The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
390
Insulin glargine administered subcutaneously once daily.
Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)
sanofi-aventis, US
Bridgewater, New Jersey, United States
Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
Time frame: 12 weeks from Baseline
Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage
Time frame: 60 weeks from Baseline
Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 60 weeks from Baseline
Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
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* 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.
Time frame: 60 Weeks from Baseline