Clinical trials report

Abstract

Riddle MC, et al.: Comparison of basal insulin added to oral agents versus twicedaily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 2005, 28:254-259. Rating: •Of importance.Introduction: A recent survey by the American Association of Clinical Endocrinologists (AACE) has indicated that more than two thirds of patients with diabetes do not meet the standards of care (ie, they do not have A 1c concentrations below 6.5%) [1,2]. Barriers to achieving this goal include failure to recognize type 2 diabetes as a progressive disorder, lack of timely progression of therapy, and reluctance to initiate insulin when needed. Both patients and doctors often hesitate to start insulin. One concern is lack of clarity on the best way to start insulin. Another concern relates to the newly recognized importance of prandial hyperglycemia control as one approaches A 1c targets [3]. Thus, when and how to start insulin is not the only issue-when and how to start meal insulin is also important. Two recent papers have compared regimens for insulin initiation and come to different conclusions. Both are discussed in this report. Aims:To compare the efficacy and safety of adding oncedaily basal insulin versus switching to twice-daily premixed insulin in patients with type 2 diabetes insufficiently controlled by oral antidiabetic drugs (OADs).Methods: This is a 24-week-long, randomized, open-label, parallel, multicenter, multinational (66 sites, 10 European countries) trial to compare the efficacy and safety of achieving American Diabetes Association criteria for good control (< 7%) and to do so without nocturnal hypoglycemia. The two insulin regimens were insulin glargine given before breakfast added to previously used OADs versus discontinuing OADs and switching to a fixed-ratio neutral protamine Hagedorn (NPH) and regular combination (70/30) twice daily at breakfast and supper. Secretagogues were changed to glimepiride 3 to 4 mg/d but dosage was not adjusted. Metformin was prescribed at the prestudy dosage without any titration. Patients were included if they had type 2 diabetes for at least 1 year and were on stable metformin and sulfonylureas for at least 1 month, were between 35 to 75 years old, had a body mass index ≤ 35, had an A 1c between 7.5 and 10.5, and had a fasting glucose ≥ 120 mg/dL.