Trial Outcomes & Findings for A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus (NCT NCT01558271)
NCT ID: NCT01558271
Last Updated: 2015-05-22
Results Overview
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication \[OAM\] yes/no), baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
492 participants
Primary outcome timeframe
Baseline, 26 weeks
Results posted on
2015-05-22
Participant Flow
Participant milestones
| Measure |
LY2189265
Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Liraglutide
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
281
|
70
|
141
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
280
|
70
|
137
|
|
Overall Study
Completed 26 Weeks
|
271
|
63
|
128
|
|
Overall Study
COMPLETED
|
263
|
59
|
124
|
|
Overall Study
NOT COMPLETED
|
18
|
11
|
17
|
Reasons for withdrawal
| Measure |
LY2189265
Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Liraglutide
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
6
|
12
|
|
Overall Study
Physician Decision
|
0
|
2
|
1
|
Baseline Characteristics
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Liraglutide
n=137 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
Total
n=487 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.15 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
57.66 years
STANDARD_DEVIATION 8.34 • n=7 Participants
|
57.91 years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
57.44 years
STANDARD_DEVIATION 9.63 • n=4 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
396 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
280 participants
n=5 Participants
|
70 participants
n=7 Participants
|
137 participants
n=5 Participants
|
487 participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
280 participants
n=5 Participants
|
70 participants
n=7 Participants
|
137 participants
n=5 Participants
|
487 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 26 weeksPopulation: Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication \[OAM\] yes/no), baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Outcome measures
| Measure |
Liraglutide
n=136 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=68 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
|
-1.33 percentage of HbA1c
Standard Error 0.07
|
-1.43 percentage of HbA1c
Standard Error 0.05
|
0.14 percentage of HbA1c
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, 52 weeksPopulation: Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.
LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.
Outcome measures
| Measure |
Liraglutide
n=136 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=68 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks
|
-1.19 percentage of HbA1c
Standard Error 0.08
|
-1.39 percentage of HbA1c
Standard Error 0.06
|
-1.55 percentage of HbA1c
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Up to 26 and 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.
The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% at Week 26 and Week 52 was analyzed with a Cochran-Mantel-Haenszel test stratified by prestudy therapy (OAM yes/no) and baseline BMI group (\<25 or \>=25 kg/m\^2).
Outcome measures
| Measure |
Liraglutide
n=136 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=68 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved HbA1c <=6.5% or <7%
HbA1c <7%, 26 weeks
|
69.1 percentage of participants
|
71.4 percentage of participants
|
5.9 percentage of participants
|
|
Percentage of Participants Who Achieved HbA1c <=6.5% or <7%
HbA1c <=6.5%, 26 weeks
|
49.3 percentage of participants
|
50.0 percentage of participants
|
1.5 percentage of participants
|
|
Percentage of Participants Who Achieved HbA1c <=6.5% or <7%
HbA1c <7%, 52 weeks
|
60.3 percentage of participants
|
67.9 percentage of participants
|
70.6 percentage of participants
|
|
Percentage of Participants Who Achieved HbA1c <=6.5% or <7%
HbA1c <=6.5%, 52 weeks
|
41.2 percentage of participants
|
49.3 percentage of participants
|
52.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable FBG data. Only pre-rescue measurements were used.
LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects, baseline FBG as a covariate, and participant as a random effect.
Outcome measures
| Measure |
Liraglutide
n=134 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=276 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=62 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks
26 weeks
|
-39.75 milligrams per deciliter (mg/dL)
Standard Error 2.27
|
-39.18 milligrams per deciliter (mg/dL)
Standard Error 1.60
|
1.03 milligrams per deciliter (mg/dL)
Standard Error 3.30
|
|
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks
52 weeks
|
-37.15 milligrams per deciliter (mg/dL)
Standard Error 2.47
|
-38.93 milligrams per deciliter (mg/dL)
Standard Error 1.72
|
-40.93 milligrams per deciliter (mg/dL)
Standard Error 3.62
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who received at least one dose of study medication with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.
Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, and at bedtime. LS means were calculated using analysis of covariance (ANCOVA) model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects and baseline SMBG as a covariate.
