Trial Outcomes & Findings for A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus (NCT NCT01584232)
NCT ID: NCT01584232
Last Updated: 2014-10-20
Results Overview
Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and 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
361 participants
Primary outcome timeframe
Baseline, 26 weeks
Results posted on
2014-10-20
Participant Flow
Participant milestones
| Measure |
LY2189265 + OAM
LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
180
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
181
|
180
|
|
Overall Study
COMPLETED
|
173
|
177
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
LY2189265 + OAM
LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
LY2189265 + OAM
n=181 Participants
LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=180 Participants
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Total
n=361 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.52 years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
56.14 years
STANDARD_DEVIATION 11.33 • n=7 Participants
|
56.83 years
STANDARD_DEVIATION 10.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
258 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
181 participants
n=5 Participants
|
180 participants
n=7 Participants
|
361 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
181 participants
n=5 Participants
|
180 participants
n=7 Participants
|
361 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 26 weeksPopulation: Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine 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, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and 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 |
LY2189265 + OAM
n=178 Participants
LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=179 Participants
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
|
-1.44 percentage of HbA1c
Standard Error 0.05
|
-0.90 percentage of HbA1c
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Up to 26 weeksPopulation: Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine 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% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and 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 |
LY2189265 + OAM
n=178 Participants
LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=179 Participants
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
HbA1c <=6.5%
|
51.1 percentage of participants
|
24.0 percentage of participants
|
|
Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks
HbA1c <7%
|
71.3 percentage of participants
|
45.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose 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, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.
Outcome measures
| Measure |
LY2189265 + OAM
n=176 Participants
LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=176 Participants
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks
|
-34.3 milligrams per deciliter (mg/dL)
Standard Error 1.9
|
-37.8 milligrams per deciliter (mg/dL)
Standard Error 1.9
|
SECONDARY outcome
Timeframe: Baseline, Up to 26 weeksPopulation: Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), 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, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects and baseline SMBG as a covariate.
Outcome measures
| Measure |
LY2189265 + OAM
n=178 Participants
LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=179 Participants
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Pre-midday meal (n=178, 179)
|
-36.16 milligrams per deciliter (mg/dL)
Standard Error 2.68
|
-27.94 milligrams per deciliter (mg/dL)
Standard Error 2.66
|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
2 hours post-midday meal (n=178, 179)
|
-43.51 milligrams per deciliter (mg/dL)
Standard Error 3.27
|
-20.30 milligrams per deciliter (mg/dL)
Standard Error 3.25
|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Pre-evening meal (n=178, 179)
|
-31.14 milligrams per deciliter (mg/dL)
Standard Error 2.77
|
-17.50 milligrams per deciliter (mg/dL)
Standard Error 2.75
|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
2 hours post-evening meal (n=177, 178)
|
-46.68 milligrams per deciliter (mg/dL)
Standard Error 3.05
|
-15.55 milligrams per deciliter (mg/dL)
Standard Error 3.03
|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Pre-morning meal (n=178, 179)
|
-33.49 milligrams per deciliter (mg/dL)
Standard Error 1.65
|
-38.66 milligrams per deciliter (mg/dL)
Standard Error 1.64
|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
2 hours post-morning meal (n=178, 179)
|
-49.54 milligrams per deciliter (mg/dL)
Standard Error 3.33
|
-36.14 milligrams per deciliter (mg/dL)
Standard Error 3.31
|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Bedtime (n=177, 172)
|
-41.53 milligrams per deciliter (mg/dL)
Standard Error 2.95
|
-17.79 milligrams per deciliter (mg/dL)
Standard Error 2.96
|
|
Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks
Second pre-morning meal (n=178, 179)
|
-30.81 milligrams per deciliter (mg/dL)
Standard Error 1.60
|
-37.02 milligrams per deciliter (mg/dL)
Standard Error 1.59
|
SECONDARY outcome
Timeframe: Baseline, 26 weeksPopulation: Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight 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, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (\<25 or \>=25 kilograms per meter squared \[kg/m\^2\]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.
