Trial Outcomes & Findings for A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus (NCT NCT01468181)
NCT ID: NCT01468181
Last Updated: 2015-01-29
Results Overview
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
394 participants
Primary outcome timeframe
Baseline through 52 Weeks
Results posted on
2015-01-29
Participant Flow
Participant milestones
| Measure |
LY2189265 + Sulfonylureas (SU)
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + Biguanides (BG)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + Thiazolidin Edione (TZD)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
131
|
61
|
65
|
66
|
71
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
131
|
61
|
65
|
66
|
71
|
|
Overall Study
COMPLETED
|
121
|
59
|
57
|
63
|
66
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
8
|
3
|
5
|
Reasons for withdrawal
| Measure |
LY2189265 + Sulfonylureas (SU)
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + Biguanides (BG)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + Thiazolidin Edione (TZD)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
8
|
1
|
6
|
2
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
1
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
Total
n=394 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.68 years
STANDARD_DEVIATION 11.59 • n=5 Participants
|
52.69 years
STANDARD_DEVIATION 10.19 • n=7 Participants
|
59.13 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
56.40 years
STANDARD_DEVIATION 10.51 • n=4 Participants
|
58.17 years
STANDARD_DEVIATION 10.30 • n=21 Participants
|
57.35 years
STANDARD_DEVIATION 10.96 • n=8 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
98 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
296 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
131 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
394 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
131 participants
n=5 Participants
|
61 participants
n=7 Participants
|
65 participants
n=5 Participants
|
66 participants
n=4 Participants
|
71 participants
n=21 Participants
|
394 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through 52 WeeksPopulation: All enrolled participants who received at least 1 dose of study drug
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
85.5 percentage of participants
|
83.6 percentage of participants
|
70.8 percentage of participants
|
80.3 percentage of participants
|
73.2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline through 52 WeeksPopulation: All enrolled participants who received at least 1 dose of study drug
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 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 |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Hypoglycemic Episodes
|
33.6 percentage of participants
|
3.3 percentage of participants
|
6.2 percentage of participants
|
6.1 percentage of participants
|
9.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, up to 26 Weeks and up to 52 WeeksPopulation: Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. Last observation carried forward (LOCF) was used to impute missing postbaseline values.
Outcome measures
| Measure |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
26 Weeks
|
-1.93 percentage of HbA1c
Standard Error 0.09
|
-1.58 percentage of HbA1c
Standard Error 0.11
|
-1.67 percentage of HbA1c
Standard Error 0.10
|
-1.71 percentage of HbA1c
Standard Error 0.13
|
-1.80 percentage of HbA1c
Standard Error 0.12
|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
52 Weeks
|
-1.67 percentage of HbA1c
Standard Error 0.09
|
-1.57 percentage of HbA1c
Standard Error 0.11
|
-1.65 percentage of HbA1c
Standard Error 0.11
|
-1.69 percentage of HbA1c
Standard Error 0.13
|
-1.65 percentage of HbA1c
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 26 weeks and 52 weeksPopulation: Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. LOCF was used to impute missing postbaseline values.
Outcome measures
| Measure |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
HbA1c ≤6.5% at Week 26
|
35.1 percentage of participants
|
54.1 percentage of participants
|
72.3 percentage of participants
|
60.6 percentage of participants
|
53.5 percentage of participants
|
|
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
HbA1c ≤6.5% at Week 52
|
31.3 percentage of participants
|
57.4 percentage of participants
|
70.8 percentage of participants
|
57.6 percentage of participants
|
47.9 percentage of participants
|
|
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
HbA1c <7.0% at Week 26
|
61.8 percentage of participants
|
73.8 percentage of participants
|
81.5 percentage of participants
|
72.7 percentage of participants
|
69.0 percentage of participants
|
|
Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%
HbA1c <7.0% at Week 52
|
48.9 percentage of participants
|
73.8 percentage of participants
|
83.1 percentage of participants
|
77.3 percentage of participants
|
62.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, up to 26 weeks and up to 52 weeksPopulation: Participants who were randomized and received at least 1 dose of study drug with evaluable FBG data. LOCF was used to impute missing postbaseline values.
