Trial Outcomes & Findings for Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use (NCT NCT01109316)
NCT ID: NCT01109316
Last Updated: 2019-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
132 participants
Primary outcome timeframe
8 weeks of each treatment
Results posted on
2019-03-27
Participant Flow
Participant milestones
| Measure |
Sequence A (L2D/L6D/A6D)
Participants received Insulin Lispro 2D (L2D (Days)), Insulin Lispro 6D (L6D) and Insulin Aspart 6D (A6D) as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D
|
Sequence B (L2D/A6D/L6D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:
Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D.
|
Sequence C (L6D/L2D/A6D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D.
|
Sequence D (L6D/A6D/L2D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:
Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D.
|
Sequence E (A6D/L2D/L6D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D.
|
Sequence F (A6D/L6D/L2D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D.
|
|---|---|---|---|---|---|---|
|
Study Period 1
STARTED
|
22
|
22
|
22
|
22
|
22
|
22
|
|
Study Period 1
Received at Least One Dose of Study Drug
|
22
|
22
|
22
|
22
|
22
|
20
|
|
Study Period 1
COMPLETED
|
22
|
22
|
19
|
21
|
20
|
20
|
|
Study Period 1
NOT COMPLETED
|
0
|
0
|
3
|
1
|
2
|
2
|
|
Study Period 2
STARTED
|
22
|
22
|
19
|
21
|
20
|
20
|
|
Study Period 2
COMPLETED
|
21
|
21
|
18
|
20
|
20
|
19
|
|
Study Period 2
NOT COMPLETED
|
1
|
1
|
1
|
1
|
0
|
1
|
|
Study Period 3
STARTED
|
21
|
21
|
18
|
20
|
20
|
19
|
|
Study Period 3
COMPLETED
|
20
|
21
|
18
|
20
|
18
|
19
|
|
Study Period 3
NOT COMPLETED
|
1
|
0
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Sequence A (L2D/L6D/A6D)
Participants received Insulin Lispro 2D (L2D (Days)), Insulin Lispro 6D (L6D) and Insulin Aspart 6D (A6D) as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D
|
Sequence B (L2D/A6D/L6D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:
Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D.
|
Sequence C (L6D/L2D/A6D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D.
|
Sequence D (L6D/A6D/L2D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:
Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D.
|
Sequence E (A6D/L2D/L6D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D.
|
Sequence F (A6D/L6D/L2D)
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D.
|
|---|---|---|---|---|---|---|
|
Study Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Study Period 1
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Study Period 1
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Study Period 1
Sponsor Decision
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Study Period 2
Entry Criteria Not Met
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Study Period 2
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Study Period 2
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Study Period 2
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Study Period 3
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Study Period 3
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Baseline characteristics by cohort
| Measure |
Sequence A (L2D/L6D/A6D)
n=22 Participants
Participants received Insulin Lispro 2D (2 Days), Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Lispro 2D, Period 2: Lispro 6D and Period 3: Insulin Aspart 6D.
|
Sequence B (L2D/A6D/L6D)
n=22 Participants
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:
Insulin Lispro 2D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 6D.
|
Sequence C (L6D/L2D/A6D)
n=22 Participants
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Lispro 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Aspart 6D.
|
Sequence D (L6D/A6D/L2D)
n=22 Participants
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1:
Insulin Lispro 6D, Period 2: Insulin Aspart 6D and Period 3: Insulin Lispro 2D.
|
Sequence E (A6D/L2D/L6D)
n=22 Participants
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 2D and Period 3: Insulin Lispro 6D.
