ADVANTAGES OF ALPHA-GLUCOSIDASE INHIBITION AS MONOTHERAPY IN ELDERLY TYPE-2 DIABETIC-PATIENTS

The objective of this study was to determine the safety, efficacy, and tolerability of the alpha-glucosidase inhibitor miglitol vs. the sulf onylurea glyburide in the treatment of elderly patients with type 2 di abetes mellitus, inadequately controlled by diet alone. This was a dou ble-blind, randomized, placebo-controlled, 1-yr trial of miglitol 25 m g TID and 50 mg TID compared with placebo and a titrated dose of glybu ride in a parallel group comparison study conducted in 30 out-patient sites across the United States. Four hundred eleven (411) diet-treated patients age 60 yr or greater were randomized to receive either place bo TID (n = 101), miglitol 25 mg TID (n = 104), miglitol 50 mg TID (n = 102), or a once-daily dose of glyburide titrated based on fasting pl asma glucose (FPG) (n = 104), for a period of 56 weeks. Efficacy was a ssessed by glycated hemoglobin (HbA1c), fasting and post-meal glucose, insulin, and lipid levels, and by 24-h urinary excretion of glucose a nd albumin. Safety and tolerability were assessed by tabulation of adv erse events, periodic laboratory determinations, and home blood glucos e monitoring. HbA(1)c treatment effects (placebo-subtracted change in HbA(1)c from baseline) at the 1-yr endpoint were -0.49%, -0.40%, and - 0.92% in the miglitol 25 mg TID, miglitol 50 mg TID, and glyburide gro ups, respectively (P < 0.05 - 0.01 vs, placebo). Postprandial insulin levels were significantly greater than placebo and miglitol in the gly buride group (P < 0.01). Hypoglycemia, weight gain, and both routine a nd serious cardiovascular events were more frequent in the glyburide g roup (P < 0.05 - 0.01 vs. placebo or miglitol groups). Diarrhea (or so ft stools) and flatulence were more common in both miglitol groups tha n in the other two groups in a dose-dependent manner, but resulted in relatively few study dropouts. Treatment with miglitol offers the elde rly type 2 diabetic patient significant reductions in daylong glycemia as measured by HbA(1)c. The greater HbA(1)c reductions seen with once -a-day glyburide occurred at a cost of significant increases in weight , insulin levels, and the incidences of clinical and subclinical hypog lycemia, which did not occur in the miglitol groups, alpha-glucosidase inhibitors are a useful and relatively safe therapeutic option in the elderly patient with type 2 diabetes.