Diabetes Mellitus, Type 1
Conditions
Keywords
diabetes, type 1
Brief summary
The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Detailed description
Phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ILPS, also referred to as NPL \[neutral protamine Hagedorn\]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.
Interventions
Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.
DRUGInsulin Levemir
Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of type 1 diabetes for one year or more * Age 18 years or older * Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2) * Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1 * As determined by the investigator, are capable and willing to do the following: * perform self monitoring of blood glucose (SMBG), * complete patient diaries as required for this protocol, * use the insulin injection device(s) according to the instructions provided, * are receptive to diabetes education, * comply with the required study visits.
Exclusion criteria
* Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1. * Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study * Are 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 or women who are breastfeeding * Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1. * Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | baseline and 32 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | 32 Weeks | — |
| 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | 32 Weeks | Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals. |
| Glycemic Variability at Endpoint | 32 Weeks | Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose \[SMBG\] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values. |
| Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Baseline to 32 Weeks | Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of \<2.8 mmol/L (\<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. |
| Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | Baseline, 8,16, 24, 32 Weeks | The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. \[Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects\]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline. |
| 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | baseline to 32 weeks | — |
| Change From Baseline in Absolute Body Weight at 32 Week Endpoint | Baseline, 32 Weeks | — |
| Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) | 32 Weeks | Total daily insulin dose adjusted for body weight (U/kg/day) was assessed. |
| Insulin Dose (Total and By Component [Basal and Bolus]) | 32 weeks | Total daily insulin dose (U/day) was assessed. |
| 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | baseline to 32 weeks | Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of \<2.8 mmol/L (\<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose. |
Countries
Argentina, Australia, Brazil, Greece, Hungary, Mexico, Romania, Russia, United States
Participant flow
Pre-assignment details
First 4 weeks (Titration Period): acclimate patients to insulin regimen and optimize insulin dose. Final 28 weeks (Maintenance Period): Minimum of 6 months' stable insulin dosage. 456 patients were screened; 69 did not meet entry criteria and 387 were randomized; 6 patients were excluded from the 387 randomized to create the Full Analysis Set.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Lispro Protamine Suspension Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks | 192 |
| Detemir Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks | 189 |
| Total | 381 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Entry Criteria Not Met | 3 | 4 |
| Overall Study | Lost to Follow-up | 7 | 6 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 5 | 5 |
| Overall Study | Sponsor Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 12 | 6 |
Baseline characteristics
| Characteristic | Total | Insulin Lispro Protamine Suspension | Detemir |
|---|---|---|---|
| Age Continuous | 36.14 years STANDARD_DEVIATION 13.2 | 36.10 years STANDARD_DEVIATION 13.33 | 36.19 years STANDARD_DEVIATION 13.09 |
| Body Mass Index (BMI) | 25.30 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.17 | 25.15 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.17 | 25.46 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.17 |
| Duration of Diabetes | 14.20 years STANDARD_DEVIATION 10.26 | 14.58 years STANDARD_DEVIATION 10.69 | 13.83 years STANDARD_DEVIATION 9.8 |
