Trial Outcomes & Findings for Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1) (NCT NCT00308139)
NCT ID: NCT00308139
Last Updated: 2015-08-26
Results Overview
Absolute change in HbA1c from Baseline (Day -3) to Week 30 \[Week 30 - Baseline\]
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
303 participants
Primary outcome timeframe
Day -3, Week 30
Results posted on
2015-08-26
Participant Flow
Participant milestones
| Measure |
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
151
|
|
Overall Study
Intent to Treat (ITT)
|
148
|
147
|
|
Overall Study
ITT in the 30-Week Assessment
|
148
|
145
|
|
Overall Study
Pharmacokinetics Population
|
129
|
0
|
|
Overall Study
Evaluable Meal Tolerance Cohort
|
27
|
24
|
|
Overall Study
30-Week Completed
|
128
|
130
|
|
Overall Study
COMPLETED
|
58
|
64
|
|
Overall Study
NOT COMPLETED
|
94
|
87
|
Reasons for withdrawal
| Measure |
Exenatide Once Weekly -> Exenatide Once Weekly
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily -> Exenatide Once Weekly
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
14
|
|
Overall Study
Lost to Follow-up
|
13
|
8
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal of Consent
|
40
|
42
|
|
Overall Study
Investigator Decision
|
11
|
10
|
|
Overall Study
Loss of Glucose Control
|
5
|
7
|
|
Overall Study
Administrative
|
1
|
4
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
Baseline characteristics by cohort
| Measure |
Exenatide Once Weekly -> Exenatide Once Weekly
n=148 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily -> Exenatide Once Weekly
n=147 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
122 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 9.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
8.3 percentage of total hemoglobin
STANDARD_DEVIATION 0.99 • n=5 Participants
|
8.3 percentage of total hemoglobin
STANDARD_DEVIATION 1.00 • n=7 Participants
|
8.3 percentage of total hemoglobin
STANDARD_DEVIATION 0.99 • n=5 Participants
|
|
Weight
|
101.7 kg
STANDARD_DEVIATION 18.76 • n=5 Participants
|
101.9 kg
STANDARD_DEVIATION 21.05 • n=7 Participants
|
101.8 kg
STANDARD_DEVIATION 19.90 • n=5 Participants
|
|
Background Oral Antidiabetic Agent
Diet and Exercise
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Background Oral Antidiabetic Agent
Metformin (MET)
|
56 participants
n=5 Participants
|
50 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Background Oral Antidiabetic Agent
Sulfonylurea (SU)
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Background Oral Antidiabetic Agent
Thiazolidinediones (TZD)
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Background Oral Antidiabetic Agent
MET+SU
|
43 participants
n=5 Participants
|
39 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Background Oral Antidiabetic Agent
MET+TZD
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Background Oral Antidiabetic Agent
SU+TZD
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Background Oral Antidiabetic Agent
SU+MET+TZD
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day -3, Week 30Population: The ITT Population consisted of all randomized subjects who received at least one injection of study medication. Missing data up to Week 30 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Absolute change in HbA1c from Baseline (Day -3) to Week 30 \[Week 30 - Baseline\]
Outcome measures
| Measure |
Exenatide Once Weekly
n=148 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=147 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week 30
|
-1.87 percentage of total hemoglobin
Standard Error 0.082 • Interval -2.03 to -1.71
|
-1.54 percentage of total hemoglobin
Standard Error 0.082 • Interval -1.7 to -1.38
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 22Measure by Geometric mean ratio (GMR) of plasma exenatide average steady state concentration Css,avg at Visit 11-14 to Visit 24-27 with 90% confidence interval
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using the last observation carried forward (LOCF) approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Absolute change in HbA1c from Baseline (Day -3) to Week 364
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in HbA1c From Baseline to Week 364
|
-1.49 percentage of total hemoglobin
95% Confidence Interval 0.155 • Interval -1.8 to -1.19
|
-1.57 percentage of total hemoglobin
95% Confidence Interval 0.144 • Interval -1.85 to -1.28
|
-1.53 percentage of total hemoglobin
95% Confidence Interval 0.115 • Interval -1.76 to -1.31
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 30Population: ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentage of subjects achieving HbA1c target value of \<7% at Week 30.
