|
87 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Day 5; DBP
|
76 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 3; Follow-up; DBP
|
87 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day -1; SBP
|
138 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day 1; SBP
|
139 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day 4; SBP
|
127 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day 5; SBP
|
123 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Follow-up; SBP
|
160 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day -1; DBP
|
83 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day 1; DBP
|
90 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day 4; DBP
|
83 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Day 5; DBP
|
81 Millimeter of mercury
|
—
|
|
Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety
Par. 4; Follow-up; DBP
|
86 Millimeter of mercury
|
—
|
PRIMARY outcome
Timeframe: Up to 12 daysPopulation: All Subjects Population
HR was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for HR up to follow-up (up to 12 days) has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 4; Day 4
|
77 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 1; Day -1
|
69 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 1; Day 1
|
65 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 1; Day 4
|
66 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 1; Day 5
|
84 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 1; Follow-up
|
68 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 2; Day -1
|
57 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 2; Day 1
|
64 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 2; Day 4
|
62 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 2; Day 5
|
82 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 2; Follow-up
|
58 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 3; Day -1
|
72 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 3; Day 1
|
74 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 3; Day 4
|
78 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 3; Day 5
|
82 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 3; Follow-up
|
78 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 4; Day -1
|
78 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 4; Day 1
|
89 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 4; Day 5
|
82 Beats per minute
|
—
|
|
Part A: Assessment of Heart Rate (HR) as a Measure of Safety
Par. 4; Follow-up
|
72 Beats per minute
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of hematology parameters including basophils, eosinophil, lymphocytes, monocytes, platelet count, total neutrophils, and WBC. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.1; Basophils
|
0.02 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.1; Eosinophils
|
0.11 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.1; Lymphocytes
|
1.57 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.1; Monocytes
|
0.35 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.1; Platelet count
|
268 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.1; Total Neutrophils
|
6.33 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.1; WBC
|
8.4 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.2; Basophils
|
0.02 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.2; Eosinophils
|
0.04 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.2; Lymphocytes
|
1.39 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.2; Monocytes
|
0.25 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.2; Platelet count
|
217 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.2; Total Neutrophils
|
2.54 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.2; WBC
|
4.2 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.3; Basophils
|
0.03 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.3; Eosinophils
|
0.21 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.3; Lymphocytes
|
1.77 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.3; Monocytes
|
0.58 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.3; Platelet count
|
202 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.3; Total Neutrophils
|
5.09 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.3; WBC
|
7.7 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.4; Basophils
|
0.04 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.4; Eosinophils
|
0.23 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.4; Lymphocytes
|
3.06 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.4; Monocytes
|
0.89 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.4; Platelet count
|
230 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.4; Total Neutrophils
|
1.2 Giga unit per liter
|
—
|
|
Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points
Par.4; WBC
|
5.4 Giga unit per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of RBC count. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Red Blood Cell (RBC) Count at Indicated Time Points
Par. 1
|
4.7 Tetra unit per liter
|
—
|
|
Part A: Red Blood Cell (RBC) Count at Indicated Time Points
Par. 2
|
4.8 Tetra unit per liter
|
—
|
|
Part A: Red Blood Cell (RBC) Count at Indicated Time Points
Par. 3
|
5 Tetra unit per liter
|
—
|
|
Part A: Red Blood Cell (RBC) Count at Indicated Time Points
Par. 4
|
4.9 Tetra unit per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of hemoglobin level. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Hemoglobin Level at Indicated Time Points
Par. 1
|
125 Grams per liter
|
—
|
|
Part A: Hemoglobin Level at Indicated Time Points
Par. 2
|
133 Grams per liter
|
—
|
|
Part A: Hemoglobin Level at Indicated Time Points
Par. 3
|
149 Grams per liter
|
—
|
|
Part A: Hemoglobin Level at Indicated Time Points
Par. 4
|
156 Grams per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of hematocrit level. Individual Par. data at indicated time points has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Hematocrit Level at Indicated Time Points
