| Outcome Measures: |
Primary: Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites), Responders defined as patients who achieved an HbA1c value \<7.0% versus nonresponders. Patients who did not achieve an HbA1c value \<7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders., At week 60|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population, Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol., At week 60|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis), Responders defined as patients who achieved an HbA1c value \<7.0% versus nonresponders. Patients who did not achieve an HbA1c value \<7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders., At week 60 | Secondary: Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30), Absolute Change in HbA1c from Baseline to Week 60., From baseline to week 60|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30), Patients who achieved an HbA1c value \<7.0% were defined as responders. Patients who did not achieve HbA1c values \<7.0% and patients with missing HbA1c values were considered nonresponders., At week 60|Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl, Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration. A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of \<50 mg/dL with reported symptoms., At week 60|Adjusted Incidence Rate of Hypoglycemia, Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia. A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) \<36 mg/dL during or soon after the event. A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion. Nocturnal = events occurring between 00:00 \& 06:00 based on a 24-hour clock. An event is included if the HE start date is within the treatment period., Week 60|Adjusted Hypoglycemic Event Rates (Event/Patient-year), Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study. An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to \& including 1 day after the date of last dose of study drug)., Week 60
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