Efficacy and Safety of Acarbose in Metformin-Treated Patients With Type 2 Diabetes
- Julio Rosenstock, MD,
- Ann Brown, MD,
- Jerome Fischer, MD,
- Adesh Jain, MD,
- Thomas Littlejohn, MD,
- Dan Nadeau, MD,
- Allen Sussman, MD,
- Terry Taylor, MD,
- Alice Krol, MS and
- James Magner, MD
- Dallas Diabetes and Endocrine Center Dallas
- Diabetes and Glandular Research San Antonio, Texas
- Duke University Medical Center Durham
- Piedmont Medical Research Associates Winston-Salem, North Carolina
- Medical Research Institute Sidell, Louisiana
- Diabetes and Nutrition Center, Eastern Maine Medical Center Bangor, Maine
- Valley Diabetes and Endocrine Center Renton, Washington
- Departments of Metabolics, Bayer Corporation Pittsburgh, Pennsylvania
- Statistics and Data Systems, Bayer Corporation, Bayer Corporation Pittsburgh, Pennsylvania
- Address correspondence and reprint requests to Julio Rosenstock, MD, Dallas Diabetes and Endocrine Center, 7777 Forest Lane C-618, Dallas, TX 75230.
OBJECTIVE 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).
RESEARCH DESIGN AND METHODS 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.
RESULTS 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.
CONCLUSIONS 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.
- Received May 15, 1998.
- Revision received August 31, 1998.
- Accepted August 31, 1998.
- Copyright © 1998 by the American Diabetes Association