• Diabetes care · Feb 2005

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

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

    • Hans U Janka, Gerd Plewe, Matthew C Riddle, Christine Kliebe-Frisch, Matthias A Schweitzer, and Hannele Yki-Järvinen.
    • Zentralkrankenhaus, Bremen-Nord, II Medizinische Abteilung, Hammersbecker Str. 228, 28755 Bremen, Germany. hans.janka@klinikum-bremen-nord.de
    • Diabetes Care. 2005 Feb 1; 28 (2): 254-9.

    ObjectiveTo 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 MethodsIn a 24-week, multinational, multicenter, open, parallel group clinical trial, 371 insulin-naive patients with poor glycemic control (fasting blood glucose [FBG] >/=120 mg/dl, HbA(1c) 7.5-10.5%) on OADs (sulfonylurea plus metformin) were randomized to once-daily morning insulin glargine plus glimepiride and metformin (glargine plus OAD) or to 30% regular/70% human NPH insulin (70/30) twice daily without OADs. Insulin dosage was titrated to target FBG ResultsMean HbA(1c) decrease from baseline was significantly more pronounced (-1.64 vs. -1.31%, P = 0.0003), and more patients reached HbA(1c) ConclusionsInitiating 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.

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