Clinical Research On Type 2 Diabetes With Twice- Or Thrice-daily Dosing With Biphasic Insulin Aspart 30

Objective:To assess the efficacy and safety of twice- and thrice-daily biphasic insulin aspart 30 (BIAsp 30) in Chinese subjects with type 2 diabetes mellitus(T2DM) by retrospective analysis.Methods:129 subjects with T2DM were hospitalized and accepted BIAsp 30 therapy in the 1st affiliated hospital of Shantou University Medical College from November 2007 to November 2009. Study subjects were newly diagnosed and inadequately controlled with oral antidiabetes drugs and other types of insulin. Study subjects divided into twice- and thrice-daily BIAsp 30 (BID and TID groups, respectively) without OADs according to the number of insulin injections. All patients were hospitalized for treatment of BIAsp 30 for more than 2 weeks after discharge, and continued the regimen for more than 12 weeks. Comparing with glycemic control, hypoglycemia events and insulin doses between BID and TID groups.Results:1. After 2 weeks'hospitalization, glycemic decreased significantly in both groups (P<0.01), Thrice-daily BIAsp 30 decreased 0.74-1.23mmol/L compare to twice-daily BIAsp 30, but without statistical significance (P>0.05).2. After 12 weeks'treatment of BIAsp 30, HbA1c decreased significantly in both groups (BID group -1.67±1.98%, TID group -2.08±1.71%, P<0.01). TID group showed better improvement in HbA1c (0.41% compared to BID group), but without statistical significance (P>0.05).The rates of achievement of HbA1c<6.5% and 7.0% were 46.7% and 62.9% in BID group, and 40.3% and 64.2% in TID group (P>0.05).3. During hospitalization, a total of 33 hypoglycemic events occurred in 28 of the 129 subjects. Of these, 21 events (33.9%) were associated with the BID group, and 12 events (17.9%) were associated with the TID group, which were significantly lower than the BID group (P=0.038). 4. During hospitalization, the mean daily insulin doses were 0.43±0.15units/kg in the BID group, which were significantly lower than the TID group (0.60±0.17units/kg, P<0.01).Conclusions:Twice- and thrice-daily BIAsp30 were effective in Chinese subjects with poorly controlled type 2 diabetes. Thrice-daily BIAsp30 increased insulin dose, but offered better reduction in HbA1c without increasing risk of hypoglycemia.