|
Sequence F (A6D/L6D/L2D)
n=22 Participants
Participants received Insulin Lispro 2D, Insulin Lispro 6D and Insulin Aspart 6D as per below dosing schedule Period 1: Insulin Aspart 6D, Period 2: Insulin Lispro 6D and Period 3: Insulin Lispro 2D.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.28 years
STANDARD_DEVIATION 19.62 • n=5 Participants
|
36.61 years
STANDARD_DEVIATION 14.07 • n=7 Participants
|
42.63 years
STANDARD_DEVIATION 17.39 • n=5 Participants
|
47.23 years
STANDARD_DEVIATION 18.78 • n=4 Participants
|
41.15 years
STANDARD_DEVIATION 14.22 • n=21 Participants
|
38.34 years
STANDARD_DEVIATION 14.93 • n=8 Participants
|
41.37 years
STANDARD_DEVIATION 16.68 • n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
96 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
120 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
129 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
132 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 8 weeks of each treatmentPopulation: All randomized participants who completed at least one post-randomization visit. Those included in the Primary analysis had to have at least one reservoir in-use cycle with an SMBG measurement on Day 6 during the pre-specified collection period.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=119 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=116 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=117 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Mean of Last Five 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Day 2 for Insulin Lispro 2D and Day 6 for Insulin Aspart 6D Pump Reservoir In-use
|
9.03 millimoles per liter (mmol/L)
Standard Deviation 2.17
|
9.33 millimoles per liter (mmol/L)
Standard Deviation 2.31
|
8.72 millimoles per liter (mmol/L)
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who completed at least one post-randomization visit and one SMBG measurement on Day 2 for insulin lispro 2 day or Day 6 for the respective treatment arm: insulin lispro 6 day and insulin aspart 6 day.
Mean SMBG for combined periods; all reported SMBG values on days 1-6 for Insulin Lispro 6 Day and Insulin Aspart 6 Day, and days 1-2 for Insulin Lispro 2 Day.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=122 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=122 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=122 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Mean SMBG
|
8.79 mmol/L
Standard Deviation 2.73
|
9.01 mmol/L
Standard Deviation 2.87
|
8.83 mmol/L
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who completed at least one post-randomization visit. Participants included in insulin analyses are only those for whom data existed regarding insulin dose.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=117 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=117 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=117 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Daily Bolus Insulin
|
14.33 Units (U) of insulin
Standard Deviation 5.88
|
14.51 Units (U) of insulin
Standard Deviation 6.33
|
14.44 Units (U) of insulin
Standard Deviation 6.11
|
|
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Daily Basal Insulin
|
18.62 Units (U) of insulin
Standard Deviation 9.32
|
18.77 Units (U) of insulin
Standard Deviation 8.89
|
18.34 Units (U) of insulin
Standard Deviation 8.72
|
|
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Daily Total Insulin
|
32.36 Units (U) of insulin
Standard Deviation 10.28
|
32.37 Units (U) of insulin
Standard Deviation 10.12
|
31.99 Units (U) of insulin
Standard Deviation 10.15
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks for each treatmentPopulation: All randomized participants who completed at least one post-randomization visit, and had a baseline and a post-randomization HbA1c measurement for the respective treatment period. Last Observation Carried Forward (LOCF) method was utilized in this analysis.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=121 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=120 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=121 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values
|
-0.04 percentage of glycosylated hemoglobin
Standard Deviation 0.59
|
0.06 percentage of glycosylated hemoglobin
Standard Deviation 0.56
|
0.00 percentage of glycosylated hemoglobin
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=121 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=120 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=121 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%
HbA1c <7%
|
40 participants
|
38 participants
|
44 participants
|
|
Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%
HbA1c ≤6.5%
|
21 participants
|
16 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.
Hyperglycemia was defined as an event with (1) a measured blood glucose concentration \>250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration \>300 mg/dL (16.7 mmol/L) and \<3 hours after eating.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=122 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Hyperglycemia
|
99.2 percentage of participants
|
98.4 percentage of participants
|
98.4 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who received at least one dose of study drug. Participants included in hyperglycemia analyses are only those for whom data existed regarding hyperglycemia.
Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration \>250 milligrams per deciliter (mg/dL) (13.9 mmol/L) and ≥3 hours after eating, or (2) a measured blood glucose concentration \>300 mg/dL (16.7 mmol/L) and \<3 hours after eating. Rate is presented as the number of hyperglycemic episodes adjusted for 30 days.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=122 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Hyperglycemic Episode Rate Per 30 Days
|
15.91 hyperglycemic episodes per 30 days
Standard Deviation 12.78
|
16.91 hyperglycemic episodes per 30 days
Standard Deviation 13.98
|
15.76 hyperglycemic episodes per 30 days
Standard Deviation 12.04
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.
Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=122 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Pump Complications
Pump Complication: Premature Reservoir Change
|
23.8 percentage of participants
|
38.6 percentage of participants
|
36.3 percentage of participants
|
|
Percentage of Participants With Pump Complications
Pump Complication: Premature Infusion Set Change
|
42.6 percentage of participants
|
59.1 percentage of participants
|
56.5 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who completed at least one post-randomization visit. Participants included in pump complication analyses are only those for whom data existed regarding pump complications.
Overall Pump Complications were any combination of: tubing clogged, kinked, disconnected, pulled out, blood in tubing; too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm; at site - skin abscess, excessive redness, swelling (not nodule), bleeding, bruising; reservoir change (infusion set change reason only); and other. When either a reservoir change or an infusion set change was reported, participants were questioned whether change was early (prior to 6 days for L6D or A6D, or prior to 2 days for L2D). If 'yes', then recorded as premature change.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=122 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Pump Complication Rate Per 30 Days
Pump Complication: Premature Reservoir Change
|
0.16 pump complications per 30 days
Standard Deviation 0.34
|
0.40 pump complications per 30 days
Standard Deviation 0.76
|
0.51 pump complications per 30 days
Standard Deviation 1.05
|
|
Pump Complication Rate Per 30 Days
Pump Complication: Premature Infusion Set Change
|
0.44 pump complications per 30 days
Standard Deviation 0.65
|
0.84 pump complications per 30 days
Standard Deviation 1.18
|
0.94 pump complications per 30 days
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.
Hypoglycemia was defined as an event which was associated with 1. reported signs and symptoms of hypoglycemia, and/or 2. a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L).
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=122 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Hypoglycemia
|
100.0 percentage of participants
|
100.0 percentage of participants
|
99.2 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeks for each treatmentPopulation: All randomized participants who received at least one dose of study drug. Participants included in hypoglycemia analyses are only those for whom data existed regarding hypoglycemia.
Hypoglycemia was defined as an event which was associated with 1. reported signs and symptoms of hypoglycemia, and/or 2. a documented blood glucose (BG) concentration of ≤ 70 mg/dL (3.9 mmol/L). Rate is presented as the number of hypoglycemic episodes adjusted for 30 days.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=122 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Hypoglycemia Episode Rate Per 30 Days
|
17.90 hypoglycemic episodes per 30 days
Standard Deviation 11.13
|
15.66 hypoglycemic episodes per 30 days
Standard Deviation 12.29
|
17.52 hypoglycemic episodes per 30 days
Standard Deviation 11.76
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks for each treatmentPopulation: All randomized participants who received at least one dose of study drug and had both baseline and post-baseline weight measurements for the respective treatment period.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=121 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=122 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=122 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight
|
0.44 kilograms (kg)
Standard Deviation 2.13
|
0.34 kilograms (kg)
Standard Deviation 2.04
|
0.65 kilograms (kg)
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks for each treatmentPopulation: All randomized participants who received at least one dose of study drug and had both baseline and post-baseline blood pressure measurements for the respective treatment period.
