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Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use

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ClinicalTrials.gov Identifier: NCT01109316
Recruitment Status : Completed
First Posted : April 23, 2010
Results First Posted : October 30, 2012
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Insulin lispro 2 day reservoir in-use
Drug: Insulin lispro 6 day reservoir in-use
Drug: Insulin aspart 6 day reservoir in-use
Enrollment 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequence A (L2D/L6D/A6D) Sequence B (L2D/A6D/L6D) Sequence C (L6D/L2D/A6D) Sequence D (L6D/A6D/L2D) Sequence E (A6D/L2D/L6D) Sequence F (A6D/L6D/L2D)
Hide Arm/Group Description 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

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.

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.

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.

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. 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.
Period Title: Study Period 1
Started 22 22 22 22 22 22
Received at Least One Dose of Study Drug 22 22 22 22 22 20
Completed 22 22 19 21 20 20
Not Completed 0 0 3 1 2 2
Reason Not Completed
Adverse Event             0             0             1             0             0             0
Lost to Follow-up             0             0             1             1             0             0
Withdrawal by Subject             0             0             1             0             2             0
Sponsor Decision             0             0             0             0             0             2
Period Title: Study Period 2
Started 22 22 19 21 20 20
Completed 21 21 18 20 20 19
Not Completed 1 1 1 1 0 1
Reason Not Completed
Entry Criteria Not Met             0             1             0             0             0             0
Physician Decision             0             0             0             1             0             0
Protocol Violation             1             0             0             0             0             0
Withdrawal by Subject             0             0             1             0             0             1
Period Title: Study Period 3
Started 21 21 18 20 20 19
Completed 20 21 18 20 18 19
Not Completed 1 0 0 0 2 0
Reason Not Completed
Lost to Follow-up             0             0             0             0             1             0
Withdrawal by Subject             1             0             0             0             1             0
Arm/Group Title Sequence A (L2D/L6D/A6D) Sequence B (L2D/A6D/L6D) Sequence C (L6D/L2D/A6D) Sequence D (L6D/A6D/L2D) Sequence E (A6D/L2D/L6D) Sequence F (A6D/L6D/L2D) Total
Hide Arm/Group Description 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.

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.

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.

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.