Outcome measures
| Measure |
Liraglutide
n=133 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=277 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=69 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Pre-morning meal, 26 weeks
|
-34.93 milligrams per deciliter (mg/dL)
Standard Error 2.19
|
-39.65 milligrams per deciliter (mg/dL)
Standard Error 1.55
|
-0.15 milligrams per deciliter (mg/dL)
Standard Error 3.04
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
2 hours post-morning meal, 26 weeks
|
-61.67 milligrams per deciliter (mg/dL)
Standard Error 3.96
|
-69.64 milligrams per deciliter (mg/dL)
Standard Error 2.80
|
-9.29 milligrams per deciliter (mg/dL)
Standard Error 5.48
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Pre-midday meal, 26 weeks
|
-45.08 milligrams per deciliter (mg/dL)
Standard Error 2.91
|
-48.47 milligrams per deciliter (mg/dL)
Standard Error 2.05
|
3.91 milligrams per deciliter (mg/dL)
Standard Error 4.03
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
2 hours post-midday meal, 26 weeks
|
-66.71 milligrams per deciliter (mg/dL)
Standard Error 4.16
|
-67.57 milligrams per deciliter (mg/dL)
Standard Error 2.94
|
-1.50 milligrams per deciliter (mg/dL)
Standard Error 5.77
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Pre-evening meal, 26 weeks
|
-36.62 milligrams per deciliter (mg/dL)
Standard Error 3.05
|
-39.64 milligrams per deciliter (mg/dL)
Standard Error 2.15
|
9.25 milligrams per deciliter (mg/dL)
Standard Error 4.22
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
2 hours post-evening meal
|
-53.14 milligrams per deciliter (mg/dL)
Standard Error 4.01
|
-56.70 milligrams per deciliter (mg/dL)
Standard Error 2.83
|
0.93 milligrams per deciliter (mg/dL)
Standard Error 5.56
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Bedtime, 26 weeks
|
-51.07 milligrams per deciliter (mg/dL)
Standard Error 3.94
|
-53.39 milligrams per deciliter (mg/dL)
Standard Error 2.81
|
4.26 milligrams per deciliter (mg/dL)
Standard Error 5.51
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Pre-morning meal, 52 weeks
|
-33.41 milligrams per deciliter (mg/dL)
Standard Error 2.23
|
-37.46 milligrams per deciliter (mg/dL)
Standard Error 1.58
|
-30.12 milligrams per deciliter (mg/dL)
Standard Error 3.10
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
2 hours post-morning meal, 52 weeks
|
-60.69 milligrams per deciliter (mg/dL)
Standard Error 4.06
|
-66.96 milligrams per deciliter (mg/dL)
Standard Error 2.87
|
-65.91 milligrams per deciliter (mg/dL)
Standard Error 5.62
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Pre-midday meal, 52 weeks
|
-46.25 milligrams per deciliter (mg/dL)
Standard Error 2.63
|
-47.03 milligrams per deciliter (mg/dL)
Standard Error 1.86
|
-45.15 milligrams per deciliter (mg/dL)
Standard Error 3.64
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
2 hours post-midday meal, 52 weeks
|
-62.57 milligrams per deciliter (mg/dL)
Standard Error 3.88
|
-68.21 milligrams per deciliter (mg/dL)
Standard Error 2.74
|
-58.52 milligrams per deciliter (mg/dL)
Standard Error 5.38
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Pre-evening meal, 52 weeks
|
-32.86 milligrams per deciliter (mg/dL)
Standard Error 2.67
|
-41.04 milligrams per deciliter (mg/dL)
Standard Error 1.08
|
-36.13 milligrams per deciliter (mg/dL)
Standard Error 3.70
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
2 hours post-evening meal, 52 weeks
|
-42.30 milligrams per deciliter (mg/dL)
Standard Error 3.65
|
-55.01 milligrams per deciliter (mg/dL)
Standard Error 2.58
|
-55.26 milligrams per deciliter (mg/dL)
Standard Error 5.06
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks
Bedtime, 52 weeks
|
-49.10 milligrams per deciliter (mg/dL)
Standard Error 3.35
|
-55.76 milligrams per deciliter (mg/dL)
Standard Error 2.39
|
-51.19 milligrams per deciliter (mg/dL)
Standard Error 4.69
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who received at least one dose of study medication with evaluable body weight data. Only pre-rescue measurements were used.
LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects, baseline body weight as a covariate, and participant as a random effect.
Outcome measures
| Measure |
Liraglutide
n=136 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Body Weight at 26 Weeks and 52 Weeks
26 weeks
|
-0.36 kilograms (kg)
Standard Error 0.20
|
-0.02 kilograms (kg)
Standard Error 0.14
|
-0.63 kilograms (kg)
Standard Error 0.29
|
|
Change From Baseline in Body Weight at 26 Weeks and 52 Weeks
52 weeks
|
-0.13 kilograms (kg)
Standard Error 0.26
|
-0.17 kilograms (kg)
Standard Error 0.18
|
-1.03 kilograms (kg)
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%S data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.
HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in insulin sensitivity was assessed based on change from baseline of HOMA2-%S using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects and baseline HOMA2-%S as a covariate.
Outcome measures
| Measure |
Liraglutide
n=131 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=275 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=62 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HOMA2-%S based on FI, 26 weeks (n=254, 57, 115)
|
-4.82 percentage of HOMA2
Standard Error 3.43
|
-4.83 percentage of HOMA2
Standard Error 2.34
|
-2.97 percentage of HOMA2
Standard Error 4.83
|
|
Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HOMA2-%S based on FCP, 26 weeks (n=275, 62, 131)
|
-2.46 percentage of HOMA2
Standard Error 2.75
|
-5.48 percentage of HOMA2
Standard Error 1.93
|
-6.32 percentage of HOMA2
Standard Error 3.99
|
|
Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HOMA2-%S based on FI, 52 weeks (n=260, 60, 120)
|
-5.26 percentage of HOMA2
Standard Error 3.38
|
-7.75 percentage of HOMA2
Standard Error 2.34
|
NA percentage of HOMA2
Standard Error NA
For ANCOVA analyses at 52 weeks, LS Means were not calculated for the Placebo/LY2189265 group as the purpose of the Week 52 analysis was to evaluate the efficacy and safety of LY2189265 compared with Liraglutide treatment for a full 52 weeks.
|
|
Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HOMA2-%S based on FCP, 52 weeks (n=275, 62, 131)
|
-10.68 percentage of HOMA2
Standard Error 2.68
|
-11.72 percentage of HOMA2
Standard Error 1.88
|
NA percentage of HOMA2
Standard Error NA
For ANCOVA analyses at 52 weeks, LS Means were not calculated for the Placebo/LY2189265 group as the purpose of the Week 52 analysis was to evaluate the efficacy and safety of LY2189265 compared with Liraglutide treatment for a full 52 weeks.
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%B data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.
HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in beta-cell function was assessed based on change from baseline of HOMA2-%B using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects and baseline HOMA2-%B as a covariate.
Outcome measures
| Measure |
Liraglutide
n=131 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=275 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=62 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HHOMA2-%B based on FI, 26 weeks (n=254, 57, 115)
|
25.35 percentage of HOMA2
Standard Error 2.23
|
28.42 percentage of HOMA2
Standard Error 1.54
|
0.08 percentage of HOMA2
Standard Error 3.14
|
|
Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HOMA2-%B based on FCP, 26 weeks (n=275, 62, 131)
|
25.86 percentage of HOMA2
Standard Error 1.79
|
27.77 percentage of HOMA2
Standard Error 1.27
|
2.94 percentage of HOMA2
Standard Error 2.61
|
|
Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HOMA2-%B based on FI, 52 weeks (n=260, 60, 120)
|
25.89 percentage of HOMA2
Standard Error 1.99
|
27.81 percentage of HOMA2
Standard Error 1.39
|
NA percentage of HOMA2
Standard Error NA
For ANCOVA analyses at 52 weeks, LS Means were not calculated for the Placebo/LY2189265 group as the purpose of the Week 52 analysis was to evaluate the efficacy and safety of LY2189265 compared with Liraglutide treatment for a full 52 weeks.
