ACARBOSE IN NIDDM PATIENTS WITH POOR CONTROL ON CONVENTIONAL ORAL-AGENTS - A 24-WEEK PLACEBO-CONTROLLED STUDY

OBJECTIVE - To determine the efficacy of acarbose, compared with place bo, on the metabolic control of NIDDM patients inadequately controlled on maximal doses of conventional oral agents. RESEARCH DESIGN AND MET HODS - In this three-center double-blind study 90 Chinese NIDDM patien ts with persistent poor glycemic control despite maximal doses of sulf onylurea and metformin were randomly assigned to receive additional tr eatment with acarbose 100 mg thrice daily or placebo for 24 weeks, aft er 6 weeks of dietary reinforcement. Efficacy was assessed by changes in HbA(1c), fasting and 1-h postprandial plasma glucose and insulin le vels, and fasting lipid levels. RESULTS - Acarbose treatment was assoc iated with significantly greater reductions in HbA(1c) (-0.5 +/- 0.2% vs. placebo 0.1 +/- 0.2% [means +/- SEM], P = 0.038), 1-h postprandial glucose (-2.3 +/- 0.4 mmol/l vs. placebo 0.7 +/- 0.4 mmol/l, P < 0.00 1) and body weight (-0.54 +/- 0.32 kg vs, placebo 0.42 +/- 0.29 kg, P < 0.05). There was no significant difference between the two groups re garding changes in fasting plasma glucose and lipids or fasting and po stprandial insulin levels. Flatulence was the most common side effect (acarbose vs, placebo: 28/45 vs. 11/44, P < 0.05). One patient on acar bose had asymptomatic elevations in serum transaminases that normalize d in 4 weeks after acarbose withdrawal. Another patient on acarbose de veloped severe hypoglycemia; glycemic control was subsequently maintai ned on half the baseline dosage of sulfonylurea. CONCLUSIONS - In NIDD M patients inadequately controlled on conventional oral agents, acarbo se in moderate doses resulted in beneficial effects on glycemic contro l, especially postprandial glycemia, and mean body weight. Additional use of acarbose can be considered as a useful alternative in such pati ents if they are reluctant to accept insulin therapy.