Trial Outcomes & Findings for Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies (NCT NCT01175824)
NCT ID: NCT01175824
Last Updated: 2014-02-24
Results Overview
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
478 participants
Primary outcome timeframe
Baseline, 24 weeks
Results posted on
2014-02-24
Participant Flow
Participant milestones
| Measure |
Insulin Lispro Low Mixture
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
236
|
242
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
236
|
240
|
|
Overall Study
COMPLETED
|
220
|
220
|
|
Overall Study
NOT COMPLETED
|
16
|
22
|
Reasons for withdrawal
| Measure |
Insulin Lispro Low Mixture
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
4
|
|
Overall Study
Protocol Violation
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
|
Overall Study
Entry Criteria Not Met
|
6
|
4
|
Baseline Characteristics
Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
Baseline characteristics by cohort
| Measure |
Insulin Lispro Low Mixture
n=236 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=240 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Total
n=476 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 9.93 • n=99 Participants
|
57.7 years
STANDARD_DEVIATION 9.12 • n=107 Participants
|
57.5 years
STANDARD_DEVIATION 9.52 • n=206 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
262 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
214 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
80 participants
n=99 Participants
|
80 participants
n=107 Participants
|
160 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
133 participants
n=99 Participants
|
136 participants
n=107 Participants
|
269 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
40 participants
n=99 Participants
|
39 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
20 participants
n=99 Participants
|
23 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Region of Enrollment
China
|
15 participants
n=99 Participants
|
13 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Region of Enrollment
Egypt
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Region of Enrollment
India
|
40 participants
n=99 Participants
|
41 participants
n=107 Participants
|
81 participants
n=206 Participants
|
|
Region of Enrollment
Korea, Republic of
|
25 participants
n=99 Participants
|
26 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
40 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
38 participants
n=99 Participants
|
38 participants
n=107 Participants
|
76 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
23 participants
n=99 Participants
|
23 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Region of Enrollment
Turkey
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: Per protocol population: randomized participants with the exception of participants who did not complete Week 24 visit, received study drug different from their randomized study treatment, violated any of the inclusion, exclusion, or discontinuation criteria, or were significantly noncompliant.
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=220 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=216 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Change in HbA1c From Baseline to 24 Weeks Endpoint (Per Protocol Population)
|
-1.30 percentage of HbA1c
Interval -1.44 to -1.16
|
-1.09 percentage of HbA1c
Interval -1.24 to -0.95
|
PRIMARY outcome
Timeframe: Baseline, 24 weeksPopulation: Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.
The change from baseline to 24 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=220 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=220 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Change in HbA1c From Baseline to 24 Weeks Endpoint (Intention-to-Treat Population)
|
-1.30 percentage of HbA1c
Interval -1.44 to -1.16
|
-1.08 percentage of HbA1c
Interval -1.22 to -0.94
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at the 12 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.
The change from baseline to 12 weeks in the percentage of glycosylated hemoglobin A1c (HbA1c) in plasma. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline HbA1c concentration as a covariate, treatment, country, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=222 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=226 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Change in the HbA1c Concentration From Baseline to 12 Weeks Endpoint
|
-1.12 percentage of HbA1c
Interval -1.26 to -0.98
|
-1.01 percentage of HbA1c
Interval -1.15 to -0.87
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had HbA1c data at 24 weeks. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=220 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=220 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks
HbA1c <7%
|
76 participants
|
66 participants
|
|
Number of Participants Who Achieve a Target HbA1c Concentration of Less Than 7% or Less Than or Equal to 6.5% at 24 Weeks
HbA1c <=6.5%
|
36 participants
|
31 participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, and 24 weeksPopulation: Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had fasting plasma glucose concentration data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline fasting plasma glucose value as a covariate, treatment, country, baseline HbA1c stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=222 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=222 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks
Change at 12 Weeks (n= 222, 222)
|
1.04 millimoles per liter (mmol/L)
Interval 0.67 to 1.41
|
0.64 millimoles per liter (mmol/L)
Interval 0.27 to 1.0
|
|
Change in the Fasting Plasma Glucose Concentration From Baseline to 12 Weeks and 24 Weeks
Change at 24 Weeks (n=219, 217)
|
0.89 millimoles per liter (mmol/L)
Interval 0.52 to 1.27
|
0.75 millimoles per liter (mmol/L)
Interval 0.38 to 1.12
|
SECONDARY outcome
Timeframe: 12 weeks, 24 weeksPopulation: Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.