|
|
Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks
HOMA2-%B based on FCP, 52 weeks (n=275, 62, 131)
|
28.85 percentage of HOMA2
Standard Error 1.93
|
29.59 percentage of HOMA2
Standard Error 1.37
|
NA percentage of HOMA2
Standard Error NA
For ANCOVA analyses at 52 weeks, LS Means were not calculated for the Placebo/LY2189265 group as the purpose of the Week 52 analysis was to evaluate the efficacy and safety of LY2189265 compared with Liraglutide treatment for a full 52 weeks.
|
SECONDARY outcome
Timeframe: Baseline through 26 weeks and Baseline through 52 weeksPopulation: Participants who received at least one dose of study medication.
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week or 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Liraglutide
n=137 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Percentage of Participants With Hypoglycemic Episodes
26 weeks
|
1.5 percentage of participants
|
2.1 percentage of participants
|
1.4 percentage of participants
|
|
Percentage of Participants With Hypoglycemic Episodes
52 weeks
|
2.9 percentage of participants
|
2.9 percentage of participants
|
2.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through 26 weeks and Baseline through 52 weeksPopulation: Participants who received at least one dose of study medication. One participant in the Liraglutide reporting group received study drug but discontinued from the study on the same day and, therefore, was not included in the analysis.
The 30-day total hypoglycemia rate over 26 weeks and 52 weeks of treatment is summarized. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Liraglutide
n=136 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
30-Day Rate of Hypoglycemic Episodes
26 weeks
|
0.00 events per participant per 30 days
Standard Deviation 0.02
|
0.01 events per participant per 30 days
Standard Deviation 0.04
|
0.00 events per participant per 30 days
Standard Deviation 0.02
|
|
30-Day Rate of Hypoglycemic Episodes
52 weeks
|
0.01 events per participant per 30 days
Standard Deviation 0.04
|
0.00 events per participant per 30 days
Standard Deviation 0.02
|
0.01 events per participant per 30 days
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: Baseline through 26 weeks and Baseline through 52 weeksPopulation: Participants who received at least one dose of study medication.
Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Liraglutide
n=137 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks
26 weeks
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks
52 weeks
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable pulse rate data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Sitting pulse rate was measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects and baseline pulse rate as a covariate.
Outcome measures
| Measure |
Liraglutide
n=136 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks
26 weeks
|
4.77 beats per minute (bpm)
Standard Error 0.64
|
3.35 beats per minute (bpm)
Standard Error 0.45
|
1.49 beats per minute (bpm)
Standard Error 0.90
|
|
Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks
52 weeks
|
5.13 beats per minute (bpm)
Standard Error 0.60
|
3.11 beats per minute (bpm)
Standard Error 0.42
|
4.42 beats per minute (bpm)
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable blood pressure data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (\<25 or \>=25 kg/m\^2) as fixed effects and baseline blood pressure as a covariate.
Outcome measures
| Measure |
Liraglutide
n=136 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks
SBP, 26 weeks
|
-2.10 milliliters of mercury (mmHG)
Standard Error 0.89
|
0.62 milliliters of mercury (mmHG)
Standard Error 0.62
|
0.53 milliliters of mercury (mmHG)
Standard Error 1.25
|
|
Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks
DBP, 26 weeks
|
0.43 milliliters of mercury (mmHG)
Standard Error 0.56
|
1.09 milliliters of mercury (mmHG)
Standard Error 0.39
|
0.29 milliliters of mercury (mmHG)
Standard Error 0.78
|
|
Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks
SBP, 52 weeks
|
-1.86 milliliters of mercury (mmHG)
Standard Error 0.95
|
1.32 milliliters of mercury (mmHG)
Standard Error 0.66
|
0.37 milliliters of mercury (mmHG)
Standard Error 1.37
|
|
Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks
DBP, 52 weeks
|
1.17 milliliters of mercury (mmHG)
Standard Error 0.60
|
1.41 milliliters of mercury (mmHG)
Standard Error 0.41
|
1.16 milliliters of mercury (mmHG)
Standard Error 0.86
|
SECONDARY outcome
Timeframe: Baseline through 26 weeks and Baseline through 52 weeksPopulation: Participants who received at least one dose of study medication.
Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Liraglutide
n=137 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks
26 weeks
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks
52 weeks
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable pancreatic enzyme data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Pancreatic enzyme (lipase and total amylase) concentrations were measured.
Outcome measures
| Measure |
Liraglutide
n=131 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=275 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=65 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks
Lipase, 26 weeks
|
11.0 units/liter
Interval 5.0 to 21.0
|
7.0 units/liter
Interval 1.0 to 13.0
|
1.0 units/liter
Interval -6.0 to 5.0
|
|
Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks
Total Amylase, 26 weeks
|
7.0 units/liter
Interval 1.0 to 15.0
|
7.0 units/liter
Interval 2.0 to 15.0
|
0.0 units/liter
Interval -6.0 to 6.0
|
|
Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks
Lipase, 52 weeks
|
9.0 units/liter
Interval 3.0 to 19.0
|
6.0 units/liter
Interval 1.0 to 12.0
|
6.0 units/liter
Interval 2.0 to 12.0
|
|
Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks
Total Amylase, 52 weeks
|
6.0 units/liter
Interval 1.0 to 11.0
|
7.0 units/liter
Interval 1.0 to 14.0
|
9.0 units/liter
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable serum calcitonin data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Outcome measures
| Measure |
Liraglutide
n=131 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=274 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=65 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks
52 weeks
|
0.0 picograms/milliliter
Interval 0.0 to 0.0
|
0.0 picograms/milliliter
Interval 0.0 to 0.0
|
0.0 picograms/milliliter
Interval 0.0 to 0.0
|
|
Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks
26 weeks
|
0.0 picograms/milliliter
Interval 0.0 to 0.0
|
0.0 picograms/milliliter
Interval 0.0 to 0.0
|
0.0 picograms/milliliter
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline through 26 weeks and Baseline through 52 weeksPopulation: Participants who received at least one dose of study medication and had LY2189265 evaluable ADA data.
A participant was considered to have treatment-emergent LY2189265 ADAs if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from the baseline measurement.
Outcome measures
| Measure |
Liraglutide
n=134 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=279 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=68 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks
52 weeks (n=279, 68, 134)
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks
26 weeks (n=279, 68, 133)
|
0 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through 26 weeks and Baseline through 52 weeksPopulation: Participants who received at least one dose of study medication.
Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26 and 52 weeks.
Outcome measures
| Measure |
Liraglutide
n=137 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=280 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks
26 weeks
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks
52 weeks
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized and received at least one dose of study medication with evaluable ECG data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Fridericia Corrected QT (QTcF) Interval and PR Interval are summarized. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means were calculated using ANCOVA model with treatment as a fixed effect and the baseline ECG parameter as the covariate.
Outcome measures
| Measure |
Liraglutide
n=128 Participants
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
LY2189265
n=274 Participants
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=65 Participants
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks
PR, 52 weeks (n=270, 65, 126)
|
3.71 milliseconds (msec)
Standard Error 1.03
|
2.81 milliseconds (msec)
Standard Error 0.82
|
2.60 milliseconds (msec)
Standard Error 1.33
|
|
Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks
QTcF, 26 weeks (n=273, 64, 128)
|
-1.89 milliseconds (msec)
Standard Error 1.02
|
-2.02 milliseconds (msec)
Standard Error 0.70
|
-0.96 milliseconds (msec)
Standard Error 1.44
|
|
Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks
QTcF, 52 weeks (n=274, 64, 128)
|
-4.35 milliseconds (msec)
Standard Error 1.00
|
-2.76 milliseconds (msec)
Standard Error 0.68
|
-0.80 milliseconds (msec)
Standard Error 1.41
|
|
Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks
PR, 26 weeks (n=269, 65, 126)
|
2.07 milliseconds (msec)
Standard Error 0.88
|
2.20 milliseconds (msec)
Standard Error 0.60
|
-0.45 milliseconds (msec)
Standard Error 1.22
|
Adverse Events
LY2189265
Serious events: 9 serious events
Other events: 182 other events
Deaths: 0 deaths
Placebo/LY2189265
Serious events: 5 serious events
Other events: 53 other events
Deaths: 0 deaths
Liraglutide
Serious events: 7 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2189265
n=280 participants at risk
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 participants at risk
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Liraglutide
n=137 participants at risk
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Hepatobiliary disorders
Bile duct stone
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Bacterial infection
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Gastroenteritis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Hiv infection
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/52
|
6.7%
1/15 • Number of events 1
|
0.00%
0/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/228
|
1.8%
1/55 • Number of events 1
|
0.00%
0/113