Outcome measures
| Measure |
Exenatide Once Weekly
n=148 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=147 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <7%
|
70.9 percentage of subjects
|
51.0 percentage of subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentages of subjects achieving HbA1c target value of \<7% at Week 364
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <7%
|
41.4 percentage of subjects
|
50.0 percentage of subjects
|
45.9 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 30Population: ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 30.
Outcome measures
| Measure |
Exenatide Once Weekly
n=148 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=147 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <=6.5%
|
3.0 percentage of subjects
|
16.3 percentage of subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 364
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <=6.5%
|
22.4 percentage of subjects
|
37.5 percentage of subjects
|
30.3 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 30Population: ITT Population. Missing data up to Week 30 were imputed using LOCF for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement. Subjects without post-baseline measurement were categorized as not achieving goal.
Percentage of subjects achieving HbA1c target values of \<=6.0% at Week 30.
Outcome measures
| Measure |
Exenatide Once Weekly
n=148 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=147 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Percentage of Subjects Achieving HbA1c Target of <=6.0%
|
23.0 percentage of subjects
|
16.3 percentage of subjects
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 29 to Week 30Population: The Pharmacokinetics Population consisted of subjects who received exenatide LAR treatment, and had adequate plasma exenatide concentration-time data to allow for reliable evaluation of exenatide LAR pharmacokinetics.
Steady-state plasma exenatide concentration over the dosing interval of Week 29 to Week 30 (0-168 hours) was evaluated. Geometric mean for the average steady-state concentration and its 10th and 90th percentiles were reported.
Outcome measures
| Measure |
Exenatide Once Weekly
n=114 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Exenatide LAR Steady State Concentration From Week 29 to Week 30
|
300.23 pg/mL
Interval 145.13 to 702.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 14Population: Evaluable Meal Tolerance Cohort consisted of ITT subjects who participated in the meal tolerance test and had adequate data to allow the reliable assessment of pharmacodynamics. Only subjects with non-missing baseline and Week 14 values were included in analysis.
Change in 2h Postprandial Glucose from baseline (Day -3) to Week 14
Outcome measures
| Measure |
Exenatide Once Weekly
n=22 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=21 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in 2 Hours (2h) Postprandial Glucose From Baseline to Week 14
|
-95.88 mg/dL
Standard Error 8.420 • Interval -112.92 to -78.83
|
-125.96 mg/dL
Standard Error 8.292 • Interval -142.74 to -109.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 22Measure by geometric mean ratio of the maximum steady state plasma exenatide concentration Css, max at Visit 11-14 to Visit 24-27 with 90% confidence interval and incidence of treatment-emergent injection site adverse events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day -3, Week 30Population: ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in body weight from baseline (Day -3) to Week 30
Outcome measures
| Measure |
Exenatide Once Weekly
n=148 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=147 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Body Weight From Baseline to Week 30
|
-3.67 kg
Standard Error 0.468 • Interval -4.59 to -2.75
|
-3.59 kg
Standard Error 0.468 • Interval -4.51 to -2.67
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in body weight from baseline (Day -3) to Week 364
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Body Weight From Baseline to Week 364
|
-5.25 kg
95% Confidence Interval 0.468 • Interval -7.23 to -3.27
|
-2.71 kg
95% Confidence Interval 0.468 • Interval -4.55 to -0.87
|
-3.87 kg
Interval -5.36 to -2.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 30Population: ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in fasting plasma glucose from baseline (Day -3) to Week 30.
Outcome measures
| Measure |
Exenatide Once Weekly
n=148 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=147 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline to Week 30
|
-41.5 mg/dL
Standard Error 2.97 • Interval -47.4 to -35.7
|
-24.6 mg/dL
Standard Error 2.90 • Interval -30.3 to -18.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in fasting plasma glucose from baseline (Day -3) to Week 364.
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Fasting Plasma Glucose From Baseline to Week 364
|
-18.3 mg/dL
95% Confidence Interval 2.97 • Interval -30.8 to -5.7
|
-27.7 mg/dL
95% Confidence Interval 2.90 • Interval -39.0 to -16.4
|
-23.6 mg/dL
Interval -33.0 to -14.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 30Population: ITT Population using observed data.
