Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DRUGInsulin Lispro 6 Day (6D)
Administered by infusion pump for 12 week treatment period
DRUGInsulin Aspart 6 Day (6D)
Administered by infusion pump for 12 week treatment period
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 1. reported signs and symptoms of hypoglycemia, and/or 2. 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 1. reported signs and symptoms of hypoglycemia, and/or 2. a documented blood glucose (BG) concentration of \<= 70 mg/dL (3.9 mmol/L) |
| Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | 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 | — |
| Change From Baseline to 12 Week Endpoint for Each Treatment in Weight | 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. |
Countries
France, Germany, Hungary
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lispro 6D/Aspart 6D Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks. | 67 |
| Aspart 6D/Lispro 6D Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks. | 66 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1-First Treatment Intervention | Adverse Event | 1 | 0 |
| Period 1-First Treatment Intervention | Entry Criteria Not Met | 1 | 1 |
| Period 1-First Treatment Intervention | Physician Decision | 1 | 0 |
| Period 1-First Treatment Intervention | Withdrawal by Subject | 3 | 4 |
| Period 2-Second Treatment Intervention | Physician Decision | 1 | 0 |
| Period 2-Second Treatment Intervention | Sponsor Decision | 1 | 0 |
| Period 2-Second Treatment Intervention | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Lispro 6D/Aspart 6D | Aspart 6D/Lispro 6D | Total |
|---|---|---|---|
| Age Continuous | 40.71 years STANDARD_DEVIATION 11.91 | 44.73 years STANDARD_DEVIATION 12.96 | 42.70 years STANDARD_DEVIATION 12.56 |
| Race/Ethnicity, Customized White | 67 participants | 66 participants | 133 participants |
| Region of Enrollment France | 15 participants | 14 participants | 29 participants |
| Region of Enrollment Germany | 19 participants | 15 participants | 34 participants |
| Region of Enrollment Hungary | 33 participants | 37 participants | 70 participants |
| Sex: Female, Male Female | 48 Participants | 45 Participants | 93 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 127 | 31 / 127 |
| serious Total, serious adverse events | 3 / 127 | 7 / 127 |
Outcome results
Primary
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
Time frame: Day 6 of each reservoir cycle for the last 6 weeks of each 12-week treatment period (Week 7 through Week 12)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro 6D | 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 | 8.83 millimoles per liter (mmol/L) | Standard Deviation 1.55 |
| Insulin Aspart 6D | 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 | 8.43 millimoles per liter (mmol/L) | Standard Deviation 1.97 |
Comparison: This was the primary gated analysis.95% CI: [0.06, 0.66]
Secondary
Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values
Time frame: Baseline, endpoint for each 12-week treatment period
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro 6D | Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values | -0.16 percentage of HbA1c | Standard Deviation 0.54 |
| Insulin Aspart 6D | Change From Baseline to 12 Weeks for Each Treatment in Glycated Hemoglobin A1c (HbA1c) Values | -0.31 percentage of HbA1c | Standard Deviation 0.5 |
95% CI: [0.08, 0.24]
Secondary
Mean Daily Insulin Dose (Total, Basal, and Bolus)
Time frame: Days 1-6 for each reservoir cycle throughout each 12-week treatment period
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro 6D | Mean Daily Insulin Dose (Total, Basal, and Bolus) | Daily Total Insulin | 32.90 Units (U) of insulin | Standard Deviation 8.43 |
| Insulin Lispro 6D | Mean Daily Insulin Dose (Total, Basal, and Bolus) | Daily Basal Insulin | 17.83 Units (U) of insulin | Standard Deviation 5.26 |
| Insulin Lispro 6D | Mean Daily Insulin Dose (Total, Basal, and Bolus) | Daily Bolus Insulin (N=116, 117) | 16.26 Units (U) of insulin | Standard Deviation 6.21 |
| Insulin Aspart 6D | Mean Daily Insulin Dose (Total, Basal, and Bolus) | Daily Total Insulin | 32.48 Units (U) of insulin | Standard Deviation 8.42 |
| Insulin Aspart 6D | Mean Daily Insulin Dose (Total, Basal, and Bolus) | Daily Basal Insulin | 17.71 Units (U) of insulin | Standard Deviation 5.27 |
| Insulin Aspart 6D | Mean Daily Insulin Dose (Total, Basal, and Bolus) | Daily Bolus Insulin (N=116, 117) | 16.09 Units (U) of insulin | Standard Deviation 6.23 |
95% CI: [-0.13, 0.88]
95% CI: [-0.26, 0.31]
95% CI: [-0.15, 0.6]
Secondary
Mean SMBG
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro 6D | Mean SMBG | SMBG Days 1-6 (N=124, 124) | 8.70 millimoles per liter (mmol/L) | Standard Deviation 2.51 |
| Insulin Lispro 6D | Mean SMBG | SMBG Day 2 | 8.56 millimoles per liter (mmol/L) | Standard Deviation 2.51 |
| Insulin Lispro 6D | Mean SMBG | SMBG Day 6 (N=124, 124) | 8.93 millimoles per liter (mmol/L) | Standard Deviation 2.68 |
| Insulin Aspart 6D | Mean SMBG | SMBG Days 1-6 (N=124, 124) | 8.47 millimoles per liter (mmol/L) | Standard Deviation 2.46 |
| Insulin Aspart 6D | Mean SMBG | SMBG Day 2 | 8.40 millimoles per liter (mmol/L) | Standard Deviation 2.47 |
| Insulin Aspart 6D | Mean SMBG | SMBG Day 6 (N=124, 124) | 8.57 millimoles per liter (mmol/L) | Standard Deviation 2.64 |
95% CI: [-0.1, 0.47]
95% CI: [0.25, 0.58]
Secondary
Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7%
Time frame: Endpoint for each 12-week treatment period
Population: All randomized participants who completed a post-randomization visit and had an HbA1c measurement for the respective treatment period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro 6D | Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% | HbA1c ≤6.5% | 18 participants |
| Insulin Lispro 6D | Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% | HbA1c <7% | 38 participants |
| Insulin Aspart 6D | Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% | HbA1c ≤6.5% | 21 participants |
| Insulin Aspart 6D | Number of Participants Who Achieve or Maintain a Glycated Hemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than 7% | HbA1c <7% | 56 participants |
95% CI: [0.39, 1.63]
95% CI: [0.2, 0.63]
Other Pre-specified
Change From Baseline to 12 Week Endpoint for Each Treatment in Weight
Time frame: Baseline, endpoint for each 12-week treatment period
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro 6D | Change From Baseline to 12 Week Endpoint for Each Treatment in Weight | -0.04 kilograms (kg) | Standard Deviation 2.25 |
| Insulin Aspart 6D | Change From Baseline to 12 Week Endpoint for Each Treatment in Weight | 0.56 kilograms (kg) | Standard Deviation 2.15 |
p-value: <0.001Crossover Model
Other Pre-specified
Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure
Time frame: Baseline, endpoint for each 12-week treatment period
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro 6D | Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure | Systolic Blood Pressure (SBP) | -2.25 millimeters of mercury (mmHg) | Standard Deviation 14.71 |
| Insulin Lispro 6D | Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure | Diastolic Blood Pressure (DBP) | -1.61 millimeters of mercury (mmHg) | Standard Deviation 10.36 |
| Insulin Aspart 6D | Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure | Systolic Blood Pressure (SBP) | -1.36 millimeters of mercury (mmHg) | Standard Deviation 12.12 |
| Insulin Aspart 6D | Change From Baseline to 12 Weeks Endpoint for Each Treatment in Blood Pressure | Diastolic Blood Pressure (DBP) | -1.57 millimeters of mercury (mmHg) | Standard Deviation 9.13 |
p-value: 0.147Crossover Model
p-value: 0.894Crossover Model
Other Pre-specified
Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus)
Time frame: Baseline, endpoint for each 12-week treatment period
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro 6D | Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | Total Insulin Dose | 5.21 Units (U) of insulin | Standard Deviation 8.94 |
| Insulin Lispro 6D | Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | Basal Insulin Dose | 2.34 Units (U) of insulin | Standard Deviation 3.51 |
| Insulin Lispro 6D | Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | Bolus Insulin Dose (N=112, 112) | 2.19 Units (U) of insulin | Standard Deviation 5.58 |
| Insulin Aspart 6D | Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | Total Insulin Dose | 4.97 Units (U) of insulin | Standard Deviation 7.57 |
