Insulin Lispro 6 Days Versus Insulin Aspart 6 Days in Pump Use
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01134107
Collaborator
(none)
133
15
2
13
8.9
0.7
Study Details
Study Description
Brief Summary
Patients will continue to use their current insulin pump for this study. Patients will receive insulin lispro and insulin aspart during this study. One medication will be taken for 12 weeks and then the other medication for 12 weeks. Neither the patient nor the study doctor will know which medication is being taken at any time. The order in which the two medications are taken will be determined by chance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
133 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Crossover Trial of CSII Reservoir In-use Comparing Insulin Lispro Formulation to Insulin Aspart in Patients With Type 1 Diabetes Mellitus
Study Start Date
:
Nov 1, 2010
Actual Primary Completion Date
:
Dec 1, 2011
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Insulin Lispro 6 Day (6D)
|
Drug: Insulin Lispro 6 Day (6D)
Administered by infusion pump for 12 week treatment period
Other Names:
|
| Active Comparator: Insulin Aspart 6 Day (6D)
|
Drug: Insulin Aspart 6 Day (6D)
Administered by infusion pump for 12 week treatment period
|
Outcome Measures
Primary Outcome Measures
- Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use [Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)]
Secondary Outcome Measures
- Mean SMBG [Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period]
Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D.
- Mean Daily Insulin Dose (Total, Basal, and Bolus) [Days 1-6 for each reservoir cycle throughout each 12-week treatment period]
- Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values [Baseline, endpoint for each 12-week treatment period]
- Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% [Endpoint for each 12-week treatment period]
Other Outcome Measures
- Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) [Baseline, endpoint for each 12-week treatment period]
- Percentage of Participants Having a Hyperglycemic Episode [Days 1-6 for each reservoir cycle throughout each 12-week treatment period]
A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [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
- Hyperglycemic Episode Rate Per 30 Days [Days 1-6 for each reservoir cycle throughout each 12-week treatment period]
Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [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.
- Percentage of Participants With Pump Complications [Days 1-6 for each reservoir cycle throughout each 12-week treatment period]
Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.
- Pump Complications Rate Per 30 Days [Days 1-6 for each reservoir cycle throughout each 12-week treatment period]
Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change.
- Percentage of Participants Having a Hypoglycemic Episode [All days for each reservoir cycle throughout each 12-week treatment period]
A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). All Reported Hypoglycemic Episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)
- Hypoglycemic Episode Rate Per 30 Days [All days for each reservoir cycle throughout each 12-week treatment period]
All Reported Hypoglycemic Episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L)
- Change From Baseline to 12 Week Endpoint for Each Treatment in Weight [Baseline, endpoint for each 12-week treatment period]
- Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure [Baseline, endpoint for each 12-week treatment period]
Eligibility Criteria
Criteria
Ages Eligible for Study:
13 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosed with type 1 diabetes (World Health Organization criteria) for at least 24 months
-
Treated with continuous subcutaneous insulin infusion (CSII) therapy for the previous 6 months
-
Mean total daily insulin dose for 3 days prior to screening less than or equal to 46 units/day if using a 300-Unit reservoir, less than or equal to 30 units/day if using a 200 unit reservoir, or less than or equal to 26 units/day if using a 180 unit reservoir
-
Baseline body mass index (BMI) less than or equal to 35.0 kilograms per meter squared (kg/m2)
-
Baseline glycated hemoglobin A1c (HbA1c) 5% to 9%
Exclusion Criteria:
-
Impaired renal function (serum creatinine greater than or equal to 2.0 milligrams per deciliter (mg/dL))
-
Legal blindness
-
Have had any episode in the 12 months prior to screening of hypoglycemic coma, seizures, or disorientation
-
Have had hypoglycemia unawareness (routinely asymptomatic at blood glucose less than 45 mg/dL [2.5 millimoles per liter (mmol/L)]) in the 12 months prior to screening.
-
Have had any emergency room visits or hospitalizations due to poor glucose control in the 12 months prior to screening.
-
Have had a pump-related infusion site abscess in the 12 months prior to screening.
-
Have had multiple, clinically significant occlusions as judged by the investigator.
-
Have had any infection with Staphylococcus aureus in the past 5 years
-
Have one of the following concomitant diseases: presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, or any other serious disease considered by the investigator to be exclusionary.