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
Other adverse events
| Measure |
LY2189265
n=280 participants at risk
Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Placebo/LY2189265
n=70 participants at risk
Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
|
Liraglutide
n=137 participants at risk
Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Cardiac disorders
Palpitations
|
1.8%
5/280 • Number of events 5
|
0.00%
0/70
|
0.00%
0/137
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Ear and labyrinth disorders
Eustachian tube obstruction
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Ear and labyrinth disorders
Vertigo
|
0.71%
2/280 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Endocrine disorders
Goitre
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Endocrine disorders
Hyperthyroidism
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Asthenopia
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Eye disorders
Cataract
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/280
|
1.4%
1/70 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.71%
2/280 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
|
Eye disorders
Dry eye
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Eyelid oedema
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Glaucoma
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Iritis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Keratitis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Macular oedema
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Pingueculitis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Eye disorders
Retinal tear
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Eye disorders
Vitreous haemorrhage
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.2%
9/280 • Number of events 10
|
1.4%
1/70 • Number of events 1
|
3.6%
5/137 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal distension
|
4.3%
12/280 • Number of events 12
|
0.00%
0/70
|
5.1%
7/137 • Number of events 7
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/280 • Number of events 3
|
2.9%
2/70 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
4/280 • Number of events 4
|
2.9%
2/70 • Number of events 2
|
2.2%
3/137 • Number of events 3
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
7.9%
22/280 • Number of events 24
|
5.7%
4/70 • Number of events 4
|
8.0%
11/137 • Number of events 11
|
|
Gastrointestinal disorders
Dental caries
|
1.4%
4/280 • Number of events 5
|
4.3%
3/70 • Number of events 3
|
2.9%
4/137 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
20/280 • Number of events 23
|
8.6%
6/70 • Number of events 6
|
4.4%
6/137 • Number of events 6
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
1.4%
4/280 • Number of events 5
|
1.4%
1/70 • Number of events 1
|
2.2%
3/137 • Number of events 3
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
0.71%
2/280 • Number of events 3
|
0.00%
0/70
|
0.00%
0/137
|
|
Gastrointestinal disorders
Flatulence
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
1.5%
2/137 • Number of events 2
|
|
Gastrointestinal disorders
Gastric disorder
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Gastrointestinal disorders
Gastric polyps
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.71%
2/280 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
2.2%
3/137 • Number of events 5
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.71%
2/280 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
2.9%
4/137 • Number of events 4
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.36%
1/280 • Number of events 3
|
0.00%
0/70
|
0.00%
0/137
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.1%
3/280 • Number of events 3
|
0.00%
0/70
|
2.9%
4/137 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
6.1%
17/280 • Number of events 25
|
2.9%
2/70 • Number of events 2
|
8.0%
11/137 • Number of events 18
|
|
Gastrointestinal disorders
Periodontal disease
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Gastrointestinal disorders
Radicular cyst
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
5/280 • Number of events 6
|
0.00%
0/70
|
0.73%
1/137 • Number of events 2
|
|
General disorders
Application site haematoma
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
1.5%
2/137 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
General disorders
Device failure
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
General disorders
Early satiety
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
General disorders
Fatigue
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
2.2%
3/137 • Number of events 3
|
|
General disorders
Feeling abnormal
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
General disorders
Induration
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
General disorders
Injection site bruising
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
General disorders
Injection site dermatitis
|
0.36%
1/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
General disorders
Injection site erythema
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
2.9%
4/137 • Number of events 5
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
General disorders
Injection site induration
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
General disorders
Injection site pain
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
General disorders
Injection site pruritus
|
1.8%
5/280 • Number of events 5
|
0.00%
0/70
|
3.6%
5/137 • Number of events 6
|
|
General disorders
Injection site rash
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
General disorders
Injection site reaction
|
1.1%
3/280 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
General disorders
Injection site swelling
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
General disorders
