AN ASIAN MULTICENTER CLINICAL-TRIAL TO ASSESS THE EFFICACY AND TOLERABILITY OF ACARBOSE COMPARED WITH PLACEBO IN TYPE-2 DIABETIC-PATIENTS PREVIOUSLY TREATED WITH DIET

OBJECTIVE-To assess the efficacy, safety, and tolerability of acarbose versus placebo during a 24-week treatment period in Asian type 2 diab etic patients with dietary failure. RESEARCH DESIGN AND METHODS-After a 6-week screening period, 126 multiethnic Asian type 2 diabetic patie nts (64 men, 62 women; mean age +/- SD, 53.4 +/- 10 years) were random ized to receive acarbose (n = 63) or placebo (n = 63). The dosage was increased from 50 mg t.i.d. at week 0 to 100 mg t.i.d. at week 4. Pati ents were then followed up at weeks 10, 16, and 24. At each visit, bod y weight, blood pressure, and metabolic indexes were measured. At week s 0 and 24, fasting plasma glucose and insulin were measured before an d 1 h after the administration of an individually tailored breakfast. RESULTS-Using the intention-to-treat analysis, there were greater redu ctions in (mean [95% Cl]) HbA(1c) (-0.70 [-1.00 to -0.39] vs. -0.27% [ -0.54 to 0]; P = 0.04), fasting plasma glucose (-0.37 [-0.75 to 0.02] vs. 0.41 mmol/l [-0.08 to 0.90];P = 0.017) and 1-h plasma glucose (-0. 77 [-1.44 to -0.10] vs. 0.65 mmol/l [-0.07 to 1.36];P = 0.05) in the a carbose group compared with the placebo group. With acarbose treatment , 78% of patients achieved an HbA(1c) <8% compared with 56% in the pla cebo group (P = 0.003). There was a greater reduction in body weight ( -1.31 [-2.46 to -0.15] vs. 0.16 kg [-3.36 to 0.10];P = 0.02) and highe r incidence of flatulence (56 vs. 37%; P = 0.032) in the acarbose than in the placebo group. Using baseline HbA(1c) and race as covariates, there were no significant interethnic differences in treatment respons es (P = 0.232 for treatment-race interaction; P < 0.001 for treatment effect). The dropout rates were similar between the two groups (acarbo se, 11 of 63; placebo, 6 of 63). There were no significant laboratory adverse events in either group. CONCLUSIONS-In this multicenter study involving six ethnic groups, acarbose 100 mg t.i.d. was an effective, safe, and generally well-tolerated therapy in Asian type 2 diabetic pa tients with dietary failure. In some patients with troublesome gastroi ntestinal symptoms, a lower dosage may be necessary.