-
Participants with malignancy other than basal cell or squamous cell skin cancer who have not yet been treated, are currently being treated, or who were diagnosed less than 5 years ago.
-
Have had a blood transfusion or severe blood loss within the 3 months prior to screening or have known hemoglobinopathy, hemolytic or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with HbA1c methodology.
-
Are receiving chronic systemic glucocorticoid therapy, or have received such therapy within the 4 weeks preceding screening.
-
Have an irregular sleep/wake cycle in the investigator's opinion.
-
Have a known hypersensitivity or allergy to any of the study insulins or their excipients
-
Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
-
Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving off-label use of an investigational drug or device, or currently enrolled in any other type of medical research not to be scientifically or medically compatible with this study.
-
Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Caen | France | 14033 | |
| 2 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Corbeil-Essonnes | France | 91106 | |
| 3 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | La Rochelle | France | 17019 | |
| 4 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Marseille | France | 13009 | |
| 5 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montpellier | France | 34295 | |
| 6 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Narbonne | France | 11108 | |
| 7 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ludwigshafen | Germany | 67059 | |
| 8 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mainz | Germany | 55116 | |
| 9 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Münster | Germany | 48145 | |
| 10 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Neuwied | Germany | 56564 | |
| 11 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Potsdam | Germany | 14469 | |
| 12 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bekescsaba | Hungary | 5600 | |
| 13 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Budapest | Hungary | 1023 | |
| 14 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nyiregyhaza | Hungary | 4400 | |
| 15 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zalaegerszeg | Hungary | 8900 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01134107
Other Study ID Numbers:
- 12175
- F3Z-MC-IOPW
First Posted:
May 31, 2010
Last Update Posted:
Apr 11, 2013
Last Verified:
Apr 1, 2013
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lispro 6D/Aspart 6D | Aspart 6D/Lispro 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks. | Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks. |
| Period Title: Period 1-First Treatment Intervention | ||
| STARTED | 67 | 66 |
| Received at Least One Dose of Study Drug | 66 | 66 |
| COMPLETED | 61 | 61 |
| NOT COMPLETED | 6 | 5 |
| Period Title: Period 1-First Treatment Intervention | ||
| STARTED | 61 | 61 |
| COMPLETED | 57 | 61 |
| NOT COMPLETED | 4 | 0 |
Baseline Characteristics
| Arm/Group Title | Lispro 6D/Aspart 6D | Aspart 6D/Lispro 6D | Total |
|---|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks. | Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks. | Total of all reporting groups |
| Overall Participants | 67 | 66 | 133 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
40.71
(11.91)
|
44.73
(12.96)
|
42.70
(12.56)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
48
71.6%
|
45
68.2%
|
93
69.9%
|
| Male |
19
28.4%
|
21
31.8%
|
40
30.1%
|
| Race/Ethnicity, Customized (participants) [Number] | |||
| White |
67
100%
|
66
100%
|
133
100%
|
| Region of Enrollment (participants) [Number] | |||
| France |
15
22.4%
|
14
21.2%
|
29
21.8%
|
| Hungary |
33
49.3%
|
37
56.1%
|
70
52.6%
|
| Germany |
19
28.4%
|
15
22.7%
|
34
25.6%
|
Outcome Measures
| Title | Mean of Last Six 7-point Self Monitored Blood Glucose (SMBG) Taken on Day 6 for Insulin Lispro 6D and Insulin Aspart 6D Pump Reservoir In-use |
|---|---|
| Description | |
| Time Frame | Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12) |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 118 | 118 |
| Mean (Standard Deviation) [millimoles per liter (mmol/L)] |
8.83
(1.55)
|
8.43
(1.97)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| 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. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.36 | |
| Confidence Interval |
(2-Sided) 95% 0.06 to 0.66 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline HbA1c | |
| Title | Mean SMBG |
|---|---|
| Description | Mean SMBG for combined periods; all reported SMBG values on Days 1-6, Day 2, and Day 6 for Insulin Lispro 6D and Insulin Aspart 6D. |
| Time Frame | Days 1-6 and Day 2 and Day 6 for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who completed at least one post-randomization visit and one SMBG measurement on a Day 6, or Day 2 depending on the analysis, for the respective treatment arm: insulin lispro 6D and insulin aspart 6D. |
| Arm/Group Title | Insulin Lispro 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 126 | 126 |
| SMBG Days 1-6 (N=124, 124) |
8.70
(2.51)
|
8.47
(2.46)
|
| SMBG Day 2 |
8.56
(2.51)
