Trial Outcomes & Findings for A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus (NCT NCT01792284)
NCT ID: NCT01792284
Last Updated: 2018-04-20
Results Overview
HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
COMPLETED
PHASE3
212 participants
At 12 Week in Each Randomization Period
2018-04-20
Participant Flow
Participants completed a 12 week (wk) Lead-in Period during which insulin peglispro was administered at fixed time in the evening. Participants were then randomized to a fixed evening dose regimen or a variable time dose regimen for 12 wks (Randomization Period 1); after 12 wks, they crossed over to the alternate regimen (Randomization Period 2).
Participant milestones
| Measure |
LY2605541 Fixed Time Dosing (All Participants)
Lead-in Period: Participant-specific dose of LY2605541 administered subcutaneously (SQ) at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on self-monitored blood glucose (SMBG).
Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 milligrams/deciliter (mg/dL) Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
|---|---|---|---|
|
Lead-in Period
STARTED
|
212
|
0
|
0
|
|
Lead-in Period
COMPLETED
|
182
|
0
|
0
|
|
Lead-in Period
NOT COMPLETED
|
30
|
0
|
0
|
|
Randomization Period 1
STARTED
|
0
|
92
|
90
|
|
Randomization Period 1
Received at Least 1 Dose of Study Drug
|
0
|
92
|
90
|
|
Randomization Period 1
COMPLETED
|
0
|
90
|
85
|
|
Randomization Period 1
NOT COMPLETED
|
0
|
2
|
5
|
|
Randomization Period 2
STARTED
|
0
|
90
|
85
|
|
Randomization Period 2
Received at Least 1 Dose of Study Drug
|
0
|
90
|
85
|
|
Randomization Period 2
COMPLETED
|
0
|
87
|
85
|
|
Randomization Period 2
NOT COMPLETED
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
LY2605541 Fixed Time Dosing (All Participants)
Lead-in Period: Participant-specific dose of LY2605541 administered subcutaneously (SQ) at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on self-monitored blood glucose (SMBG).
Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 milligrams/deciliter (mg/dL) Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
|---|---|---|---|
|
Lead-in Period
Adverse Event
|
15
|
0
|
0
|
|
Lead-in Period
Lost to Follow-up
|
2
|
0
|
0
|
|
Lead-in Period
Protocol Violation
|
1
|
0
|
0
|
|
Lead-in Period
Withdrawal by Subject
|
10
|
0
|
0
|
|
Lead-in Period
Physician Decision
|
1
|
0
|
0
|
|
Lead-in Period
Protocol Required Discontinuation
|
1
|
0
|
0
|
|
Randomization Period 1
Withdrawal by Subject
|
0
|
1
|
1
|
|
Randomization Period 1
Physician Decision
|
0
|
1
|
1
|
|
Randomization Period 1
Adverse Event
|
0
|
0
|
2
|
|
Randomization Period 1
Lost to Follow-up
|
0
|
0
|
1
|
|
Randomization Period 2
Protocol Violation
|
0
|
1
|
0
|
|
Randomization Period 2
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=212 Participants
Participants entered a 12-week Lead-in Period where they received fixed time of dose of LY2605541 with bolus insulin lispro. Participants were then randomized to either a fixed time of dose or a variable time of dose regimen for 12 weeks administered with bolus insulin lispro; after 12 weeks, they crossed over to the alternate regimen. LY2605541 dose was adjusted using a dosing algorithm based on the participant's BG values and documented hypoglycemia during the previous week. Insulin dose were determined by insulin algorithms based on SMBG.
Fixed time of dose: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks administered with bolus insulin lispro.
Variable time of dose: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks administered with bolus insulin lispro.
|
|---|---|
|
Age, Continuous
|
43.08 years
STANDARD_DEVIATION 13.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
186 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
199 Participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 12 Week in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.
HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=180 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Hemoglobin A1c (HbA1c) at 12 Weeks
|
6.87 percentage of HbA1c
Standard Error 0.04
|
6.93 percentage of HbA1c
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline (Day 1) of Randomization Period through 24 Weeks (12 weeks in each Randomization Period)Population: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HE data during Randomization Periods.
Total hypoglycemic events (HE) include any event based on a blood glucose \<=70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. Group Means are presented and were calculated from negative binomial regression models (number of episodes = treatment + period + treatment sequence + baseline HbA1c \[\<=8.0% or \>8.0%\], with log \[exposure in days/30\] as an offset variable). Group Mean (LS mean) is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=180 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Total HE
|
10.54 events/participant/30 days
Standard Error 0.67
|
10.37 events/participant/30 days
Standard Error 0.62
|
|
30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events
Nocturnal HE
|
1.52 events/participant/30 days
Standard Error 0.13
|
1.34 events/participant/30 days
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline (Day 1) of Randomization Period through 24 weeks (12 weeks in each Randomization Period)Population: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HE data during Randomization Periods
Total HE include any event based on a blood glucose \<=70 mg/dL (3.9 mmol/L), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=180 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Nocturnal HE
|
78.4 percentage of participants
|
80.6 percentage of participants
|
|
Percentage of Participants With Total and Nocturnal Hypoglycemic Events
Total HE
|
98.2 percentage of participants
|
97.8 percentage of participants
|
SECONDARY outcome
Timeframe: At 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FBG data.
FBG was measured by self-monitored blood glucose (SMBG). LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FBG (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=179 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Fasting Blood Glucose (FBG) Measured by Self-Monitored Blood Glucose
|
131.35 mg/dL
Standard Error 2.86
|
139.65 mg/dL
Standard Error 2.87
|
SECONDARY outcome
Timeframe: At 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FBG data.
FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in FBG (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=179 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Intra-Participant Variability of FBG at 12 Weeks
|
37.97 mg/dL
Standard Error 1.73
|
39.80 mg/dL
Standard Error 1.73
|
SECONDARY outcome
Timeframe: At 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FSG data.
LS means for FSG (obtained from clinical laboratory tests) were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FSG (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=177 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Fasting Serum Glucose (FSG) at 12 Weeks
|
121.51 mg/dL
Standard Error 4.27
|
120.45 mg/dL
Standard Error 4.25
|
SECONDARY outcome
Timeframe: Randomization, 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG data.
SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=164 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=169 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
2 hours post-morning meal
|
-1.24 mg/dL
Standard Error 4.03
|
8.13 mg/dL
Standard Error 4.04
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
Pre-evening meal
|
1.98 mg/dL
Standard Error 3.81
|
-1.34 mg/dL
Standard Error 3.84
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
Pre-morning meal
|
-7.77 mg/dL
Standard Error 3.79
|
0.07 mg/dL
Standard Error 3.80
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
Pre-midday meal
|
0.27 mg/dL
Standard Error 3.55
|
14.87 mg/dL
Standard Error 3.57
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
2 hours post-midday meal
|
10.91 mg/dL
Standard Error 3.93
|
5.40 mg/dL
Standard Error 3.95
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
2 hours post-evening meal
|
5.49 mg/dL
Standard Error 4.06
|
8.33 mg/dL
Standard Error 4.03
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
Bedtime
|
8.40 mg/dL
Standard Error 4.15
|
5.36 mg/dL
Standard Error 4.17
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
0300 hours
|
-7.05 mg/dL
Standard Error 3.55
|
4.71 mg/dL
Standard Error 3.62
|
|
Change From Randomization to 12 Weeks in 9-Point SMBG
Subsequent morning pre-meal
|
-7.84 mg/dL
Standard Error 3.20
|
-2.44 mg/dL
Standard Error 3.22
|
SECONDARY outcome
Timeframe: At 12 Week in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG data.
SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=164 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=169 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
Pre-evening meal
|
137.75 mg/dL
Standard Error 3.81
|
134.43 mg/dL
Standard Error 3.84
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
2 hours post-evening meal
|
150.37 mg/dL
Standard Error 4.06
|
153.21 mg/dL
Standard Error 4.03
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
Bedtime
|
153.81 mg/dL
Standard Error 4.15
|
150.77 mg/dL
Standard Error 4.17
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
Pre-morning meal
|
133.21 mg/dL
Standard Error 3.79
|
141.05 mg/dL
Standard Error 3.80
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
2 hours post-morning meal
|
151.03 mg/dL
Standard Error 4.03
|
160.41 mg/dL
Standard Error 4.04
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
Pre-midday meal
|
122.96 mg/dL
Standard Error 3.55
|
137.55 mg/dL
Standard Error 3.57
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
2 hours post-midday meal
|
147.05 mg/dL
Standard Error 3.93
|
141.54 mg/dL
Standard Error 3.95
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
0300 hours
|
131.40 mg/dL
Standard Error 3.55
|
143.16 mg/dL
Standard Error 3.62
|
|
Self-Monitored Blood Glucose (SMBG) at 12 Weeks
Subsequent morning pre-meal
|
125.16 mg/dL
Standard Error 3.20
|
130.57 mg/dL
Standard Error 3.22
|
SECONDARY outcome
Timeframe: At 12 Week in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG variability data.
A summary of glucose variability (intra-participant variability) as measured by the average of between-day standard deviations of individual SMBG time points. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in SMBG (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=154 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=153 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Intra-participant Variability in SMBG at 12 Weeks
|
34.82 mg/dL
Standard Error 1.30
|
36.21 mg/dL
Standard Error 1.28
|
SECONDARY outcome
Timeframe: Randomization, 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable body weight data.
LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline body weight (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=170 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=177 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Change From Randomization to 12 Weeks in Body Weight
|
-0.06 kilograms (kg)
Standard Error 0.19
|
0.00 kilograms (kg)
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Day 1 of Lead-In Period, 36 WeeksPopulation: All enrolled participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable body weight data.
LS means were calculated using MMRM analysis, including visit and baseline weight (last non-missing value at or before the beginning of Lead-in Period) as covariates.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=210 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Change From Day 1 of Lead-In Period to 36 Weeks in Body Weight
|
-1.16 kg
Standard Error 0.29
|
—
|
SECONDARY outcome
Timeframe: Randomization, 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.
LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=180 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Change From Randomization to 12 Weeks in HbA1c
|
0.10 percentage of HbA1c
Standard Error 0.04
|
0.18 percentage of HbA1c
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Day 1 of Lead-in Period through 36 WeeksPopulation: Participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable anti-LY2605541 antibody data.
The number of participants with a treatment emergent anti-LY2605541 antibody response (TEAR) is presented. Positive TEAR was defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from 1) undetectable to detectable or from 2) detectable to the value with at least 130% relative increase from baseline.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=210 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Participants With Treatment-Emergent Anti-LY2605541 Antibody Response
|
80 participants
|
—
|
SECONDARY outcome
Timeframe: At 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable insulin dose data.
LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline insulin dose (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=180 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Basal, Bolus, and Total Insulin Doses at 12 Weeks
Total Insulin
|
0.71 units/kg/day
Standard Error 0.01
|
0.71 units/kg/day
Standard Error 0.01
|
|
Basal, Bolus, and Total Insulin Doses at 12 Weeks
Basal
|
0.50 units/kg/day
Standard Error 0.01
|
0.51 units/kg/day
Standard Error 0.01
|
|
Basal, Bolus, and Total Insulin Doses at 12 Weeks
Bolus
|
0.20 units/kg/day
Standard Error 0.01
|
0.20 units/kg/day
Standard Error 0.01
|
SECONDARY outcome
Timeframe: At 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable bolus to total insulin dose data.