Par. 1
|
0.399 Proportion of RBC in blood
|
—
|
|
Part A: Hematocrit Level at Indicated Time Points
Par. 2
|
0.426 Proportion of RBC in blood
|
—
|
|
Part A: Hematocrit Level at Indicated Time Points
Par. 3
|
0.466 Proportion of RBC in blood
|
—
|
|
Part A: Hematocrit Level at Indicated Time Points
Par. 4
|
0.462 Proportion of RBC in blood
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and GGT. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 1; ALT
|
21 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 1; AST
|
20 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 1; GGT
|
46 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 2; ALT
|
25 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 2; AST
|
18 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 2; GGT
|
76 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 3; ALT
|
11 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 3; AST
|
12 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 3; GGT
|
19 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 4; ALT
|
17 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 4; AST
|
20 International unit per liter
|
—
|
|
Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points
Par. 4; GGT
|
30 International unit per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, and urea/BUN levels. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Glucose
|
9.2 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Calcium
|
2.44 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Magnesium
|
0.86 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Potassium
|
5.6 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Sodium
|
139 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Phosphorus inorganic
|
1.5 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Chloride
|
105 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 1; Urea/BUN
|
7.5 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Glucose
|
7.5 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Calcium
|
2.44 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Magnesium
|
0.9 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Potassium
|
5.1 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Sodium
|
139 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Phosphorus inorganic
|
1.25 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Chloride
|
105 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 2; Urea/BUN
|
6.5 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Glucose
|
9.1 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Calcium
|
2.38 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Magnesium
|
0.8 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Potassium
|
4.2 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Sodium
|
140 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Phosphorus inorganic
|
1.2 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Chloride
|
103 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 3; Urea/BUN
|
7 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Glucose
|
7.9 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Calcium
|
2.4 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Magnesium
|
0.8 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Potassium
|
4.3 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Sodium
|
138 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Phosphorus inorganic
|
1.15 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Chloride
|
101 Millimoles per liter
|
—
|
|
Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels
Par. 4; Urea/BUN
|
4.5 Millimoles per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of clinical chemistry parameters including creatinine, direct bilirubin, total bilirubin, indirect bilirubin levels. Individual Par. data at indicated time points has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 1; Direct Bilirubin
|
2 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 1; Creatinine
|
67.2 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 1; Total Bilirubin
|
10 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 1; Indirect Bilirubin
|
8 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 2; Creatinine
|
105.2 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 2; Direct Bilirubin
|
2 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 2; Total Bilirubin
|
6 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 2; Indirect Bilirubin
|
4 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 3; Creatinine
|
76.9 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 3; Direct Bilirubin
|
4 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 3; Total Bilirubin
|
16 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 3; Indirect Bilirubin
|
12 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 4; Creatinine
|
83.1 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 4; Direct Bilirubin
|
2 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 4; Total Bilirubin
|
6 Micromoles per liter
|
—
|
|
Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points
Par. 4; Indirect Bilirubin
|
4 Micromoles per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Estimated glomerular filtration rate was calculated using the "modification of diet in renal disease" (MDRD) formula by multiplying 175 with serum creatinine\^-1.154 multiplied by age\^-0.203 multiplied by 0.742 (if female) multiplied by 1.212 (if African American Par.). Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Estimated Glomerular Filtration Rate at Indicated Time Points
Part. 1
|
1.3026 Milliliter per second per 1.73 meter ^2
|
—
|
|
Part A: Estimated Glomerular Filtration Rate at Indicated Time Points
Part. 2
|
1.2859 Milliliter per second per 1.73 meter ^2
|
—
|
|
Part A: Estimated Glomerular Filtration Rate at Indicated Time Points
Part. 3
|
1.5197 Milliliter per second per 1.73 meter ^2