|
8.40
(2.47)
|
| SMBG Day 6 (N=124, 124) |
8.93
(2.68)
|
8.57
(2.64)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority margin of 0.6 mmol/L was used. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.18 | |
| Confidence Interval |
(2-Sided) 95% -0.10 to 0.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Insulin Lispro 6 Day (Day 1-6) minus Insulin Aspart 6 Day (Day 1-6); adjusted for Treatment + Sequence + Period + Baseline HbA1c | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority margin of 0.6 mmol/L was used. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.42 | |
| Confidence Interval |
(2-Sided) 95% 0.25 to 0.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Insulin Lispro 6 Day (Day 6) minus Insulin Lispro 6 Day (Day 2); adjusted for DayGroup + Period + Baseline HbA1c | |
| Title | Mean Daily Insulin Dose (Total, Basal, and Bolus) |
|---|---|
| Description | |
| Time Frame | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 119 | 119 |
| Daily Total Insulin |
32.90
(8.43)
|
32.48
(8.42)
|
| Daily Basal Insulin |
17.83
(5.26)
|
17.71
(5.27)
|
| Daily Bolus Insulin (N=116, 117) |
16.26
(6.21)
|
16.09
(6.23)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.38 | |
| Confidence Interval |
(2-Sided) 95% -0.13 to 0.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Daily Total Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.02 | |
| Confidence Interval |
(2-Sided) 95% -0.26 to 0.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Daily Basal Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.23 | |
| Confidence Interval |
(2-Sided) 95% -0.15 to 0.60 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Daily Bolus Insulin: Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Sequence + Period + Baseline Insulin Basal/Bolus/Total Dose | |
| Title | Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values |
|---|---|
| Description | |
| Time Frame | Baseline, endpoint for each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 127 | 126 |
| Mean (Standard Deviation) [percentage of HbA1c] |
-0.16
(0.54)
|
-0.31
(0.50)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
| Estimated Value | 0.16 | |
| Confidence Interval |
(2-Sided) 95% 0.08 to 0.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Least Squares Mean Difference = Insulin Lispro 6 Day minus Insulin Aspart 6 Day; adjusted for Treatment + Period + Sequence + Baseline HbA1c | |
| Title | Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% |
|---|---|
| Description | |
| Time Frame | Endpoint for each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 127 | 126 |
| HbA1c ≤6.5% |
18
26.9%
|
21
31.8%
|
| HbA1c <7% |
38
56.7%
|
56
84.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.39 to 1.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Odds Ratio of HbA1c ≤6.5% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 0.36 | |
| Confidence Interval |
(2-Sided) 95% 0.20 to 0.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Odds Ratio of HbA1c <7% for Insulin Lispro 6 Day versus Insulin Aspart 6 Day. | |
| Title | Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) |
|---|---|
| Description | |
| Time Frame | Baseline, endpoint for each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 119 | 115 |
| Total Insulin Dose |
5.21
(8.94)
|
4.97
(7.57)
|
| Basal Insulin Dose |
2.34
(3.51)
|
1.91
(3.80)
|
| Bolus Insulin Dose (N=112, 112) |
2.19
(5.58)
|
1.80
(4.70)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.595 |
| Comments | P-value for Total Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Total Dose. | |
| Method | Crossover Model | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.506 |
| Comments | P-value for Basal Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Basal Dose. | |
| Method | Crossover Model | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.790 |
| Comments | P-value for Bolus Insulin Dose computed using Crossover model: Variable = Treatment + Sequence + Period + Baseline Insulin Bolus Dose. | |
| Method | Crossover Model | |
| Comments | ||
| Title | Percentage of Participants Having a Hyperglycemic Episode |
|---|---|
| Description | A hyperglycemic episode was defined as an event with (1) a measured blood glucose concentration >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [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 | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 124 | 124 |
| Number [percentage of participants] |
97.6
145.7%
|
98.4
149.1%
|
| Title | Hyperglycemic Episode Rate Per 30 Days |
|---|---|
| Description | Hyperglycemia was defined as an episode with (1) a measured blood glucose concentration >250 milligrams per deciliter [mg/dL] (13.9 millimoles per liter [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 | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 124 | 124 |
| Mean (Standard Deviation) [hyperglycemic episodes per 30 days] |
15.47
(9.25)
|
14.23
(10.19)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.059 |
| Comments | ||
| Method | negative binomial test | |
| Comments | P-value computed using a negative binomial test including factors for treatment, period and sequence. | |