Outcome measures
| Measure |
LY2189265 + OAM
n=180 Participants
LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=180 Participants
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Change From Baseline in Body Weight at 26 Weeks
|
-0.48 kilograms (kg)
Standard Error 0.17
|
0.94 kilograms (kg)
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline through 26 WeeksPopulation: Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used.
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 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 + OAM
n=181 Participants
LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=180 Participants
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Percentage of Participants With Hypoglycemic Episodes
|
26.0 percentage of participants
|
47.8 percentage of participants
|
Adverse Events
LY2189265 + OAM
Serious events: 9 serious events
Other events: 133 other events
Deaths: 0 deaths
Insulin Glargine + OAM
Serious events: 3 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LY2189265 + OAM
n=181 participants at risk
LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=180 participants at risk
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Anal abscess
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.55%
1/181 • Number of events 2
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Fall
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver carcinoma ruptured
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
2/181 • Number of events 2
|
0.00%
0/180
|
|
Nervous system disorders
Spinal cord infarction
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Nervous system disorders
Viith nerve paralysis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
Other adverse events
| Measure |
LY2189265 + OAM
n=181 participants at risk
LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
Insulin Glargine + OAM
n=180 participants at risk
Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks
Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Cardiac disorders
Angina pectoris
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Age-related macular degeneration
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Eye disorders
Asthenopia
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Cataract
|
0.55%
1/181 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Conjunctival haemorrhage
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Eye disorders
Conjunctivitis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Eye disorders
Conjunctivitis allergic
|
1.1%
2/181 • Number of events 2
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Cystoid macular oedema
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Eye disorders
Diabetic retinopathy
|
2.2%
4/181 • Number of events 4
|
1.1%
2/180 • Number of events 2
|
|
Eye disorders
Dry eye
|
0.55%
1/181 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Keratitis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Eye disorders
Macular degeneration
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Macular oedema
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Eye disorders
Photopsia
|
0.00%
0/181
|
0.56%
1/180 • Number of events 2
|
|
Eye disorders
Retinal vein occlusion
|
0.55%
1/181 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.1%
2/181 • Number of events 13
|
0.00%
0/180
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
4/181 • Number of events 5
|
0.56%
1/180 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
3/181 • Number of events 6
|
0.00%
0/180
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
3/181 • Number of events 3
|
0.00%
0/180
|
|
Gastrointestinal disorders
Constipation
|
8.8%
16/181 • Number of events 19
|
3.3%
6/180 • Number of events 7
|
|
Gastrointestinal disorders
Dental caries
|
1.7%
3/181 • Number of events 3
|
2.2%
4/180 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
22/181 • Number of events 31
|
2.2%
4/180 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
4/181 • Number of events 6
|
0.00%
0/180
|
|
Gastrointestinal disorders
Enterocolitis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
2/181 • Number of events 2
|
2.2%
4/180 • Number of events 4
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Gastrointestinal disorders
Nausea
|
9.4%
17/181 • Number of events 27
|
1.1%
2/180 • Number of events 2
|
|
Gastrointestinal disorders
Periodontal disease
|
0.55%
1/181 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.55%
1/181 • Number of events 1
|
1.7%
3/180 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
9/181 • Number of events 13
|
1.1%
2/180 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
General disorders
Chills
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
General disorders
Fatigue
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
General disorders
Feeling abnormal
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
General disorders
Infusion site induration
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
General disorders
Injection site bruising
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
General disorders
Injection site dermatitis
|
0.55%
1/181 • Number of events 21
|
0.00%
0/180
|
|
General disorders
Injection site hypersensitivity
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
General disorders
Injection site pruritus
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
General disorders
Malaise
|
0.00%
0/181
|
0.56%
1/180 • Number of events 2
|
|
General disorders
Oedema
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
General disorders
Oedema due to renal disease
|
0.00%
0/181
|
0.56%
1/180 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.55%
1/181 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic calcification