| Hemoglobin A1c (HbA1c) | 8.75 percent of HbA1c STANDARD_DEVIATION 1.28 | 8.87 percent of HbA1c STANDARD_DEVIATION 1.29 | 8.64 percent of HbA1c STANDARD_DEVIATION 1.27 |
| Race/Ethnicity Aboriginal and/or Torres Strait Islander | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity African | 3 participants | 2 participants | 1 participants |
| Race/Ethnicity Caucasian | 325 participants | 165 participants | 160 participants |
| Race/Ethnicity East Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity Hispanic | 53 participants | 25 participants | 28 participants |
| Race/Ethnicity Native American | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity West Asian | 0 participants | 0 participants | 0 participants |
| Region of Enrollment Argentina | 32 participants | 16 participants | 16 participants |
| Region of Enrollment Australia | 34 participants | 17 participants | 17 participants |
| Region of Enrollment Brazil | 39 participants | 20 participants | 19 participants |
| Region of Enrollment Greece | 32 participants | 16 participants | 16 participants |
| Region of Enrollment Hungary | 33 participants | 16 participants | 17 participants |
| Region of Enrollment Mexico | 26 participants | 14 participants | 12 participants |
| Region of Enrollment Romania | 43 participants | 22 participants | 21 participants |
| Region of Enrollment Russian Federation | 73 participants | 37 participants | 36 participants |
| Region of Enrollment United States | 69 participants | 34 participants | 35 participants |
| Sex: Female, Male Female | 187 Participants | 96 Participants | 91 Participants |
| Sex: Female, Male Male | 194 Participants | 96 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 93 / — | 86 / — |
| serious Total, serious adverse events | 10 / — | 3 / — |
Outcome results
Primary
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Time frame: baseline and 32 weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Baseline | 8.88 percent of HbA1c | Standard Error 0.1 |
| Insulin Lispro Protamine Suspension | Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Change from Baseline | -0.69 percent of HbA1c | Standard Error 0.07 |
| Detemir | Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Baseline | 8.68 percent of HbA1c | Standard Error 0.1 |
| Detemir | Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint | Change from Baseline | -0.59 percent of HbA1c | Standard Error 0.07 |
Comparison: Hypothesis: basal analog insulin lispro protamine suspension (ILPS), is inferior to basal analog insulin detemir, as measured by change in HbA1c from baseline to endpoint.p-value: 0.33295% CI: [-0.29, 0.1]ANCOVA
Secondary
1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of \<2.8 mmol/L (\<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
Time frame: baseline to 32 weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Hypoglycemic Rate | 66.41 hypoglycemic events per 1 year | Standard Deviation 90.91 |
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Hypoglycemic Rate | 76.45 hypoglycemic events per 1 year | Standard Deviation 85.07 |
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Nocturnal Hypoglcemic Rate | 8.90 hypoglycemic events per 1 year | Standard Deviation 18.65 |
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Nocturnal Hypoglycemic Rate | 9.65 hypoglycemic events per 1 year | Standard Deviation 15.01 |
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Non-Nocturnal Hypoglycemic Rate | 57.08 hypoglycemic events per 1 year | Standard Deviation 83.17 |
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Non-Nocturnal Hypoglycemic Rate | 66.58 hypoglycemic events per 1 year | Standard Deviation 78.63 |
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Severe Hypoglycemic Rate | 0.63 hypoglycemic events per 1 year | Standard Deviation 3.08 |
| Insulin Lispro Protamine Suspension | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Severe Hypoglycemic Rate | 0.42 hypoglycemic events per 1 year | Standard Deviation 1.43 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Severe Hypoglycemic Rate | 0.25 hypoglycemic events per 1 year | Standard Deviation 1.26 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Hypoglycemic Rate | 52.60 hypoglycemic events per 1 year | Standard Deviation 70.62 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Non-Nocturnal Hypoglycemic Rate | 46.88 hypoglycemic events per 1 year | Standard Deviation 65.28 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Hypoglycemic Rate | 61.21 hypoglycemic events per 1 year | Standard Deviation 64.25 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Severe Hypoglycemic Rate | 0.10 hypoglycemic events per 1 year | Standard Deviation 0.79 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Nocturnal Hypoglcemic Rate | 5.60 hypoglycemic events per 1 year | Standard Deviation 13.2 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Non-Nocturnal Hypoglycemic Rate | 54.83 hypoglycemic events per 1 year | Standard Deviation 58.94 |