| Insulin Aspart 6D | Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | Basal Insulin Dose | 1.91 Units (U) of insulin | Standard Deviation 3.8 |
| Insulin Aspart 6D | Change From Baseline to 12 Weeks for Daily Insulin Dose (Total, Basal, and Bolus) | Bolus Insulin Dose (N=112, 112) | 1.80 Units (U) of insulin | Standard Deviation 4.7 |
p-value: 0.595Crossover Model
p-value: 0.506Crossover Model
p-value: 0.79Crossover Model
Other Pre-specified
Hyperglycemic Episode Rate Per 30 Days
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro 6D | Hyperglycemic Episode Rate Per 30 Days | 15.47 hyperglycemic episodes per 30 days | Standard Deviation 9.25 |
| Insulin Aspart 6D | Hyperglycemic Episode Rate Per 30 Days | 14.23 hyperglycemic episodes per 30 days | Standard Deviation 10.19 |
p-value: 0.059negative binomial test
Other Pre-specified
Hypoglycemic Episode Rate Per 30 Days
All Reported Hypoglycemic Episodes are defined as an event which is 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: All days for each reservoir cycle throughout each 12-week treatment period
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro 6D | Hypoglycemic Episode Rate Per 30 Days | 16.94 hypoglycemic episodes per 30 days | Standard Deviation 10.69 |
| Insulin Aspart 6D | Hypoglycemic Episode Rate Per 30 Days | 18.90 hypoglycemic episodes per 30 days | Standard Deviation 11.58 |
p-value: <0.001Negative Binomial Test
Other Pre-specified
Percentage of Participants Having a Hyperglycemic Episode
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Lispro 6D | Percentage of Participants Having a Hyperglycemic Episode | 97.6 percentage of participants |
| Insulin Aspart 6D | Percentage of Participants Having a Hyperglycemic Episode | 98.4 percentage of participants |
Other Pre-specified
Percentage of Participants Having a Hypoglycemic Episode
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 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: All days for each reservoir cycle throughout each 12-week treatment period
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro 6D | Percentage of Participants Having a Hypoglycemic Episode | Documented Hypoglycemic Episodes | 91.3 percentage of participants |
| Insulin Lispro 6D | Percentage of Participants Having a Hypoglycemic Episode | All Reported Hypoglycemic Episodes | 99.2 percentage of participants |
| Insulin Aspart 6D | Percentage of Participants Having a Hypoglycemic Episode | Documented Hypoglycemic Episodes | 93.7 percentage of participants |
| Insulin Aspart 6D | Percentage of Participants Having a Hypoglycemic Episode | All Reported Hypoglycemic Episodes | 99.2 percentage of participants |
p-value: 1Gart's Test
Other Pre-specified
Percentage of Participants With Pump Complications
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro 6D | Percentage of Participants With Pump Complications | Pump Complication: Premature Reservoir Change | 42.5 percentage of participants |
| Insulin Lispro 6D | Percentage of Participants With Pump Complications | Pump Complication: Premature Infusion Set Change | 74.8 percentage of participants |
| Insulin Aspart 6D | Percentage of Participants With Pump Complications | Pump Complication: Premature Reservoir Change | 44.1 percentage of participants |
| Insulin Aspart 6D | Percentage of Participants With Pump Complications | Pump Complication: Premature Infusion Set Change | 70.9 percentage of participants |
p-value: 1Gart's Test
p-value: 0.472Gart's Test
Other Pre-specified
Pump Complications Rate Per 30 Days
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro 6D | Pump Complications Rate Per 30 Days | Pump Complication: Premature Reservoir Change | 0.42 pump complications per 30 days | Standard Deviation 0.93 |
| Insulin Lispro 6D | Pump Complications Rate Per 30 Days | Pump Complication: Premature Infusion Set Change | 1.01 pump complications per 30 days | Standard Deviation 1.41 |
| Insulin Aspart 6D | Pump Complications Rate Per 30 Days | Pump Complication: Premature Reservoir Change | 0.45 pump complications per 30 days | Standard Deviation 1.03 |
| Insulin Aspart 6D | Pump Complications Rate Per 30 Days | Pump Complication: Premature Infusion Set Change | 1.10 pump complications per 30 days | Standard Deviation 1.47 |
p-value: 0.383negative binomial test
p-value: 0.499negative binomial test