| Outcome Measures: |
Primary: Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12, 12 weeks from Baseline | Secondary: Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage, 60 weeks from Baseline|Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%, 60 weeks from Baseline|Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime), 60 weeks from Baseline|Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions), 60 weeks from Baseline|Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia, * Symptomatic hypoglycemia (BG\<70 mg/dL, BG\<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat \& a cold, clammy feeling. * Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but \<70 mg/dL * Severe hypoglycemia: assistance of another party is required \& either: * SMBG of \<36 mg/dL, or * with prompt response to treatment with oral carbohydrates, IV glucose or glucagon. * Serious hypoglycemia: * Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion., 60 weeks from Baseline|Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia, * Symptomatic hypoglycemia (BG\<70 mg/dL, BG\<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat \& a cold, clammy feeling. * Mild-to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but \<70 mg/dL * Severe hypoglycemia: assistance of another party is required \& either: * SMBG of \<36 mg/dL, or * with prompt response to treatment with oral carbohydrates, IV glucose or glucagon. * Serious hypoglycemia: * Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion., 60 Weeks from Baseline
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