7-point Self-monitored Blood Glucose (SMBG) Profiles are measures of blood glucose taken 7 times a day at the morning pre-meal, morning 2-hours post-meal, midday pre-meal, midday 2-hours post-meal, evening pre-meal, evening 2-hours post-meal, and 0300 hour \[3 am\]. Each participant took measures on 3 non-consecutive days and the average was calculated for each of the 7 time points. The mean of the 7-point averages was calculated for all the participants at baseline, Weeks 12 and 24. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=229 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=235 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
pre-morning meal (Week 12) (n=223, 222)
|
6.87 millimoles per liter (mmol/L)
Interval 6.67 to 7.07
|
6.20 millimoles per liter (mmol/L)
Interval 6.01 to 6.4
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
2 hour post-morning meal (Week 12) (n=220, 221)
|
8.82 millimoles per liter (mmol/L)
Interval 8.5 to 9.13
|
9.01 millimoles per liter (mmol/L)
Interval 8.7 to 9.33
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
pre-midday meal (Week 12) (n=220, 221)
|
6.96 millimoles per liter (mmol/L)
Interval 6.68 to 7.24
|
7.44 millimoles per liter (mmol/L)
Interval 7.17 to 7.72
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
2 hours post-midday meal (Week 12) (n=220, 221)
|
9.46 millimoles per liter (mmol/L)
Interval 9.14 to 9.78
|
9.14 millimoles per liter (mmol/L)
Interval 8.83 to 9.45
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
pre-evening meal (Week 12) (n=221, 221)
|
7.98 millimoles per liter (mmol/L)
Interval 7.69 to 8.28
|
8.25 millimoles per liter (mmol/L)
Interval 7.96 to 8.54
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
2 hours post-evening meal (Week 12) (n=217, 220)
|
9.15 millimoles per liter (mmol/L)
Interval 8.79 to 9.52
|
9.10 millimoles per liter (mmol/L)
Interval 8.74 to 9.46
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
3 am - during the night (Week 12)(n=197, 201)
|
8.21 millimoles per liter (mmol/L)
Interval 7.87 to 8.55
|
8.52 millimoles per liter (mmol/L)
Interval 8.19 to 8.86
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
pre-morning meal (Week 24) (n=217, 216)
|
6.60 millimoles per liter (mmol/L)
Interval 6.41 to 6.79
|
6.26 millimoles per liter (mmol/L)
Interval 6.07 to 6.45
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
2 hours post-morning meal (Week 24) (n=216, 215)
|
8.52 millimoles per liter (mmol/L)
Interval 8.22 to 8.83
|
8.86 millimoles per liter (mmol/L)
Interval 8.56 to 9.16
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
pre-midday meal (Week 24) (n=215, 216)
|
6.82 millimoles per liter (mmol/L)
Interval 6.54 to 7.09
|
7.44 millimoles per liter (mmol/L)
Interval 7.17 to 7.71
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
2 hours post-midday meal (Week 24) (n=216, 216)
|
9.08 millimoles per liter (mmol/L)
Interval 8.76 to 9.4
|
8.99 millimoles per liter (mmol/L)
Interval 8.68 to 9.3
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
pre-evening meal (Week 24) (n=216, 216)
|
7.70 millimoles per liter (mmol/L)
Interval 7.41 to 7.99
|
7.95 millimoles per liter (mmol/L)
Interval 7.66 to 8.24
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
2 hours post-evening meal (Week 24) (n=212, 216)
|
9.11 millimoles per liter (mmol/L)
Interval 8.76 to 9.47
|
8.95 millimoles per liter (mmol/L)
Interval 8.6 to 9.3
|
|
7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
3 am - during the night (Week 24)(n=198, 195)
|
8.05 millimoles per liter (mmol/L)
Interval 7.72 to 8.38
|
8.26 millimoles per liter (mmol/L)
Interval 7.93 to 8.59
|
SECONDARY outcome
Timeframe: 12 weeks, 24 weeksPopulation: Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had SMBG glycemic variability data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.