Outcome measures
| Measure |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG)
26 Weeks
|
-46.8 milligrams/deciliters (mg/dL)
Standard Error 4.2
|
-37.9 milligrams/deciliters (mg/dL)
Standard Error 4.0
|
-46.8 milligrams/deciliters (mg/dL)
Standard Error 4.7
|
-42.1 milligrams/deciliters (mg/dL)
Standard Error 4.5
|
-42.7 milligrams/deciliters (mg/dL)
Standard Error 3.9
|
|
Change From Baseline in Fasting Blood Glucose (FBG)
52 Weeks
|
-43.2 milligrams/deciliters (mg/dL)
Standard Error 3.8
|
-36.0 milligrams/deciliters (mg/dL)
Standard Error 4.2
|
-47.0 milligrams/deciliters (mg/dL)
Standard Error 4.7
|
-39.6 milligrams/deciliters (mg/dL)
Standard Error 5.0
|
-45.8 milligrams/deciliters (mg/dL)
Standard Error 4.0
|
SECONDARY outcome
Timeframe: Baseline, up to 26 weeks and up to 52 weeksPopulation: Participants who were randomized and received at least 1 dose of study drug with evaluable SMBG data. LOCF was used to impute missing postbaseline. values.
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. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.
Outcome measures
| Measure |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Pre-evening meal at 52 Weeks (n=130,61,65,66,70)
|
-43.90 mg/dL
Standard Error 5.39
|
-25.34 mg/dL
Standard Error 5.55
|
-54.66 mg/dL
Standard Error 7.35
|
-42.15 mg/dL
Standard Error 7.44
|
-51.64 mg/dL
Standard Error 6.10
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Pre-morning mean at 26 Weeks (n=131,61,64,66,71)
|
-44.70 mg/dL
Standard Error 4.57
|
-34.60 mg/dL
Standard Error 3.88
|
-45.97 mg/dL
Standard Error 4.99
|
-35.40 mg/dL
Standard Error 3.85
|
-48.26 mg/dL
Standard Error 4.33
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Pre-morning mean at 52 Weeks (n=131,61,64,66,71)
|
-42.93 mg/dL
Standard Error 3.89
|
-37.19 mg/dL
Standard Error 3.83
|
-45.69 mg/dL
Standard Error 5.05
|
-39.83 mg/dL
Standard Error 4.24
|
-46.45 mg/dL
Standard Error 4.30
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
2hr postmorning meal at 26Weeks(n=131,61,65,66,71)
|
-69.66 mg/dL
Standard Error 5.69
|
-64.23 mg/dL
Standard Error 6.35
|
-73.43 mg/dL
Standard Error 6.70
|
-65.73 mg/dL
Standard Error 5.94
|
-67.99 mg/dL
Standard Error 7.24
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
2hr postmorning meal at 52Weeks(n=131,61,65,66,71)
|
-58.50 mg/dL
Standard Error 5.63
|
-63.81 mg/dL
Standard Error 7.22
|
-73.62 mg/dL
Standard Error 7.27
|
-67.51 mg/dL
Standard Error 6.49
|
-73.78 mg/dL
Standard Error 7.95
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Pre-midday meal at 26 Weeks (n=131,61,65,66,71)
|
-49.95 mg/dL
Standard Error 4.85
|
-26.26 mg/dL
Standard Error 4.93
|
-54.75 mg/dL
Standard Error 6.24
|
-51.80 mg/dL
Standard Error 6.68
|
-54.51 mg/dL
Standard Error 5.79
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Pre-midday meal at 52 Weeks (n=131,61,65,66,71)
|
-43.90 mg/dL
Standard Error 5.15
|
-33.34 mg/dL
Standard Error 5.12
|
-55.96 mg/dL
Standard Error 6.42
|
-50.21 mg/dL
Standard Error 7.04
|
-56.07 mg/dL
Standard Error 5.60
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
2hr postmidday meal at 26 Weeks(n=131,60,65,66,71)
|
-67.24 mg/dL
Standard Error 5.24
|
-50.03 mg/dL
Standard Error 5.70
|
-67.70 mg/dL
Standard Error 7.37
|
-80.02 mg/dL
Standard Error 7.93
|
-68.49 mg/dL
Standard Error 7.84
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
2hr postmidday meal at 52 Weeks(n=131,60,65,66,71)
|
-57.27 mg/dL
Standard Error 5.44
|
-52.70 mg/dL
Standard Error 5.26
|
-63.47 mg/dL
Standard Error 7.12
|
-81.64 mg/dL
Standard Error 8.68
|
-65.46 mg/dL
Standard Error 7.23
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Pre-evening meal at 26 Weeks (n=130,61,65,66,70)
|
-44.57 mg/dL
Standard Error 5.63
|
-25.66 mg/dL
Standard Error 5.28
|
-57.82 mg/dL
Standard Error 6.83
|
-43.22 mg/dL
Standard Error 7.53
|
-46.85 mg/dL
Standard Error 5.88
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
2hr postevening meal at 26Weeks(n=128,61,65,66,69)
|
-62.24 mg/dL
Standard Error 6.05
|
-45.41 mg/dL
Standard Error 6.71
|
-71.15 mg/dL
Standard Error 7.57
|
-66.14 mg/dL
Standard Error 8.22
|
-68.75 mg/dL
Standard Error 7.88
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
2hr postevening meal at 52Weeks(n=128,61,65,66,69)
|
-58.98 mg/dL
Standard Error 5.71
|
-48.61 mg/dL
Standard Error 6.45
|
-63.82 mg/dL
Standard Error 7.00
|
-69.30 mg/dL
Standard Error 8.60
|
-64.22 mg/dL
Standard Error 7.07
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Bedtime at 26 Weeks (n=128, 61, 65, 63, 67)
|
-61.07 mg/dL
Standard Error 5.08
|
-49.98 mg/dL
Standard Error 6.48
|
-63.98 mg/dL
Standard Error 6.90
|
-66.19 mg/dL
Standard Error 8.75
|
-64.01 mg/dL
Standard Error 6.56
|
|
Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)
Bedtime at 52 Weeks (n=128, 61, 65, 63, 67)
|
-54.07 mg/dL
Standard Error 5.24
|
-52.70 mg/dL
Standard Error 6.45
|
-66.74 mg/dL
Standard Error 7.31
|
-68.42 mg/dL
Standard Error 9.05
|
-64.41 mg/dL
Standard Error 6.21
|
SECONDARY outcome
Timeframe: Baseline, up to 26 weeks and up to 52 weeksPopulation: Participants who were randomized and received at least 1 dose of study drug with evaluable body weight data. LOCF was used to impute missing postbaseline values.