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 30
Outcome measures
| Measure |
Exenatide Once Weekly
n=126 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=130 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Blood Pressure From Baseline to Week 30
Sitting Systolic Blood Pressure
|
-4.4 mmHg
Standard Error 1.04
|
-3.8 mmHg
Standard Error 1.28
|
—
|
—
|
—
|
|
Change in Blood Pressure From Baseline to Week 30
Sitting Diastolic Blood Pressure
|
-1.1 mmHg
Standard Error 0.76
|
-2.3 mmHg
Standard Error 0.83
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population using observed data.
Change in Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure from baseline to Week 364
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Blood Pressure From Baseline to Week 364
Sitting Systolic Blood Pressure
|
1.3 mmHg
Standard Deviation 16.21
|
1.0 mmHg
Standard Deviation 17.32
|
1.2 mmHg
Standard Deviation 16.73
|
—
|
—
|
|
Change in Blood Pressure From Baseline to Week 364
Sitting Diastolic Blood Pressure
|
-1.7 mmHg
Standard Deviation 8.87
|
-3.6 mmHg
Standard Deviation 9.59
|
-2.7 mmHg
Standard Deviation 9.26
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 30Population: ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in total cholesterol from baseline (Day -3) to Week 30.
Outcome measures
| Measure |
Exenatide Once Weekly
n=139 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=137 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Total Cholesterol From Baseline to Week 30
|
-11.9 mg/dL
Standard Error 2.29 • Interval -16.4 to -7.4
|
-3.8 mg/dL
Standard Error 2.35 • Interval -8.4 to 0.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in total cholesterol from baseline (Day -3) to Week 364.
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Total Cholesterol From Baseline to Week 364
|
-15.0 mg/dL
95% Confidence Interval 2.29 • Interval -23.6 to -6.4
|
-4.8 mg/dL
95% Confidence Interval 2.35 • Interval -13.0 to 3.3
|
-9.6 mg/dL
Interval -16.2 to -3.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 30Population: ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 30.
Outcome measures
| Measure |
Exenatide Once Weekly
n=139 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=137 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 30
|
-0.9 mg/dL
Standard Error 0.56 • Interval -2.0 to 0.2
|
-1.3 mg/dL
Standard Error 0.57 • Interval -2.5 to -0.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in high-density lipoprotein cholesterol (HDL-C) from baseline (Day -3) to Week 364.
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 364
|
2.2 mg/dL
95% Confidence Interval 0.56 • Interval -0.2 to 4.7
|
3.4 mg/dL
95% Confidence Interval 0.57 • Interval 1.0 to 5.7
|
2.8 mg/dL
Interval 1.0 to 4.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Change in low-density lipoprotein cholesterol (LDL-C) from baseline (Day -3) to Week 364.
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 364
|
-13.6 mg/dL
95% Confidence Interval 0.56 • Interval -21.3 to -6.0
|
-7.5 mg/dL
95% Confidence Interval 0.57 • Interval -14.7 to -0.3
|
-10.4 mg/dL
Interval -16.2 to -4.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 30Population: ITT Population. Missing data up to Week 30 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Ratio of triglycerides (measured in mg/dL) at Week 30 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Outcome measures
| Measure |
Exenatide Once Weekly
n=139 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=137 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Ratio of Triglycerides at Week 30 to Baseline
|
0.85 ratio
Standard Error 0.029 • Interval 0.8 to 0.91
|
0.89 ratio
Standard Error 0.031 • Interval 0.84 to 0.96
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -3, Week 364Population: 7-Year Completer Population. Missing data up to Week 364 were imputed using the LOCF approach for subjects who had data for at least one scheduled visit (including Early Termination) subsequent to the baseline measurement.
Ratio of triglycerides (measured in mg/dL) at Week 364 to baseline (Day -3). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Outcome measures
| Measure |
Exenatide Once Weekly
n=58 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=64 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=122 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Ratio of Triglycerides at Week 364 to Baseline
|
0.91 ratio
95% Confidence Interval 0.029 • Interval 0.8 to 1.02
|
0.94 ratio
95% Confidence Interval 0.031 • Interval 0.84 to 1.06
|
0.93 ratio
Interval 0.85 to 1.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Week 364Population: ITT Population who participated in the 30-week assessment period and using SU at screening.
