title: Efficacy and tolerability of acarbose in Asian patients with type 2 diabetes inadequately controlled with diet and sulfonylureas.
abstract: The objective of this study was to investigate the efficacy, tolerability, and safety of acarbose in the improvement of glycemic control in Asian patients with type 2 diabetes inadequately controlled by diet and sulfonylureas. A 24-week, double-blind, placebo-controlled multicenter group comparison study was conducted. Patients were randomized to receive acarbose titrated up to 100-mg tid (n=36) or matching placebo (n=33). Concomitant sulfonylurea treatment remained unchanged throughout the study. The primary efficacy parameter was the change in HbA(1c) from baseline to double-blind endpoint. Secondary efficacy variables consisted of the change from baseline to endpoint in blood glucose (fasting and 1-h postprandial), serum insulin (fasting and 1-h postprandial), and urinary glucose. In the intention-to-treat (ITT) analysis, acarbose treatment was associated with significantly greater reductions in glycated hemoglobin (HbA(1c)) (-0.91% vs. placebo 0.13%, P=.0018) and 1-h postprandial blood glucose levels (-2.84 mmol/l vs. placebo -0.28 mmol/l, P=.002) compared to placebo. There were no significant differences between the treatment groups regarding changes in fasting blood glucose, fasting or 1-h postprandial serum insulin, urinary glucose, or body weight. Adverse events occurred with similar frequency in both treatment arms except for drug-related gastrointestinal side-effects associated with acarbose (acarbose 48.5% and placebo 12.5%). This study has shown that the use of acarbose in Asian patients with type 2 diabetes inadequately controlled by diet and sulfonylureas is efficacious in improving metabolic control and that acarbose is safe and well tolerated.
authors.affiliation: National Taiwan University Hospital, Taipei, Taiwan. cthdmc@gcn.net.tw
authors.forename: Boniface J
authors.initials: BJ
authors.lastname: Lin
authors.forename: Huey-Peir
authors.initials: HP
authors.lastname: Wu
authors.forename: H S
authors.initials: HS
authors.lastname: Huang
authors.forename: Jyuhn-Huarng
authors.initials: JH
authors.lastname: Juang
authors.forename: Jyuhn
authors.initials: J
authors.lastname: Huarng
authors.forename: A
authors.initials: A
authors.lastname: Sison
authors.forename: Dato Khalid
authors.initials: DK
authors.lastname: bin Abdul Kadir
authors.forename: Chung-Gu
authors.initials: CG
authors.lastname: Cho
authors.forename: Witaya
authors.initials: W
authors.lastname: Sridama
mesh_terms: D020909:Acarbose / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy* / Q000208:ethnology*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006442:Glycated Hemoglobin / Q000378:metabolism; D006029:Glycosuria; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007328:Insulin / Q000097:blood; D008297:Male; D008875:Middle Aged; D010919:Placebos; D019233:Retreatment; D013453:Sulfonylurea Compounds / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D020909:Acarbose; D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D010919:Placebos; D013453:Sulfonylurea Compounds