Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes, type 2
Brief summary
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.
Interventions
DRUGInsulin lispro mid mixture (MM)
Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks
DRUGInsulin glargine
Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes * Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label * Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.
Exclusion criteria
* Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label. * Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion. * Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks. * Have a body mass index greater than 40 kg/m2. * Have had more than one episode of severe hypoglycemia in the last24 weeks * Are pregnant, intend to be pregnant during the course of the study or are breastfeeding * Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c (HbA1c) at 36 Week Endpoint | 36 weeks | Level of hemoglobin A1c at endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | 12-24-36 weeks | — |
| 7-point Self-monitored Blood Glucose Profiles | Baseline, 12-24-36 weeks | Actual daily mean blood glucose levels at specified time points. |
| Glycemic Variability | Baseline, 12-24-36 weeks | Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring 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 Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Baseline to 36 Weeks | Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF. |
| 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Baseline to 36 Weeks | Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF. |
| Hemoglobin A1c (HbA1c) at Interval Visits | 12, 24, and 36 weeks | Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks. |
| Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial | 36 Weeks | Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day \[U/kg/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF. |
| Endpoint Insulin Dose; Total, Basal, and Prandial | 36 Weeks | Total daily insulin dose (Units of insulin per day \[U/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF. |
| Number of Insulin Injections Per Day | Weeks 12, 24, 30, 36 | — |
| Change From Baseline in Absolute Body Weight at 36 Week Endpoint | Baseline, 36 Weeks | Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline. |
| Number of Patients With at Least One Severe Hypoglycemia Episode | Baseline to 36 Weeks | Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose \<2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF. |
Countries
Australia, Canada, France, Mexico, Russia, South Korea, Spain
Participant flow
Pre-assignment details
636 patients were screened; 128 were screen failures; 24 discontinued prior to randomization; 484 patients were randomized. Baseline Characteristics are provided for the Intent to Treat Population, which was defined as patients with baseline and at least one post-baseline value.
Participants by arm
| Arm | Count |
|---|---|
| Insulin Lispro Mid Mixture Insulin lispro mid mixture (MM) up to three times a day (TID) | 239 |
| Insulin Glargine Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed. | 240 |
| Total | 479 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Death | 0 | 3 |
| Overall Study | Entry Criteria Not Met | 2 | 0 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Physician Decision | 5 | 5 |
| Overall Study | Protocol Violation | 3 | 4 |
| Overall Study | Sponsor Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 12 | 11 |
Baseline characteristics
| Characteristic | Insulin Lispro Mid Mixture | Total | Insulin Glargine |
|---|---|---|---|
| Age Continuous | 58.40 years STANDARD_DEVIATION 9.21 | 58.92 years STANDARD_DEVIATION 9.55 | 59.45 years STANDARD_DEVIATION 9.87 |
| Body Height | 163.27 centimeters (cm) STANDARD_DEVIATION 9.27 | 163.98 centimeters (cm) STANDARD_DEVIATION 9.39 | 164.68 centimeters (cm) STANDARD_DEVIATION 9.48 |
| Body Mass Index (BMI) | 29.51 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.76 | 29.25 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.66 | 29.00 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.55 |
| Body Mass Index (BMI) Group BMI <25 kg/m^2 | 34 participants | 82 participants | 48 participants |
| Body Mass Index (BMI) Group BMI ≥25 kg/m^2 and <30 kg/m^2 | 106 participants | 209 participants | 103 participants |
| Body Mass Index (BMI) Group BMI ≥30 kg/m^2 | 99 participants | 188 participants | 89 participants |
| Body Weight | 78.85 kilograms (kg) STANDARD_DEVIATION 15.5 | 78.86 kilograms (kg) STANDARD_DEVIATION 15.28 | 78.87 kilograms (kg) STANDARD_DEVIATION 15.1 |
| Duration of Diabetes | 10.86 years STANDARD_DEVIATION 5.54 | 11.33 years STANDARD_DEVIATION 6.48 | 11.79 years STANDARD_DEVIATION 7.29 |
| Duration of Diabetes Group >10 years | 116 participants | 229 participants | 113 participants |
| Duration of Diabetes Group <5 years | 28 participants | 55 participants | 27 participants |
| Duration of Diabetes Group ≥5 years and ≤10 years | 95 participants | 195 participants | 100 participants |
| Hemoglobin A1c (HbA1c) | 9.55 percent HbA1c STANDARD_DEVIATION 1.18 | 9.47 percent HbA1c STANDARD_DEVIATION 1.18 | 9.39 percent HbA1c STANDARD_DEVIATION 1.17 |
| Hemoglobin A1c (HbA1c) Group ≤8.5% HbA1c | 60 participants | 127 participants | 67 participants |
| Hemoglobin A1c (HbA1c) Group >8.5% HbA1c | 179 participants | 352 participants | 173 participants |
| Race/Ethnicity African | 2 participants | 3 participants | 1 participants |
| Race/Ethnicity Caucasian | 134 participants | 270 participants | 136 participants |
| Race/Ethnicity East Asian | 25 participants | 52 participants | 27 participants |
| Race/Ethnicity Hispanic | 51 participants | 97 participants | 46 participants |
| Race/Ethnicity West Asian (Indian sub-continent) | 27 participants | 57 participants | 30 participants |
| Region of Enrollment Australia | 18 participants | 37 participants | 19 participants |
| Region of Enrollment Canada | 27 participants | 51 participants | 24 participants |
| Region of Enrollment France | 21 participants | 40 participants | 19 participants |
| Region of Enrollment Greece | 19 participants | 39 participants | 20 participants |
| Region of Enrollment India | 26 participants | 55 participants | 29 participants |
| Region of Enrollment Korea, Republic of | 24 participants | 49 participants | 25 participants |
| Region of Enrollment Mexico | 51 participants | 98 participants | 47 participants |
| Region of Enrollment Russian Federation | 24 participants | 50 participants | 26 participants |
| Region of Enrollment Spain | 29 participants | 60 participants | 31 participants |
| Sex: Female, Male Female | 131 Participants | 251 Participants | 120 Participants |
| Sex: Female, Male Male | 108 Participants | 228 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 91 / 239 | 92 / 240 |
| serious Total, serious adverse events | 11 / 239 | 11 / 240 |
Outcome results
Primary
Hemoglobin A1c (HbA1c) at 36 Week Endpoint
Level of hemoglobin A1c at endpoint.