| Title | Percentage of Participants With Pump Complications |
|---|---|
| Description | Overall pump complications are defined as any combination of the following, reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change. |
| Time Frame | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 127 | 127 |
| Pump Complication: Premature Reservoir Change |
42.5
63.4%
|
44.1
66.8%
|
| Pump Complication: Premature Infusion Set Change |
74.8
111.6%
|
70.9
107.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | P-value for overall pump complications associated with a premature reservoir change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used. | |
| Method | Gart's Test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.472 |
| Comments | P-value for overall pump complications associated with a premature infusion set change computed using Gart's Test. Participants represented in both treatment groups and with non-missing incidence value in each treatment period are used. | |
| Method | Gart's Test | |
| Comments | ||
| Title | Pump Complications Rate Per 30 Days |
|---|---|
| Description | Overall pump complications are defined as any combination of the following reported by the participant: tubing clogged, tubing kinked, tubing disconnect, tubing pulled out, blood in tubing, too much heat, too much cold, empty reservoir, low battery, occlusion alarm, no delivery alarm, skin abscess at site, excessive redness at site, swelling (not nodule) at site, bleeding at site, bruising at site, 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 the change occurred early (prior to 6 days). If he/she responded 'yes', then the reported change was recorded as a premature change. |
| Time Frame | Days 1-6 for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 127 | 127 |
| Pump Complication: Premature Reservoir Change |
0.42
(0.93)
|
0.45
(1.03)
|
| Pump Complication: Premature Infusion Set Change |
1.01
(1.41)
|
1.10
(1.47)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.383 |
| Comments | P-value for Premature Reservoir Change computed using negative binomial test including factors for treatment, period and sequence. | |
| Method | negative binomial test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.499 |
| Comments | P-value for Premature Infusion Set Change computed using negative binomial test including factors for treatment, period and sequence. | |
| Method | negative binomial test | |
| Comments | ||
| Title | Percentage of Participants Having a Hypoglycemic Episode |
|---|---|
| Description | A Documented Hypoglycemic Episode is defined as an event which is associated with a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L). All Reported Hypoglycemic Episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L) |
| Time Frame | All days for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 127 | 127 |
| Documented Hypoglycemic Episodes |
91.3
136.3%
|
93.7
142%
|
| All Reported Hypoglycemic Episodes |
99.2
148.1%
|
99.2
150.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | The p-value is for the Documented Hypoglycemic Episodes category treatment arm comparison. The p-value for the All Reported Hypoglycemic Episodes category could not be generated using Gart's Test. | |
| Method | Gart's Test | |
| Comments | Participants represented in both treatment groups, and with non-missing incidence value in each treatment period, were used for p-value calculation. | |
| Title | Hypoglycemic Episode Rate Per 30 Days |
|---|---|
| Description | All Reported Hypoglycemic Episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <= 70 mg/dL (3.9 mmol/L) |
| Time Frame | All days for each reservoir cycle throughout each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 127 | 127 |
| Mean (Standard Deviation) [hypoglycemic episodes per 30 days] |
16.94
(10.69)
|
18.90
(11.58)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Negative Binomial Test | |
| Comments | P-value computed using a negative binomial test including factors for treatment, period and sequence. | |
| Title | Change From Baseline to 12 Week Endpoint for Each Treatment in Weight |
|---|---|
| Description | |
| Time Frame | Baseline, endpoint for each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 126 | 123 |
| Mean (Standard Deviation) [kilograms (kg)] |
-0.04
(2.25)
|
0.56
(2.15)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Crossover Model | |
| Comments | P-value computed using crossover model. Response = treatment + sequence + period + baseline body weight | |
| Title | Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure |
|---|---|
| Description | |
| Time Frame | Baseline, endpoint for each 12-week treatment period |
Outcome Measure Data
| 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 6D | Insulin Aspart 6D |
|---|---|---|
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period |
| Measure Participants | 126 | 121 |
| Systolic Blood Pressure (SBP) |
-2.25
(14.71)
|
-1.36
(12.12)
|
| Diastolic Blood Pressure (DBP) |
-1.61
(10.36)
|
-1.57
(9.13)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.147 |
| Comments | P-value for the Systolic Blood Pressure (SBP) computed using crossover model. Response = treatment + sequence + period + baseline systolic blood pressure. | |
