Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes

OBJECTIVE - To compare the efficacy and safety of adding once-daily basal insulin versus switching to twice-daily premixed insulin in type 2 diabetic patients insufficiently controlled by oral antidiabetic agents (OADs). RESEARCH DESIGN AND METHODS - in a 24-week, multinational, multicenter, open, parallel group clinical trial, 371 insulin-naive patients With poor glycemic control (fasting blood glucose [FBG] greater than or equal to120 mg/dI, HbA(1c) 7.5-10.5%) on OADs (sulfonylurea plus inetformin) were randomized to once-daily morning insulin glargine plus glimepiride and metformin (glargine plus OAD) or to 30% reaular/70% human NPH insulin (70/30) twice daily without OADs. Insulin dosage Was titrated to target FBG less than or equal to 100 mg/dl (both insulins) and predinner blood glucose less than or equal to100 mg/dl (70/30 only) using a weekly forced-titration algorithm. RESULTS - Mean HbA(1c) decrease front baseline was significantly more pronounced (-1.64 vs. -1.31%, P = 0.0003), and more patients reached HbA(1c) less than or equal to 7.0% without confirmed nocturnal hypoglycemia (45.5 vs. 28.6%, P = 0.0013) with glargine plus OAD than with 70/30. Similarly, FBG decrease was greater with glargine plus OAD (ad -17 mg/dl [-0.9 mmol/l], o P < 0.0001), and more patients reached target FBG less than or equal to 1.00 mg/dl with glargine plus OAD than with 70/30 (31.6 vs. 15.0%, P = 0.0001). Glargine plus OAD patients had fewer confirmed hypoglycemic episodes than 70/30 patients (mean 4.07 vs. 9.87/patient-year, P < 0.0001). CONCLUSIONS - Initiating insulin treatment by adding basal insulin glargine once daily to glimepiride plus metformin treatment was safer and more effective than beginning twice-daily injections of 70/30 and discontinuing OADs in type 2 diabetic patients inadequately controlled with OADs.