The Efficacy And Safety Of Treatment By Biphasic Insulin Aspart In Type 2 Diabetes Mellitus

Objective: To observe and compare the therapeutic effects and safety of the biphasic insulin aspart thrice daily and the biphasic insulin aspart twice daily in type 2 diabetes mellitus (T2DM).Methods: Thirty-seven patients with T2DM were randomly divided into two groups: treated respectively with the biphasic insulin aspart thrice daily (BIAsp50-50-30, n=20) and the biphasic insulin aspart twice daily (BIAsp30-30, n=17) for 16 weeks. Glycosylated hemoglobin A1c (HbA1c), blood glucose at 7 time points and lipid were measured pre-treatment and after-treatment, and hypoglycemia was also observed.Results: After 16 weeks treatment, HbA1c, 7 points blood glucose , Low-density lipoprotein cholesterol (LDL-C) and free fatty acid (FFA) were decreased significantly in the group of BIAsp50-50-30 (P<0.01 or P<0.05). The group of BIAsp30-30 had a significant decrease in HbA1c and 6 points blood glucose except 2h post-lunch blood glucose (P<0.01 or P<0.05), but LDL-C and FFA had no change (P>0.05). There was no significant difference between the two groups before treatment (P>0.05). No severe hypoglycemia happened, 3 patient(s15%) and 4 patient(s24%) separately in BIAsp50-50-30 group and BIAsp30-30 group had mild hypoglycemia,1 patient in BIAsp30-30 group had skin pruritus at injection site.Conclusion: Biphasic insulin aspart combined with oral metformin to improve the glycemia control of T2DM, the BIAsp50-50-30 program is superior to BIAsp30-30 program, as it has a better control on post-lunch blood glucose, LDL-C and FFA level.