Efficacy and Safety of Acarbose in Metformin-Treated Patients With Type 2 Diabetes

• Julio Rosenstock

  Dallas Diabetes and Endocrine Center Dallas

• Ann Brown

  Duke University Medical Center Durham

• Jerome Fischer

  Diabetes and Glandular Research San Antonio, Texas

• Adesh Jain

  Medical Research Institute Sidell, Louisiana

• Thomas Littlejohn

  Piedmont Medical Research Associates Winston-Salem, North Carolina

• Dan Nadeau

  Diabetes and Nutrition Center, Eastern Maine Medical Center Bangor, Maine

• Allen Sussman

  Valley Diabetes and Endocrine Center Renton, Washington

• Terry Taylor

  Departments of Metabolics, Bayer Corporation Pittsburgh, Pennsylvania

• Alice Krol

  Statistics and Data Systems, Bayer Corporation, Bayer Corporation Pittsburgh, Pennsylvania

• James Magner

  Departments of Metabolics, Bayer Corporation Pittsburgh, Pennsylvania

抄録

To demonstrate the efficacy, tolerability, and safety of acarbosecompared with placebo in patients with type 2 diabetes inadequatelycontrolled with diet and metformin (2,000 or 2,500 mg/day in divideddoses). This study had a multicenter randomized double-blind placebo-controlled parallel-group comparison design. The trial lasted 31 weeks and consisted of a 1-week screening period, a 6-week placebo pretreatment period, and a 24-week period of acarbose or placebo, with a forced titration from 25–50 mg t.i.d. and a titration of 50–100 mg tid that was based on glucose control. The primary efficacy variable wasthe mean change from baseline in HbAlc. Secondary efficacy variables included mean changes from baseline in fasting and postprandial plasma glucose, serum insulin, and triglyceride levels. The addition of acarbose to patients on background metformin and diet therapy showed a statistically significant reduction in mean HbAlc of 0.65%. There were statistically significant reductions in fasting and postprandial plasma glucose and serum insulin levels compared with placebo. Gastrointestinal side effects were more frequently reported in the acarbose-treated patients. No significant differences in liver transaminase elevations were observed between patients treated with acarbose and those treated with placebo. The results of this study demonstrate that the addition of acarbose to patients with type 2 diabetes who are inadequately controlled with metformin and diet is safe and generally well tolerated and that it significantly lowers HbAlc and fasting and postprandial glucoseand insulin levels.

収録刊行物

• Diabetes Care

  Diabetes Care 21 (12), 2050-2055, 1998-12-01

  American Diabetes Association

キーワード

• Advanced and Specialized Nursing
• Endocrinology, Diabetes and Metabolism
• Internal Medicine

詳細情報

• CRID: 1364233269151269632
• NII論文ID: 30026281740
• NII書誌ID: AA00160920
• DOI: 10.2337/diacare.21.12.2050
• ISSN: 19355548
• ISSN: 01495992
• Web Site: https://diabetesjournals.org/care/article-pdf/21/12/2050/585355/21-12-2050.pdf
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