Efficacy and tolerability of acarbose in Asian patients with type 2 diabetes inadequately controlled with diet and sulfonylureas
Journal
Journal of Diabetes and its Complications
Journal Volume
17
Journal Issue
4
Pages
179-185
Date Issued
2003
Author(s)
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 HbA1c 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 (HbA1c) (-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. ? 2003 Elsevier Inc. All rights reserved.
Subjects
Acarbose; Asian type 2 diabetes mellitus; Efficacy; Glycemic control; Tolerability
SDGs
Other Subjects
acarbose; biguanide derivative; glucocorticoid; insulin; ispagula; placebo; sulfonylurea derivative; abdominal distension; abdominal pain; adult; adverse drug reaction; aged; anorexia; article; asthenia; clinical article; clinical trial; constipation; controlled clinical trial; controlled study; diabetic diet; diarrhea; double blind procedure; drug efficacy; drug tolerability; dyspepsia; dyspnea; female; flatulence; gangrene; gastrointestinal symptom; human; male; multicenter study; non insulin dependent diabetes mellitus; priority journal; randomized controlled trial; treatment outcome; vertigo; vomiting
Publisher
Elsevier Inc.
Type
journal article