The 7-point SMBG profile was calculated as the average blood glucose concentration across the 7 pre-specified time points in a day that was then averaged over 3 non-consecutive days in the 2 weeks prior to the 12 week visit and 24 week visit. Glycemic variability was calculated as the standard deviation of the 7-point SMBG profiles. Standard deviation was first calculated for each day and then averaged over 3 non-consecutive days for each visit. The least squares (LS) mean was estimated from mixed-effects model with repeated measures that included the baseline value of the variable as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c)stratification level, week of visit, and treatment-by-week interaction as fixed effects, and participant and error as random effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=220 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=221 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
SMBG glycemic variability, 12 weeks (n=220, 221)
|
2.12 millimoles/liter (mmol/L)
Interval 2.01 to 2.24
|
2.13 millimoles/liter (mmol/L)
Interval 2.01 to 2.24
|
|
Glycemic Variability From the 7-point Self-Monitored Blood Glucose (SMBG) Profiles at 12 Weeks and 24 Weeks
SMBG glycemic variability, 24 weeks (n=216, 216)
|
2.03 millimoles/liter (mmol/L)
Interval 1.92 to 2.14
|
1.99 millimoles/liter (mmol/L)
Interval 1.88 to 2.1
|
SECONDARY outcome
Timeframe: 12 weeks, 24 weeksPopulation: Intention-to-treat population (ITT): randomized participants who received at least 1 dose of study drug and had dosing data at the specified time points. Participants were analyzed per their assigned treatment arm regardless of the treatment they actually received.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=236 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=240 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
Basal Insulin Dose at 12 Weeks (n=224, 224)
|
38.4 international units (IU)
Standard Deviation 17.70 • Interval 24.0 to 48.9
|
37.1 international units (IU)
Standard Deviation 18.34 • Interval 22.0 to 49.5
|
|
Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
Total Insulin Dose at 12 Weeks (n=224, 224)
|
51.2 international units (IU)
Standard Deviation 23.60 • Interval 32.0 to 65.2
|
49.2 international units (IU)
Standard Deviation 20.89 • Interval 33.0 to 63.3
|
|
Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
Total Insulin Dose at 24 Weeks LOCF (n=236, 240)
|
53.1 international units (IU)
Standard Deviation 24.60 • Interval 34.0 to 68.0
|
50.8 international units (IU)
Standard Deviation 21.96 • Interval 34.0 to 66.0
|
|
Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
Basal Insulin Dose at 24 Weeks LOCF (n=236, 240)
|
39.8 international units (IU)
Standard Deviation 18.45 • Interval 25.5 to 51.0
|
37.4 international units (IU)
Standard Deviation 18.76 • Interval 22.0 to 50.0
|
|
Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
Prandial Insulin Dose at 12 Weeks (n=224, 224)
|
12.8 international units (IU)
Standard Deviation 5.90 • Interval 8.0 to 16.3
|
12.1 international units (IU)
Standard Deviation 5.10 • Interval 8.0 to 16.0
|
|
Daily Insulin Dose: Total, Basal, and Prandial at 12 Weeks and 24 Weeks
Prandial Insulin Dose at 24 Weeks LOCF(n=236, 240)
|
13.3 international units (IU)
Standard Deviation 6.15 • Interval 8.5 to 17.0
|
13.5 international units (IU)
Standard Deviation 6.46 • Interval 8.0 to 17.2
|
SECONDARY outcome
Timeframe: Baseline, 12 weeks, 24 weeksPopulation: Safety population: randomized participants who took at least 1 dose of study drug and had evaluable body weight data at the specified time points.