Proportion of bolus to total insulin dose is presented, where LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline proportion of bolus to total insulin dose (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=171 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=178 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Proportion of Bolus to Total Insulin Doses at 12 Weeks
|
0.29 units/day
Standard Error 0.01
|
0.28 units/day
Standard Error 0.01
|
SECONDARY outcome
Timeframe: At 12 Week in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG excursion data.
Excursion results were calculated by subtracting the 0300 hours glucose value from the next day pre-morning glucose value within a single SMBG profile. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline 0300-hour to next day pre-breakfast excursion (last nonmissing value at or before randomization), baseline HbA1c (\<=8.0% or \>8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=158 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=162 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
0300-Hour Blood Glucose to Fasting Blood Glucose Excursion
|
-6.41 mg/dL
Standard Error 3.64
|
-15.24 mg/dL
Standard Error 3.70
|
SECONDARY outcome
Timeframe: Day 1 of Lead-In Period, 36 WeeksPopulation: All enrolled participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable lipid data.
LS means were calculated using MMRM analysis including visit and baseline lipid level (last nonmissing value at or before the beginning of Lead-in) as covariates.
Outcome measures
| Measure |
LY2605541 Fixed Time Dosing
n=202 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)
Triglycerides
|
26.44 mg/dL
Standard Error 3.83
|
—
|
|
Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)
HDL-C
|
-5.70 mg/dL
Standard Error 0.82
|
—
|
|
Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)
Total Cholesterol
|
3.75 mg/dL
Standard Error 1.91
|
—
|
|
Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)
LDL-C
|
4.45 mg/dL
Standard Error 1.63
|
—
|
SECONDARY outcome
Timeframe: At 12 Weeks in Each Randomization PeriodPopulation: Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.
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 |
LY2605541 Fixed Time Dosing
n=167 Participants
Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks.
|
LY2605541 Variable Time Dosing
n=167 Participants
Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Dosing schedules were to remain approximately the same throughout the 12 weeks.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7.0% and ≤6.5% at 12 Weeks
HbA1c <7.0%
|
60.5 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants With HbA1c <7.0% and ≤6.5% at 12 Weeks
HbA1c <=6.5%
|
34.1 percentage of participants
|
34.1 percentage of participants
|
Adverse Events
LY2605541 (All Participants)
LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing
LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing
Serious adverse events
| Measure |
LY2605541 (All Participants)
n=212 participants at risk
All participants who received at least 1 dose of LY2605541 during the Lead-In Period, Randomization Period 1, and Randomization Period 2.
|
LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing
n=177 participants at risk
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing
n=180 participants at risk
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/212 • Number of events 1
|
0.00%
0/177
|
0.00%
0/180
|
|
Cardiac disorders
Coronary artery disease
|
0.47%
1/212 • Number of events 2
|
0.00%
0/177
|
0.56%
1/180 • Number of events 1
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.47%
1/212 • Number of events 2
|
0.00%
0/177
|
0.00%
0/180
|
|
Infections and infestations
Cellulitis
|
0.47%
1/212 • Number of events 1
|
0.00%
0/177
|
0.00%
0/180
|
|
Infections and infestations
Osteomyelitis
|
0.47%
1/212 • Number of events 1
|
0.56%
1/177 • Number of events 1
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.4%
3/212 • Number of events 4
|
0.00%
0/177
|
0.56%
1/180 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.47%
1/212 • Number of events 3
|
0.00%
0/177
|
0.56%
1/180 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.94%
2/212 • Number of events 2
|
0.00%
0/177
|
0.00%
0/180
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
11.3%
24/212 • Number of events 34
|
5.1%
9/177 • Number of events 9
|
3.3%
6/180 • Number of events 8
|
|
Nervous system disorders
Convulsion
|
0.47%
1/212 • Number of events 1
|
0.00%
0/177
|
0.56%
1/180 • Number of events 1
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.94%
2/212 • Number of events 2
|
0.56%
1/177 • Number of events 1
|
0.00%
0/180
|
Other adverse events
| Measure |
LY2605541 (All Participants)
n=212 participants at risk
All participants who received at least 1 dose of LY2605541 during the Lead-In Period, Randomization Period 1, and Randomization Period 2.