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. 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 of all reporting groups
Overall Number of Baseline Participants 22 22 22 22 22 22 132
Hide Baseline Analysis Population Description
All randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 22 participants 22 participants 22 participants 22 participants 132 participants
42.28  (19.62) 36.61  (14.07) 42.63  (17.39) 47.23  (18.78) 41.15  (14.22) 38.34  (14.93) 41.37  (16.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 22 participants 22 participants 22 participants 22 participants 132 participants
Female 15 16 15 14 18 18 96
Male 7 6 7 8 4 4 36
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 22 participants 22 participants 22 participants 22 participants 132 participants
Hispanic or Latino 1 4 1 0 3 3 12
Not Hispanic or Latino 21 18 21 22 19 19 120
Unknown or Not Reported 0 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 22 participants 22 participants 22 participants 22 participants 132 participants
American Indian or Alaska Native 0 0 0 0 0 0 0
Asian 0 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0
Black or African American 0 1 0 0 0 0 1
White 22 21 22 21 22 21 129
More than one race 0 0 0 1 0 1 2
Unknown or Not Reported 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 22 participants 22 participants 22 participants 22 participants 132 participants
22 22 22 22 22 22 132
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 8 weeks of each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 119 116 117
Mean (Standard Deviation)
Unit of Measure: millimoles per liter (mmol/L)
9.03  (2.17) 9.33  (2.31) 8.72  (1.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments This was the primary gated analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin of 0.6 mmol/L was used.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.20 to 0.76
Estimation Comments Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age stratum + Baseline HbA1c.
2.Secondary Outcome
Title Mean SMBG
Hide Description 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.
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 122 122 122
Mean (Standard Deviation)
Unit of Measure: mmol/L
8.79  (2.73) 9.01  (2.87) 8.83  (2.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin of 0.6 mmol/L was used.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.07 to 0.52
Estimation Comments Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin of 0.6 mmol/L was used.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.25
Confidence Interval (2-Sided) 95%
-0.05 to 0.56
Estimation Comments Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Age Stratum + Baseline HbA1c; where participant is treated as a random effect.
3.Secondary Outcome
Title Mean Daily Insulin Dose (Total, Basal, and Bolus)
Hide Description [Not Specified]
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 117 117 117
Mean (Standard Deviation)
Unit of Measure: Units (U) of insulin
Daily Bolus Insulin Number Analyzed 116 participants 115 participants 115 participants
14.33  (5.88) 14.51  (6.33) 14.44  (6.11)
Daily Basal Insulin Number Analyzed 117 participants 117 participants 117 participants
18.62  (9.32) 18.77  (8.89) 18.34  (8.72)
Daily Total Insulin Number Analyzed 117 participants 117 participants 117 participants
32.36  (10.28) 32.37  (10.12) 31.99  (10.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.29 to 0.51
Estimation Comments Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.16
Confidence Interval (2-Sided) 95%
-0.41 to 0.73
Estimation Comments Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.18 to 0.24
Estimation Comments Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.56 to 0.27
Estimation Comments Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.48 to 0.60
Estimation Comments Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.85 to 0.65
Estimation Comments Least Squares Mean Difference of Daily Bolus Insulin = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose + Age Stratum.
4.Secondary Outcome
Title Change From Baseline to 8 Weeks Endpoint for Each Treatment in Hemoglobin A1c (HbA1c) Values
Hide Description [Not Specified]
Time Frame Baseline, 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 121 120 121
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
-0.04  (0.59) 0.06  (0.56) 0.00  (0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.02 to 0.14
Estimation Comments Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
0.01 to 0.18
Estimation Comments Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c.
5.Secondary Outcome
Title Number of Participants Who Achieve or Maintain an HbA1c Less Than or Equal to 6.5% and Less Than 7%
Hide Description [Not Specified]
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 121 120 121
Measure Type: Number
Unit of Measure: participants
HbA1c ≤6.5% 21 16 18
HbA1c <7% 40 38 44
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.50 to 1.75
Estimation Comments Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.29 to 1.67
Estimation Comments Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.56 to 1.41
Estimation Comments Odds Ratio of HbA1c <7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.66 to 1.64
Estimation Comments Odds Ratio of HbA1c <7% for Insulin Lispro 6 Day versus Insulin Lispro 2 Day.
6.Secondary Outcome
Title Percentage of Participants With Hyperglycemia
Hide Description 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.
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 122 127 124
Measure Type: Number
Unit of Measure: percentage of participants
99.2 98.4 98.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
Method Gart's Test
Comments [Not Specified]
7.Secondary Outcome
Title Hyperglycemic Episode Rate Per 30 Days
Hide Description 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.
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 122 127 124
Mean (Standard Deviation)
Unit of Measure: hyperglycemic episodes per 30 days
15.91  (12.78) 16.91  (13.98) 15.76  (12.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments P-value computed using a negative binomial test including factors for treatment, period, and sequence.
Method Negative Binomial Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments P-value computed using a negative binomial test including factors for treatment, period, and sequence.
Method Negative Binomial Test
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Pump Complications
Hide Description 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.
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 122 127 124
Measure Type: Number
Unit of Measure: percentage of participants
Pump Complication: Premature Reservoir Change 23.8 38.6 36.3
Pump Complication: Premature Infusion Set Change 42.6 59.1 56.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.736
Comments P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
Method Gart's Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value for Premature Reservoir Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
Method Gart's Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
Method Gart's Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments P-value for Premature Infusion Set Change. P-value computed using Treatment comparison Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used for p-value calculation.
Method Gart's Test
Comments [Not Specified]
9.Secondary Outcome
Title Pump Complication Rate Per 30 Days
Hide Description 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.
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 122 127 124
Mean (Standard Deviation)
Unit of Measure: pump complications per 30 days
Pump Complication: Premature Reservoir Change 0.16  (0.34) 0.40  (0.76) 0.51  (1.05)
Pump Complication: Premature Infusion Set Change 0.44  (0.65) 0.84  (1.18) 0.94  (1.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.
Method Negative Binomial Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Premature Reservoir Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.
Method Negative Binomial Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.737
Comments P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.
Method Negative Binomial Test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Premature Infusion Set Change. P-value is computed using negative binomial test including factors for treatment, period and sequence.
Method Negative Binomial Test
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With Hypoglycemia
Hide Description

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).
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 122 127 124
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 99.2
11.Secondary Outcome
Title Hypoglycemia Episode Rate Per 30 Days
Hide Description