The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included baseline weight as a covariate, treatment, country, baseline glycosylated hemoglobin A1c (HbA1c) stratification level, week of visit, and the treatment-by-week interaction as fixed effects, and participant and error as random effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=224 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=225 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Change in Weight From Baseline to 12 Weeks and 24 Weeks
Change at 12 weeks (n=224, 225)
|
0.54 kilograms (kg)
Interval 0.25 to 0.83
|
0.34 kilograms (kg)
Interval 0.05 to 0.62
|
|
Change in Weight From Baseline to 12 Weeks and 24 Weeks
Change at 24 weeks (n=219, 217)
|
1.13 kilograms (kg)
Interval 0.75 to 1.52
|
0.50 kilograms (kg)
Interval 0.11 to 0.89
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: Safety population: randomized participants who took at least 1 dose of study drug.
A hypoglycemic episode was defined as an event associated with 1) reported signs and symptoms of hypoglycemia, and/or 2) a documented blood glucose (BG) concentration of \<= 70 milligrams per deciliter \[mg/dL, 3.9 millimoles per liter (mmol/L)\].
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=236 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=240 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
The Number of Participants With a Hypoglycemic Episodes (Incidence)
|
144 participants
|
150 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had ITSQ scores at 24 weeks. Last observation carried forward (LOCF).
ITSQ: validated instrument containing 22 items which are measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother) used to assess insulin treatment satisfaction. Items are divided into 5 domains: Inconvenience of Regimen (5 items: domain score range 5 to 35), Lifestyle Flexibility (3 items: domain score range 3 to 21), Glycemic Control (3 items: domain score range 3 to 21), Hypoglycemic Control (5 items: domain score range 5 to 35), Insulin Delivery Device (6 items: domain score range 6 to 42) lower scores reflect better outcome. ITSQ Total Overall Score ranged from 22 to 154. Raw domain scores transformed on 0-100 scale, where transformed domain score = 100×\[(7-raw domain score)/6\]. Higher scores indicate better treatment satisfaction. Least squares (LS) mean estimated from analysis of covariance (ANCOVA) model that included baseline score as covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=230 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=229 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Insulin Treatment Satisfaction Questionnaire (ITSQ) Score at 24 Weeks
|
80.91 units on a scale
Interval 79.02 to 82.81
|
81.84 units on a scale
Interval 79.97 to 83.72
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Randomized participants who received at least 1 dose of study drug and had PAM-D21 scores at 24 weeks.
PAM-D21 is a validated questionnaire consisting of 21 items to assess a participant's perceptions about their diabetes treatment regimens and perceived emotional and physical side-effects. The PAM-D21 consists of 4 subscales: Convenience/Flexibility (items 1 to 3); Perceived Effectiveness (items 4 to 6); Emotional Effects (items 7 to 11); and Physical Effects (items 12 to 21). Item scores range from 1 (none of the time) to 4 (all of the time). Subscale scores were linearly transformed to a 0-100, with higher score corresponds to better perceptions about diabetes medications. The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included baseline score as a covariate and treatment, glycosylated hemoglobin A1c (HbA1c) stratum, and country as fixed effects.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=231 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=230 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks
Convenience/Flexibility (n= 231, 230)
|
83.90 units on a scale
Interval 81.0 to 86.8
|
84.13 units on a scale
Interval 81.26 to 87.0
|
|
Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks
Perceived Effectiveness (n=231, 230)
|
76.78 units on a scale
Interval 73.32 to 80.23
|
78.76 units on a scale
Interval 75.34 to 82.17
|
|
Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks
Emotional Effects (n=231, 230)
|
81.84 units on a scale
Interval 78.87 to 84.8
|
81.86 units on a scale
Interval 78.92 to 84.79
|
|
Perceptions About Medications-Diabetes 21 (PAM-D21) Questionnaire Score at 24 Weeks
Physical Effects (n=231, 228)
|
87.89 units on a scale
Interval 86.2 to 89.58
|
89.04 units on a scale
Interval 87.37 to 90.72
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: Safety population: randomized participants who took at least 1 dose of study drug.