Time frame: 36 weeks
Population: Number of participants in the per-protocol population. Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro Mid Mixture | Hemoglobin A1c (HbA1c) at 36 Week Endpoint | 7.66 percent HbA1c | Standard Error 0.37 |
| Insulin Glargine | Hemoglobin A1c (HbA1c) at 36 Week Endpoint | 7.49 percent HbA1c | Standard Error 0.36 |
Comparison: Assuming 15% drop-out rate after randomization, remaining 213 patients in each treatment group would allow confirmation of noninferiority with no treatment difference and a noninferiority limit of 0.3% using upper limit of 2-sided confidence interval at significance level of 0.05 with 80% power.p-value: 0.09795% CI: [-0.03, 0.37]ANCOVA
Secondary
30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal)
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Time frame: Baseline to 36 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Mid Mixture | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Endpoint Hypoglycemic Rate | 1.57 hypoglycemic event per 30 days | Standard Deviation 2.98 |
| Insulin Lispro Mid Mixture | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Overall Hypoglycemic Rate | 1.88 hypoglycemic event per 30 days | Standard Deviation 2.44 |
| Insulin Lispro Mid Mixture | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Endpoint Nocturnal Hypoglycemic Rate | 0.26 hypoglycemic event per 30 days | Standard Deviation 0.79 |
| Insulin Lispro Mid Mixture | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Overall Nocturnal Hypoglycemic Rate | 0.26 hypoglycemic event per 30 days | Standard Deviation 0.43 |
| Insulin Lispro Mid Mixture | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Endpoint Non-Nocturnal Hypoglycemic Rate | 1.31 hypoglycemic event per 30 days | Standard Deviation 2.8 |
| Insulin Lispro Mid Mixture | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Overall Non-Nocturnal Hypoglycemic Rate | 1.63 hypoglycemic event per 30 days | Standard Deviation 2.25 |
| Insulin Glargine | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Endpoint Non-Nocturnal Hypoglycemic Rate | 1.87 hypoglycemic event per 30 days | Standard Deviation 3.29 |
| Insulin Glargine | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Endpoint Hypoglycemic Rate | 2.19 hypoglycemic event per 30 days | Standard Deviation 3.6 |
| Insulin Glargine | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Overall Nocturnal Hypoglycemic Rate | 0.28 hypoglycemic event per 30 days | Standard Deviation 0.5 |
| Insulin Glargine | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Overall Hypoglycemic Rate | 2.21 hypoglycemic event per 30 days | Standard Deviation 2.87 |
| Insulin Glargine | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Overall Non-Nocturnal Hypoglycemic Rate | 1.93 hypoglycemic event per 30 days | Standard Deviation 2.71 |
| Insulin Glargine | 30-Day Adjusted Rates of Self-Reported Hypoglycemic Episodes (Including Nocturnal and Non-Nocturnal) | Endpoint Nocturnal Hypoglycemic Rate | 0.32 hypoglycemic event per 30 days | Standard Deviation 0.84 |
p-value: 0.022ANOVA
p-value: 0.218ANOVA
p-value: 0.311ANOVA
p-value: 0.615ANOVA
p-value: 0.018ANOVA
p-value: 0.255ANOVA
Secondary
7-point Self-monitored Blood Glucose Profiles
Actual daily mean blood glucose levels at specified time points.