| Detemir | 1-Year Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Nocturnal Hypoglycemic Rate | 6.01 hypoglycemic events per 1 year | Standard Deviation 10.31 |
p-value: 0.28ANCOVA
p-value: 0.193ANCOVA
p-value: 0.042ANCOVA
p-value: 0.001ANCOVA
p-value: 0.579ANCOVA
p-value: 0.531ANCOVA
p-value: 0.017ANCOVA
p-value: 0.038ANCOVA
Secondary
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint
Time frame: baseline to 32 weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Hypogylcemic Rate | 5.45 hypoglycemic events per 30 days | Standard Deviation 7.47 |
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Hypoglycemic Rate | 6.28 hypoglycemic events per 30 days | Standard Deviation 6.99 |
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Nocturnal Hypoglycemic Rate | 0.73 hypoglycemic events per 30 days | Standard Deviation 1.53 |
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Nocturnal Hypoglycemic Rate | 0.79 hypoglycemic events per 30 days | Standard Deviation 1.23 |
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Non-Nocturnal Hypoglycemic Rate | 4.69 hypoglycemic events per 30 days | Standard Deviation 6.83 |
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Non-Nocturnal Hypoglycemic Rate | 5.47 hypoglycemic events per 30 days | Standard Deviation 6.46 |
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Severe Hypoglycemic Rate | 0.05 hypoglycemic events per 30 days | Standard Deviation 0.25 |
| Insulin Lispro Protamine Suspension | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Severe Hypoglycemic Rate | 0.03 hypoglycemic events per 30 days | Standard Deviation 0.12 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Severe Hypoglycemic Rate | 0.02 hypoglycemic events per 30 days | Standard Deviation 0.1 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Hypogylcemic Rate | 4.32 hypoglycemic events per 30 days | Standard Deviation 5.8 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Non-Nocturnal Hypoglycemic Rate | 3.85 hypoglycemic events per 30 days | Standard Deviation 5.36 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Hypoglycemic Rate | 5.03 hypoglycemic events per 30 days | Standard Deviation 5.28 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Severe Hypoglycemic Rate | 0.01 hypoglycemic events per 30 days | Standard Deviation 0.06 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Endpoint Nocturnal Hypoglycemic Rate | 0.46 hypoglycemic events per 30 days | Standard Deviation 1.08 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Non-Nocturnal Hypoglycemic Rate | 4.50 hypoglycemic events per 30 days | Standard Deviation 4.84 |
| Detemir | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe) Overall and at Endpoint | Overall Nocturnal Hypoglycemic Rate | 0.49 hypoglycemic events per 30 days | Standard Deviation 0.85 |
Secondary
7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint
Actual daily mean blood glucose levels at endpoint. The SMBG excursion is the difference between the postprandial and preprandial blood glucose concentration taken at the morning, midday and evening meals.
Time frame: 32 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Morning Pre-Meal (N=175,N=182) | 9.09 millimoles per Liter (mmol/L) | Standard Deviation 3.18 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Evening Pre-Meal (N=174,N=181) | 8.92 millimoles per Liter (mmol/L) | Standard Deviation 2.72 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean Pre-Meal (N=174,N=181) | 8.77 millimoles per Liter (mmol/L) | Standard Deviation 2.37 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Evening Postprandial Meal (N=172,N=181) | 9.05 millimoles per Liter (mmol/L) | Standard Deviation 2.97 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Morning Postprandial Meal (N=171,N=178) | 8.68 millimoles per Liter (mmol/L) | Standard Deviation 2.89 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual 0300 Hours (N=167,N=173) | 8.49 millimoles per Liter (mmol/L) | Standard Deviation 2.85 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean Morning+Evening Pre-Meal (N=174,N=181) | 9.00 millimoles per Liter (mmol/L) | Standard Deviation 2.55 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Morning SMBG Excursion (N=171,N=178) | -0.34 millimoles per Liter (mmol/L) | Standard Deviation 2.94 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Midday Pre-Meal (N=175,N=181) | 8.29 millimoles per Liter (mmol/L) | Standard Deviation 2.92 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Midday SMBG Excursion (N=170,N=176) | 0.38 millimoles per Liter (mmol/L) | Standard Deviation 2.52 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean Postprandial Meal (N=168,N=176) | 8.70 millimoles per Liter (mmol/L) | Standard Deviation 2.08 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Evening SMBG Excursion (N=172,N=181) | 0.12 millimoles per Liter (mmol/L) | Standard Deviation 2.72 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Midday Postprandial Meal (N=170,N=177) | 8.54 millimoles per Liter (mmol/L) | Standard Deviation 2.49 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Daily Mean SMBG Excursion (N=168,N=176) | 0.06 millimoles per Liter (mmol/L) | Standard Deviation 1.68 |
| Insulin Lispro Protamine Suspension | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean 7-Point SMBG (N=164,N=172) | 8.67 millimoles per Liter (mmol/L) | Standard Deviation 1.97 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Daily Mean SMBG Excursion (N=168,N=176) | 0.01 millimoles per Liter (mmol/L) | Standard Deviation 1.71 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean 7-Point SMBG (N=164,N=172) | 8.48 millimoles per Liter (mmol/L) | Standard Deviation 1.8 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean Pre-Meal (N=174,N=181) | 8.56 millimoles per Liter (mmol/L) | Standard Deviation 2.1 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean Postprandial Meal (N=168,N=176) | 8.58 millimoles per Liter (mmol/L) | Standard Deviation 2.09 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Daily Mean Morning+Evening Pre-Meal (N=174,N=181) | 8.75 millimoles per Liter (mmol/L) | Standard Deviation 2.48 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Morning Pre-Meal (N=175,N=182) | 8.62 millimoles per Liter (mmol/L) | Standard Deviation 3 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Morning Postprandial Meal (N=171,N=178) | 8.56 millimoles per Liter (mmol/L) | Standard Deviation 2.73 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Midday Pre-Meal (N=175,N=181) | 8.19 millimoles per Liter (mmol/L) | Standard Deviation 2.39 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Midday Postprandial Meal (N=170,N=177) | 8.61 millimoles per Liter (mmol/L) | Standard Deviation 2.44 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Evening Pre-Meal (N=174,N=181) | 8.87 millimoles per Liter (mmol/L) | Standard Deviation 2.9 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Evening Postprandial Meal (N=172,N=181) | 8.60 millimoles per Liter (mmol/L) | Standard Deviation 2.71 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual 0300 Hours (N=167,N=173) | 8.29 millimoles per Liter (mmol/L) | Standard Deviation 2.57 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Morning SMBG Excursion (N=171,N=178) | -0.12 millimoles per Liter (mmol/L) | Standard Deviation 2.83 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Midday SMBG Excursion (N=170,N=176) | 0.46 millimoles per Liter (mmol/L) | Standard Deviation 2.59 |
| Detemir | 7-Point Self-Monitored Blood Glucose (SMBG) at Endpoint | Actual Evening SMBG Excursion (N=172,N=181) | -0.24 millimoles per Liter (mmol/L) | Standard Deviation 3.05 |
p-value: 0.259ANCOVA
p-value: 0.468ANCOVA
p-value: 0.395ANCOVA
p-value: 0.414ANCOVA
p-value: 0.275ANCOVA
p-value: 0.611ANCOVA
p-value: 0.763ANCOVA
p-value: 0.977ANCOVA
p-value: 0.586ANCOVA
p-value: 0.093ANCOVA
p-value: 0.516ANCOVA
p-value: 0.576ANCOVA
p-value: 0.876ANCOVA
p-value: 0.261ANCOVA
p-value: 0.567ANCOVA
Secondary
Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values
The summary statistics represents the mean of all subjects. Change from baseline is calculated for each individual subject for the specific visit and then the mean change from baseline is calculated by averaging out for all subjects. \[Sum over all (i) {A1c at Week 8 for Subject(i) minus A1c Baseline for Subject (i)}/Total Subjects\]. Therefore, for example, the Change from Baseline is not equal to the difference of Mean A1c for Week 8 minus Mean A1c for baseline.
