OBJECTIVE - To compare long-term glycemic control and safety of using insulin aspart (IAsp) with that of regular human insulin (HI). RESEARCH DESIGN AND METHODS - This was a multicenter randomized open-label 6-month study (882 subjects) with a 6-month extension period (714 subjects) that enrolled subjects with type 1 diabetes. Subjects administered IAsp immediately before meals or regular HI 30 min before meals; basal NPH insulin was taken as a single bedtime dose in the majority of subjects. Glycemic control was assessed with HbA(1c) values and 8-point blood glucose profiles at 3-month intervals. RESULTS - Mean postprandial blood glucose levels (mg/dl ± SEM) were significantly lower for subjects in the IAsp group compared with subjects in the HI group after breakfast (156 ± 3.4 vs. 185 ± 4.7), lunch (137 ± 3.1 vs. 162 ± 4.1), and dinner (153 ± 3.1 vs. 168 ± 4.1), when assessed after 6 months of treatment. Mean HbA(1c) values (% ± SEM) were slightly, but significantly, lower for the IAsp group (7.78% ± 0.03) than for the regular HI group (7.93% ± 0.05, P = 0.005) at 6 months. Similar postprandial blood glucose and HbA(1c) values were observed at 12 months. Adverse events and overall hypoglycemic episodes were similar for both treatment groups. CONCLUSIONS - Postprandial glycemic control was significantly better with IAsp compared with HI after 6 and 12 months of treatment. The improvement was not obtained at an increased risk of hypoglycemia. HbA(1c) was slightly, but significantly, lower for IAsp compared with HI at 6 and 12 months.
ASJC Scopus subject areas
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Advanced and Specialized Nursing