Trial Outcomes & Findings for A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy (NCT NCT03830281)
NCT ID: NCT03830281
Last Updated: 2021-01-22
Results Overview
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
471 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2021-01-22
Participant Flow
The purpose of the lead-in period was to assess basal rates and bolus calculator settings and adjust if needed prior to randomization. Participants (Pts) were then randomized to insulin lispro (Humalog) or ultra-rapid lispro as both basal and bolus insulin and delivered bolus doses 0 to 2 minutes prior to each meal (pre-meal).
Participant milestones
| Measure |
Insulin Lispro (Humalog)
Participants received individual dose of 100 units per milliliter (U/mL) insulin lispro (Humalog) by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Lead-in Period (2 Weeks)
STARTED
|
471
|
0
|
|
Lead-in Period (2 Weeks)
COMPLETED
|
432
|
0
|
|
Lead-in Period (2 Weeks)
NOT COMPLETED
|
39
|
0
|
|
Treatment Period (16 Weeks)
STARTED
|
217
|
215
|
|
Treatment Period (16 Weeks)
COMPLETED
|
205
|
198
|
|
Treatment Period (16 Weeks)
NOT COMPLETED
|
12
|
17
|
Reasons for withdrawal
| Measure |
Insulin Lispro (Humalog)
Participants received individual dose of 100 units per milliliter (U/mL) insulin lispro (Humalog) by continuous subcutaneous insulin infusion (CSII); where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Lead-in Period (2 Weeks)
Adverse Event
|
2
|
0
|
|
Lead-in Period (2 Weeks)
Not Met Eligibility Criteria
|
6
|
0
|
|
Lead-in Period (2 Weeks)
Physician Decision
|
2
|
0
|
|
Lead-in Period (2 Weeks)
Withdrawal by Subject
|
29
|
0
|
|
Treatment Period (16 Weeks)
Adverse Event
|
1
|
7
|
|
Treatment Period (16 Weeks)
Lost to Follow-up
|
4
|
3
|
|
Treatment Period (16 Weeks)
Sponsor Decision
|
1
|
1
|
|
Treatment Period (16 Weeks)
Physician Decision
|
1
|
0
|
|
Treatment Period (16 Weeks)
Withdrawal by Subject
|
5
|
6
|
Baseline Characteristics
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Baseline characteristics by cohort
| Measure |
Insulin Lispro (Humalog)
n=217 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=215 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Total
n=432 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 14.9 • n=93 Participants
|
48.2 years
STANDARD_DEVIATION 15.4 • n=4 Participants
|
46.4 years
STANDARD_DEVIATION 15.3 • n=27 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=93 Participants
|
120 Participants
n=4 Participants
|
239 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=93 Participants
|
95 Participants
n=4 Participants
|
193 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
180 Participants
n=93 Participants
|
178 Participants
n=4 Participants
|
358 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
207 Participants
n=93 Participants
|
202 Participants
n=4 Participants
|
409 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
24 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
86 Participants
n=93 Participants
|
84 Participants
n=4 Participants
|
170 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
22 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Hemoglobin A1c
|
7.54 Percentage of HbA1c
STANDARD_DEVIATION 0.58 • n=93 Participants
|
7.56 Percentage of HbA1c
STANDARD_DEVIATION 0.59 • n=4 Participants
|
7.55 Percentage of HbA1c
STANDARD_DEVIATION 0.58 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and at least one post-baseline HbA1c data.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=207 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=191 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 16
|
-0.09 Percentage of HbA1c
Standard Error 0.030
|
-0.06 Percentage of HbA1c
Standard Error 0.031
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and at least one post-baseline 1-hour PPG data.
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=193 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=182 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Change From Baseline in 1-hour Postprandial Glucose (PPG) During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand at Week 16
|
-2.2 milligrams per deciliter (mg/dL)
Standard Error 5.02
|
-26.3 milligrams per deciliter (mg/dL)
Standard Error 5.33
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and at least one post-baseline 2-hour PPG data.