Local swelling
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
General disorders
Malaise
|
0.71%
2/280 • Number of events 8
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
General disorders
Pyrexia
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
General disorders
Thirst
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
General disorders
Xerosis
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.8%
5/280 • Number of events 5
|
0.00%
0/70
|
1.5%
2/137 • Number of events 2
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Hepatobiliary disorders
Liver injury
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Immune system disorders
Seasonal allergy
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Acute sinusitis
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Infections and infestations
Anisakiasis
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Body tinea
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
2.5%
7/280 • Number of events 9
|
2.9%
2/70 • Number of events 2
|
2.2%
3/137 • Number of events 4
|
|
Infections and infestations
Bronchitis viral
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Candida infection
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Chronic sinusitis
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.71%
2/280 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Enteritis infectious
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Fungal skin infection
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Gastroenteritis
|
2.5%
7/280 • Number of events 7
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Gastroenteritis viral
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Infections and infestations
Gingivitis
|
1.1%
3/280 • Number of events 3
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Helicobacter gastritis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Helicobacter infection
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.36%
1/280 • Number of events 1
|
4.3%
3/70 • Number of events 3
|
1.5%
2/137 • Number of events 2
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Infections and infestations
Nasopharyngitis
|
18.6%
52/280 • Number of events 61
|
10.0%
7/70 • Number of events 12
|
17.5%
24/137 • Number of events 34
|
|
Infections and infestations
Oral herpes
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Otitis externa
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Infections and infestations
Otitis media
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Parotitis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Periodontitis
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
1.1%
3/280 • Number of events 3
|
4.3%
3/70 • Number of events 4
|
2.2%
3/137 • Number of events 3
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Pyoderma
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Rhinitis
|
1.1%
3/280 • Number of events 3
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Infections and infestations
Sinusitis
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Infections and infestations
Tinea infection
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Tinea pedis
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
|
Infections and infestations
Tooth abscess
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Infections and infestations
Upper respiratory tract infection
|
0.36%
1/280 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 3
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
4/280 • Number of events 4
|
0.00%
0/70
|
3.6%
5/137 • Number of events 5
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/280
|
2.9%
2/70 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.1%
3/280 • Number of events 3
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.71%
2/280 • Number of events 3
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
1.5%
2/137 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Scratch
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.36%
1/280 • Number of events 1
|
2.9%
2/70 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Amylase increased
|
1.1%
3/280 • Number of events 3
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Investigations
Arteriogram coronary
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Aspartate aminotransferase increased
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Blood creatine phosphokinase increased
|
1.1%
3/280 • Number of events 3
|
0.00%
0/70
|
2.2%
3/137 • Number of events 4
|
|
Investigations
Blood triglycerides increased
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Blood uric acid increased
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Blood urine present
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Crystal urine present
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Investigations
Lipase increased
|
3.6%
10/280 • Number of events 11
|
2.9%
2/70 • Number of events 2
|
2.2%
3/137 • Number of events 3
|
|
Investigations
Liver function test abnormal
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Monocyte count increased
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Investigations
Occult blood positive
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Pancreatic enzymes increased
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/228
|
1.8%
1/55 • Number of events 1
|
0.00%
0/113
|
|
Investigations
Skin test positive
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
Transaminases increased
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Investigations
White blood cell count decreased
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.71%
2/280 • Number of events 2
|
2.9%
2/70 • Number of events 2
|
5.8%
8/137 • Number of events 8
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
1.5%
