Efficacy and Safety of Acarbose in Insulin-Treated Patients With Type 2 Diabetes
- David E Kelley, MD,
- Pascual Bidot, MD,
- Zachary Freedman, MD,
- Burritt Haag, MD,
- David Podlecki, MD,
- Marc Rendell, MD,
- David Schimel, MD,
- Stuart Weiss, MD,
- Terry Taylor, MD,
- Alice Krol, MS and
- James Magner, MS
- Division of Endocrinology, University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania
- Departments of Metabolics, Bayer Corporation Pittsburgh, Pennsylvania
- Statistics and Data Systems, Bayer Corporation Pittsburgh, Pennsylvania
- Florida Pharmaceutical Research Palm Harbor, Florida
- Department of Medicine, Genesee Hospital Rochester, New York
- Endocrine Metabolic Division, Baystate Medical Center Springfield, Massachusetts
- Longmont Medical Research Network Longmont, Colorado
- Creighton Diabetes Center, Creighton University Omaha, Nebraska
- Midwest Clinical Research Institute San Diego, California
- Lake Bluff, Illinois San Diego Endocrine and Medical Clinic San Diego, California
- Address correspondence and reprint requests to David Kelley, MD, University of Pittsburgh School of Medicine, Division of Endocrinology, E1140 Biomedical Science Tower, Pittsburgh, PA 15261.
Abstract
OBJECTIVE To demonstrate the efficacy, tolerability, and safety of acarbose compared with placebo in patients with type 2 diabetes inadequately controlled with diet and insulin.
RESEARCH DESIGN AND METHODS A multicenter randomized double-blind placebo-controlled parallel-group comparison study was conducted. The trial was 26 weeks with a 2-week screening period and a 24-week period of treatment with acarbose or placebo, with forced titration from 25 mg t.i.d. to 50 mg t.i.d. after 4 weeks, and titration of 50 mg t.i.d. to 100 mg t.i.d. after 12 weeks based on glucose control. The dosage of insulin was toremain stable. The primary efficacy variable was mean change from baseline in HbA1c, and secondary efficacy variables included mean changes in fasting and postprandial plasma glucose and triglyceride levels.
RESULTS The addition of acarbose to the treatment of patients receiving background insulin and diet therapy resulted in a statistically significant reduction in mean HbA1c of 0.69% compared with placebo. Therewere statistically significant reductions in postprandial plasma glucose and glucose area under the curve, and in postprandial serum triglyceride levels in the acarbose-treated patients. Gastrointestinal side effects were more frequently reported in the acarbose-treated patients. There were no significant differences in hypoglycemic events or liver transaminase elevations between groups.
CONCLUSIONS This study demonstrated that the addition of acarbose to patients with type 2 diabetes who are inadequately controlled with insulin and diet is safe and generally well tolerated and that it significantly lowers HbA1c and postprandial glucose levels.
- Received May 15, 1998.
- Revision received August 31, 1998.
- Accepted August 31, 1998.
- Copyright © 1998 by the American Diabetes Association
