Trial Outcomes & Findings for A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus (NCT NCT01648582)
NCT ID: NCT01648582
Last Updated: 2019-09-18
Results Overview
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
774 participants
Primary outcome timeframe
Baseline, 26 Weeks
Results posted on
2019-09-18
Participant Flow
This was a parallel-arm, non-inferiority study. Study treatment continued for up to 52 weeks and participants were randomized in a 1:1:1 ratio to one of the 3 treatment arms: 1.5 milligrams (mg) dulaglutide once-weekly , 0.75 mg dulaglutide once-weekly, or insulin glargine once-daily.
Participant milestones
| Measure |
1.5 mg Dulaglutide
1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
|
|---|---|---|---|
|
Overall Study
STARTED
|
258
|
257
|
259
|
|
Overall Study
Received at Least One Dose of Study Drug
|
258
|
257
|
259
|
|
Overall Study
Modified Intent-to-Treat Population
|
253
|
252
|
250
|
|
Overall Study
COMPLETED
|
226
|
219
|
227
|
|
Overall Study
NOT COMPLETED
|
32
|
38
|
32
|
Reasons for withdrawal
| Measure |
1.5 mg Dulaglutide
1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
11
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
6
|
8
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
17
|
17
|
|
Overall Study
Physician Decision
|
0
|
1
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
1
|
Baseline Characteristics
A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
1.5 mg Dulaglutide
n=253 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=252 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=250 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Total
n=755 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.03 years
STANDARD_DEVIATION 9.572 • n=5 Participants
|
54.54 years
STANDARD_DEVIATION 10.006 • n=7 Participants
|
55.44 years
STANDARD_DEVIATION 9.197 • n=5 Participants
|
55.00 years
STANDARD_DEVIATION 9.593 • n=4 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
338 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
417 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
213 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
631 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
83 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
China
|
200 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
591 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 26 WeeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=253 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=252 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=250 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks
|
-1.73 percentage of HbA1c
Standard Error 0.067
|
-1.33 percentage of HbA1c
Standard Error 0.067
|
-1.16 percentage of HbA1c
Standard Error 0.067
|
SECONDARY outcome
Timeframe: Baseline, 52 WeeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=253 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=252 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=250 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in HbA1c at 52 Weeks
|
-1.47 percentage of HbA1c
Standard Error 0.076
|
-1.03 percentage of HbA1c
Standard Error 0.076
|
-0.89 percentage of HbA1c
Standard Error 0.075
|
SECONDARY outcome
Timeframe: Up to 26 and 52 weeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the last observation carried forward (LOCF) method.
The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=253 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=252 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=250 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks
HbA1c <7%, Week 26
|
64.8 percentage of participants
|
52.8 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks
HbA1c ≤6.5%, Week 26
|
51.4 percentage of participants
|
38.9 percentage of participants
|
21.6 percentage of participants
|
|
Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks
HbA1c <7%, Week 52
|
51.8 percentage of participants
|
45.6 percentage of participants
|
32.0 percentage of participants
|
|
Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks
HbA1c ≤6.5%, Week 52
|
37.2 percentage of participants
|
31.3 percentage of participants
|
17.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.
LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=253 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=252 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=250 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks
Change from baseline in FBG, 26 Weeks
|
-2.35 millimoles per liter (mmol/L)
Standard Error 0.162
|
-1.71 millimoles per liter (mmol/L)
Standard Error 0.161
|
-2.59 millimoles per liter (mmol/L)
Standard Error 0.161
|
|
Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks
Change from baseline in FBG, 52 Weeks
|
-2.23 millimoles per liter (mmol/L)
Standard Error 0.166
|
-1.53 millimoles per liter (mmol/L)
Standard Error 0.165
|
-2.35 millimoles per liter (mmol/L)
Standard Error 0.164
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.
Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Morning pre-meal, Week 26
|
-2.18 mmol/L
Standard Error 0.104
|
-1.89 mmol/L
Standard Error 0.103
|
-2.83 mmol/L
Standard Error 0.103
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Morning 2 hours post-meal, Week 26
|
-3.81 mmol/L
Standard Error 0.190
|
-3.43 mmol/L
Standard Error 0.188
|
-3.32 mmol/L
Standard Error 0.188
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Mid-day pre-meal, Week 26
|
-2.45 mmol/L
Standard Error 0.159
|
-2.07 mmol/L
Standard Error 0.157
|
-2.10 mmol/L
Standard Error 0.157
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Mid-day 2 hours post-meal, Week 26
|
-3.16 mmol/L
Standard Error 0.182
|
-2.71 mmol/L
Standard Error 0.179
|
-2.11 mmol/L
Standard Error 0.179
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Evening pre-meal, Week 26
|
-2.25 mmol/L
Standard Error 0.150
|
-1.74 mmol/L
Standard Error 0.147
|
-1.62 mmol/L
Standard Error 0.148
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Evening 2 hours post-meal, Week 26
|
-3.00 mmol/L
Standard Error 0.180
|
-2.58 mmol/L
Standard Error 0.178
|
-2.11 mmol/L
Standard Error 0.178
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Bed time, Week 26
|
-2.95 mmol/L
Standard Error 0.170
|
-2.51 mmol/L
Standard Error 0.167
|
-2.16 mmol/L
Standard Error 0.167
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Morning pre-meal, Week 52
|
-2.06 mmol/L
Standard Error 0.108
|
-1.76 mmol/L
Standard Error 0.108
|
-2.83 mmol/L
Standard Error 0.107
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Morning 2 hours post-meal, Week 52
|
-3.58 mmol/L
Standard Error 0.201
|
-3.25 mmol/L
Standard Error 0.200
|
-3.05 mmol/L
Standard Error 0.197
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Mid-day pre-meal, Week 52
|
-2.37 mmol/L
Standard Error 0.162
|
-1.89 mmol/L
Standard Error 0.162
|
-1.94 mmol/L
Standard Error 0.160
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Mid-day 2 hours post-meal, Week 52
|
-2.75 mmol/L
Standard Error 0.187
|
-2.61 mmol/L
Standard Error 0.186
|
-2.12 mmol/L
Standard Error 0.184
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Evening pre-meal, Week 52
|
-2.15 mmol/L
Standard Error 0.159
|
-1.61 mmol/L
Standard Error 0.158
|
-1.51 mmol/L
Standard Error 0.156
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Evening 2 hours post-meal, Week 52
|
-2.93 mmol/L
Standard Error 0.183
|
-2.54 mmol/L
Standard Error 0.182
|
-2.10 mmol/L
Standard Error 0.180
|
|
Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks
Bed time, Week 52
|
-2.90 mmol/L
Standard Error 0.172
|
-2.50 mmol/L
Standard Error 0.171
|
-1.91 mmol/L
Standard Error 0.168
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.
The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using a homeostasis model assessment with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=253 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=252 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks
Insulin-Based HOMA2-%B, 52 Weeks
|
45.12 percentage of HOMA2-%B
Standard Error 4.147
|
36.64 percentage of HOMA2-%B
Standard Error 4.061
|
—
|
|
Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks
Insulin-Based HOMA2-%B, 26 Weeks
|
34.41 percentage of HOMA2-%B
Standard Error 3.831
|
31.17 percentage of HOMA2-%B
Standard Error 3.761
|
—
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.
The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an homeostasis model assessment with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=253 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=252 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks
Insulin-Based HOMA2-%S, Week 52
|
-10.19 percentage of HOMA2-%S
Standard Error 3.677
|
-12.32 percentage of HOMA2-%S
Standard Error 3.609
|
—
|
|
Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks
Insulin-Based HOMA2-%S, Week 26
|
-6.86 percentage of HOMA2-%S
Standard Error 3.649
|
-10.03 percentage of HOMA2-%S
Standard Error 3.591
|
—
|
SECONDARY outcome
Timeframe: Baseline through 26 weeks and 52 weeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Rate of Hypoglycemic Events
1-year Rate of HE, Week 26
|
1.27 events per participant per year
Standard Deviation 4.485
|
0.98 events per participant per year
Standard Deviation 4.202
|
2.13 events per participant per year
Standard Deviation 6.724
|
|
Rate of Hypoglycemic Events
Severe HE Week 26
|
NA events per participant per year
Standard Deviation NA
Data not available because no severe hypoglycemic episodes occurred.
|
NA events per participant per year
Standard Deviation NA
Data not available because no severe hypoglycemic episodes occurred.
|
NA events per participant per year
Standard Deviation NA
Data not available because no severe hypoglycemic episodes occurred.
|
|
Rate of Hypoglycemic Events
Nocturnal HE Week 26
|
0.19 events per participant per year
Standard Deviation 0.904
|
0.13 events per participant per year
Standard Deviation 0.762
|
0.38 events per participant per year
Standard Deviation 1.444
|
|
Rate of Hypoglycemic Events
1-year Rate of HE, Week 52
|
0.89 events per participant per year
Standard Deviation 3.777
|
0.80 events per participant per year
Standard Deviation 3.914
|
1.92 events per participant per year
Standard Deviation 6.983
|
|
Rate of Hypoglycemic Events
Severe HE Week 52
|
NA events per participant per year
Standard Deviation NA
Data not available because no severe hypoglycemic episodes occurred.
|
NA events per participant per year
Standard Deviation NA
Data not available because no severe hypoglycemic episodes occurred.
|
NA events per participant per year
Standard Deviation NA
Data not available because no severe hypoglycemic episodes occurred.
|
|
Rate of Hypoglycemic Events
Nocturnal HE Week 52
|
0.11 events per participant per year
Standard Deviation 0.488
|
0.10 events per participant per year
Standard Deviation 0.551
|
0.31 events per participant per year
Standard Deviation 1.261
|
SECONDARY outcome
Timeframe: Baseline through 26 Weeks and 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter \[mmol/L\]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Number of Self-reported Hypoglycemic Events
Total HE Week 26
|
19.4 percentage of participants
|
16.7 percentage of participants
|
29.6 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Severe HE Week 26
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Nocturnal HE Week 26
|
6.2 percentage of participants
|
3.9 percentage of participants
|
11.1 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Documented Symptomatic Week 26
|
11.2 percentage of participants
|
7.8 percentage of participants
|
17.0 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Asymptomatic HE Week 26
|
10.1 percentage of participants
|
8.2 percentage of participants
|
14.2 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Probable HE Week 26
|
4.3 percentage of participants
|
5.1 percentage of participants
|
7.5 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Total HE Week 52
|
22.5 percentage of participants
|
19.8 percentage of participants
|
34.8 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Severe HE Week 52
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Nocturnal HE Week 52
|
7.0 percentage of participants
|
4.3 percentage of participants
|
13.8 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Documented Symptomatic HE Week 52
|
12.4 percentage of participants
|
9.7 percentage of participants
|
20.6 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Asymptomatic HE Week 52
|
12.0 percentage of participants
|
10.1 percentage of participants
|
19.4 percentage of participants
|
|
Number of Self-reported Hypoglycemic Events
Probable HE Week 52
|
4.7 percentage of participants
|
5.4 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)
SBP 26 Weeks
|
-5.53 millimeters of mercury (mmHg)]
Standard Error 12.037
|
-2.77 millimeters of mercury (mmHg)]
Standard Error 11.920
|
-2.22 millimeters of mercury (mmHg)]
Standard Error 12.743
|
|
Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)
DBP 26 Weeks
|
-1.58 millimeters of mercury (mmHg)]
Standard Error 7.842
|
-0.92 millimeters of mercury (mmHg)]
Standard Error 7.898
|
-1.61 millimeters of mercury (mmHg)]
Standard Error 8.417
|
|
Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)
SBP 52 Weeks
|
-2.18 millimeters of mercury (mmHg)]
Standard Error 11.134
|
-0.61 millimeters of mercury (mmHg)]
Standard Error 12.081
|
-0.25 millimeters of mercury (mmHg)]
Standard Error 11.717
|
|
Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)
DBP 52 Weeks
|
-0.19 millimeters of mercury (mmHg)]
Standard Error 7.542
|
0.44 millimeters of mercury (mmHg)]
Standard Error 7.582
|
-1.13 millimeters of mercury (mmHg)]
Standard Error 8.810
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate
Change From Baseline on Pulse rate at Week 26
|
4.63 beats per minute (bpm)
Standard Error 8.681
|
0.65 beats per minute (bpm)
Standard Error 8.631
|
-0.86 beats per minute (bpm)
Standard Error 9.546
|
|
Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate
Change From Baseline on Pulse rate at Week 52
|
4.18 beats per minute (bpm)
Standard Error 8.336
|
3.18 beats per minute (bpm)
Standard Error 8.917
|
0.07 beats per minute (bpm)
Standard Error 8.205
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
QTcF Interval 26 Weeks
|
-1.65 millisecond (msec)
Standard Deviation 13.157
|
0.76 millisecond (msec)
Standard Deviation 11.643
|
2.56 millisecond (msec)
Standard Deviation 11.911
|
|
Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
PR Interval 26 Weeks
|
3.09 millisecond (msec)
Standard Deviation 1.700
|
2.88 millisecond (msec)
Standard Deviation 10.801
|
-0.86 millisecond (msec)
Standard Deviation 10.272
|
|
Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
QTcF Interval 52 Weeks
|
0.55 millisecond (msec)
Standard Deviation 11.209
|
1.19 millisecond (msec)
Standard Deviation 12.165
|
4.03 millisecond (msec)
Standard Deviation 11.446
|
|
Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
PR Interval 52 Weeks
|
3.60 millisecond (msec)
Standard Deviation 12.425
|
3.55 millisecond (msec)
Standard Deviation 11.526
|
0.63 millisecond (msec)
Standard Deviation 11.861
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)
Week 26
|
6.13 beats per minute (bpm)
Standard Deviation 8.924
|
3.77 beats per minute (bpm)
Standard Deviation 9.002
|
-0.46 beats per minute (bpm)
Standard Deviation 9.329
|
|
Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)
Week 52
|
5.04 beats per minute (bpm)
Standard Deviation 8.223
|
3.40 beats per minute (bpm)
Standard Deviation 7.986
|
0.43 beats per minute (bpm)
Standard Deviation 8.060
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Amylase (total and pancreas-derived) and lipase concentrations were measured
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Pancreatic Enzymes
Amylase, Total 26 Weeks
|
7.50 Units/Liter (U/L)
Standard Deviation 18.755
|
7.54 Units/Liter (U/L)
Standard Deviation 22.388
|
-0.37 Units/Liter (U/L)
Standard Deviation 18.196
|
|
Change From Baseline in Pancreatic Enzymes
Amylase, pancreas derived 26 Weeks
|
5.83 Units/Liter (U/L)
Standard Deviation 14.607
|
5.14 Units/Liter (U/L)
Standard Deviation 19.360
|
-0.21 Units/Liter (U/L)
Standard Deviation 11.287
|
|
Change From Baseline in Pancreatic Enzymes
Lipase 26 Weeks
|
11.00 Units/Liter (U/L)
Standard Deviation 34.134
|
10.67 Units/Liter (U/L)
Standard Deviation 39.989
|
-2.74 Units/Liter (U/L)
Standard Deviation 21.818
|
|
Change From Baseline in Pancreatic Enzymes
Amylase, Total 52 Weeks
|
7.82 Units/Liter (U/L)
Standard Deviation 16.250
|
6.42 Units/Liter (U/L)
Standard Deviation 20.675
|
0.64 Units/Liter (U/L)
Standard Deviation 18.696
|
|
Change From Baseline in Pancreatic Enzymes
Amylase, pancreas derived 52 Weeks
|
5.48 Units/Liter (U/L)
Standard Deviation 12.449
|
4.05 Units/Liter (U/L)
Standard Deviation 15.490
|
-0.49 Units/Liter (U/L)
Standard Deviation 12.576
|
|
Change From Baseline in Pancreatic Enzymes
Lipase 52 Weeks
|
10.76 Units/Liter (U/L)
Standard Deviation 27.360
|
9.64 Units/Liter (U/L)
Standard Deviation 33.715
|
-3.66 Units/Liter (U/L)
Standard Deviation 20.484
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Serum Calcitonin
Week 26
|
0.01 picomole/liter
Standard Deviation 0.240
|
-0.07 picomole/liter
Standard Deviation 0.289
|
0.02 picomole/liter
Standard Deviation 0.256
|
|
Change From Baseline in Serum Calcitonin
Week 52
|
-0.03 picomole/liter
Standard Deviation 0.279
|
-0.08 picomole/liter
Standard Deviation 0.325
|
-0.05 picomole/liter
Standard Deviation 0.306
|
SECONDARY outcome
Timeframe: Baseline through 52 weeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Number of Participants With Adjudicated Cardiovascular (CV) Events
|
6 participants with adjudicated CV events
|
2 participants with adjudicated CV events
|
2 participants with adjudicated CV events
|
SECONDARY outcome
Timeframe: Baseline through 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
The number of participants with pancreatitis confirmed by adjudication is summarized. Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Number of Participants With Adjudicated Pancreatitis
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in Body Weight
Week 26
|
-1.47 kilogram (kg)
Standard Error 0.197
|
-0.88 kilogram (kg)
Standard Error 0.197
|
0.97 kilogram (kg)
Standard Error 0.198
|
|
Change From Baseline in Body Weight
Week 52
|
-1.08 kilogram (kg)
Standard Error 0.201
|
-0.76 kilogram (kg)
Standard Error 0.202
|
1.35 kilogram (kg)
Standard Error 0.201
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Body mass index is an estimate of body fat based on body weight divided by height squared.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change in Body Mass Index
Week 26
|
-0.53 kilogram/square meter (kg/m2)
Standard Error 0.071
|
-0.32 kilogram/square meter (kg/m2)
Standard Error 0.071
|
0.37 kilogram/square meter (kg/m2)
Standard Error 0.071
|
|
Change in Body Mass Index
Week 52
|
-0.40 kilogram/square meter (kg/m2)
Standard Error 0.072
|
-0.27 kilogram/square meter (kg/m2)
Standard Error 0.072
|
0.52 kilogram/square meter (kg/m2)
Standard Error 0.072
|
SECONDARY outcome
Timeframe: Baseline through 52 WeeksPopulation: Participants in the safety population who were randomized and received at least one dose of study drug.
Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)
Participants with >=1 TE Dula ADA
|
3.9 Percentage of participants
|
4.3 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)
Participants with TE Dula ADA and Neutralizing
|
0.8 Percentage of participants
|
1.6 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 26 Weeks, 52 WeeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.