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Outcome measures
| Measure |
Exenatide Once Weekly
n=55 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=52 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=49 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
n=50 Participants
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
n=105 Participants
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening
Minor hypoglycemic events
|
0.57 events per subject-year
Standard Error 0.139
|
0.38 events per subject-year
Standard Error 0.113
|
0.49 events per subject-year
Standard Error 0.046
|
0.22 events per subject-year
Standard Error 0.029
|
0.36 events per subject-year
Standard Error 0.026
|
|
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With SU Use at Screening
Major hypoglycemic events
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
SECONDARY outcome
Timeframe: Day 1 to Week 364Population: ITT Population who participated in the 30-week assessment period and not using SU at screening.
The major hypoglycemia category included events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment, whether or not symptoms of hypoglycemia were perceived by the subject. The minor hypoglycemia were accompanied by a blood glucose concentration of less than 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Outcome measures
| Measure |
Exenatide Once Weekly
n=93 Participants
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily
n=93 Participants
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
All Treatment
n=79 Participants
|
Exenatide Twice Daily -> Exenatide Once Weekly With SU
n=80 Participants
Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
|
Exenatide Once Weekly With SU
n=173 Participants
Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening
Major hypoglycemic events
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
0.00 events per subject-year
Standard Error 0.000
|
|
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events With Non-SU Use at Screening
Minor hypoglycemic events
|
0.00 events per subject-year
Standard Error 0.000
|
0.02 events per subject-year
Standard Error 0.020
|
0.03 events per subject-year
Standard Error 0.009
|
0.06 events per subject-year
Standard Error 0.013
|
0.04 events per subject-year
Standard Error 0.007
|
Adverse Events
Exenatide Once Weekly (WK 0-30)
Serious events: 8 serious events
Other events: 124 other events
Deaths: 0 deaths
Exenatide Twice Daily (WK 0-30)
Serious events: 5 serious events
Other events: 106 other events
Deaths: 0 deaths
Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)
Serious events: 36 serious events
Other events: 121 other events
Deaths: 0 deaths
Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)
Serious events: 29 serious events
Other events: 122 other events
Deaths: 0 deaths
Exenatide Once Weekly
Serious events: 71 serious events
Other events: 265 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide Once Weekly (WK 0-30)
n=148 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily (WK 0-30)
n=145 participants at risk
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
|
Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)
n=128 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)
n=130 participants at risk
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
Exenatide Once Weekly
n=278 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Infections and infestations
Bacteraemia
|
0.68%
1/148
|
0.00%
0/145
|
0.00%
0/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.68%
1/148
|
0.00%
0/145
|
0.78%
1/128
|
0.77%
1/130
|
1.1%
3/278
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.68%
1/148
|
0.00%
0/145
|
0.00%
0/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.68%
1/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.72%
2/278
|
|
Infections and infestations
Diverticulitis
|
0.68%
1/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.68%
1/148
|
0.00%
0/145
|
0.00%
0/128
|
1.5%
2/130
|
1.1%
3/278
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
1/148
|
0.00%
0/145
|
0.78%
1/128
|