2/137 • Number of events 2
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/280
|
1.4%
1/70 • Number of events 2
|
0.00%
0/137
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
4/280 • Number of events 4
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
8/280 • Number of events 9
|
4.3%
3/70 • Number of events 3
|
4.4%
6/137 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.8%
5/280 • Number of events 5
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
2.2%
3/137 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
1.1%
3/280 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.4%
4/280 • Number of events 4
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.36%
1/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Duodenal neoplasm
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.9%
1/52 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Diabetic neuropathy
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
1.5%
2/137 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.36%
1/280 • Number of events 1
|
4.3%
3/70 • Number of events 3
|
0.73%
1/137 • Number of events 1
|
|
Nervous system disorders
Dizziness exertional
|
0.36%
1/280 • Number of events 4
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Head discomfort
|
0.36%
1/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Headache
|
0.71%
2/280 • Number of events 2
|
2.9%
2/70 • Number of events 2
|
3.6%
5/137 • Number of events 5
|
|
Nervous system disorders
Hypoaesthesia
|
0.71%
2/280 • Number of events 2
|
7.1%
5/70 • Number of events 5
|
0.73%
1/137 • Number of events 1
|
|
Nervous system disorders
Intercostal neuralgia
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Lacunar infarction
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Nervous system disorders
Radial nerve palsy
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Nervous system disorders
Sciatica
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
0.71%
2/280 • Number of events 6
|
0.00%
0/70
|
1.5%
2/137 • Number of events 3
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.36%
1/280 • Number of events 1
|
2.9%
2/70 • Number of events 2
|
0.73%
1/137 • Number of events 1
|
|
Psychiatric disorders
Irritability
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Renal and urinary disorders
Calculus ureteric
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.4%
4/280 • Number of events 4
|
1.4%
1/70 • Number of events 1
|
0.73%
1/137 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/280
|
0.00%
0/70
|
1.5%
2/137 • Number of events 2
|
|
Renal and urinary disorders
Renal cyst
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.88%
2/228 • Number of events 2
|
0.00%
0/55
|
0.00%
0/113
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.00%
0/228
|
0.00%
0/55
|
0.88%
1/113 • Number of events 1
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/52
|
6.7%
1/15 • Number of events 1
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.44%
1/228 • Number of events 1
|
0.00%
0/55
|
0.00%
0/113
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.9%
1/52 • Number of events 1
|
0.00%
0/15
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Prostatitis
|
0.44%
1/228 • Number of events 1
|
0.00%
0/55
|
0.00%
0/113
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/228
|
0.00%
0/55
|
0.88%
1/113 • Number of events 1
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/52
|
6.7%
1/15 • Number of events 1
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
1.9%
1/52 • Number of events 1
|
0.00%
0/15
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/280
|
1.4%
1/70 • Number of events 2
|
0.00%
0/137
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.71%
2/280 • Number of events 2
|
1.4%
1/70 • Number of events 1
|
2.9%
4/137 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.71%
2/280 • Number of events 3
|
0.00%
0/70
|
0.00%
0/137
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.4%
4/280 • Number of events 8
|
0.00%
0/70
|
2.2%
3/137 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.71%
2/280 • Number of events 2
|
0.00%
0/70
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
4/280 • Number of events 5
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
4/280 • Number of events 4
|
2.9%
2/70 • Number of events 3
|
2.2%
3/137 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.36%
1/280 • Number of events 1
|
1.4%
1/70 • Number of events 1
|
1.5%
2/137 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/280
|
0.00%
0/70
|
2.2%
3/137 • Number of events 5
|
|
Social circumstances
Denture wearer
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Surgical and medical procedures
Dental prosthesis placement
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Surgical and medical procedures
Intra-cerebral aneurysm operation
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Surgical and medical procedures
Large intestinal polypectomy
|
1.1%
3/280 • Number of events 3
|
0.00%
0/70
|
0.00%
0/137
|
|
Surgical and medical procedures
Limb operation
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Surgical and medical procedures
Photocoagulation
|
0.00%
0/280
|
1.4%
1/70 • Number of events 1
|
0.00%
0/137
|
|
Surgical and medical procedures
Retinal laser coagulation
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
0.00%
0/137
|
|
Surgical and medical procedures
Tooth extraction
|
0.36%
1/280 • Number of events 1
|
0.00%
0/70
|
1.5%
2/137 • Number of events 3
|
|
Surgical and medical procedures
Tooth repair
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.5%
7/280 • Number of events 7
|
2.9%
2/70 • Number of events 2
|
2.9%
4/137 • Number of events 4
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/280
|
0.00%
0/70
|
0.73%
1/137 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60