| Method | Crossover Model | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Insulin Lispro 6D, Insulin Aspart 6D |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.894 |
| Comments | P-value for Diastolic Blood Pressure (DBP) computed using crossover model. Response = treatment + sequence + period + baseline diastolic blood pressure. | |
| Method | Crossover Model | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Insulin Lispro 6D | Insulin Aspart 6D | ||
| Arm/Group Description | Insulin Lispro 6D administered by infusion pump for 12 week treatment period | Insulin Aspart 6D administered by infusion pump for 12 week treatment period | ||
All Cause Mortality |
||||
| Insulin Lispro 6D | Insulin Aspart 6D | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Insulin Lispro 6D | Insulin Aspart 6D | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/127 (2.4%) | 7/127 (5.5%) | ||
| Metabolism and nutrition disorders | ||||
| Diabetic ketoacidosis | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Hypoglycaemia | 2/127 (1.6%) | 2 | 7/127 (5.5%) | 8 |
Other (Not Including Serious) Adverse Events |
||||
| Insulin Lispro 6D | Insulin Aspart 6D | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/127 (26.8%) | 31/127 (24.4%) | ||
| Blood and lymphatic system disorders | ||||
| Haemorrhagic anaemia | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Iron deficiency anaemia | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Diarrhoea | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Dyspepsia | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Toothache | 1/127 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| General disorders | ||||
| Device occlusion | 1/127 (0.8%) | 2 | 1/127 (0.8%) | 2 |
| Pyrexia | 1/127 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Immune system disorders | ||||
| Hypersensitivity | 2/127 (1.6%) | 2 | 0/127 (0%) | 0 |
| Seasonal allergy | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Infections and infestations | ||||
| Acute tonsillitis | 0/127 (0%) | 0 | 1/127 (0.8%) | 2 |
| Bronchitis | 0/127 (0%) | 0 | 3/127 (2.4%) | 3 |
| Cystitis | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Ear infection | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Gastroenteritis | 3/127 (2.4%) | 3 | 2/127 (1.6%) | 2 |
| Herpes zoster | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Influenza | 3/127 (2.4%) | 3 | 3/127 (2.4%) | 3 |
| Nasopharyngitis | 10/127 (7.9%) | 10 | 6/127 (4.7%) | 6 |
| Pharyngitis | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Rash pustular | 1/127 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Rhinitis | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Sinusitis | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Tracheobronchitis | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Urinary tract infection | 1/127 (0.8%) | 1 | 2/127 (1.6%) | 2 |
| Uterine infection | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Foot fracture | 1/127 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Joint dislocation | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Open wound | 1/127 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Metabolism and nutrition disorders | ||||
| Iron deficiency | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/127 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Tenosynovitis | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Nervous system disorders | ||||
| Carpal tunnel syndrome | 1/127 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Migraine | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Paraesthesia | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Renal and urinary disorders | ||||
| Microalbuminuria | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Reproductive system and breast disorders | ||||
| Menorrhagia | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 0/127 (0%) | 0 | 2/127 (1.6%) | 2 |
| Cough | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Oropharyngeal pain | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Sleep apnoea syndrome | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Lipohypertrophy | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Skin fissures | 1/127 (0.8%) | 1 | 1/127 (0.8%) | 1 |
| Subcutaneous nodule | 0/127 (0%) | 0 | 2/127 (1.6%) | 2 |
| Surgical and medical procedures | ||||
| Atherectomy | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Cataract operation | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Injection | 1/127 (0.8%) | 1 | 0/127 (0%) | 0 |
| Vascular disorders | ||||
| Hypertension | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
| Phlebitis | 0/127 (0%) | 0 | 1/127 (0.8%) | 1 |
Limitations/Caveats
Input to primary endpoint measurements (SMBG) contained approximately 40% missing data. Several analyses to account for missing data were conducted and results from these additional analyses were consistent with results from the original analysis.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01134107
Other Study ID Numbers:
- 12175
- F3Z-MC-IOPW
First Posted:
May 31, 2010
Last Update Posted:
Apr 11, 2013
Last Verified:
Apr 1, 2013