Randomization and treatment
fasting blood glucose, hypoglycemic, diabetes
HYPERGLYCEMIA, DIABETES
During the screening period patients used their regular hypoglycemic drugs and evaluations for eligibility to select study subjects were conducted based on the inclusion and exclusion criteria. During the lead-in period, the patients’ regular hypoglycemic drugs were discontinued and a premixed insulin-intensive treatment was administered for 2 weeks to quickly correct hyperglycemia. After 2 weeks of this intensive treatment, the patients were randomly divided into premixed insulin (Ins), premixed insulin plus SZ-A (Ins+SZ-A) and premixed insulin plus Met (Ins+MET) groups for the following 12 weeks (Flowchart of the study.The goal in terms of fasting blood glucose control for this study was 4.4–7.0 mmol/L. The initial premixed insulin dose was 0.4–0.5 IU/kg, after which, it was adjusted as needed, according to plasma glucose values obtained through self-monitoring. The initial dose of SZ-A (Beijing Guokaihua Intellectual Property Agency Co., LTD, Beijing, China) was 50mg, administered three times per day, at mealtimes. After four weeks, this dose was increased to 100mg three times per day at mealtimes. The Met dose (Sino-American Shanghai Squibb Pharmaceuticals Co., Ltd, Shanghai, China) was 500mg three times per day at mealtimes, throughout the entire observation period. The first 6 weeks of the treatment phase comprised the insulin dose titration period. Patients were required to self-monitor their blood glucose levels, and a trained doctor adjust their insulin doses based on the results obtained. The following 6 weeks comprised the steady dose period. The patients received diabetes education during this phase, in order to promote reasonable dietary control and proper exercise over the rest of the study period.