0.77%
1/130
|
1.1%
3/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.68%
1/148
|
0.00%
0/145
|
0.00%
0/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Gastrointestinal disorders
Tooth impacted
|
0.68%
1/148
|
0.00%
0/145
|
0.00%
0/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/148
|
0.69%
1/145
|
0.00%
0/128
|
0.00%
0/130
|
0.00%
0/278
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/148
|
0.69%
1/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Nervous system disorders
Convulsion
|
0.00%
0/148
|
0.69%
1/145
|
0.00%
0/128
|
0.00%
0/130
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/148
|
0.69%
1/145
|
0.78%
1/128
|
0.77%
1/130
|
0.72%
2/278
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/148
|
0.69%
1/145
|
0.00%
0/128
|
0.00%
0/130
|
0.00%
0/278
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/148
|
0.69%
1/145
|
0.00%
0/128
|
0.00%
0/130
|
0.00%
0/278
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/148
|
0.69%
1/145
|
3.1%
4/128
|
1.5%
2/130
|
2.2%
6/278
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/148
|
0.69%
1/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/148
|
0.69%
1/145
|
0.00%
0/128
|
0.00%
0/130
|
0.00%
0/278
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/148
|
0.00%
0/145
|
2.3%
3/128
|
0.00%
0/130
|
1.1%
3/278
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/148
|
0.00%
0/145
|
1.6%
2/128
|
0.00%
0/130
|
0.72%
2/278
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/148
|
0.00%
0/145
|
1.6%
2/128
|
0.77%
1/130
|
1.1%
3/278
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/148
|
0.00%
0/145
|
1.6%
2/128
|
0.77%
1/130
|
1.1%
3/278
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/148
|
0.00%
0/145
|
3.1%
4/128
|
0.00%
0/130
|
1.4%
4/278
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Cardiac disorders
Palpitations
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Eye disorders
Macular oedema
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Eye disorders
Retinal detachment
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/148
|
0.00%
0/145
|
1.6%
2/128
|
0.00%
0/130
|
0.72%
2/278
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
General disorders
Chest discomfort
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
General disorders
Chest pain
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
1.5%
2/130
|
0.72%
2/278
|
|
General disorders
Device dislocation
|
0.00%
0/148
|
0.69%
1/145
|
0.00%
0/128
|
0.00%
0/130
|
0.00%
0/278
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/148
|
0.00%
0/145
|
1.6%
2/128
|
0.00%
0/130
|
0.72%
2/278
|
|
General disorders
Pyrexia
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/148
|
0.00%
0/145
|
2.3%
3/128
|
0.00%
0/130
|
1.1%
3/278
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
1.5%
2/130
|
0.72%
2/278
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Infections and infestations
Appendicitis
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Infections and infestations
Bronchitis
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Infections and infestations
Cellulitis
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Infections and infestations
Infected bites
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.77%
1/130
|
0.72%
2/278
|
|
Infections and infestations
Pneumonia
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.77%
1/130
|
0.72%
2/278
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.77%
1/130
|
0.72%
2/278
|
|
Infections and infestations
Urosepsis
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Metabolism and nutrition disorders
Hyperlactacidaemia
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/148
|
0.00%
0/145
|
1.6%
2/128
|
0.77%
1/130
|
1.1%
3/278
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/148
|
0.00%
0/145
|
1.6%
2/128
|
0.00%
0/130
|
0.72%
2/278
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Nervous system disorders
Dizziness
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Nervous system disorders
Presyncope
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Nervous system disorders