The hypoglycemia rate per 30 days was calculated as the number of episodes reported for the interval between visits and during the study divided by the number of days in the given interval and multiplied by 30.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=236 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=240 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
The Rate of Hypoglycemic Episodes
|
1.07 hypoglycemic episodes per 30 day period
Standard Deviation 1.181
|
1.36 hypoglycemic episodes per 30 day period
Standard Deviation 2.172
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: Safety population: randomized participants who took at least 1 dose of study drug.
The number of participants who had a severe hypoglycemic episode anytime during the study. Severe hypoglycemia was defined as any event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Outcome measures
| Measure |
Insulin Lispro Low Mixture
n=236 Participants
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=240 Participants
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
The Number of Participants With Severe Hypoglycemic Episodes
|
2 participants
|
0 participants
|
Adverse Events
Insulin Lispro Low Mixture
Serious events: 11 serious events
Other events: 109 other events
Deaths: 0 deaths
Insulin Glargine+Insulin Lispro
Serious events: 8 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro Low Mixture
n=236 participants at risk
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=240 participants at risk
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Epiglottitis
|
0.42%
1/236 • Number of events 2
|
0.00%
0/240
|
|
Infections and infestations
Laryngitis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Respiratory tract infection
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Fall
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
3/236 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.85%
2/236 • Number of events 3
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Surgical and medical procedures
Toe amputation
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
Other adverse events
| Measure |
Insulin Lispro Low Mixture
n=236 participants at risk
Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
Insulin Glargine+Insulin Lispro
n=240 participants at risk
Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.42%
1/236 • Number of events 1
|
0.83%
2/240 • Number of events 2
|
|
Cardiac disorders
Myocardial ischaemia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Cardiac disorders
Palpitations
|
0.85%
2/236 • Number of events 2
|
0.00%
0/240
|
|
Congenital, familial and genetic disorders
Birth mark
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
3/236 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
|
Eye disorders
Cataract
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Eye disorders
Conjunctival hyperaemia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Eye disorders
Diabetic retinopathy
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Eye disorders
Eye pain
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Eye disorders
Vision blurred
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
3/236 • Number of events 3
|
0.83%
2/240 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/236
|
1.7%
4/240 • Number of events 4
|
|
Gastrointestinal disorders
Apical granuloma
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.85%
2/236 • Number of events 2
|
1.2%
3/240 • Number of events 3
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
6/236 • Number of events 6
|
1.7%
4/240 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.85%
2/236 • Number of events 2
|
1.2%
3/240 • Number of events 3
|
|
Gastrointestinal disorders
Enteritis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Enterocolitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Food poisoning
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/236
|
1.7%
4/240 • Number of events 4
|
|
Gastrointestinal disorders
Odynophagia
|
0.42%
1/236 • Number of events 1
|
0.83%
2/240 • Number of events 2
|
|
Gastrointestinal disorders
Periodontal disease
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Gastrointestinal disorders
Tongue oedema
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Toothache
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
4/236 • Number of events 4
|
0.42%
1/240 • Number of events 1
|
|
General disorders
Asthenia
|
1.3%
3/236 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
General disorders
Chest pain
|
0.42%
1/236 • Number of events 1
|
0.83%
2/240 • Number of events 2
|
|
General disorders
Discomfort
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
General disorders
Face oedema
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
General disorders
Fatigue
|
0.00%
0/236
|
0.83%
2/240 • Number of events 4
|
|
General disorders
Influenza like illness
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
General disorders
Injection site haematoma
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
General disorders
Injection site pain
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
General disorders
Oedema
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
General disorders
Oedema peripheral
|
0.42%
1/236 • Number of events 1
|
0.83%
2/240 • Number of events 2
|
|
General disorders
Pyrexia
|
1.3%
3/236 • Number of events 3
|
1.7%
4/240 • Number of events 4
|
|
Hepatobiliary disorders
Cholecystitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.85%
2/236 • Number of events 2
|
0.00%
0/240
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Acute tonsillitis
|
0.85%
2/236 • Number of events 2
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.3%
3/236 • Number of events 3
|
0.00%
0/240
|
|
Infections and infestations
Cystitis
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Dengue fever
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Furuncle
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
1.7%
4/236 • Number of events 4
|
0.00%
0/240
|
|
Infections and infestations
Gastroenteritis viral
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Gingivitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Influenza
|
1.3%
3/236 • Number of events 3
|
1.7%
4/240 • Number of events 4
|
|
Infections and infestations
Keratitis herpetic
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Localised infection
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
20/236 • Number of events 24
|
5.4%
13/240 • Number of events 13
|
|
Infections and infestations
Orchitis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Periodontitis
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.85%
2/236 • Number of events 2
|
1.2%
3/240 • Number of events 3
|
|
Infections and infestations
Pulpitis dental
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/236
|
0.42%
1/240 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
0.85%
2/236 • Number of events 3
|
0.00%
0/240
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
Infections and infestations
Rhinitis
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
0.42%
1/236 • Number of events 1
|
0.83%
2/240 • Number of events 2
|
|
Infections and infestations
Tinea pedis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Tonsillitis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Infections and infestations
Tooth abscess
|
1.3%
3/236 • Number of events 4
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.85%
2/236 • Number of events 2
|
1.2%
3/240 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
1.3%
3/236 • Number of events 4
|
2.1%
5/240 • Number of events 7
|
|
Infections and infestations
Wound infection
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
Injury, poisoning and procedural complications
Laceration
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Investigations
Alanine aminotransferase increased
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Investigations
Blood pressure increased
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Investigations
Hepatic enzyme increased
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Investigations
Weight increased
|
0.85%
2/236 • Number of events 2
|
0.00%
0/240
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.85%
2/236 • Number of events 2
|
0.00%
0/240
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
6/236 • Number of events 6
|
2.1%
5/240 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
4/236 • Number of events 4
|
2.5%
6/240 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.85%
2/236 • Number of events 2
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.42%
1/236 • Number of events 1
|
2.5%
6/240 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.85%
2/236 • Number of events 3
|
0.42%
1/240 • Number of events 1
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
2.1%
5/236 • Number of events 6
|
1.7%
4/240 • Number of events 6
|
|
Nervous system disorders
Headache
|
3.0%
7/236 • Number of events 9
|
2.9%
7/240 • Number of events 7
|
|
Nervous system disorders
Hypoaesthesia
|
0.85%
2/236 • Number of events 2
|
0.00%
0/240
|
|
Nervous system disorders
Paraesthesia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Nervous system disorders
Radiculopathy
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Nervous system disorders
Sciatica
|
0.00%
0/236
|
1.2%
3/240 • Number of events 3
|
|
Nervous system disorders
Tremor
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.85%
2/236 • Number of events 2
|
1.2%
3/240 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/120
|
0.70%
1/142 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.85%
2/236 • Number of events 3
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.42%
1/236 • Number of events 2
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/236
|
0.83%
2/240 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.42%
1/236 • Number of events 2
|
0.00%
0/240
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.85%
2/236 • Number of events 2
|
0.83%
2/240 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pityriasis
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.85%
2/236 • Number of events 2
|
0.83%
2/240 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Surgical and medical procedures
Meniscus operation
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Surgical and medical procedures
Shoulder operation
|
0.42%
1/236 • Number of events 1
|
0.00%
0/240
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/236
|
0.83%
2/240 • Number of events 4
|
|
Vascular disorders
Haematoma
|
0.00%
0/236
|
0.42%
1/240 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.42%
1/236 • Number of events 2
|
0.83%
2/240 • Number of events 2
|
|
Vascular disorders
Hypertensive crisis
|
0.42%
1/236 • Number of events 1
|
0.42%
1/240 • Number of events 1
|
|
Vascular disorders
Vein disorder
|
0.00%
0/236
|
0.42%
1/240 • 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