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-naïve patients with poor glycemic control (fasting blood glucose [FBG] Ն120 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 Յ100 mg/dl (both insulins) and predinner blood glucose Յ100 mg/dl (70/30 only) using a weekly forced-titration algorithm.RESULTS -Mean HbA 1c decrease from baseline was significantly more pronounced (Ϫ1.64 vs. Ϫ1.31%, P ϭ 0.0003), and more patients reached HbA 1c Յ7.0% without confirmed nocturnal hypoglycemia (45.5 vs. 28.6%, P ϭ 0.0013) with glargine plus OAD than with 70/30. Similarly, FBG decrease was greater with glargine plus OAD (adjusted mean difference Ϫ17 mg/dl [-0.9 mmol/l], P Ͻ 0.0001), and more patients reached target FBG Յ100 mg/dl with glargine plus OAD than with 70/30 (31.6 vs. 15.0%, P ϭ 0.0001). Glargine plus OAD patients had fewer confirmed hypoglycemic episodes than 70/30 patients (mean 4.07 vs. 9.87/patient-year, P Ͻ 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. Diabetes Care 28:254 -259, 2005T he association between poor glycemic control and the occurrence of micro-and macrovascular complications has been demonstrated in patients with type 1 and type 2 diabetes (1-3); however, achieving glycemic control, preferably with HbA 1c values Ͻ7%, can markedly reduce the risk of such complications (4) and is now recommended clinical practice (5,6). In many patients, insulin treatment is required to achieve good glycemic control (1).Consensus opinion on how or when to initiate insulin treatment in type 2 diabetic patients is lacking, and treatment regimens are known to vary between countries. Since most patients with type 2 diabetes are older and physicians' time is limited, the insulin regimen should be easy to apply. However, few studies have directly compared the leading methods. We studied two commonly used, simple regimens for initiating insulin therapy. One approach consists of stopping oral antidiabetic agent (OAD) therapy and initiating two injections of insulin, often premixed insulin containing a fixed ratio of regular and intermediateacting insulin (NPH), administered twice daily. The European Diabetes Policy Group (5) recommended that, in the majority of patients with type 2 diabetes, insulin therapy should be initiated using premixed insulin twice daily. N...

Data of 623 nonselected diabetic outpatients are presented who were screened for peripheral vascular disease (PVD) and for cardiovascular risk factors. PVD was diagnosed in 15.9% of the diabetic patients (14.4% women and 18.0% men). Nine percent of the patients had signs of marked mediasclerosis at the ankle level. Multivariate statistical analysis revealed that PVD was closely associated with systolic hypertension and also with the duration of diabetes, a relationship that was highly significant (P less than 0.001) for the peripheral type (below the knee) of PVD. Diabetic patients with arterial disease at the pelvic or femoral site exhibited a higher number of cardiovascular risk factors. In contrast, in patients with the peripheral type, significantly higher blood glucose values were found. Therefore, the quality of metabolic control may play an important part in the development of this form of diabetic macroangiopathy.

In elderly patients, addition of once-daily morning glargine+OAD is a simple regimen to initiate insulin therapy, restoring glycemic control more effectively and with less hypoglycemia than twice-daily 70/30 alone.

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