Outcome measures
| Measure |
LY2189265 + SU
n=131 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight
26 Weeks
|
0.02 kilograms (kg)
Standard Error 0.22
|
-0.74 kilograms (kg)
Standard Error 0.39
|
-1.22 kilograms (kg)
Standard Error 0.33
|
0.78 kilograms (kg)
Standard Error 0.30
|
0.19 kilograms (kg)
Standard Error 0.25
|
|
Change From Baseline in Body Weight
52 Weeks
|
0.10 kilograms (kg)
Standard Error 0.24
|
-0.87 kilograms (kg)
Standard Error 0.40
|
-1.24 kilograms (kg)
Standard Error 0.42
|
1.02 kilograms (kg)
Standard Error 0.35
|
0.04 kilograms (kg)
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline, up to 26 weeks and up to 52 weeksPopulation: Participants who were randomized and received at least 1 dose of study drug with evaluable HOMA2 data. LOCF was used to impute missing postbaseline values.
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).
Outcome measures
| Measure |
LY2189265 + SU
n=127 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=59 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=62 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=59 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=64 Participants
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
HOMA2-%B, 26 Weeks
|
29.10 percentage of HOMA2
Standard Error 2.75
|
28.15 percentage of HOMA2
Standard Error 2.79
|
30.88 percentage of HOMA2
Standard Error 3.25
|
27.34 percentage of HOMA2
Standard Error 2.60
|
26.93 percentage of HOMA2
Standard Error 2.59
|
|
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
HOMA2-%B, 52 Weeks
|
26.06 percentage of HOMA2
Standard Error 2.77
|
26.05 percentage of HOMA2
Standard Error 2.97
|
28.06 percentage of HOMA2
Standard Error 3.61
|
25.38 percentage of HOMA2
Standard Error 2.53
|
33.51 percentage of HOMA2
Standard Error 3.81
|
|
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
HOMA2-%S, 26 Weeks
|
-4.80 percentage of HOMA2
Standard Error 3.40
|
-3.48 percentage of HOMA2
Standard Error 4.39
|
7.57 percentage of HOMA2
Standard Error 5.60
|
-5.50 percentage of HOMA2
Standard Error 5.21
|
-4.41 percentage of HOMA2
Standard Error 4.05
|
|
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
HOMA2-%S, 52 Weeks
|
-3.99 percentage of HOMA2
Standard Error 3.18
|
-3.83 percentage of HOMA2
Standard Error 4.89
|
6.86 percentage of HOMA2
Standard Error 5.24
|
0.47 percentage of HOMA2
Standard Error 5.87
|
-5.51 percentage of HOMA2
Standard Error 4.71
|
Adverse Events
LY2189265 + SU
Serious events: 9 serious events
Other events: 112 other events
Deaths: 0 deaths
LY2189265 + BG
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
LY2189265 + a-GI
Serious events: 4 serious events
Other events: 46 other events
Deaths: 0 deaths
LY2189265 + TZD
Serious events: 1 serious events
Other events: 53 other events
Deaths: 0 deaths
LY2189265 + Glinides
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2189265 + SU
n=131 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Cardiac disorders
Angina unstable
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatic enzyme abnormality
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Oedema
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Hepatobiliary disorders
Bile duct stone
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Injury, poisoning and procedural complications
Concussion
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/36
|
0.00%
0/21
|
10.0%
1/10 • Number of events 1
|
0.00%
0/14
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/95
|
2.5%
1/40 • Number of events 1
|
0.00%
0/55
|
0.00%
0/52
|
0.00%
0/54
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
Other adverse events
| Measure |
LY2189265 + SU
n=131 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
|
LY2189265 + BG
n=61 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
|
LY2189265 + a-GI
n=65 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
|
LY2189265 + TZD
n=66 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
|
LY2189265 + Glinides
n=71 participants at risk
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/131
|
1.6%
1/61 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Cardiac disorders
Cardiac failure congestive
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Cardiac disorders
Palpitations
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
1.4%
1/71 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
2.3%
3/131 • Number of events 3
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Endocrine disorders
Hypothyroidism
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Asthenopia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Eye disorders
Blepharitis
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Cataract
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/131
|
3.3%
2/61 • Number of events 2
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Diabetic retinopathy
|
3.1%
4/131 • Number of events 4
|
0.00%
0/61
|
0.00%
0/65
|
4.5%
3/66 • Number of events 3
|
0.00%
0/71
|
|
Eye disorders
Dry eye
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Glaucoma