|
—
|
|
Part A: Estimated Glomerular Filtration Rate at Indicated Time Points
Part. 4
|
1.6533 Milliliter per second per 1.73 meter ^2
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Blood samples were collected for analysis of clinical chemistry parameters including total protein and albumin levels. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 1; Total Protein
|
77 Grams per liter
|
—
|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 1; Albumin levels
|
43 Grams per liter
|
—
|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 2; Total Protein
|
75 Grams per liter
|
—
|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 2; Albumin levels
|
46 Grams per liter
|
—
|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 3; Total Protein
|
71 Grams per liter
|
—
|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 3; Albumin levels
|
44 Grams per liter
|
—
|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 4; Total Protein
|
74 Grams per liter
|
—
|
|
Part A: Total Protein, Albumin Levels at Indicated Time Points
Par. 4; Albumin levels
|
46 Grams per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Samples were collected to analyze albumin level in urine. Individual Par. data at indicated time point has been collected.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Albumin Level in Urine at Indicated Time Points
Par. 1
|
35 Milligrams per liter
|
—
|
|
Part A: Albumin Level in Urine at Indicated Time Points
Par. 2
|
35 Milligrams per liter
|
—
|
|
Part A: Albumin Level in Urine at Indicated Time Points
Par. 3
|
5 Milligrams per liter
|
—
|
|
Part A: Albumin Level in Urine at Indicated Time Points
Par. 4
|
5 Milligrams per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Samples were collected to analyze concentration of creatinine in urine. Individual Par. at indicated time point has been presented at indicated time points.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Concentration of Creatinine in Urine at Indicated Time Points
Par. 1
|
12450 Micromoles per liter
|
—
|
|
Part A: Concentration of Creatinine in Urine at Indicated Time Points
Par. 2
|
16240 Micromoles per liter
|
—
|
|
Part A: Concentration of Creatinine in Urine at Indicated Time Points
Par. 3
|
13300 Micromoles per liter
|
—
|
|
Part A: Concentration of Creatinine in Urine at Indicated Time Points
Par. 4
|
22020 Micromoles per liter
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Urine samples were collected to analyze presence of ketones, occult blood, glucose, nitrates and leukocyte esterase in urine. The dipstick test gives results in a semi-quantitative manner. NA represents data was not available due to lab data transfer error. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 1; Ketones; Negative
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 1; Occult blood; Trace
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 1; Glucose
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 1; Nitrates
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 1; Leukocyte esterase
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 2; Ketones; Negative
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 2; Occult blood; Negative
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 2; Glucose
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 2; Nitrates
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 2; Leukocyte esterase
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 3; Ketones; Negative
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 3; Occult blood; Negative
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 3; Glucose
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 3; Nitrates
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 3; Leukocyte esterase
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 4; Ketones; Negative
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 4; Occult blood; Negative
|
1 Participants
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par. 4; Glucose
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 4; Nitrates
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
|
Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points
Par 4; Leukocyte esterase
|
NA Participants
NA represents data was not available due to lab data transfer error.
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Samples were collected to analyze the presence of RBC and WBC in urine by microscopy. Individual Par. data at indicated time point has been presented. "NA" indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal. The RBC and WBC values of "1" for participant 1 actually reflect 0-1.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Par.1; RBC
|
1 High Power field
|
—
|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Par. 1; WBC
|
1 High Power field
|
—
|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Par. 2; RBC
|
NA High Power field
NA indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal.
|
—
|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Par. 2; WBC
|
NA High Power field
NA indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal.
|
—
|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Par. 3; RBC
|
NA High Power field
NA indicated data was not available as RBC and WBC count would only available if blood or protein were abnormal.
|
—
|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Part. 3; WBC
|
NA High Power field
NA indicated data was not available as RBC and WBC count would only available if blood or protein were abnormal.
|
—
|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Part 4; RBC
|
NA High Power field
NA indicated data was not available as RBC and WBC count would only available if blood or protein were abnormal.
|
—
|
|
Part A: Presence RBC and WBC in Urine Assessed by Microscopy
Part. 4; WBC
|
NA High Power field
NA indicated data was not available as RBC and WBC count would only available if blood or protein were abnormal.