The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
EQ-5D Health State Score Responses
Mobility - no problem Week 26
|
219 participants
|
215 participants
|
210 participants
|
|
EQ-5D Health State Score Responses
Mobility - some problem Week 26
|
7 participants
|
16 participants
|
20 participants
|
|
EQ-5D Health State Score Responses
Mobility - extreme problem Week 26
|
0 participants
|
0 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Mobility - missing Week 26
|
4 participants
|
1 participants
|
4 participants
|
|
EQ-5D Health State Score Responses
Self-care - no problem Week 26
|
223 participants
|
227 participants
|
224 participants
|
|
EQ-5D Health State Score Responses
Self-care - some problem Week 26
|
0 participants
|
0 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Self-care - extreme problem Week 26
|
0 participants
|
0 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Self-care - missing Week 26
|
4 participants
|
1 participants
|
4 participants
|
|
EQ-5D Health State Score Responses
Usual activities - no problems Week 26
|
219 participants
|
220 participants
|
218 participants
|
|
EQ-5D Health State Score Responses
Usual activities - some problems Week 26
|
7 participants
|
11 participants
|
11 participants
|
|
EQ-5D Health State Score Responses
Usual activities - extreme problems Week 26
|
0 participants
|
0 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Usual activities - missing Week 26
|
4 participants
|
1 participants
|
4 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - no problems Week 26
|
193 participants
|
201 participants
|
188 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - some problems Week 26
|
32 participants
|
30 participants
|
37 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - ambiguous
|
0 participants
|
0 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - missing Week 26
|
4 participants
|
1 participants
|
4 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - no problems Week 26
|
208 participants
|
204 participants
|
203 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - some problems Week 26
|
19 participants
|
27 participants
|
26 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - extreme problems Week 26
|
0 participants
|
0 participants
|
1 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - missing Week 26
|
4 participants
|
1 participants
|
4 participants
|
|
EQ-5D Health State Score Responses
Mobility - no problems Week 52
|
218 participants
|
207 participants
|
214 participants
|
|
EQ-5D Health State Score Responses
Mobility - some problems Week 52
|
8 participants
|
14 participants
|
16 participants
|
|
EQ-5D Health State Score Responses
Mobility - extreme problems Week 52
|
0 participants
|
1 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Mobility - missing Week 52
|
0 participants
|
0 participants
|
1 participants
|
|
EQ-5D Health State Score Responses
Self-care - no problems Week 52
|
224 participants
|
215 participants
|
223 participants
|
|
EQ-5D Health State Score Responses
Self-care - some problems Week 52
|
2 participants
|
7 participants
|
7 participants
|
|
EQ-5D Health State Score Responses
Self-care - extreme problems Week 52
|
0 participants
|
0 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Self-care - missing Week 52
|
0 participants
|
0 participants
|
1 participants
|
|
EQ-5D Health State Score Responses
Usual Activities - no problems Week 52
|
219 participants
|
211 participants
|
219 participants
|
|
EQ-5D Health State Score Responses
Usual Activities - some problems Week 52
|
6 participants
|
10 participants
|
11 participants
|
|
EQ-5D Health State Score Responses
Usual Activities - extreme problems Week 52
|
1 participants
|
1 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Usual Activities - missing Week 52
|
0 participants
|
0 participants
|
1 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - no problems Week 52
|
191 participants
|
188 participants
|
185 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - some problems Week 52
|
34 participants
|
33 participants
|
43 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - extreme problems Week 52
|
1 participants
|
1 participants
|
1 participants
|
|
EQ-5D Health State Score Responses
Pain/Discomfort - missing Week 52
|
0 participants
|
0 participants
|
1 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - no problems Week 52
|
205 participants
|
207 participants
|
201 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - some problems Week 52
|
21 participants
|
15 participants
|
29 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - extreme problems Week 52
|
0 participants
|
0 participants
|
0 participants
|
|
EQ-5D Health State Score Responses
Anxiety/Depression - missing Week 52
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, 26 weeks, 52 weeksPopulation: Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.
The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.
Outcome measures
| Measure |
1.5 mg Dulaglutide
n=258 Participants
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 Participants
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 Participants
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
|---|---|---|---|
|
Change From Baseline in EQ-5D Visual Analog Scale Score
Week 26
|
1.08 units on a scale
Standard Deviation 12.644
|
1.67 units on a scale
Standard Deviation 13.456
|
1.41 units on a scale
Standard Deviation 10.885
|
|
Change From Baseline in EQ-5D Visual Analog Scale Score
Week 52
|
2.65 units on a scale
Standard Deviation 12.029
|
2.34 units on a scale
Standard Deviation 14.003
|
2.55 units on a scale
Standard Deviation 12.257
|
Adverse Events
1.5 mg Dulaglutide
Serious events: 24 serious events
Other events: 184 other events
Deaths: 0 deaths
0.75 mg Dulaglutide
Serious events: 15 serious events
Other events: 188 other events
Deaths: 0 deaths
Insulin Glargine
Serious events: 9 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1.5 mg Dulaglutide
n=258 participants at risk
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 participants at risk
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 participants at risk
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
|
|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Cardiac disorders
Cardiac failure chronic
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Coronary artery disease
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Myocardial ischaemia
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Eye disorders
Vision blurred
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Pancreatitis
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
General disorders
Chest pain
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
General disorders
Cyst
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Bronchitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Gallbladder empyema
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Gastroenteritis
|
0.39%
1/258 • Number of events 2
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Pneumonia
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Pulmonary tuberculoma