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of variance (ANCOVA) model with independent variables: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal CGM/FGM use during study Flag + Treatment (Type III sum of squares).The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=192 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=183 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Change From Baseline in 2-hour PPG During MMTT Efficacy Estimand at Week 16
|
-4.2 mg/dL
Standard Error 6.27
|
-32.0 mg/dL
Standard Error 6.59
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants with non-missing baseline value and at least one non-missing post-baseline value.
Percentage of time with sensor glucose values between 70 and 180 mg/dL using continuous glucose monitoring (CGM). Least square (LS) mean difference will provided for CGM data normalized to a 24hrs period. Daytime: 0600 hours to midnight (06:00:00-23:59:59 on the 24-hour clock). Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=181 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=172 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
Daytime
|
58.6 percentage of time
Standard Error 0.75
|
59.3 percentage of time
Standard Error 0.77
|
|
Percentage of Time With Sensor Glucose Values Between 70 and 180 mg/dL Efficacy Estimand at Week 16
24-Hour
|
57.5 percentage of time
Standard Error 0.76
|
57.9 percentage of time
Standard Error 0.79
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: All randomized participants with evaluable hypoglycemic data.
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience coma with or without seizures, and may require parenteral therapy. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group \*36525.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=217 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=214 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Rate of Severe Hypoglycemia at Week 16
|
2.95 Events per 100 participant years
|
6.36 Events per 100 participant years
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: All randomized participants with evaluable hypoglycemic data.
Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of \<54 mg/dL \[3.0 millimole per liter (mmol/L)\]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=217 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=214 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Rate of Documented Symptomatic Hypoglycemia at Week 16
|
30.7 Events per participant per year
Standard Error 2.48
|
24.6 Events per participant per year
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and at least one post-baseline 1,5-AG data.
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (Pooled Country + Hemoglobin A1C Stratum + Personal continuous glucose Monitor (CGM) or Flash glucose monitor (FGM) use during study flag), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=202 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=185 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 16
|
0.16 milligram per liter (mg/L)
Standard Error 0.116
|
0.11 milligram per liter (mg/L)
Standard Error 0.121
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and at least one post-baseline SMBG data.
SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, HbA1c stratum : less than or equal to (≤)7.5%, greater than (\>)7.5% and participant's personal CGM or FGM use during the study), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=195 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=178 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Morning Premeal
|
0.2 mg/dL
Standard Error 2.76
|
0.5 mg/dL
Standard Error 2.89
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Morning 1-hour Postmeal
|
-3.1 mg/dL
Standard Error 3.15
|
-12.9 mg/dL
Standard Error 3.31
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Morning 2-hour Postmeal
|
-2.7 mg/dL
Standard Error 3.04
|
-2.9 mg/dL
Standard Error 3.21
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Midday Premeal
|
-0.6 mg/dL
Standard Error 2.82
|
4.9 mg/dL
Standard Error 2.98
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Midday 1-hour Postmeal
|
-4.2 mg/dL
Standard Error 2.85
|
-6.3 mg/dL
Standard Error 3.03
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Midday 2-hour Postmeal
|
-0.2 mg/dL
Standard Error 3.14
|
4.4 mg/dL
Standard Error 3.31
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Evening Premeal
|
3.8 mg/dL
Standard Error 3.28
|
17.5 mg/dL
Standard Error 3.41
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Evening 1-hour Postmeal
|
2.6 mg/dL
Standard Error 3.21
|
8.6 mg/dL
Standard Error 3.41
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Evening 2-hour Postmeal
|
6.3 mg/dL
Standard Error 3.36
|
12.2 mg/dL
Standard Error 3.54
|
|
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 16
Bedtime
|
8.6 mg/dL
Standard Error 6.37
|
19.0 mg/dL
Standard Error 6.58
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with baseline and at least one post-baseline basal insulin dose data.
LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=199 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=186 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Change From Baseline in Insulin Dose at Week 16
Daily Basal Insulin Dose
|
-0.2 units per day (U/day)
Standard Error 0.43
|
-0.1 units per day (U/day)
Standard Error 0.44
|
|
Change From Baseline in Insulin Dose at Week 16
Daily Bolus Insulin Dose
|
0.8 units per day (U/day)
Standard Error 0.66
|
-1.0 units per day (U/day)
Standard Error 0.68
|
|
Change From Baseline in Insulin Dose at Week 16
Total Daily Insulin Dose
|
0.6 units per day (U/day)
Standard Error 0.80
|
-1.1 units per day (U/day)
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: All randomized participants with non-missing baseline value and at least one non-missing post-baseline value.