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Specific Gravity of Urine at Indicated Time Points
Par. 1
|
1.021 Kilograms per meter^3
|
—
|
|
Part A: Specific Gravity of Urine at Indicated Time Points
Par. 2
|
1.019 Kilograms per meter^3
|
—
|
|
Part A: Specific Gravity of Urine at Indicated Time Points
Par. 3
|
1.023 Kilograms per meter^3
|
—
|
|
Part A: Specific Gravity of Urine at Indicated Time Points
Par. 4
|
1.027 Kilograms per meter^3
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: All Subjects Population
Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine.Individual Par. data at indicated time point has been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points
Par. 3
|
6 Points on a scale
|
—
|
|
Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points
Par. 1
|
5 Points on a scale
|
—
|
|
Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points
Par. 2
|
5.5 Points on a scale
|
—
|
|
Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points
Par. 4
|
5 Points on a scale
|
—
|
PRIMARY outcome
Timeframe: Up to 12 daysPopulation: All Subjects Population
An AE is any untoward medical occurrence in a clinical investigation Par. temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Number of Par. with AEs and SAEs have been presented.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)
Any AE
|
1 Participants
|
—
|
|
Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)
Any SAE
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 12 daysPopulation: All Subjects Population.
GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT.
Outcome measures
| Measure |
Part A: Exenatide SC Injection
n=4 Participants
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|
|
Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with An WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
The VAS was used to measure the intensity of nausea analyzed on the basis of scores ranging from 0 (no nausea) to 100 (severe nausea). This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
The GEBT containing 13C-Spirulina was used to measure the time to half-gastric emptying. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
The rate of \[13\]C dose excreted in breath was assessed to study gastric empting using GEBT. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
EGG with WLT is a standardized test to induce gastric distention. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
Vital signs included SBP, DBP and heart rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils, WBC, RBC, hemoglobin and hematocrit levels. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
Clinical chemistry parameters included ALT, AST, GGT, glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, BUN, creatinine, direct bilirubin, total bilirubin, indirect bilirubin, glomerular filtration rate (MDRD Enzymatic level), total protein, and albumin level. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
Urinalysis included analysis of concentration of creatinine, presence of ketones and occult blood in urine (using dipstick test), presence RBC and WBC in urine (using microscopy), specific gravity and pH of urine. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
An AE is any untoward medical occurrence in a clinical investigation Par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.
GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. This analysis was planned but not performed for Part B as the study was terminated during Part A.
Outcome measures
Outcome data not reported
Adverse Events
Part A: Exenatide SC Injection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: Exenatide SC Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B: Albiglutide SC Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Exenatide SC Injection
n=4 participants at risk
Eligible Par. received 10 micrograms of exenatide twice daily for 5 days injected subcutaneously into in the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Exenatide SC Injection
Eligible Par. were planned to receive 5 micrograms of exenatide twice daily for 4 weeks, then up-titrated to 10 micrograms twice daily for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen. Exenatide was to be administered via an auto-injector within 60 minutes before the morning and evening meals.
|
Part B: Albiglutide SC Injection
Eligible Par. were planned to receive 30 milligrams of albiglutide, weekly for 4 weeks, then up titrated to 50 milligrams, weekly for 4 weeks injected subcutaneously into the abdomen, thigh or upper arm region using a prefilled injector pen in the morning.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • Number of events 1 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
|
General disorders
Early satiety
|
25.0%
1/4 • Number of events 1 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
|
General disorders
Feeling jittery
|
25.0%
1/4 • Number of events 1 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
|
—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
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—
0/0 • On-treatment adverse events (AEs) and serious adverse events (SAEs) were collected from the start of the study treatment until the follow up (up to 12 days).
AEs and SAEs were collected in Part A from All Subjects Population comprised all Par. who received at least one dose of study medication. The data were not collected for Part B because no Par. were enrolled into this part of the study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER