OBJECTIVE: To evaluate the long-term efficacy, safety, and tolerability of the alpha-glucosidase inhibitor @entity35855 in the treatment of African-American @entity1 with @entity164 2 @entity6 . RESEARCH DESIGN AND METHODS: A total of 345 African-American @entity164 2 @entity6 @entity1 (mean age 55.6 years, BMI 31.9 kg/m2, duration of @entity6 4.9 years, baseline HbA1C 8.7%) treated with either diet alone or @entity4136 were randomized to 1 year of double-blind treatment with either placebo (n = 117) or @entity35855 (n = 228) at doses of 50 or 100 mg t.i.d., titrated based on tolerability. The primary efficacy criterion was change from baseline in HbA1C at the 6-month visit. Secondarily efficacy parameters included changes from baseline in plasma @entity413 and serum insulin (both fasting and 120 min after a standardized test meal), fasting lipids, and urinary albumin-to- @entity1011 ratio. Safety and tolerability evaluations were primarily based on reporting of adverse events and symptoms and on periodic laboratory analyses. RESULTS: @entity35855 treatment was associated with a mean placebo-subtracted reduction in @entity4051 C from baseline of 1.19% at 6 months. Fasting and 120-min postprandial plasma @entity413 levels were reduced in parallel to HbA1C, in association with @entity35855 treatment. Significant reductions versus placebo in 120-min postprandial insulin levels, in LDL @entity165 , and in fasting @entity1674 , were also seen in the @entity35855 group at individual study time points. Softer, more frequent stools and flatulence were significantly more common in the @entity35855 group. @entity293 , @entity811 , and @entity281 were significantly more common in the placebo group. CONCLUSIONS: @entity35855 treatment appears to be at least as efficacious in the African-American @entity164 2 population as in the U.S. @entity164 2 population at large, with comparable tolerability. alpha-Glucosidase treatment may be an important therapeutic option in these @entity1 in view of their greater risk for microvascular complications and the accumulating body of evidence that better @entity413 control reduces the risk of these complications.

Chronic treatment of African-American @entity164 2 XXXX @entity1 with alpha-glucosidase inhibition.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity4051 :: ('3039', 'Gene') :: ['HbA1'] @entity35855 :: ('MESH:C045621', 'Chemical') :: ['Miglitol', 'miglitol'] @entity6 :: ('MESH:D003920', 'Disease') :: ['diabetic', 'diabetes'] @entity1674 :: ('MESH:D014280', 'Chemical') :: ['triglycerides'] @entity281 :: ('MESH:D007239', 'Disease') :: ['herpes simplex infections'] @entity164 :: ('MESH:D017827', 'Disease') :: ['type'] @entity293 :: ('MESH:D014552', 'Disease') :: ['Urinary tract infections'] @entity1011 :: ('MESH:D003404', 'Chemical') :: ['creatinine'] @entity4136 :: ('CHEBI:26831', 'Chemical') :: ['sulfonylurea'] @entity811 :: ('MESH:D006417', 'Disease') :: ['hematuria'] @entity413 :: ('MESH:D005947', 'Chemical') :: ['glucose'] @entity165 :: ('MESH:D002784', 'Chemical') :: ['cholesterol']
@entity6 :: (MESH:D003920,Disease) :: ['diabetic']
