| Outcome Measures: |
Primary: to measure change in glycemic control as measured by hemoglobin A1c (A1c)., from baseline to endpoint (last available post-treatment assessment) | Secondary: Change in A1c, from baseline to individual study time points|Percentage of subjects achieving an A1c ≤7.0; percent of preteens (12 years and below) achieving 8%; teens (13-18 years) achieving 7.5%, During the study conduct|Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined, from baseline to endpoint|Change in urinary spot random microalbumin-to-creatinine (A/C) ratio, from baseline to endpoint|Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined, from baseline to endpoint|Change in average basal insulin doses, from baseline to endpoint|Change in lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL], low-density lipoprotein cholesterol [LDL], and triglycerides [TGs]), from baseline to endpoint|Change in glucose, from baseline to endpoint|Occurrence of hypoglycemia, from the informed consent signature to the end of the study|Adverse events (AEs), from the informed consent signature to the end of the study|Clinical values: physical examination, vital signs, change in age-adjusted body mass index (BMI), from the informed consent signature to the end of the study
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