|
LY2605541 Fixed Time Dosing, LY2605541 Variable Time Dosing
n=177 participants at risk
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
LY2605541 Variable Time Dosing, LY2605541 Fixed Time Dosing
n=180 participants at risk
Randomization Period 1: Participant-specific dose of LY2605541 administered SQ on a variable schedule (8- and 40-hour dosing intervals) for 12 weeks. Participants were dosed in the morning on Monday, Wednesday, and Friday and in the evening on Tuesday, Thursday, Saturday, and Sunday. Dosing schedules were to remain approximately the same throughout the 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Randomization Period 2: Participant-specific dose of LY2605541 administered SQ at approximately the same time every evening for 12 weeks. Participant-specific dose of insulin lispro SQ when \>20% of calories were consumed (pre-meal).
Insulin dose and adjustments to insulin dose were determined by insulin algorithms based on SMBG. Target glucose values were as follows:
Preprandial and bedtime BG between 71 and 130 mg/dL Insulin adjustment and glucose correction between 71 and 100 mg/dL.
|
|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.94%
2/212 • Number of events 2
|
1.1%
2/177 • Number of events 2
|
0.56%
1/180 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.4%
3/212 • Number of events 3
|
0.00%
0/177
|
0.00%
0/180
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
6/212 • Number of events 7
|
0.56%
1/177 • Number of events 1
|
0.56%
1/180 • Number of events 2
|
|
Gastrointestinal disorders
Food poisoning
|
0.94%
2/212 • Number of events 2
|
1.1%
2/177 • Number of events 2
|
0.00%
0/180
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
3/212 • Number of events 3
|
0.56%
1/177 • Number of events 1
|
0.00%
0/180
|
|
Gastrointestinal disorders
Nausea
|
4.7%
10/212 • Number of events 10
|
1.7%
3/177 • Number of events 3
|
1.7%
3/180 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
6/212 • Number of events 7
|
0.56%
1/177 • Number of events 1
|
1.1%
2/180 • Number of events 2
|
|
General disorders
Fatigue
|
1.9%
4/212 • Number of events 4
|
1.1%
2/177 • Number of events 2
|
1.7%
3/180 • Number of events 3
|
|
General disorders
Injection site pain
|
1.4%
3/212 • Number of events 3
|
0.56%
1/177 • Number of events 1
|
0.00%
0/180
|
|
General disorders
Injection site swelling
|
4.7%
10/212 • Number of events 23
|
0.56%
1/177 • Number of events 1
|
1.1%
2/180 • Number of events 2
|
|
General disorders
Local swelling
|
1.4%
3/212 • Number of events 4
|
0.56%
1/177 • Number of events 1
|
1.7%
3/180 • Number of events 4
|
|
General disorders
Oedema peripheral
|
1.4%
3/212 • Number of events 3
|
1.1%
2/177 • Number of events 2
|
0.00%
0/180
|
|
Infections and infestations
Bronchitis
|
2.8%
6/212 • Number of events 6
|
1.1%
2/177 • Number of events 2
|
1.7%
3/180 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
4.2%
9/212 • Number of events 13
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Infections and infestations
Gastroenteritis viral
|
3.3%
7/212 • Number of events 7
|
2.3%
4/177 • Number of events 4
|
0.56%
1/180 • Number of events 1
|
|
Infections and infestations
Hordeolum
|
1.4%
3/212 • Number of events 3
|
0.56%
1/177 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Influenza
|
6.1%
13/212 • Number of events 14
|
1.1%
2/177 • Number of events 3
|
1.1%
2/180 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
15.6%
33/212 • Number of events 47
|
6.2%
11/177 • Number of events 12
|
4.4%
8/180 • Number of events 8
|
|
Infections and infestations
Sinusitis
|
5.2%
11/212 • Number of events 12
|
1.7%
3/177 • Number of events 3
|
2.8%
5/180 • Number of events 5
|
|
Infections and infestations
Tooth infection
|
1.9%
4/212 • Number of events 4
|
0.56%
1/177 • Number of events 1
|