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Eye disorders
Iritis
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Eye disorders
Macular oedema
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Eye disorders
Photophobia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Retinal haemorrhage
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.5%
2/131 • Number of events 4
|
1.6%
1/61 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
3.0%
2/66 • Number of events 2
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
4/131 • Number of events 8
|
0.00%
0/61
|
3.1%
2/65 • Number of events 2
|
3.0%
2/66 • Number of events 2
|
2.8%
2/71 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
2/131 • Number of events 5
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Acute abdomen
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Cheilitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Constipation
|
15.3%
20/131 • Number of events 22
|
4.9%
3/61 • Number of events 3
|
12.3%
8/65 • Number of events 8
|
4.5%
3/66 • Number of events 3
|
7.0%
5/71 • Number of events 6
|
|
Gastrointestinal disorders
Dental caries
|
1.5%
2/131 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
4.2%
3/71 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhoea
|
9.9%
13/131 • Number of events 14
|
14.8%
9/61 • Number of events 13
|
4.6%
3/65 • Number of events 3
|
7.6%
5/66 • Number of events 8
|
9.9%
7/71 • Number of events 9
|
|
Gastrointestinal disorders
Dyspepsia
|
4.6%
6/131 • Number of events 18
|
3.3%
2/61 • Number of events 2
|
1.5%
1/65 • Number of events 2
|
0.00%
0/66
|
7.0%
5/71 • Number of events 8
|
|
Gastrointestinal disorders
Eructation
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/131
|
0.00%
0/61
|
3.1%
2/65 • Number of events 2
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
4/131 • Number of events 4
|
4.9%
3/61 • Number of events 3
|
3.1%
2/65 • Number of events 2
|
4.5%
3/66 • Number of events 3
|
2.8%
2/71 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.3%
3/131 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
4.6%
3/65 • Number of events 4
|
1.5%
1/66 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Gastrointestinal disorders
Gingival pain
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Nausea
|
13.0%
17/131 • Number of events 82
|
3.3%
2/61 • Number of events 2
|
6.2%
4/65 • Number of events 8
|
7.6%
5/66 • Number of events 6
|
4.2%
3/71 • Number of events 3
|
|
Gastrointestinal disorders
Pancreatic enzyme abnormality
|
2.3%
3/131 • Number of events 3
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Gastrointestinal disorders
Periodontal disease
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Gastrointestinal disorders
Stomatitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
3.0%
2/66 • Number of events 2
|
0.00%
0/71
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
8/131 • Number of events 11
|
1.6%
1/61 • Number of events 1
|
4.6%
3/65 • Number of events 3
|
4.5%
3/66 • Number of events 5
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Chest pain
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Facial pain
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Fatigue
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Feeling abnormal
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Injection site bruising
|
0.76%
1/131 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Injection site discomfort
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Injection site eczema
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
General disorders
Injection site erythema
|
1.5%
2/131 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
General disorders
Injection site haemorrhage
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Injection site induration
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Injection site pain
|
0.76%
1/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 2
|
|
General disorders
Injection site pruritus
|
1.5%
2/131 • Number of events 4
|
0.00%
0/61
|
3.1%
2/65 • Number of events 2
|
4.5%
3/66 • Number of events 3
|
4.2%
3/71 • Number of events 3
|
|
General disorders
Injection site reaction
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Injection site swelling
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Local swelling
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
General disorders
Malaise
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Oedema
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
3.0%
2/66 • Number of events 2
|
0.00%
0/71
|
|
General disorders
Oedema peripheral
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
General disorders
Pain
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
General disorders
Pyrexia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
General disorders
Xerosis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.5%
2/131 • Number of events 2
|
1.6%
1/61 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
4.5%
3/66 • Number of events 3
|
0.00%
0/71
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Immune system disorders
Seasonal allergy