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Sinusitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Accident
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/119
|
0.88%
1/113 • Number of events 1
|
0.00%
0/112
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Cerebral infarction
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Cerebrovascular stenosis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Transient ischaemic attack
|
0.78%
2/258 • Number of events 2
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Renal and urinary disorders
Perinephritis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Vascular disorders
Hypertension
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
Other adverse events
| Measure |
1.5 mg Dulaglutide
n=258 participants at risk
1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
0.75 mg Dulaglutide
n=257 participants at risk
0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
|
Insulin Glargine
n=253 participants at risk
Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and /or a sulfonylurea.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/258
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.2%
3/258 • Number of events 3
|
0.39%
1/257 • Number of events 1
|
0.79%
2/253 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
19/258 • Number of events 22
|
5.4%
14/257 • Number of events 19
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.5%
9/258 • Number of events 10
|
2.3%
6/257 • Number of events 6
|
3.6%
9/253 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
17.8%
46/258 • Number of events 49
|
19.5%
50/257 • Number of events 54
|
18.6%
47/253 • Number of events 48
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/258
|
1.9%
5/257 • Number of events 5
|
0.40%
1/253 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.3%
6/258 • Number of events 6
|
2.7%
7/257 • Number of events 7
|
1.6%
4/253 • Number of events 4
|
|
Infections and infestations
Influenza
|
0.78%
2/258 • Number of events 2
|
1.2%
3/257 • Number of events 4
|
1.2%
3/253 • Number of events 3
|
|
Infections and infestations
Laryngitis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Localised infection
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Low density lipoprotein increased
|
0.78%
2/258 • Number of events 2
|
1.2%
3/257 • Number of events 3
|
0.00%
0/253
|
|
Investigations
Pancreatic enzymes increased
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Platelet count decreased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Protein urine
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Protein urine present
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.79%
2/253 • Number of events 2
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.78%
2/258 • Number of events 2
|
1.6%
4/257 • Number of events 4
|
1.6%
4/253 • Number of events 4
|
|
Investigations
Weight decreased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Blood and lymphatic system disorders
Microcytosis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 2
|
0.00%
0/253
|
|
Cardiac disorders
Arrhythmia
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/258
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
3/258 • Number of events 3
|
0.78%
2/257 • Number of events 2
|
0.79%
2/253 • Number of events 2
|
|
Cardiac disorders
Extrasystoles
|
0.39%
1/258 • Number of events 2
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Cardiac disorders
Myocardial infarction
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Myocardial ischaemia
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Palpitations
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.78%
2/258 • Number of events 3
|
0.00%
0/257
|
0.00%
0/253
|
|
Cardiac disorders
Tachycardia
|
0.78%
2/258 • Number of events 2
|
0.78%
2/257 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.39%
1/258 • Number of events 1
|
0.78%
2/257 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Endocrine disorders
Thyroid mass
|
1.2%
3/258 • Number of events 3
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Eye disorders
Cataract
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Eye disorders
Dry eye
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Eye disorders
Eye inflammation
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Eye disorders
Eye pain
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Eye disorders
Keratitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Eye disorders
Retinopathy
|
0.00%
0/258
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Eye disorders
Vision blurred
|
1.6%
4/258 • Number of events 4
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.9%
5/258 • Number of events 6
|
1.2%
3/257 • Number of events 4
|
0.00%
0/253
|
|
Gastrointestinal disorders
Abdominal distension
|
7.0%
18/258 • Number of events 29
|
5.1%
13/257 • Number of events 16
|
0.00%
0/253
|
|
Gastrointestinal disorders
Abdominal pain
|
0.78%
2/258 • Number of events 6
|
1.2%
3/257 • Number of events 4
|
0.40%
1/253 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
6/258 • Number of events 7
|
0.39%
1/257 • Number of events 1
|
1.2%
3/253 • Number of events 5
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Constipation
|
3.5%
9/258 • Number of events 11
|
3.1%
8/257 • Number of events 8
|
0.00%
0/253
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
43/258 • Number of events 92
|
10.9%
28/257 • Number of events 51
|
2.8%
7/253 • Number of events 7
|
|
Gastrointestinal disorders
Dry mouth
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
5/258 • Number of events 6
|
3.1%
8/257 • Number of events 11
|
0.79%
2/253 • Number of events 2
|
|
Gastrointestinal disorders
Enteritis
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.2%
3/258 • Number of events 3
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Gastrointestinal disorders
Eructation
|
1.6%
4/258 • Number of events 6
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
4/258 • Number of events 5
|
0.39%
1/257 • Number of events 2
|
0.00%
0/253
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.78%
2/258 • Number of events 3
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastritis
|
0.78%
2/258 • Number of events 2
|
0.39%
1/257 • Number of events 3
|
1.6%
4/253 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.6%
4/258 • Number of events 7
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 2
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/258
|
0.39%
1/257 • Number of events 2
|
0.00%
0/253
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Nausea
|
10.5%
27/258 • Number of events 47
|
5.4%
14/257 • Number of events 21
|
0.79%
2/253 • Number of events 2
|
|
Gastrointestinal disorders
Oesophagitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Pancreatitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Gastrointestinal disorders
Regurgitation
|
1.2%
3/258 • Number of events 3
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Gastrointestinal disorders
Toothache
|
0.78%
2/258 • Number of events 2
|
1.2%
3/257 • Number of events 3
|
1.2%
3/253 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