0.00%
0/180
|
|
Infections and infestations
Upper respiratory tract infection
|
14.2%
30/212 • Number of events 33
|
5.1%
9/177 • Number of events 9
|
5.6%
10/180 • Number of events 10
|
|
Infections and infestations
Urinary tract infection
|
2.4%
5/212 • Number of events 5
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
0.94%
2/212 • Number of events 3
|
1.1%
2/177 • Number of events 2
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
1.9%
4/212 • Number of events 4
|
0.56%
1/177 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Injury, poisoning and procedural complications
Laceration
|
1.9%
4/212 • Number of events 5
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
1.9%
4/212 • Number of events 4
|
1.1%
2/177 • Number of events 2
|
1.7%
3/180 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
4/212 • Number of events 4
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Investigations
Blood creatine phosphokinase increased
|
2.4%
5/212 • Number of events 5
|
0.56%
1/177 • Number of events 1
|
0.56%
1/180 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
2.4%
5/212 • Number of events 5
|
0.56%
1/177 • Number of events 1
|
1.1%
2/180 • Number of events 2
|
|
Investigations
Liver function test abnormal
|
1.4%
3/212 • Number of events 3
|
0.00%
0/177
|
0.56%
1/180 • Number of events 1
|
|
Investigations
Weight decreased
|
2.8%
6/212 • Number of events 6
|
1.7%
3/177 • Number of events 3
|
1.7%
3/180 • Number of events 3
|
|
Investigations
Weight increased
|
1.4%
3/212 • Number of events 3
|
0.00%
0/177
|
0.56%
1/180 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.94%
2/212 • Number of events 3
|
1.1%
2/177 • Number of events 2
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
6/212 • Number of events 6
|
1.1%
2/177 • Number of events 2
|
2.2%
4/180 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
5/212 • Number of events 6
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
3/212 • Number of events 3
|
0.00%
0/177
|
0.56%
1/180 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.9%
4/212 • Number of events 4
|
0.00%
0/177
|
0.00%
0/180
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
3/212 • Number of events 3
|
0.00%
0/177
|
1.1%
2/180 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.4%
3/212 • Number of events 3
|
0.56%
1/177 • Number of events 1
|
1.1%
2/180 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
7/212 • Number of events 7
|
1.7%
3/177 • Number of events 3
|
1.1%
2/180 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.94%
2/212 • Number of events 2
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Nervous system disorders
Headache
|
3.3%
7/212 • Number of events 10
|
1.1%
2/177 • Number of events 3
|
2.2%
4/180 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
8/212 • Number of events 10
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.4%
3/212 • Number of events 3
|
1.1%
2/177 • Number of events 2
|
0.00%
0/180
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.3%
7/212 • Number of events 9
|
1.1%
2/177 • Number of events 3
|
1.7%
3/180 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
1.9%
4/212 • Number of events 4
|
1.1%
2/177 • Number of events 2
|
0.56%
1/180 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.1%
13/212 • Number of events 14
|
2.8%
5/177 • Number of events 5
|
0.56%
1/180 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
4.7%
10/212 • Number of events 15
|
1.7%
3/177 • Number of events 3
|
1.1%
2/180 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
4/212 • Number of events 4
|
1.1%
2/177 • Number of events 2
|
1.1%
2/180 • Number of events 2
|
|
Vascular disorders
Hypertension
|
1.9%
4/212 • Number of events 4
|
1.7%
3/177 • Number of events 3
|
1.7%
3/180 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60