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
7.6%
10/131 • Number of events 14
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
3.0%
2/66 • Number of events 4
|
2.8%
2/71 • Number of events 2
|
|
Infections and infestations
Cellulitis
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Chronic sinusitis
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Eczema infected
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Enteritis infectious
|
2.3%
3/131 • Number of events 3
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
3.0%
2/66 • Number of events 4
|
0.00%
0/71
|
|
Infections and infestations
Folliculitis
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Furuncle
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Gastroenteritis
|
3.1%
4/131 • Number of events 4
|
4.9%
3/61 • Number of events 3
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Genital herpes
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Gingivitis
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Infections and infestations
Helicobacter infection
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Infections and infestations
Herpes zoster
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Influenza
|
4.6%
6/131 • Number of events 6
|
11.5%
7/61 • Number of events 7
|
0.00%
0/65
|
0.00%
0/66
|
4.2%
3/71 • Number of events 3
|
|
Infections and infestations
Nasopharyngitis
|
23.7%
31/131 • Number of events 51
|
26.2%
16/61 • Number of events 25
|
16.9%
11/65 • Number of events 15
|
24.2%
16/66 • Number of events 26
|
22.5%
16/71 • Number of events 18
|
|
Infections and infestations
Oral herpes
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Paronychia
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Periodontitis
|
0.00%
0/131
|
3.3%
2/61 • Number of events 2
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Infections and infestations
Pharyngitis
|
5.3%
7/131 • Number of events 8
|
3.3%
2/61 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
9.1%
6/66 • Number of events 6
|
0.00%
0/71
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Infections and infestations
Sinusitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Infections and infestations
Skin infection
|
0.00%
0/131
|
3.3%
2/61 • Number of events 2
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Tinea pedis
|
1.5%
2/131 • Number of events 2
|
3.3%
2/61 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Tonsillitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Infections and infestations
Viral infection
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
2/131 • Number of events 2
|
6.6%
4/61 • Number of events 4
|
1.5%
1/65 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
2.8%
2/71 • Number of events 2
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Head injury
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Investigations
Alanine aminotransferase increased
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Investigations
Amylase increased
|
2.3%
3/131 • Number of events 4
|
0.00%
0/61
|
3.1%
2/65 • Number of events 2
|
3.0%
2/66 • Number of events 2
|
1.4%
1/71 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Investigations
Blood creatine phosphokinase increased
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Investigations
Blood pressure diastolic increased
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Investigations
Blood pressure increased
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Investigations
Blood urea increased
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Investigations
Blood uric acid increased
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Investigations
Lipase increased
|
8.4%
11/131 • Number of events 11
|
9.8%
6/61 • Number of events 6
|
9.2%
6/65 • Number of events 7
|
4.5%
3/66 • Number of events 3
|
2.8%
2/71 • Number of events 2
|
|
Investigations
Pancreatic enzymes increased
|
1.5%
2/131 • Number of events 2
|
4.9%
3/61 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Weight decreased
|
0.00%
0/131
|
3.3%
2/61 • Number of events 2
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Investigations
Weight increased
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
6.1%
4/66 • Number of events 4
|
1.4%
1/71 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.6%
10/131 • Number of events 16
|
4.9%
3/61 • Number of events 3
|
4.6%
3/65 • Number of events 3
|
1.5%
1/66 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Metabolism and nutrition disorders
Gout
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
2.8%
2/71 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
4/131 • Number of events 4
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
4.2%
3/71 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
8/131 • Number of events 8
|
3.3%
2/61 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
9.1%
6/66 • Number of events 7
|
1.4%
1/71 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Knee deformity
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.3%
3/131 • Number of events 3
|
3.3%
2/61 • Number of events 2
|
0.00%
0/65
|
3.0%
2/66 • Number of events 2