Time frame: Baseline, 8,16, 24, 32 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 8 Week HbA1c (n=184, n=179) | 8.08 percent of HbA1c | Standard Error 0.07 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 24 Week HbA1c (n=171, n=174) | 8.07 percent of HbA1c | Standard Error 0.08 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 16 Week HbA1c (n=174, n=173) | 7.94 percent of HbA1c | Standard Error 0.07 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 24 Week Change from Baseline | -0.69 percent of HbA1c | Standard Error 0.08 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 8 Week Change from Baseline | -0.68 percent of HbA1c | Standard Error 0.07 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 32 Week HbA1c (n=165, n=165) | 8.09 percent of HbA1c | Standard Error 0.08 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 16 Week Change from Baseline | -0.81 percent of HbA1c | Standard Error 0.07 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 32 Week Change from Baseline | -0.68 percent of HbA1c | Standard Error 0.08 |
| Insulin Lispro Protamine Suspension | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | Baseline | 8.88 percent of HbA1c | Standard Error 0.1 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 32 Week Change from Baseline | -0.62 percent of HbA1c | Standard Error 0.08 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | Baseline | 8.68 percent of HbA1c | Standard Error 0.1 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 8 Week HbA1c (n=184, n=179) | 8.11 percent of HbA1c | Standard Error 0.07 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 8 Week Change from Baseline | -0.64 percent of HbA1c | Standard Error 0.07 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 16 Week HbA1c (n=174, n=173) | 8.08 percent of HbA1c | Standard Error 0.08 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 16 Week Change from Baseline | -0.67 percent of HbA1c | Standard Error 0.08 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 24 Week HbA1c (n=171, n=174) | 8.11 percent of HbA1c | Standard Error 0.08 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 24 Week Change from Baseline | -0.65 percent of HbA1c | Standard Error 0.08 |
| Detemir | Actual and Change From Baseline Hemoglobin A1c (HbA1c) Values | 32 Week HbA1c (n=165, n=165) | 8.14 percent of HbA1c | Standard Error 0.08 |
p-value: 0.71895% CI: [-0.22, 0.15]ANCOVA
p-value: 0.18795% CI: [-0.34, 0.07]ANCOVA
p-value: 0.70495% CI: [-0.25, 0.17]ANCOVA
p-value: 0.59995% CI: [-0.27, 0.15]ANCOVA
Secondary
Change From Baseline in Absolute Body Weight at 32 Week Endpoint
Time frame: Baseline, 32 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | Change From Baseline in Absolute Body Weight at 32 Week Endpoint | Baseline | 72.76 kilograms | Standard Deviation 15.53 |
| Insulin Lispro Protamine Suspension | Change From Baseline in Absolute Body Weight at 32 Week Endpoint | Change from Baseline | 1.54 kilograms | Standard Deviation 3.18 |
| Detemir | Change From Baseline in Absolute Body Weight at 32 Week Endpoint | Baseline | 72.69 kilograms | Standard Deviation 14.59 |
| Detemir | Change From Baseline in Absolute Body Weight at 32 Week Endpoint | Change from Baseline | 0.58 kilograms | Standard Deviation 3.19 |
Comparison: If the first secondary null hypothesis (glycemic variability) is rejected, then the second secondary hypothesis (weight change) is tested at an error rate of 0.05.p-value: 0.00395% CI: [0.34, 1.6]ANCOVA
Secondary
Glycemic Variability at Endpoint
Glycemic variability was measured by standard deviation (SD) value of fasting blood glucose as measured by intra-patient glycemic variability (determined by the 7-point self-monitored blood glucose \[SMBG\] profiles at endpoint); mean value (M-value), which was the mean of the intra-days self-monitored blood glucose values, and by the mean of daily difference (MODD), which was the mean of the between-days self-monitored blood glucose values.