Time frame: Baseline, 12-24-36 weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Baseline: Evening Pre-Meal (n=227, n=229) | 10.38 millimoles per Liter (mmol/L) | Standard Error 1.09 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Evening Pre-Meal (n=209, n=211) | 7.50 millimoles per Liter (mmol/L) | Standard Error 0.81 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Midday Pre-Meal (n=215, n=220) | 8.63 millimoles per Liter (mmol/L) | Standard Error 0.76 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Evening Postprandial Meal (n=207, n= 207) | 8.21 millimoles per Liter (mmol/L) | Standard Error 0.82 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Baseline: Midday Pre-Meal (n=227, n=230) | 10.15 millimoles per Liter (mmol/L) | Standard Error 1.07 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 24 Week: 0300 Hours (n=181, n=184) | 7.14 millimoles per Liter (mmol/L) | Standard Error 0.71 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Midday Postprandial Meal (n=196, n=209) | 9.92 millimoles per Liter (mmol/L) | Standard Error 0.91 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Morning Pre-Meal (n=200, n=210) | 6.96 millimoles per Liter (mmol/L) | Standard Error 0.67 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Baseline: Evening Postprandial Meal (n=226,n= 229) | 11.87 millimoles per Liter (mmol/L) | Standard Error 1.05 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Morning Postprandial Meal (n=179, n=194) | 10.09 millimoles per Liter (mmol/L) | Standard Error 0.92 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Evening Pre-Meal (n=216, n=221) | 8.75 millimoles per Liter (mmol/L) | Standard Error 0.8 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Midday Pre-Meal (n=199, n=210) | 7.33 millimoles per Liter (mmol/L) | Standard Error 0.77 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Baseline: Morning Pre-Meal (n=228, n=231) | 10.22 millimoles per Liter (mmol/L) | Standard Error 0.91 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Midday Postprandial Meal (n=182, n=195) | 10.31 millimoles per Liter (mmol/L) | Standard Error 0.92 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Evening Postprandial Meal (n=213, n= 223) | 8.23 millimoles per Liter (mmol/L) | Standard Error 0.9 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Evening Pre-Meal (n=199, n=207) | 8.13 millimoles per Liter (mmol/L) | Standard Error 0.81 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Baseline: 0300 Hours (n=205, n=202) | 9.37 millimoles per Liter (mmol/L) | Standard Error 1.08 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Evening Postprandial Meal (n=195, n= 225) | 9.46 millimoles per Liter (mmol/L) | Standard Error 0.85 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 12 Week: 0300 Hours (n=185, n=187) | 6.97 millimoles per Liter (mmol/L) | Standard Error 0.79 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 36 Week: 0300 Hours (n=167, n=177) | 8.18 millimoles per Liter (mmol/L) | Standard Error 1.06 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Baseline: Midday Postprandial Meal (n=215, n=223) | 11.40 millimoles per Liter (mmol/L) | Standard Error 1.12 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Morning Pre-Meal (n=228, n=231) | 6.98 millimoles per Liter (mmol/L) | Standard Error 0.68 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Morning Pre-Meal (n=210, n=213) | 6.72 millimoles per Liter (mmol/L) | Standard Error 0.64 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Morning Postprandial Meal (n=213, n=222) | 9.98 millimoles per Liter (mmol/L) | Standard Error 0.94 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Morning Pre-Meal (n=218, n=226) | 7.26 millimoles per Liter (mmol/L) | Standard Error 0.64 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Midday Pre-Meal (n=227, n=230) | 7.36 millimoles per Liter (mmol/L) | Standard Error 0.8 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Morning Postprandial Meal (n=193, n=201) | 9.87 millimoles per Liter (mmol/L) | Standard Error 0.91 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Midday Postprandial Meal (n=215, n=223) | 10.28 millimoles per Liter (mmol/L) | Standard Error 0.91 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Baseline: Morning Postprandial Meal (n=213, n=222) | 12.49 millimoles per Liter (mmol/L) | Standard Error 1.18 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Evening Pre-Meal (n=227, n=229) | 8.15 millimoles per Liter (mmol/L) | Standard Error 0.81 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Midday Pre-Meal (n=209, n=213) | 7.99 millimoles per Liter (mmol/L) | Standard Error 0.79 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Evening Postprandial Meal (n=226,n= 229) | 9.27 millimoles per Liter (mmol/L) | Standard Error 0.85 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Morning Postprandial Meal (n=192, n=206) | 11.56 millimoles per Liter (mmol/L) | Standard Error 0.94 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | Endpoint: 0300 Hours (n=205, n=202) | 7.78 millimoles per Liter (mmol/L) | Standard Error 0.75 |
| Insulin Lispro Mid Mixture | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Midday Postprandial Meal (n=196, n=203) | 9.38 millimoles per Liter (mmol/L) | Standard Error 0.9 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Endpoint: 0300 Hours (n=205, n=202) | 7.89 millimoles per Liter (mmol/L) | Standard Error 0.74 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Baseline: Morning Pre-Meal (n=228, n=231) | 9.64 millimoles per Liter (mmol/L) | Standard Error 0.9 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Baseline: Midday Pre-Meal (n=227, n=230) | 9.62 millimoles per Liter (mmol/L) | Standard Error 1.05 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Baseline: Midday Postprandial Meal (n=215, n=223) | 11.22 millimoles per Liter (mmol/L) | Standard Error 1.1 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Baseline: Evening Pre-Meal (n=227, n=229) | 10.31 millimoles per Liter (mmol/L) | Standard Error 1.07 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Baseline: Evening Postprandial Meal (n=226,n= 229) | 11.76 millimoles per Liter (mmol/L) | Standard Error 1.03 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Baseline: 0300 Hours (n=205, n=202) | 9.17 millimoles per Liter (mmol/L) | Standard Error 1.06 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Morning Pre-Meal (n=218, n=226) | 6.68 millimoles per Liter (mmol/L) | Standard Error 0.63 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Morning Postprandial Meal (n=192, n=206) | 11.28 millimoles per Liter (mmol/L) | Standard Error 0.92 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Midday Pre-Meal (n=215, n=220) | 8.10 millimoles per Liter (mmol/L) | Standard Error 0.75 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Midday Postprandial Meal (n=196, n=209) | 9.43 millimoles per Liter (mmol/L) | Standard Error 0.89 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Evening Pre-Meal (n=216, n=221) | 7.98 millimoles per Liter (mmol/L) | Standard Error 0.79 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 12 Week: Evening Postprandial Meal (n=213, n= 223) | 9.40 millimoles per Liter (mmol/L) | Standard Error 0.89 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 12 Week: 0300 Hours (n=185, n=187) | 7.12 millimoles per Liter (mmol/L) | Standard Error 0.78 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Morning Pre-Meal (n=210, n=213) | 6.07 millimoles per Liter (mmol/L) | Standard Error 0.63 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Morning Postprandial Meal (n=193, n=201) | 9.45 millimoles per Liter (mmol/L) | Standard Error 0.89 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Midday Pre-Meal (n=209, n=213) | 7.82 millimoles per Liter (mmol/L) | Standard Error 0.77 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Midday Postprandial Meal (n=196, n=203) | 9.15 millimoles per Liter (mmol/L) | Standard Error 0.88 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Evening Pre-Meal (n=209, n=211) | 6.94 millimoles per Liter (mmol/L) | Standard Error 0.79 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 24 Week: Evening Postprandial Meal (n=207, n= 207) | 8.69 millimoles per Liter (mmol/L) | Standard Error 0.81 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 24 Week: 0300 Hours (n=181, n=184) | 7.18 millimoles per Liter (mmol/L) | Standard Error 0.7 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Morning Pre-Meal (n=200, n=210) | 6.48 millimoles per Liter (mmol/L) | Standard Error 0.65 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Morning Postprandial Meal (n=179, n=194) | 10.29 millimoles per Liter (mmol/L) | Standard Error 0.9 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Midday Pre-Meal (n=199, n=210) | 7.46 millimoles per Liter (mmol/L) | Standard Error 0.76 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Midday Postprandial Meal (n=182, n=195) | 10.30 millimoles per Liter (mmol/L) | Standard Error 0.91 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Evening Pre-Meal (n=199, n=207) | 7.97 millimoles per Liter (mmol/L) | Standard Error 0.79 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 36 Week: Evening Postprandial Meal (n=195, n= 225) | 9.85 millimoles per Liter (mmol/L) | Standard Error 0.83 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | 36 Week: 0300 Hours (n=167, n=177) | 8.25 millimoles per Liter (mmol/L) | Standard Error 1.05 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Morning Pre-Meal (n=228, n=231) | 6.53 millimoles per Liter (mmol/L) | Standard Error 0.67 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Morning Postprandial Meal (n=213, n=222) | 10.29 millimoles per Liter (mmol/L) | Standard Error 0.92 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Midday Pre-Meal (n=227, n=230) | 7.52 millimoles per Liter (mmol/L) | Standard Error 0.79 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Midday Postprandial Meal (n=215, n=223) | 10.34 millimoles per Liter (mmol/L) | Standard Error 0.9 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Evening Pre-Meal (n=227, n=229) | 7.98 millimoles per Liter (mmol/L) | Standard Error 0.8 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Endpoint: Evening Postprandial Meal (n=226,n= 229) | 9.84 millimoles per Liter (mmol/L) | Standard Error 0.83 |
| Insulin Glargine | 7-point Self-monitored Blood Glucose Profiles | Baseline: Morning Postprandial Meal (n=213, n=222) | 12.39 millimoles per Liter (mmol/L) | Standard Error 1.16 |
p-value: 0.01495% CI: [0.12, 1.04]ANOVA
p-value: 0.73595% CI: [-0.51, 0.72]ANOVA
p-value: 0.05195% CI: [0, 1.08]ANOVA
p-value: 0.53695% CI: [-0.39, 0.75]ANOVA
p-value: 0.79395% CI: [-0.48, 0.62]ANOVA
p-value: 0.69395% CI: [-0.43, 0.64]ANOVA
p-value: 0.49995% CI: [-0.38, 0.77]ANOVA
p-value: <0.00195% CI: [0.26, 0.92]ANCOVA
p-value: 0.27895% CI: [-0.22, 0.78]ANCOVA
p-value: 0.00995% CI: [0.14, 0.93]ANCOVA
p-value: 0.04995% CI: [0, 0.97]ANCOVA
p-value: <0.00195% CI: [0.35, 1.18]ANCOVA
p-value: <0.00195% CI: [-1.63, -0.7]ANCOVA
p-value: 0.50695% CI: [-0.59, 0.29]ANCOVA
p-value: <0.00195% CI: [0.31, 0.99]ANCOVA
p-value: 0.09495% CI: [-0.07, 0.91]ANCOVA
p-value: 0.40895% CI: [-0.24, 0.59]ANCOVA
p-value: 0.4395% CI: [-0.57, 0.24]ANCOVA
p-value: 0.35195% CI: [-0.25, 0.71]ANCOVA
p-value: 0.0195% CI: [0.13, 0.98]ANCOVA
p-value: 0.02995% CI: [-0.92, -0.05]ANCOVA
p-value: 0.81695% CI: [-0.45, 0.35]ANCOVA
p-value: 0.00895% CI: [0.13, 0.85]ANCOVA
p-value: 0.43895% CI: [-0.71, 0.31]ANCOVA
p-value: 0.54895% CI: [-0.54, 0.29]ANCOVA
p-value: 0.96495% CI: [-0.5, 0.52]ANCOVA
p-value: 0.45395% CI: [-0.27, 0.6]ANCOVA
p-value: 0.09695% CI: [-0.84, 0.07]ANCOVA
p-value: 0.7795% CI: [-0.51, 0.37]ANCOVA
p-value: 0.0195% CI: [0.11, 0.8]ANCOVA
p-value: 0.20195% CI: [-0.8, 0.17]ANCOVA
p-value: 0.81495% CI: [-0.52, 0.41]ANCOVA
p-value: 0.42795% CI: [-0.24, 0.57]ANCOVA
p-value: 0.00995% CI: [-1, -0.14]ANCOVA
p-value: 0.56995% CI: [-0.51, 0.28]ANCOVA
Secondary
Change From Baseline in Absolute Body Weight at 36 Week Endpoint
Change in body weight was calculated as weight at endpoint (last observation carried forward) minus weight at baseline.
Time frame: Baseline, 36 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 Mid Mixture | Change From Baseline in Absolute Body Weight at 36 Week Endpoint | Baseline | 76.71 kilograms | Standard Error 5.09 |
| Insulin Lispro Mid Mixture | Change From Baseline in Absolute Body Weight at 36 Week Endpoint | Change from Baseline | 3.09 kilograms | Standard Error 1.44 |
| Insulin Glargine | Change From Baseline in Absolute Body Weight at 36 Week Endpoint | Baseline | 77.00 kilograms | Standard Error 5.01 |
| Insulin Glargine | Change From Baseline in Absolute Body Weight at 36 Week Endpoint | Change from Baseline | 3.19 kilograms | Standard Error 1.42 |
p-value: 0.80395% CI: [-0.8, 0.62]ANCOVA
Secondary
Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial
Total daily insulin dose adjusted for body weight (Units of insulin per kilogram per day \[U/kg/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Time frame: 36 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 Mid Mixture | Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial | Daily Basal (n=239, n=240) | 0.27 U/kg/day | Standard Error 0.07 |
| Insulin Lispro Mid Mixture | Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial | Daily Prandial (n=239, n=130) | 0.36 U/kg/day | Standard Error 0.08 |
| Insulin Lispro Mid Mixture | Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial | Daily Total (n=239, n=240) | 0.57 U/kg/day | Standard Error 0.11 |
| Insulin Glargine | Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial | Daily Basal (n=239, n=240) | 0.35 U/kg/day | Standard Error 0.07 |
| Insulin Glargine | Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial | Daily Prandial (n=239, n=130) | 0.29 U/kg/day | Standard Error 0.08 |
| Insulin Glargine | Endpoint Insulin Dose Per Body Weight; Total, Basal, and Prandial | Daily Total (n=239, n=240) | 0.51 U/kg/day | Standard Error 0.11 |
p-value: <0.00195% CI: [-0.12, -0.05]ANCOVA
p-value: <0.00195% CI: [0.04, 0.11]ANCOVA
p-value: 0.01795% CI: [0.01, 0.12]ANCOVA
Secondary
Endpoint Insulin Dose; Total, Basal, and Prandial
Total daily insulin dose (Units of insulin per day \[U/day\]) was assessed. Basal insulin is the amount of insulin required to manage normal daily blood glucose fluctuations. Prandial insulin is taken at meal time. Insulin glargine is a basal insulin and insulin lispro is a prandial insulin. Insulin lispro mid-mix is a 50/50 mixture of a basal insulin and insulin lispro. Endpoint: last visit interval based on LOCF.
Time frame: 36 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 Mid Mixture | Endpoint Insulin Dose; Total, Basal, and Prandial | Daily Basal (n=239, n=240) | 19.90 U/day | Standard Error 5.46 |
| Insulin Lispro Mid Mixture | Endpoint Insulin Dose; Total, Basal, and Prandial | Daily Prandial (n=239, n=130) | 27.73 U/day | Standard Error 6.23 |
| Insulin Lispro Mid Mixture | Endpoint Insulin Dose; Total, Basal, and Prandial | Daily Total (n=239, n=240) | 43.44 U/day | Standard Error 8.65 |
| Insulin Glargine | Endpoint Insulin Dose; Total, Basal, and Prandial | Daily Basal (n=239, n=240) | 26.86 U/day | Standard Error 5.37 |
| Insulin Glargine | Endpoint Insulin Dose; Total, Basal, and Prandial | Daily Total (n=239, n=240) | 38.25 U/day | Standard Error 8.51 |
| Insulin Glargine | Endpoint Insulin Dose; Total, Basal, and Prandial | Daily Prandial (n=239, n=130) | 21.68 U/day | Standard Error 6.19 |
p-value: <0.00195% CI: [-9.65, -4.26]ANCOVA
p-value: <0.00195% CI: [3.39, 8.71]ANCOVA
p-value: 0.01795% CI: [0.93, 9.46]ANCOVA
Secondary
Glycemic Variability
Glycemic variability was measured by mean blood glucose value (M-value), which was the mean of the intra-days self-monitoring 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: Baseline, 12-24-36 weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Mid Mixture | Glycemic Variability | Baseline MODD (n=226, n=229) | 2.09 millimoles per liter (mmol/L) | Standard Error 0.33 |
| Insulin Lispro Mid Mixture | Glycemic Variability | Baseline M-Value (n=228, n=231) | 48.02 millimoles per liter (mmol/L) | Standard Error 14.73 |
| Insulin Lispro Mid Mixture | Glycemic Variability | 12 Week MODD (n=214, n=221) | 1.51 millimoles per liter (mmol/L) | Standard Error 0.31 |
| Insulin Lispro Mid Mixture | Glycemic Variability | 12 Week M-Value (n=218, n=226) | 30.07 millimoles per liter (mmol/L) | Standard Error 7.24 |
| Insulin Lispro Mid Mixture | Glycemic Variability | 24 Week MODD (n=208, n=211) | 1.57 millimoles per liter (mmol/L) | Standard Error 0.33 |
| Insulin Lispro Mid Mixture | Glycemic Variability | 24 Week M-Value (n=210, n=213) | 22.67 millimoles per liter (mmol/L) | Standard Error 7.05 |
| Insulin Lispro Mid Mixture | Glycemic Variability | 36 Week MODD (n=198, n=206) | 1.55 millimoles per liter (mmol/L) | Standard Error 0.32 |
| Insulin Lispro Mid Mixture | Glycemic Variability | 36 Week M-Value (n=200, n=210) | 26.46 millimoles per liter (mmol/L) | Standard Error 7.26 |
| Insulin Lispro Mid Mixture | Glycemic Variability | Endpoint MODD (n=226, n=229) | 1.51 millimoles per liter (mmol/L) | Standard Error 0.32 |
| Insulin Lispro Mid Mixture | Glycemic Variability | Endpoint M-Value (n=228, n=231) | 26.27 millimoles per liter (mmol/L) | Standard Error 7.41 |
| Insulin Glargine | Glycemic Variability | 36 Week M-Value (n=200, n=210) | 27.41 millimoles per liter (mmol/L) | Standard Error 7.12 |
| Insulin Glargine | Glycemic Variability | Baseline MODD (n=226, n=229) | 2.07 millimoles per liter (mmol/L) | Standard Error 0.32 |
| Insulin Glargine | Glycemic Variability | 24 Week M-Value (n=210, n=213) | 20.14 millimoles per liter (mmol/L) | Standard Error 6.93 |
| Insulin Glargine | Glycemic Variability | Baseline M-Value (n=228, n=231) | 46.75 millimoles per liter (mmol/L) | Standard Error 14.47 |
| Insulin Glargine | Glycemic Variability | Endpoint M-Value (n=228, n=231) | 27.99 millimoles per liter (mmol/L) | Standard Error 7.28 |
| Insulin Glargine | Glycemic Variability | 12 Week MODD (n=214, n=221) | 1.54 millimoles per liter (mmol/L) | Standard Error 0.31 |
| Insulin Glargine | Glycemic Variability | 36 Week MODD (n=198, n=206) | 1.60 millimoles per liter (mmol/L) | Standard Error 0.32 |
| Insulin Glargine | Glycemic Variability | 12 Week M-Value (n=218, n=226) | 28.49 millimoles per liter (mmol/L) | Standard Error 7.12 |
| Insulin Glargine | Glycemic Variability | Endpoint MODD (n=226, n=229) | 1.61 millimoles per liter (mmol/L) | Standard Error 0.31 |
| Insulin Glargine | Glycemic Variability | 24 Week MODD (n=208, n=211) | 1.66 millimoles per liter (mmol/L) | Standard Error 0.32 |
p-value: 0.77695% CI: [-0.14, 0.19]ANOVA
p-value: 0.73795% CI: [-6.14, 8.68]ANOVA
p-value: 0.70195% CI: [-0.19, 0.13]ANCOVA
p-value: 0.495% CI: [-2.11, 5.27]ANCOVA
p-value: 0.32195% CI: [-0.26, 0.09]ANCOVA
p-value: 0.17995% CI: [-1.16, 6.21]ANCOVA
p-value: 0.57395% CI: [-0.22, 0.12]ANCOVA
p-value: 0.62995% CI: [-4.79, 2.9]ANCOVA
p-value: 0.2595% CI: [-0.26, 0.07]ANCOVA
p-value: 0.36295% CI: [-5.44, 1.99]ANCOVA
Secondary
Hemoglobin A1c (HbA1c) at Interval Visits
Levels of HbA1c at 12 weeks and 24 weeks and 36 weeks.
Time frame: 12, 24, and 36 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 Mid Mixture | Hemoglobin A1c (HbA1c) at Interval Visits | 12 Week Interval (n=222, n=222) | 8.02 percent HbA1c | Standard Error 0.32 |
| Insulin Lispro Mid Mixture | Hemoglobin A1c (HbA1c) at Interval Visits | 24 Week Interval (n=206, n=217) | 7.53 percent HbA1c | Standard Error 0.33 |
| Insulin Lispro Mid Mixture | Hemoglobin A1c (HbA1c) at Interval Visits | 36 Week Interval (n=202, n=208) | 7.53 percent HbA1c | Standard Error 0.37 |
| Insulin Glargine | Hemoglobin A1c (HbA1c) at Interval Visits | 12 Week Interval (n=222, n=222) | 7.85 percent HbA1c | Standard Error 0.31 |
| Insulin Glargine | Hemoglobin A1c (HbA1c) at Interval Visits | 24 Week Interval (n=206, n=217) | 7.36 percent HbA1c | Standard Error 0.32 |
| Insulin Glargine | Hemoglobin A1c (HbA1c) at Interval Visits | 36 Week Interval (n=202, n=208) | 7.44 percent HbA1c | Standard Error 0.37 |
p-value: 0.04795% CI: [0, 0.33]ANCOVA
p-value: 0.04395% CI: [0.01, 0.35]ANCOVA
p-value: 0.34395% CI: [-0.1, 0.29]ANCOVA
Secondary
Number of Insulin Injections Per Day
Time frame: Weeks 12, 24, 30, 36
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro Mid Mixture | Number of Insulin Injections Per Day | Week 12 | 1.33 insulin injections | Standard Error 0.19 |
| Insulin Lispro Mid Mixture | Number of Insulin Injections Per Day | Week 24 | 1.97 insulin injections | Standard Error 0.28 |
| Insulin Lispro Mid Mixture | Number of Insulin Injections Per Day | Week 30 | 2.05 insulin injections | Standard Error 0.3 |
| Insulin Lispro Mid Mixture | Number of Insulin Injections Per Day | Week 36 | 2.03 insulin injections | Standard Error 0.3 |
| Insulin Lispro Mid Mixture | Number of Insulin Injections Per Day | Endpoint | 1.98 insulin injections | Standard Error 0.3 |
| Insulin Glargine | Number of Insulin Injections Per Day | Endpoint | 1.79 insulin injections | Standard Error 0.29 |
| Insulin Glargine | Number of Insulin Injections Per Day | Week 36 | 1.80 insulin injections | Standard Error 0.29 |
| Insulin Glargine | Number of Insulin Injections Per Day | Week 24 | 1.76 insulin injections | Standard Error 0.27 |
| Insulin Glargine | Number of Insulin Injections Per Day | Week 12 | 1.00 insulin injections | Standard Error 0.18 |
| Insulin Glargine | Number of Insulin Injections Per Day | Week 30 | 1.81 insulin injections | Standard Error 0.3 |
p-value: <0.00195% CI: [0.24, 0.42]ANCOVA
p-value: 0.00395% CI: [0.07, 0.36]ANCOVA
p-value: 0.00295% CI: [0.09, 0.4]ANCOVA
p-value: 0.00595% CI: [0.07, 0.38]ANCOVA
p-value: 0.01195% CI: [0.04, 0.34]ANCOVA
Secondary
Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia
Hypoglycemic episode defined: any time patient felt that he/she was experiencing a sign or symptom associated with hypoglycemia, or had old Roche blood glucose level \<70 mg/dL even if not associated with signs, symptoms, or treatment consistent with current guidelines. Nocturnal hypoglycemia defined: any hypoglycemic event that occurred between bedtime and waking. Non-nocturnal hypoglycemia defined: any hypoglycemic event that occurred between waking and bedtime. Overall episodes: those that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Time frame: Baseline to 36 Weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. The last visit of trial interval was used to calculate hypoglycemic episodes at Endpoint if patient completes trial and last observation carried forward was used if the patient dropped out of the study early.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro Mid Mixture | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Endpoint Hypoglycemic Episodes | 87 participants |
| Insulin Lispro Mid Mixture | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Overall Hypoglycemic Episodes | 178 participants |
| Insulin Lispro Mid Mixture | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Endpoint Nocturnal Hypoglycemic Episodes | 30 participants |
| Insulin Lispro Mid Mixture | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Overall Nocturnal Hypoglycemic Episodes | 112 participants |
| Insulin Lispro Mid Mixture | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Endpoint Non-Nocturnal Hypoglycemic Episodes | 71 participants |
| Insulin Lispro Mid Mixture | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Overall Non-Nocturnal Hypoglycemic Episodes | 175 participants |
| Insulin Glargine | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Endpoint Non-Nocturnal Hypoglycemic Episodes | 98 participants |
| Insulin Glargine | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Endpoint Hypoglycemic Episodes | 106 participants |
| Insulin Glargine | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Overall Nocturnal Hypoglycemic Episodes | 112 participants |
| Insulin Glargine | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Overall Hypoglycemic Episodes | 179 participants |
| Insulin Glargine | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Overall Non-Nocturnal Hypoglycemic Episodes | 179 participants |
| Insulin Glargine | Number of Patients With at Least One Self-reported Hypoglycemic Episode, Including Nocturnal (and Non-nocturnal) Hypoglycemia | Endpoint Nocturnal Hypoglycemic Episodes | 37 participants |
p-value: 0.094Fisher Exact
p-value: 1Fisher Exact
p-value: 0.43Fisher Exact
p-value: 1Fisher Exact
p-value: 0.013Fisher Exact
p-value: 0.756Fisher Exact
Secondary
Number of Patients With at Least One Severe Hypoglycemia Episode
Severe hypoglycemia was defined as hypoglycemic event that meets at least one of the following criteria: not capable of treating self and blood glucose \<2.8 millimoles per liter (mmol/L); not capable of treating self, blood glucose is missing and prompt recovery after oral carbohydrate or glucagon or intravenous glucose; hypoglycemic event outcome was coma, hopitalization, emergency room visit, or automobile accident. The overall category is a severe hypoglycemic event that occurred at any time during the post-randomization visits. Endpoint: last visit interval based on LOCF.
Time frame: Baseline to 36 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 Mid Mixture | Number of Patients With at Least One Severe Hypoglycemia Episode | Endpoint Severe Hypoglycemic Episodes | 1 participants |
| Insulin Lispro Mid Mixture | Number of Patients With at Least One Severe Hypoglycemia Episode | Overall Severe Hypoglycemic Episodes | 8 participants |
| Insulin Glargine | Number of Patients With at Least One Severe Hypoglycemia Episode | Endpoint Severe Hypoglycemic Episodes | 1 participants |
| Insulin Glargine | Number of Patients With at Least One Severe Hypoglycemia Episode | Overall Severe Hypoglycemic Episodes | 5 participants |
p-value: 0.416Fisher Exact
Secondary
Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint
Time frame: 12-24-36 weeks
Population: Number of randomized patients with baseline and at least one post-baseline value. Intent to treat population. If the patient completed the trial, the endpoint was 36 weeks (Week 36), but if the patient dropped out of the study early, the last observation carried forward (LOCF) was considered as the endpoint (Endpoint).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c ≤7.0% (n=206, n=217) | 39.8 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c >7.0% (n=222, n=222) | 78.8 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c <7.0% (n=222, n=222) | 18.9 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c ≥7.0% (n=222, n=222) | 81.1 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c ≤6.5% (n=222, n=222) | 8.1 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c >6.5% (n=222, n=222) | 91.9 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c ≤7.0% (n=222, n=222) | 21.2 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c >7.0% (n=206, n=217) | 60.2 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c <7.0% (n=206, n=217) | 35.4 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c ≥7.0% (n=206, n=217) | 64.6 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c ≤6.5% (n=206, n=217) | 16.0 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c >6.5% (n=206, n=217) | 84.0 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c ≤7.0% (n=202, n=208) | 39.6 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c >7.0% (n=202, n=208) | 60.4 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c <7.0% (n=202, n=208) | 37.6 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c ≥7.0% (n=202, n=208) | 62.4 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c ≤6.5% (n=202, n=208) | 15.3 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c >6.5% (n=202, n=208) | 84.7 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c ≤7.0% (n=234, n=235) | 36.8 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c >7.0% (n=234, n=235) | 63.2 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c <7.0% (n=234, n=235) | 35.0 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c ≥7.0% (n=234, n=235) | 65.0 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c ≤6.5% (n=234, n=235) | 13.2 percentage of participants |
| Insulin Lispro Mid Mixture | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c >6.5% (n=234, n=235) | 86.8 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c ≤6.5% (n=234, n=235) | 19.1 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c ≤7.0% (n=222, n=222) | 25.2 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c ≤7.0% (n=202, n=208) | 44.7 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c >7.0% (n=222, n=222) | 74.8 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c ≤7.0% (n=234, n=235) | 43.0 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c <7.0% (n=222, n=222) | 21.6 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c >7.0% (n=202, n=208) | 55.3 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c ≥7.0% (n=222, n=222) | 78.4 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c ≥7.0% (n=234, n=235) | 60.9 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c ≤6.5% (n=222, n=222) | 10.8 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c <7.0% (n=202, n=208) | 40.4 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 12: HbA1c >6.5% (n=222, n=222) | 89.2 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c >7.0% (n=234, n=235) | 57.0 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c ≤7.0% (n=206, n=217) | 47.0 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c ≥7.0% (n=202, n=208) | 59.6 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c >7.0% (n=206, n=217) | 53.0 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c >6.5% (n=234, n=235) | 80.9 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c <7.0% (n=206, n=217) | 38.7 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c ≤6.5% (n=202, n=208) | 19.2 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c ≥7.0% (n=206, n=217) | 61.3 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Endpoint (LOCF): HbA1c <7.0% (n=234, n=235) | 39.1 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c ≤6.5% (n=206, n=217) | 21.7 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 36: HbA1c >6.5% (n=202, n=208) | 80.8 percentage of participants |
| Insulin Glargine | Percentage of Patients Who Achieved Hemoglobin A1c Less Than or Equal to 6.5%, Greater Than 6.5%, Less Than 7%, Greater Than or Equal to 7%, Less Than or Equal to 7%, and Greater Than 7% at Interval Visits and Endpoint | Week 24: HbA1c >6.5% (n=206, n=217) | 78.3 percentage of participants |
p-value: 0.432Regression, Logistic
p-value: 0.602Regression, Logistic
p-value: 0.37Regression, Logistic
p-value: 0.198Regression, Logistic
p-value: 0.636Regression, Logistic
p-value: 0.185Regression, Logistic
p-value: 0.393Regression, Logistic
p-value: 0.739Regression, Logistic
p-value: 0.396Regression, Logistic
p-value: 0.227Regression, Logistic
p-value: 0.482Regression, Logistic
p-value: 0.108Regression, Logistic