Syncope
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/148
|
0.00%
0/145
|
0.00%
0/128
|
0.77%
1/130
|
0.36%
1/278
|
|
Vascular disorders
Hypertension
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.77%
1/130
|
0.72%
2/278
|
|
Vascular disorders
Hypotension
|
0.00%
0/148
|
0.00%
0/145
|
0.78%
1/128
|
0.00%
0/130
|
0.36%
1/278
|
Other adverse events
| Measure |
Exenatide Once Weekly (WK 0-30)
n=148 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily (WK 0-30)
n=145 participants at risk
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
|
Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)
n=128 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week.
|
Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)
n=130 participants at risk
Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
|
Exenatide Once Weekly
n=278 participants at risk
Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -\> exenatide once weekly (WK 31-364), and exenatide twice daily -\> exenatide once weekly (WK 31-364).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
10.8%
16/148
|
18.6%
27/145
|
16.4%
21/128
|
16.2%
21/130
|
19.4%
54/278
|
|
Infections and infestations
Urinary tract infection
|
10.1%
15/148
|
7.6%
11/145
|
18.0%
23/128
|
23.1%
30/130
|
22.7%
63/278
|
|
Infections and infestations
Gastroenteritis viral
|
8.1%
12/148
|
5.5%
8/145
|
14.1%
18/128
|
8.5%
11/130
|
13.3%
37/278
|
|
Infections and infestations
Upper respiratory tract infection
|
8.1%
12/148
|
17.2%
25/145
|
42.2%
54/128
|
49.2%
64/130
|
44.6%
124/278
|
|
Gastrointestinal disorders
Dyspepsia
|
7.4%
11/148
|
2.1%
3/145
|
5.5%
7/128
|
6.9%
9/130
|
9.4%
26/278
|
|
General disorders
Injection site erythema
|
7.4%
11/148
|
0.00%
0/145
|
5.5%
7/128
|
4.6%
6/130
|
7.6%
21/278
|
|
General disorders
Fatigue
|
6.1%
9/148
|
3.4%
5/145
|
8.6%
11/128
|
9.2%
12/130
|
11.2%
31/278
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.4%
11/148
|
4.1%
6/145
|
11.7%
15/128
|
10.0%
13/130
|
14.0%
39/278
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
10/148
|
5.5%
8/145
|
26.6%
34/128
|
31.5%
41/130
|
28.1%
78/278
|
|
Nervous system disorders
Headache
|
6.1%
9/148
|
4.8%
7/145
|
11.7%
15/128
|
11.5%
15/130
|
13.7%
38/278
|
|
General disorders
Injection site bruising
|
4.7%
7/148
|
9.7%
14/145
|
5.5%
7/128
|
7.7%
10/130
|
8.6%
24/278
|
|
Infections and infestations
Sinusitis
|
4.7%
7/148
|
6.9%
10/145
|
20.3%
26/128
|
26.9%
35/130
|
23.7%
66/278
|
|
Nervous system disorders
Dizziness
|
3.4%
5/148
|
6.2%
9/145
|
7.8%
10/128
|
7.7%
10/130
|
9.0%
25/278
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
2/148
|
1.4%
2/145
|
6.2%
8/128
|
3.8%
5/130
|
5.4%
15/278
|
|
Eye disorders
Cataract
|
1.4%
2/148
|
0.00%
0/145
|
11.7%
15/128
|
6.9%
9/130
|
9.0%
25/278
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
5/148
|
1.4%
2/145
|
6.2%
8/128
|
6.2%
8/130
|
6.8%
19/278
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
5/148
|
2.1%
3/145
|
6.2%
8/128
|
6.2%
8/130
|
7.2%
20/278
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/148
|
1.4%
2/145
|
5.5%
7/128
|
6.2%
8/130
|
6.1%
17/278
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.68%
1/148
|
0.00%
0/145
|
8.6%
11/128
|
7.7%
10/130
|
7.9%
22/278
|
|
Gastrointestinal disorders
Toothache
|
0.68%
1/148
|
2.1%
3/145
|
4.7%
6/128
|
6.9%
9/130
|
5.8%
16/278
|
|
Immune system disorders
Seasonal allergy
|
1.4%
2/148
|
1.4%
2/145
|
10.2%
13/128
|
3.8%
5/130
|
7.2%
20/278
|
|
Infections and infestations
Bronchitis
|
2.7%
4/148
|
4.1%
6/145
|
14.1%
18/128
|
19.2%
25/130
|
16.5%
46/278
|
|
Infections and infestations
Conjunctivitis
|
0.68%
1/148
|
1.4%
2/145
|
4.7%
6/128
|
6.9%
9/130
|
5.8%
16/278
|
|
Infections and infestations
Ear infection
|
0.00%
0/148
|
0.69%
1/145
|
4.7%
6/128
|
5.4%
7/130
|
4.7%
13/278
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/148
|
0.00%
0/145
|
7.0%
9/128
|
4.6%
6/130
|
5.4%
15/278
|
|
Infections and infestations
Herpes zoster
|
0.68%
1/148
|
0.69%
1/145
|
5.5%
7/128
|
7.7%
10/130
|
6.5%
18/278
|
|
Infections and infestations
Influenza
|
1.4%
2/148
|
2.1%
3/145
|
8.6%
11/128
|