The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit. LS mean was determined by MMRM model with covariates: Baseline + Pooled Country + + Hemoglobin A1C Stratum + Personal CGM or FGM use during study flag + Treatment + Time + Treatment\*Time (Type III sum of squares). The analysis included data prior to permanent discontinuation of study drug.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=195 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=183 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Change From Baseline in Bolus/Total Insulin Dose Ratio at Week 16
|
0.6 Percentage of bolus/total insulin dose
Standard Error 0.66
|
-1.3 Percentage of bolus/total insulin dose
Standard Error 0.68
|
SECONDARY outcome
Timeframe: Week 16Population: All randomized participants with baseline and at least one post-baseline HbA1c \<7% data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to the post-baseline data.
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=207 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=191 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Percentage of Participants With HbA1c <7%
|
20.77 Percentage of participants
|
18.85 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: All randomized participants with baseline and at least one post-baseline value.
Percentage of participants with at least 1 pump occlusion alarm that leads to an unplanned infusion set change was evaluated.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=212 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=210 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Pump Occlusion Alarm That Leads to an Unplanned Infusion Set Change
|
12.7 Percentage of participants
|
14.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 16Population: All randomized participants with baseline and at least one post-baseline value.
Percentage of participants with at least 1 event of unexplained hyperglycemia \>300 milligrams per deciliter (mg/dL) confirmed by SMBG that leads to an unplanned infusion set change was evaluated.
Outcome measures
| Measure |
Insulin Lispro (Humalog)
n=217 Participants
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=215 Participants
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Event of Unexplained Hyperglycemia >300 mg/dL Confirmed by SMBG That Leads to an Unplanned Infusion Set Change
|
18.4 Percentage of participants
|
16.3 Percentage of participants
|
Adverse Events
Insulin Lispro (Humalog) Lead-in
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Insulin Lispro (Humalog)
Serious events: 10 serious events
Other events: 31 other events
Deaths: 0 deaths
Ultra-Rapid Lispro
Serious events: 17 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro (Humalog) Lead-in
n=471 participants at risk
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Insulin Lispro (Humalog)
n=217 participants at risk
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=215 participants at risk
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.93%
2/215 • Number of events 2 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Vitreous haemorrhage
|
0.21%
1/471 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal dilatation
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.21%
1/471 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Impaired healing
|
0.21%
1/471 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Abscess limb
|
0.21%
1/471 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.21%
1/471 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Foreign body in respiratory tract
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.00%
0/261 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.84%
1/119 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/120 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Intraocular pressure increased
|
0.21%
1/471 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.4%
3/217 • Number of events 3 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.4%
3/215 • Number of events 3 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.92%
2/217 • Number of events 2 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.3%
5/215 • Number of events 6 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.46%
1/217 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/215 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/471 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/217 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.47%
1/215 • Number of events 1 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
Insulin Lispro (Humalog) Lead-in
n=471 participants at risk
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Insulin Lispro (Humalog)
n=217 participants at risk
Participants received individual dose of 100 U/mL insulin lispro (Humalog) by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
Ultra-Rapid Lispro
n=215 participants at risk
Participants received individual dose of 100 U/mL ultra rapid lispro by CSII; where mealtime boluses were delivered 0 to 2 minutes prior to the start of each meal, with basal infusion rates 24 hours/day, and correction boluses as necessary.
|
|---|---|---|---|
|
General disorders
Infusion site pain
|
0.64%
3/471 • Number of events 3 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.8%
6/217 • Number of events 6 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.3%
35/215 • Number of events 41 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Infusion site reaction
|
1.3%
6/471 • Number of events 6 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.4%
16/217 • Number of events 16 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
21.9%
47/215 • Number of events 60 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
6/471 • Number of events 6 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.0%
13/217 • Number of events 14 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
6.0%
13/215 • Number of events 15 • Up to 20 Weeks
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place