16/258 • Number of events 23
|
2.3%
6/257 • Number of events 6
|
0.79%
2/253 • Number of events 2
|
|
General disorders
Asthenia
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
General disorders
Chest discomfort
|
0.00%
0/258
|
1.2%
3/257 • Number of events 3
|
0.00%
0/253
|
|
General disorders
Chest pain
|
0.39%
1/258 • Number of events 2
|
1.9%
5/257 • Number of events 5
|
0.00%
0/253
|
|
General disorders
Chills
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
General disorders
Discomfort
|
0.00%
0/258
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
General disorders
Fatigue
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Hunger
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
General disorders
Hyperthermia
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Induration
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
General disorders
Injection site erythema
|
0.00%
0/258
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
General disorders
Injection site induration
|
0.00%
0/258
|
0.39%
1/257 • Number of events 19
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Injection site pain
|
0.00%
0/258
|
0.39%
1/257 • Number of events 2
|
0.00%
0/253
|
|
General disorders
Injection site pruritus
|
0.00%
0/258
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
General disorders
Injection site swelling
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
General disorders
Malaise
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
General disorders
Nodule
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Oedema
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
1.2%
3/253 • Number of events 5
|
|
General disorders
Pain
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
General disorders
Peripheral swelling
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
General disorders
Pyrexia
|
0.78%
2/258 • Number of events 2
|
0.39%
1/257 • Number of events 1
|
1.6%
4/253 • Number of events 4
|
|
General disorders
Temperature intolerance
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.2%
3/258 • Number of events 3
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.39%
1/258 • Number of events 1
|
1.6%
4/257 • Number of events 4
|
1.2%
3/253 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.2%
3/258 • Number of events 3
|
1.2%
3/257 • Number of events 3
|
0.40%
1/253 • Number of events 1
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Hepatobiliary disorders
Liver injury
|
0.39%
1/258 • Number of events 1
|
1.6%
4/257 • Number of events 4
|
0.40%
1/253 • Number of events 1
|
|
Hepatobiliary disorders
Non-alcoholic fatty liver
|
1.2%
3/258 • Number of events 3
|
2.7%
7/257 • Number of events 7
|
0.79%
2/253 • Number of events 2
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Immune system disorders
Anaphylactic reaction
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Immune system disorders
Drug hypersensitivity
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Immune system disorders
Immunodeficiency
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Bronchitis
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Cat scratch disease
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Conjunctivitis
|
0.78%
2/258 • Number of events 2
|
0.78%
2/257 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.39%
1/258 • Number of events 1
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
Infections and infestations
Ear infection
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Erysipelas
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Fungal infection
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Gastroenteritis
|
0.78%
2/258 • Number of events 2
|
1.6%
4/257 • Number of events 5
|
0.00%
0/253
|
|
Infections and infestations
Gingivitis
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Infections and infestations
Mastitis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
18/258 • Number of events 22
|
6.6%
17/257 • Number of events 23
|
8.7%
22/253 • Number of events 29
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.78%
2/258 • Number of events 2
|
0.39%
1/257 • Number of events 1
|
2.0%
5/253 • Number of events 5
|
|
Investigations
White blood cell count increased
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Pharyngitis bacterial
|
1.6%
4/258 • Number of events 4
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Pneumonia
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Pyelonephritis acute
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Rhinitis
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Skin infection
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Tonsillitis
|
0.39%
1/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Upper respiratory tract infection
|
2.7%
7/258 • Number of events 9
|
3.9%
10/257 • Number of events 11
|
5.1%
13/253 • Number of events 15
|
|
Infections and infestations
Urinary tract infection
|
5.0%
13/258 • Number of events 15
|
5.4%
14/257 • Number of events 14
|
4.3%
11/253 • Number of events 11
|
|
Infections and infestations
Vaginal infection
|
1.7%
2/119 • Number of events 3
|
0.00%
0/113
|
0.00%
0/112
|
|
Infections and infestations
Vestibular neuronitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Exposure via father
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/258
|
0.39%
1/257 • Number of events 2
|
0.00%
0/253
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Albumin urine present
|
0.00%
0/258
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Investigations
Amylase abnormal
|
0.00%
0/258
|
0.39%
1/257 • Number of events 3
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Amylase increased
|
2.7%
7/258 • Number of events 10
|
1.9%
5/257 • Number of events 13
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Bacterial test positive
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Blood cholesterol increased
|
2.3%
6/258 • Number of events 6
|
2.3%
6/257 • Number of events 6
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
1.2%
3/258 • Number of events 3
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Blood creatinine increased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Blood potassium abnormal
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Blood pressure increased
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.79%
2/253 • Number of events 3
|
|
Investigations
Blood triglycerides
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Blood triglycerides increased
|
1.6%
4/258 • Number of events 4
|
2.3%
6/257 • Number of events 6
|
1.2%
3/253 • Number of events 4
|
|
Investigations
Blood uric acid increased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
1.2%
3/253 • Number of events 3
|
|
Investigations
Blood urine
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Blood urine present
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Investigations
Body temperature increased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Calcium ionised increased
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Creatinine renal clearance increased
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Crystal urine present
|
0.78%
