| ObjectiveTo observe the efficacy and safety of Biphasic Insulin Aspart 30 on those Type 2 Diabetic Patients who newly diagnosed or never use Insulin for therapy before and lost the effectiveness of oral medicines.MethodsWe choose 234 T2DM patients. There was 83 patients in the newly diagnosed T2DM team (Team I), including 48 men and 35 women. The mean age is 48.37±10.32 years old, the body mass index(BMI) is 24.97±1.14 kg/m2. There was 151 patients who never use Insulin for therapy before and lost the effectiveness of oral medicines with T2DM in the other team (TeamⅡ). including 83 men and 68 women. The mean age is 50.64±8.91 years old, the mean course of T2DM is 7.55±3.35 years, the body mass index(BMI) is 24.98±1.15 kg/m2. Education of diabetic information, control of food and drink, sufficient quantum sports were given to all patients of both team before insulin therapy. The subjects were all given biphasic insulin aspart 30 subcutaneous injection twice daily, before breakfast and supper. The dosages of biphasic insulin aspart 30 were adjusted according to the anteprandial and postprandial 2 hours blood glucose of three meals. Fasting plasma glucose(FPG), postprandial 2 hours plasma glucose(2hPG), glycosylated haemoglobin(HbAlc), triglyceride(TG), total cholesterol(TC) and self-recorded daily 8-piont blood glucose(BG) were measured and compared before and after 16 weeks of treatment. The dosages of insulin analogue, hypoglycaemic events and weight were recorded.Results1. Compared with pretreatment, for Team I, FPG was 14.56±2.64mmol/L,2hPG was 19.72±2.97mmol/L, HbA1c was 9.46±1.61%, at the end of 16 weeks treatment, FPG was 6.97±0.91mmol/L,2hPG was 9.74±1.82mmol/L, HbA1c was 6.82±0.66% all decreased significantly(P<0.05). for TeamⅡ, FPG was 14.59±2.57mmol/L,2hPG was 19.80±2.22mmol/L, HbAlc was 9.61±1.70%, at the end of 16 weeks treatment, FPG was 7.09±1.15mmol/L,2hPG was 9.98±1.71mmol/L, HbA1c was 6.95±0.65% all decreased significantly(P<0.05). Change of TG, TC,low density lipoprotein-c (LDL-c) and high density lipoprotein-c (HDL-c) after treatment in both team had no statistical difference (P>0.05)2.Compared with pretreatment, at the end of 16 weeks treatment, all blood glucose at the eight time point were decreased significantly (P<0.05).3. At the end of 16 weeks treatment, the mean dosages of insulin analogue of Team I was 28.20±10.25U/d, that of TeamⅡwas 36.73±7.52 U/d, Team I was less than TeamⅡ(P<0.05). Compared with pretreatment, BMI of Team I was a little increased from 24.97±1.14kg/m2 to 25.18±1.12 kg/m2 (P<0.05), BMI of TeamⅡwas a little increased from 24.98±1.15kg/m2 to 25.15±1.13 kg/m2(P<0.05). During the treatment no hypoglycaemic event was reported. No one in the 234 patients stopped use Biphasic Insulin Aspart 30 because of Adverse Events(AE) during the treatment, and no severe hypoglycemic event was reported in both of two teams during the treatment.3 mild hypoglycemic events were reported in team I, and 5 mild hypoglycemic events were reported in teamⅡ.ConclusionsBiphasic Insulin Aspart 30 have efficacy and safety profiles in the treatment on those Type 2 Diabetic Patients who newly diagnosed or never use Insulin for therapy before and lost the effectiveness of oral medicines. Biphasic Insulin Aspart 30 twice daily was a convenient ideal insulin therapy of glycemic control in Type 2 Diabetic Patients.
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