Morning LANTUS v. Intermediate-acting Insulin 2x/Day as Basal Insulin in a Multiple Daily Inj. w/ Humalog in Adolescents w/ Type 1 Diabetes Mellitus: an Active-controlled, Open, Randomized, Gender-stratified, Two-arm, Parallel-group Study

简要总结

主要结局

次要结局

• Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined(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)
• Adverse events (AEs)(from the informed consent signature to the end of the study)
• 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 urinary spot random microalbumin-to-creatinine (A/C) ratio(from baseline to endpoint)
• Change in average basal insulin doses(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)
• 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)
• Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined(from baseline to endpoint)