13.1%
17/130
|
10.8%
30/278
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/148
|
0.00%
0/145
|
4.7%
6/128
|
5.4%
7/130
|
4.7%
13/278
|
|
Infections and infestations
Tooth abscess
|
2.0%
3/148
|
0.69%
1/145
|
5.5%
7/128
|
5.4%
7/130
|
6.1%
17/278
|
|
Infections and infestations
Tooth infection
|
2.7%
4/148
|
0.69%
1/145
|
7.8%
10/128
|
5.4%
7/130
|
7.2%
20/278
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
3/148
|
0.69%
1/145
|
9.4%
12/128
|
7.7%
10/130
|
9.0%
25/278
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
2/148
|
1.4%
2/145
|
9.4%
12/128
|
7.7%
10/130
|
8.6%
24/278
|
|
Injury, poisoning and procedural complications
Laceration
|
0.68%
1/148
|
0.69%
1/145
|
4.7%
6/128
|
6.2%
8/130
|
5.0%
14/278
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.68%
1/148
|
2.1%
3/145
|
4.7%
6/128
|
7.7%
10/130
|
6.1%
17/278
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/148
|
0.00%
0/145
|
10.2%
13/128
|
6.2%
8/130
|
7.6%
21/278
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/148
|
0.69%
1/145
|
5.5%
7/128
|
4.6%
6/130
|
4.7%
13/278
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
7/148
|
4.1%
6/145
|
19.5%
25/128
|
21.5%
28/130
|
20.9%
58/278
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
2/148
|
2.1%
3/145
|
5.5%
7/128
|
7.7%
10/130
|
6.8%
19/278
|
|
General disorders
Oedema peripheral
|
0.68%
1/148
|
0.00%
0/145
|
4.7%
6/128
|
10.8%
14/130
|
7.6%
21/278
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.7%
7/148
|
4.1%
6/145
|
21.1%
27/128
|
19.2%
25/130
|
19.8%
55/278
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.4%
2/148
|
0.00%
0/145
|
3.9%
5/128
|
7.7%
10/130
|
5.8%
16/278
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
3/148
|
2.1%
3/145
|
9.4%
12/128
|
10.0%
13/130
|
10.1%
28/278
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
2/148
|
0.00%
0/145
|
18.0%
23/128
|
11.5%
15/130
|
14.4%
40/278
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.4%
5/148
|
1.4%
2/145
|
3.1%
4/128
|
8.5%
11/130
|
6.8%
19/278
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.68%
1/148
|
1.4%
2/145
|
11.7%
15/128
|
7.7%
10/130
|
9.4%
26/278
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.68%
1/148
|
1.4%
2/145
|
16.4%
21/128
|
16.9%
22/130
|
15.8%
44/278
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.68%
1/148
|
0.00%
0/145
|
3.9%
5/128
|
6.2%
8/130
|
4.7%
13/278
|
|
Psychiatric disorders
Anxiety
|
1.4%
2/148
|
2.1%
3/145
|
7.8%
10/128
|
4.6%
6/130
|
6.5%
18/278
|
|
Psychiatric disorders
Depression
|
1.4%
2/148
|
2.8%
4/145
|
7.8%
10/128
|
9.2%
12/130
|
8.6%
24/278
|
|
Psychiatric disorders
Insomnia
|
2.7%
4/148
|
2.8%
4/145
|
7.0%
9/128
|
8.5%
11/130
|
8.6%
24/278
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.4%
2/148
|
0.69%
1/145
|
10.2%
13/128
|
6.9%
9/130
|
8.3%
23/278
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.68%
1/148
|
0.69%
1/145
|
5.5%
7/128
|
4.6%
6/130
|
5.0%
14/278
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
5/148
|
1.4%
2/145
|
10.9%
14/128
|
10.8%
14/130
|
11.9%
33/278
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/148
|
0.00%
0/145
|
3.9%
5/128
|
6.2%
8/130
|
4.7%
13/278
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
2/148
|
1.4%
2/145
|
6.2%
8/128
|
9.2%
12/130
|
7.6%
21/278
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/148
|
1.4%
2/145
|
5.5%
7/128
|
6.9%
9/130
|
5.8%
16/278
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/148
|
0.00%
0/145
|
10.9%
14/128
|
6.2%
8/130
|
7.9%
22/278
|
|
Vascular disorders
Hypertension
|
3.4%
5/148
|
2.8%
4/145
|
17.2%
22/128
|
16.9%
22/130
|
17.6%
49/278
|
|
Gastrointestinal disorders
Nausea
|
27.0%
40/148
|
33.8%
49/145
|
20.3%
26/128
|
19.2%
25/130
|
29.5%
82/278
|
|
General disorders
Injection site pruritus
|
18.2%
27/148
|
1.4%
2/145
|
3.9%
5/128
|
6.9%
9/130
|
14.4%
40/278
|
|
Gastrointestinal disorders
Diarrhoea
|
16.2%
24/148
|
12.4%
18/145
|
27.3%
35/128
|
26.2%
34/130
|
28.4%
79/278
|
|
Gastrointestinal disorders
Constipation
|
10.1%
15/148
|
6.2%
9/145
|
8.6%
11/128
|
12.3%
16/130
|
14.4%
40/278
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60