Time frame: 32 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | Glycemic Variability at Endpoint | Standard Deviation (SD) Value (N=172, N=180) | 2.64 millimoles per Liter (mmol/L) | Standard Deviation 2.09 |
| Insulin Lispro Protamine Suspension | Glycemic Variability at Endpoint | Mean Value (M-Value) (N=175, N=182) | 36.39 millimoles per Liter (mmol/L) | Standard Deviation 31.82 |
| Insulin Lispro Protamine Suspension | Glycemic Variability at Endpoint | Mean Daily Difference (MODD) Value (N=172, N=180) | 3.04 millimoles per Liter (mmol/L) | Standard Deviation 1.9 |
| Detemir | Glycemic Variability at Endpoint | Standard Deviation (SD) Value (N=172, N=180) | 2.30 millimoles per Liter (mmol/L) | Standard Deviation 1.84 |
| Detemir | Glycemic Variability at Endpoint | Mean Value (M-Value) (N=175, N=182) | 32.19 millimoles per Liter (mmol/L) | Standard Deviation 25.79 |
| Detemir | Glycemic Variability at Endpoint | Mean Daily Difference (MODD) Value (N=172, N=180) | 2.78 millimoles per Liter (mmol/L) | Standard Deviation 1.79 |
Comparison: If the primary analysis achieves statistical significance at a 0.05 level (that is, the null hypothesis for the primary analysis \[primary outcome measure\] is rejected), then the first secondary hypothesis (glycemic variability) is tested at an error rate of 0.05.95% CI: [-0.03, 0.75]
p-value: 0.132ANCOVA
p-value: 0.179ANCOVA
Secondary
Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus])
Total daily insulin dose adjusted for body weight (U/kg/day) was assessed.
Time frame: 32 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) | Total Basal Insulin (N=192, N=188) | 0.53 units of insulin per kilogram per day | Standard Deviation 0.2 |
| Insulin Lispro Protamine Suspension | Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) | Total Insulin (N=192, N=188) | 0.91 units of insulin per kilogram per day | Standard Deviation 0.3 |
| Insulin Lispro Protamine Suspension | Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) | Total Bolus Insulin (N=191, N=187) | 0.39 units of insulin per kilogram per day | Standard Deviation 0.17 |
| Detemir | Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) | Total Basal Insulin (N=192, N=188) | 0.55 units of insulin per kilogram per day | Standard Deviation 0.26 |
| Detemir | Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) | Total Insulin (N=192, N=188) | 0.99 units of insulin per kilogram per day | Standard Deviation 0.41 |
| Detemir | Insulin Dose Per Body Weight (Total and By Component [Basal and Bolus]) | Total Bolus Insulin (N=191, N=187) | 0.45 units of insulin per kilogram per day | Standard Deviation 0.22 |
p-value: 0.023ANOVA
p-value: 0.004ANOVA
p-value: 0.282ANOVA
Secondary
Insulin Dose (Total and By Component [Basal and Bolus])
Total daily insulin dose (U/day) was assessed.