|
1.4%
1/71 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.3%
3/131 • Number of events 4
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Nodal osteoarthritis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
2/131 • Number of events 3
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
3.0%
2/66 • Number of events 2
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.3%
3/131 • Number of events 3
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue neoplasm
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Nervous system disorders
Dizziness
|
3.1%
4/131 • Number of events 5
|
0.00%
0/61
|
0.00%
0/65
|
3.0%
2/66 • Number of events 2
|
0.00%
0/71
|
|
Nervous system disorders
Headache
|
3.1%
4/131 • Number of events 4
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 2
|
|
Nervous system disorders
Hypoaesthesia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Migraine
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Neuralgia
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Sciatica
|
2.3%
3/131 • Number of events 3
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
1.5%
2/131 • Number of events 17
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Tremor
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 3
|
0.00%
0/66
|
0.00%
0/71
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Psychiatric disorders
Anxiety
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Psychiatric disorders
Decreased interest
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Psychiatric disorders
Depression
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Psychiatric disorders
Insomnia
|
0.76%
1/131 • Number of events 2
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Renal and urinary disorders
Diabetic nephropathy
|
3.1%
4/131 • Number of events 4
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Renal and urinary disorders
Dysuria
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Renal and urinary disorders
Pollakiuria
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
1.4%
1/71 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/36
|
4.8%
1/21 • Number of events 1
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/17
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.1%
1/95 • Number of events 1
|
0.00%
0/40
|
0.00%
0/55
|
0.00%
0/52
|
0.00%
0/54
|
|
Reproductive system and breast disorders
Prostatitis
|
1.1%
1/95 • Number of events 1
|
0.00%
0/40
|
0.00%
0/55
|
0.00%
0/52
|
0.00%
0/54
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
4.2%
3/71 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.3%
3/131 • Number of events 3
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Cold urticaria
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
3.0%
2/66 • Number of events 2
|
1.4%
1/71 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
3/131 • Number of events 4
|
1.6%
1/61 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
0.00%
0/66
|
2.8%
2/71 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Palmoplantar keratoderma
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Perivascular dermatitis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.3%
3/131 • Number of events 6
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
1.5%
1/66 • Number of events 2
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 2
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.76%
1/131 • Number of events 1
|
1.6%
1/61 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Bladder catheterisation
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Cataract operation
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Colon polypectomy
|
0.00%
0/131
|
1.6%
1/61 • Number of events 1
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Dental care
|
1.5%
2/131 • Number of events 2
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Duodenal sphincterotomy
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.00%
0/131
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
1.4%
1/71 • Number of events 1
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Photocoagulation
|
0.76%
1/131 • Number of events 3
|
1.6%
1/61 • Number of events 2
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Skin lesion excision
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
|
Surgical and medical procedures
Tooth extraction
|
2.3%
3/131 • Number of events 3
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
3.0%
2/66 • Number of events 2
|
2.8%
2/71 • Number of events 2
|
|
Vascular disorders
Arteriosclerosis
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
1.5%
1/66 • Number of events 1
|
0.00%
0/71
|
|
Vascular disorders
Flushing
|
0.76%
1/131 • Number of events 1
|
0.00%
0/61
|
0.00%
0/65
|
0.00%
0/66
|
0.00%
0/71
|
|
Vascular disorders
Hypertension
|
3.8%
5/131 • Number of events 5
|
4.9%
3/61 • Number of events 3
|
6.2%
4/65 • Number of events 4
|
3.0%
2/66 • Number of events 2
|
4.2%
3/71 • Number of events 3
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/131
|
0.00%
0/61
|
1.5%
1/65 • Number of events 1
|
0.00%
0/66
|
0.00%
0/71
|
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