Comparision Of Basal Insulin Versus Premixed Insulin As Therapy For Type 2 Diabetes On Efficacy And Safety Of Clinical Study

Objectives:To compare the once-daily basal insulin(insulin glargine) plus 1 or 2 OAD versus twice-daily premixed insulin(70/30) plus 1 or 2 OAD as therapy for Type 2 diabetes mellitus on efficacy and safety of clinical study.Methods: Selected 40 Type 2 diabetic patients from our hospital according to the selection criteria and exclusion criteria, signed informed consent form, assessed the demographic and background, physical examination, measured fasting blood glucose(FBG),HbAlc, 7 times of the blood glucose in one day, laboratory tests (blood, urine and biochemical examination). The 40 patients were randomized to once-daily basal insulin(insulin glargine) plus 1 or 2 OAD therapy group (n = 20) and twice-daily premixed insulin(70/30) plus 1 or 2 OAD therapy group (n = 20), premixed insulin therapy group continue the original therapy, while the basal insulin therapy group stopped the original therapy of premixed insulin, and began to use once-daily basal insulin (insulin glargine) plus 1 or 2 OAD. Therapy goals: FBG≤6.0mmol / l, HbAlc≤7%, the therapy time are 16 weeks, included 6 visits. Insulin dosage was titrated to FBG, hypoglycemia, and the incidence of serious side effects. If the patients who meets the withdraw standards or gives up the therapy on himself, he should immediately exit the clinical study. At the end of the study on the 16th week, the two groups undertook the examination, such as FBG, HbAlc, monitored 7 times of the blood glucose in one day, related laboratory tests, and recorded the insulin dose used.Results: At the end of the study on the 16th week, two groups were all significantly decreased on FPG, but the basal groups decreased greater than the premixed groups (P <0.05); The 7 times of the blood glucose in one day of the basal group before return visit achieved the desired blood glucose range slightly higher than the premixed group, but no significant difference between the two groups (P> 0.05); HbA1c were decreased to varying degrees, the basal group slightly better than premixed group, but there were no significant differences (P> 0.05); The average consumption on insulin of premixed group were greater than basal group (P <0.05); premixed group was greater than the basal on body weight, but no significant difference between the two groups (P> 0.05) ;Hypoglycemia events of basal group: the first 8 weeks total had 4 cases (20%), the last 8 weeks total had 1 case(5%) , premixed group: the first 8 weeks total had 10 cases (50%), the last 8 weeks total had 7 case(35%) ,the two groups had statistical significance (P <0.05), and there were no serious side effects occurred in both of the two groups. In the basal group, the FBG of pre-therapy was higher than the post-therapy (P <0.05), HbAlc was lower than the pre- therapy (P <0.05), the percentage of ideal blood glucose on 7 times of the blood glucose in one day was higher than the pre- therapy (P <0.05), the average consumption of insulin declined (P <0.05), the body weight decreased compare to the pre- therapy, but no statistical significance (P> 0.05).Conclusions: The study suggests that for Type 2 diabetic patients, the use of once-daily basal insulin (insulin glargine) plus 1 or 2 OAD compared to twice-daily premixed insulin(70/30) plus 1 or 2 OAD, there are significant advantages in the control of FBG, HbAlc ,and low hypoglycemia, no serious side effects found during the study.