Time frame: 32 weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Protamine Suspension | Insulin Dose (Total and By Component [Basal and Bolus]) | Total Insulin (N=192, N=188) | 67.78 units of insulin per day (U/day) | Standard Deviation 27.42 |
| Insulin Lispro Protamine Suspension | Insulin Dose (Total and By Component [Basal and Bolus]) | Total Bolus Insulin (N=191, N=187) | 28.94 units of insulin per day (U/day) | Standard Deviation 14.69 |
| Insulin Lispro Protamine Suspension | Insulin Dose (Total and By Component [Basal and Bolus]) | Total Basal Insulin (N=192, N=188) | 38.99 units of insulin per day (U/day) | Standard Deviation 17.37 |
| Detemir | Insulin Dose (Total and By Component [Basal and Bolus]) | Total Insulin (N=192, N=188) | 73.84 units of insulin per day (U/day) | Standard Deviation 38.38 |
| Detemir | Insulin Dose (Total and By Component [Basal and Bolus]) | Total Bolus Insulin (N=191, N=187) | 33.32 units of insulin per day (U/day) | Standard Deviation 20.41 |
| Detemir | Insulin Dose (Total and By Component [Basal and Bolus]) | Total Basal Insulin (N=192, N=188) | 40.70 units of insulin per day (U/day) | Standard Deviation 22.29 |
p-value: 0.82ANOVA
p-value: 0.19ANOVA
p-value: 0.416ANOVA
Secondary
Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint
Nocturnal: Defined as any hypoglycemic event that occurs between bedtime and waking. Non-Nocturnal: Defined as any hypoglycemic event that occurs between waking and bedtime. Severe: An episode with symptoms consistent with neuroglycopenia in which the patient requires the assistance of another person; associated with either a blood glucose level of \<2.8 mmol/L (\<50 mg/dL) or prompt recovery after oral carbohydrate, glucagon, or intravenous glucose.
Time frame: Baseline to 32 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Hypoglycemic Episodes | 134 episodes of hypoglycemia |
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Hypoglycemic Episodes | 173 episodes of hypoglycemia |
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Nocturnal Hypoglycemic Episodes | 69 episodes of hypoglycemia |
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Nocturnal Episodes (N=191,N=186) | 125 episodes of hypoglycemia |
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Non-Nocturnal Hypoglycemic Episodes | 127 episodes of hypoglycemia |
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Non-Nocturnal Hypoglycemic Episodes | 172 episodes of hypoglycemia |
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Severe Hypoglycemic Episodes | 11 episodes of hypoglycemia |
| Insulin Lispro Protamine Suspension | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Severe Hypoglycemic Episodes (N=171,N=170) | 24 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Severe Hypoglycemic Episodes (N=171,N=170) | 13 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Hypoglycemic Episodes | 135 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Non-Nocturnal Hypoglycemic Episodes | 129 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Hypoglycemic Episodes | 173 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Severe Hypoglycemic Episodes | 3 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Endpoint Nocturnal Hypoglycemic Episodes | 55 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Non-Nocturnal Hypoglycemic Episodes | 172 episodes of hypoglycemia |
| Detemir | Number of Self-Reported Hypoglycemic Episodes (Including Nocturnal, Non-Nocturnal, and Severe Hypoglycemia) Overall and at Endpoint | Overall Nocturnal Episodes (N=191,N=186) | 111 episodes of hypoglycemia |
p-value: 0.737Fisher Exact
p-value: 0.724Fisher Exact
p-value: 0.157Fisher Exact
p-value: 0.287Fisher Exact
p-value: 0.664Fisher Exact
p-value: 0.73Fisher Exact
p-value: 0.053Fisher Exact
p-value: 0.081Fisher Exact
Secondary
Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5%
Time frame: 32 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. Last observation carried forward.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≤7.0% | 18.5 percentage of participants |
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c >7.0% | 81.5 percentage of participants |
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c <7.0% | 15.2 percentage of participants |
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≥7.0% | 84.8 percentage of participants |
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≤6.5% | 8.7 percentage of participants |
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c >6.5% | 91.3 percentage of participants |
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c <6.5% | 7.1 percentage of participants |
| Insulin Lispro Protamine Suspension | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≥6.5% | 92.9 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≥6.5% | 91.8 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≤7.0% | 18.7 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≤6.5% | 9.9 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c >7.0% | 81.3 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c <6.5% | 8.2 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c <7.0% | 15.4 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c >6.5% | 90.1 percentage of participants |
| Detemir | Percentage of Patients With Hemoglobin A1c (HbA1c) Less Than or Equal to 7.0% and HbA1c Less Than or Equal to 6.5% | With HbA1c ≥7.0% | 84.6 percentage of participants |
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 0.722Fisher Exact
p-value: 0.699Fisher Exact