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.
Time Frame 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 122 127 124
Mean (Standard Deviation)
Unit of Measure: hypoglycemic episodes per 30 days
17.90  (11.13) 15.66  (12.29) 17.52  (11.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments P-value is computed using negative binomial test including factors for treatment, period and sequence.
Method Negative Binomial Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments P-value is computed using negative binomial test including factors for treatment, period and sequence.
Method Negative Binomial Test
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to 8 Weeks Endpoint for Each Treatment in Weight
Hide Description [Not Specified]
Time Frame Baseline, 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 121 122 122
Mean (Standard Deviation)
Unit of Measure: kilograms (kg)
0.44  (2.13) 0.34  (2.04) 0.65  (2.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.060
Comments P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.
Method Crossover Model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Body Weight.
Method Crossover Model
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to 8 Weeks Endpoint for Each Treatment in Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline, 8 weeks for each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description:
Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
Overall Number of Participants Analyzed 121 122 123
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Blood Pressure (SBP) 0.80  (12.82) 0.80  (12.52) -1.07  (12.06)
Diastolic Blood Pressure (DBP) -0.14  (8.24) 1.37  (7.62) -0.33  (7.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.
Method Crossover Model
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments P-value is for Systolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Systolic Blood Pressure.
Method Crossover Model
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 6 Day, Insulin Aspart 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.
Method Crossover Model
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Insulin Lispro 2 Day, Insulin Lispro 6 Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments P-value is for Diastolic Blood Pressure. P-value computed using crossover model. Response = Treatment + Sequence + Period + Age stratum + Baseline Diastolic Blood Pressure.
Method Crossover Model
Comments [Not Specified]
Time Frame Up To 8 weeks
Adverse Event Reporting Description There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
 