Outcome measures
| Measure |
Insulin Lispro 2 Day
n=121 Participants
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=122 Participants
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=123 Participants
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure
Systolic Blood Pressure (SBP)
|
0.80 mmHg
Standard Deviation 12.82
|
0.80 mmHg
Standard Deviation 12.52
|
-1.07 mmHg
Standard Deviation 12.06
|
|
Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure
Diastolic Blood Pressure (DBP)
|
-0.14 mmHg
Standard Deviation 8.24
|
1.37 mmHg
Standard Deviation 7.62
|
-0.33 mmHg
Standard Deviation 7.88
|
Adverse Events
Insulin Lispro 2 Day
Serious events: 3 serious events
Other events: 71 other events
Deaths: 0 deaths
Insulin Lispro 6 Day
Serious events: 8 serious events
Other events: 68 other events
Deaths: 0 deaths
Insulin Aspart 6 Day
Serious events: 10 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro 2 Day
n=122 participants at risk
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 participants at risk
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 participants at risk
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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
Sternal fracture
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/127 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
4/127 • Number of events 5 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.3%
9/124 • Number of events 11 • Up To 8 weeks
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
Cervical myelopathy
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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
Hydrocephalus
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/90 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/90 • Number of events 1 • Up To 8 weeks
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 2 Day
n=122 participants at risk
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
|
Insulin Lispro 6 Day
n=127 participants at risk
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
|
Insulin Aspart 6 Day
n=124 participants at risk
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
3.3%
4/122 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/127 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
4/124 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
5/122 • Number of events 5 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.2%
4/124 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chills
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
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 erythema
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
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 haemorrhage
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 3 • Up To 8 weeks
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 mass
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.9%
5/127 • Number of events 5 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
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
Ear infection
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/127 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
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
Fungal infection
|
1.6%
2/122 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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
|
4.1%
5/122 • Number of events 5 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/124 • Number of events 3 • Up To 8 weeks
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
Influenza
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
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
|
8.2%
10/122 • Number of events 11 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
8.7%
11/127 • Number of events 12 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
10.5%
13/124 • Number of events 14 • Up To 8 weeks
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
Pharyngitis
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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
Pharyngitis streptococcal
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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
Sinusitis
|
3.3%
4/122 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/124 • Number of events 3 • Up To 8 weeks
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
Upper respiratory tract infection
|
8.2%
10/122 • Number of events 10 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.7%
6/127 • Number of events 6 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
7.3%
9/124 • Number of events 10 • Up To 8 weeks
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
Urinary tract infection
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/124 • Number of events 4 • Up To 8 weeks
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
Viral infection
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
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
Contusion
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Urine ketone body present
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 3 • Up To 8 weeks
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
Hyperlipidaemia
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
4/127 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/124 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.5%
3/122 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/122 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
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
Dizziness
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/124 • Number of events 3 • Up To 8 weeks
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
Headache
|
4.9%
6/122 • Number of events 7 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/127 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/124 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
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
Cough
|
4.1%
5/122 • Number of events 5 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/127 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
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
Dyspnoea
|
2.5%
3/122 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
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
Nasal congestion
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/127 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
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
Oropharyngeal pain
|
4.1%
5/122 • Number of events 5 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
4/127 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
4.0%
5/124 • Number of events 5 • Up To 8 weeks
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
Paranasal sinus hypersecretion
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.81%
1/124 • Number of events 1 • Up To 8 weeks
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
Rhinitis seasonal
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/127 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
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
Sinus congestion
|
2.5%
3/122 • Number of events 3 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
3.1%
4/127 • Number of events 4 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
2.4%
3/124 • Number of events 3 • Up To 8 weeks
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
Throat irritation
|
1.6%
2/122 • Number of events 2 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/127 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/124 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.82%
1/122 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.79%
1/127 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.6%
2/124 • Number of events 2 • Up To 8 weeks
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
Vulvovaginal Mycotic Infection
|
0.00%
0/90 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/93 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/90 • Number of events 1 • Up To 8 weeks
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
Smear Cervix Abnormal
|
0.00%
0/90 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
1.1%
1/93 • Number of events 1 • Up To 8 weeks
There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/90 • Up To 8 weeks
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
Restriction type: GT60