2/258 • Number of events 3
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Electrocardiogram low voltage
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.2%
3/258 • Number of events 3
|
1.6%
4/257 • Number of events 4
|
0.00%
0/253
|
|
Investigations
Glucose urine
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
Glucose urine present
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Heart rate increased
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Investigations
Lipase abnormal
|
0.00%
0/258
|
0.39%
1/257 • Number of events 3
|
0.40%
1/253 • Number of events 1
|
|
Investigations
Lipase increased
|
10.5%
27/258 • Number of events 35
|
7.0%
18/257 • Number of events 23
|
0.79%
2/253 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Metabolism and nutrition disorders
Hypolipidaemia
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.39%
1/258 • Number of events 1
|
0.78%
2/257 • Number of events 2
|
2.0%
5/253 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/258 • Number of events 1
|
1.2%
3/257 • Number of events 3
|
1.2%
3/253 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.79%
2/253 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
3/258 • Number of events 4
|
1.9%
5/257 • Number of events 8
|
0.40%
1/253 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/258
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.39%
1/258 • Number of events 1
|
0.78%
2/257 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/119
|
1.8%
2/113 • Number of events 2
|
1.8%
2/112 • Number of events 2
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Diabetic autonomic neuropathy
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Diabetic neuropathy
|
0.39%
1/258 • Number of events 1
|
0.78%
2/257 • Number of events 2
|
0.79%
2/253 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.78%
2/258 • Number of events 2
|
1.9%
5/257 • Number of events 6
|
1.2%
3/253 • Number of events 3
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Nervous system disorders
Headache
|
3.1%
8/258 • Number of events 9
|
3.1%
8/257 • Number of events 8
|
1.2%
3/253 • Number of events 3
|
|
Nervous system disorders
Hypoaesthesia
|
1.2%
3/258 • Number of events 4
|
0.39%
1/257 • Number of events 1
|
2.0%
5/253 • Number of events 6
|
|
Nervous system disorders
Lacunar infarction
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Neuropathy peripheral
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Paraesthesia
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Poor quality sleep
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Sciatica
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Nervous system disorders
Tension headache
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Nervous system disorders
Vocal cord paralysis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Psychiatric disorders
Anxiety
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Psychiatric disorders
Depression
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Renal and urinary disorders
Albuminuria
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
1.2%
3/253 • Number of events 3
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.39%
1/258 • Number of events 1
|
1.9%
5/257 • Number of events 5
|
2.0%
5/253 • Number of events 5
|
|
Renal and urinary disorders
Dysuria
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.00%
0/253
|
|
Renal and urinary disorders
Haematuria
|
0.39%
1/258 • Number of events 1
|
1.2%
3/257 • Number of events 3
|
0.79%
2/253 • Number of events 2
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Renal and urinary disorders
Hyperuricosuria
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/258
|
0.00%
0/257
|
0.79%
2/253 • Number of events 2
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
3/258 • Number of events 3
|
1.2%
3/257 • Number of events 3
|
0.00%
0/253
|
|
Renal and urinary disorders
Nephroptosis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Renal and urinary disorders
Pollakiuria
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Renal and urinary disorders
Proteinuria
|
0.78%
2/258 • Number of events 2
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
0.39%
1/258 • Number of events 1
|
1.2%
3/257 • Number of events 3
|
0.40%
1/253 • Number of events 1
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.72%
1/139 • Number of events 1
|
0.00%
0/144
|
0.00%
0/141
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.00%
0/119
|
1.8%
2/113 • Number of events 2
|
0.00%
0/112
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.84%
1/119 • Number of events 1
|
0.00%
0/113
|
0.00%
0/112
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/119
|
0.88%
1/113 • Number of events 1
|
0.00%
0/112
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/139
|
0.69%
1/144 • Number of events 1
|
0.00%
0/141
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
3/258 • Number of events 3
|
0.39%
1/257 • Number of events 1
|
2.8%
7/253 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.78%
2/258 • Number of events 4
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.78%
2/258 • Number of events 3
|
0.39%
1/257 • Number of events 1
|
1.2%
3/253 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.39%
1/258 • Number of events 1
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/258
|
0.78%
2/257 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/258
|
0.39%
1/257 • Number of events 2
|
0.00%
0/253
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.40%
1/253 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.78%
2/258 • Number of events 2
|
0.78%
2/257 • Number of events 2
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/258
|
1.2%
3/257 • Number of events 4
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.78%
2/258 • Number of events 2
|
0.78%
2/257 • Number of events 2
|
0.40%
1/253 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/258
|
0.78%
2/257 • Number of events 2
|
0.79%
2/253 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Skin and subcutaneous tissue disorders
Urticaria contact
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Surgical and medical procedures
Intestinal polypectomy
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Surgical and medical procedures
Lung lobectomy
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Surgical and medical procedures
Modified radical mastectomy
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Surgical and medical procedures
Retinal laser coagulation
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Vascular disorders
Aneurysm
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Vascular disorders
Diabetic vascular disorder
|
0.39%
1/258 • Number of events 1
|
0.00%
0/257
|
0.00%
0/253
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Vascular disorders
Hypertension
|
7.8%
20/258 • Number of events 20
|
10.9%
28/257 • Number of events 28
|
7.5%
19/253 • Number of events 19
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/258
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Vascular disorders
Varicose vein
|
0.00%
0/258
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60