Arm/Group Title Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Hide Arm/Group Description Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period. Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks. Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
All-Cause Mortality
Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/122 (2.46%)      8/127 (6.30%)      10/124 (8.06%)    
Gastrointestinal disorders       
Oesophagitis  1  0/122 (0.00%)  0 1/127 (0.79%)  1 0/124 (0.00%)  0
Injury, poisoning and procedural complications       
Sternal fracture  1  0/122 (0.00%)  0 1/127 (0.79%)  1 0/124 (0.00%)  0
Metabolism and nutrition disorders       
Diabetic ketoacidosis  1  0/122 (0.00%)  0 3/127 (2.36%)  4 0/124 (0.00%)  0
Hypoglycaemia  1 [1]  2/122 (1.64%)  2 4/127 (3.15%)  5 9/124 (7.26%)  11
Nervous system disorders       
Cervical myelopathy  1  1/122 (0.82%)  1 0/127 (0.00%)  0 0/124 (0.00%)  0
Hydrocephalus  1  0/122 (0.00%)  0 1/127 (0.79%)  1 0/124 (0.00%)  0
Reproductive system and breast disorders       
Ovarian cyst  1  0/90 (0.00%)  0 0/93 (0.00%)  0 1/90 (1.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
[1]
These events were severe hypoglycemic events.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Insulin Lispro 2 Day Insulin Lispro 6 Day Insulin Aspart 6 Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   71/122 (58.20%)      68/127 (53.54%)      71/124 (57.26%)    
Gastrointestinal disorders       
Diarrhoea  1  1/122 (0.82%)  1 0/127 (0.00%)  0 2/124 (1.61%)  2
Nausea  1  4/122 (3.28%)  4 3/127 (2.36%)  3 4/124 (3.23%)  4
Toothache  1  0/122 (0.00%)  0 0/127 (0.00%)  0 2/124 (1.61%)  2
Vomiting  1  5/122 (4.10%)  5 2/127 (1.57%)  2 4/124 (3.23%)  4
General disorders       
Asthenia  1  0/122 (0.00%)  0 2/127 (1.57%)  2 1/124 (0.81%)  1
Chills  1  2/122 (1.64%)  2 0/127 (0.00%)  0 1/124 (0.81%)  1
Infusion site erythema  1  1/122 (0.82%)  1 1/127 (0.79%)  1 2/124 (1.61%)  2
Infusion site haemorrhage  1  1/122 (0.82%)  1 1/127 (0.79%)  1 2/124 (1.61%)  3
Infusion site mass  1  1/122 (0.82%)  1 1/127 (0.79%)  1 2/124 (1.61%)  2
Pyrexia  1  2/122 (1.64%)  2 5/127 (3.94%)  5 2/124 (1.61%)  2
Infections and infestations       
Ear infection  1  1/122 (0.82%)  1 3/127 (2.36%)  3 1/124 (0.81%)  1
Fungal infection  1  2/122 (1.64%)  3 2/127 (1.57%)  2 0/124 (0.00%)  0
Gastroenteritis viral  1  5/122 (4.10%)  5 2/127 (1.57%)  2 3/124 (2.42%)  3
Influenza  1  1/122 (0.82%)  1 1/127 (0.79%)  1 2/124 (1.61%)  2
Nasopharyngitis  1  10/122 (8.20%)  11 11/127 (8.66%)  12 13/124 (10.48%)  14
Pharyngitis  1  0/122 (0.00%)  0 2/127 (1.57%)  2 0/124 (0.00%)  0
Pharyngitis streptococcal  1  0/122 (0.00%)  0 2/127 (1.57%)  2 0/124 (0.00%)  0
Sinusitis  1  4/122 (3.28%)  4 1/127 (0.79%)  1 3/124 (2.42%)  3
Upper respiratory tract infection  1  10/122 (8.20%)  10 6/127 (4.72%)  6 9/124 (7.26%)  10
Urinary tract infection  1  1/122 (0.82%)  1 2/127 (1.57%)  2 3/124 (2.42%)  4
Viral infection  1  1/122 (0.82%)  1 2/127 (1.57%)  2 1/124 (0.81%)  1
Vulvovaginal Mycotic Infection  1  0/90 (0.00%)  0 0/93 (0.00%)  0 1/90 (1.11%)  1
Smear Cervix Abnormal  1  0/90 (0.00%)  0 1/93 (1.08%)  1 0/90 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  2/122 (1.64%)  2 1/127 (0.79%)  1 1/124 (0.81%)  1
Investigations       
Urine ketone body present  1  0/122 (0.00%)  0 1/127 (0.79%)  1 2/124 (1.61%)  3
Metabolism and nutrition disorders       
Hyperlipidaemia  1  2/122 (1.64%)  2 1/127 (0.79%)  1 1/124 (0.81%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/122 (1.64%)  2 4/127 (3.15%)  4 3/124 (2.42%)  3
Back pain  1  2/122 (1.64%)  2 2/127 (1.57%)  2 2/124 (1.61%)  2
Muscle spasms  1  3/122 (2.46%)  3 0/127 (0.00%)  0 0/124 (0.00%)  0
Musculoskeletal pain  1  0/122 (0.00%)  0 2/127 (1.57%)  3 0/124 (0.00%)  0
Myalgia  1  0/122 (0.00%)  0 2/127 (1.57%)  2 0/124 (0.00%)  0
Neck pain  1  1/122 (0.82%)  1 2/127 (1.57%)  2 1/124 (0.81%)  1
Rotator cuff syndrome  1  1/122 (0.82%)  1 2/127 (1.57%)  2 2/124 (1.61%)  2
Tendonitis  1  2/122 (1.64%)  2 2/127 (1.57%)  2 1/124 (0.81%)  1
Nervous system disorders       
Dizziness  1  1/122 (0.82%)  1 1/127 (0.79%)  1 3/124 (2.42%)  3
Headache  1  6/122 (4.92%)  7 3/127 (2.36%)  3 3/124 (2.42%)  3
Psychiatric disorders       
Depression  1  2/122 (1.64%)  2 2/127 (1.57%)  2 2/124 (1.61%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  1  5/122 (4.10%)  5 3/127 (2.36%)  3 1/124 (0.81%)  1
Dyspnoea  1  3/122 (2.46%)  3 0/127 (0.00%)  0 0/124 (0.00%)  0
Nasal congestion  1  1/122 (0.82%)  1 3/127 (2.36%)  3 1/124 (0.81%)  1
Oropharyngeal pain  1  5/122 (4.10%)  5 4/127 (3.15%)  4 5/124 (4.03%)  5
Paranasal sinus hypersecretion  1  2/122 (1.64%)  2 0/127 (0.00%)  0 1/124 (0.81%)  1
Rhinitis seasonal  1  2/122 (1.64%)  2 2/127 (1.57%)  2 2/124 (1.61%)  2
Sinus congestion  1  3/122 (2.46%)  3 4/127 (3.15%)  4 3/124 (2.42%)  3
Throat irritation  1  2/122 (1.64%)  2 0/127 (0.00%)  0 0/124 (0.00%)  0
Skin and subcutaneous tissue disorders       
Subcutaneous nodule  1  1/122 (0.82%)  1 1/127 (0.79%)  1 2/124 (1.61%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Input to primary endpoint measurements (SMBG) contained approximately 40% missing data. Several analyses to account for missing data have been conducted and results from these additional analyses were consistent with results of original analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01109316     History of Changes
Other Study ID Numbers: 12174
F3Z-MC-IOPV ( Other Identifier: Eli Lilly and Company )
First Submitted: April 19, 2010
First Posted: April 23, 2010
Results First Submitted: August 8, 2012
Results First Posted: October 30, 2012
Last Update Posted: March 27, 2019