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.7%
3/181 • Number of events 3
|
1.7%
3/180 • Number of events 3
|
|
Immune system disorders
Seasonal allergy
|
0.55%
1/181 • Number of events 1
|
1.1%
2/180 • Number of events 2
|
|
Infections and infestations
Abscess oral
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Bacterial diarrhoea
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Bronchitis
|
2.2%
4/181 • Number of events 4
|
3.9%
7/180 • Number of events 10
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Cystitis
|
1.1%
2/181 • Number of events 2
|
0.00%
0/180
|
|
Infections and infestations
Enteritis infectious
|
1.1%
2/181 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Infections and infestations
Enterocolitis bacterial
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Gastroenteritis
|
2.2%
4/181 • Number of events 4
|
1.7%
3/180 • Number of events 3
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
Infections and infestations
Gingivitis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Impetigo
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Influenza
|
3.3%
6/181 • Number of events 6
|
1.1%
2/180 • Number of events 2
|
|
Infections and infestations
Laryngitis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Mastitis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
27.1%
49/181 • Number of events 55
|
25.6%
46/180 • Number of events 57
|
|
Infections and infestations
Oral herpes
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Periodontitis
|
1.7%
3/181 • Number of events 3
|
0.00%
0/180
|
|
Infections and infestations
Pharyngitis
|
2.2%
4/181 • Number of events 4
|
2.2%
4/180 • Number of events 4
|
|
Infections and infestations
Pyelonephritis acute
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Sinusitis
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Tinea infection
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.1%
2/181 • Number of events 3
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
1.1%
2/181 • Number of events 3
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Contusion
|
1.7%
3/181 • Number of events 3
|
0.56%
1/180 • Number of events 1
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.55%
1/181 • Number of events 1
|
2.2%
4/180 • Number of events 6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Investigations
Amylase increased
|
1.7%
3/181 • Number of events 3
|
0.00%
0/180
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
Investigations
Blood pressure increased
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Investigations
Blood urea increased
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Investigations
Blood urine present
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Investigations
Heart rate increased
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Investigations
Lipase increased
|
5.0%
9/181 • Number of events 9
|
0.56%
1/180 • Number of events 1
|
|
Investigations
Occult blood
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Investigations
Weight decreased
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
5/181 • Number of events 6
|
0.00%
0/180
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
2/181 • Number of events 2
|
1.7%
3/180 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
5/181 • Number of events 5
|
2.8%
5/180 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.7%
3/181 • Number of events 3
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.1%
2/181 • Number of events 2
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.55%
1/181 • Number of events 2
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.55%
1/181 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Nervous system disorders
Cerebellar infarction
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.7%
3/181 • Number of events 8
|
0.00%
0/180
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
Nervous system disorders
Vith nerve paralysis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Psychiatric disorders
Alcohol problem
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.7%
3/181 • Number of events 3
|
1.1%
2/180 • Number of events 2
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
1.1%
2/181 • Number of events 2
|
0.00%
0/180
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Renal and urinary disorders
Diabetic nephropathy
|
1.1%
2/181 • Number of events 2
|
0.56%
1/180 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.80%
1/125 • Number of events 1
|
0.75%
1/133 • Number of events 1
|
|
Reproductive system and breast disorders
Endometriosis
|
1.8%
1/56 • Number of events 1
|
0.00%
0/47
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.55%
1/181 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
2/181 • Number of events 2
|
0.56%
1/180 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.55%
1/181 • Number of events 1
|
1.1%
2/180 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/181
|
1.1%
2/180 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.55%
1/181 • Number of events 1
|
1.1%
2/180 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.8%
5/181 • Number of events 5
|
2.2%
4/180 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
2/181 • Number of events 2
|
0.00%
0/180
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
2/181 • Number of events 2
|
0.00%
0/180
|
|
Skin and subcutaneous tissue disorders
Urticaria chronic
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Surgical and medical procedures
Tooth extraction
|
0.55%
1/181 • Number of events 1
|
0.00%
0/180
|
|
Vascular disorders
Hot flush
|
0.00%
0/181
|
0.56%
1/180 • Number of events 1
|
|
Vascular disorders
Hypertension
|
3.3%
6/181 • Number of events 6
|
3.3%
6/180 • Number of events 6
|
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