Efficacy and Safety of Acarbose in Metformin-Treated Patients With Type 2 Diabetes
Abstract
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.
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Association of acarbose to metformin in sub-optimally controlled patients reduced HbA1c by about 0.8-1.0%.
“However, it has been reported that the association of acarbose to metformin in sub-optimally controlled patients reduced HbA1c by about 0.8-1.0% [38].”
From Metformin: An Old But Still the Best Treatment for Type 2 Diabetes (2013) · cites this paper as [38]
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- Authors
- Rosenstock, J., Brown, A., Fischer, J., Jain, A., Littlejohn, T., Nadeau, D., Sussman, A., Taylor, T., Krol, A., & Magner, J.
- Affiliations
- Dallas Diabetes and Endocrine Center Dallas
- Duke Medical Center (US)
- Diabetes and Glandular Research San Antonio, Texas
- Medical Research Institute Sidell, Louisiana
- Piedmont Medical Research Associates Winston-Salem, North Carolina
- Diabetes and Nutrition Center, Eastern Maine Medical Center Bangor, Maine
- Valley Medical Center (US)
- Departments of Metabolics, Bayer Corporation Pittsburgh, Pennsylvania
- Bayer (United States) (US)
- ORCID
- Rosenstock, Julio
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 1998-12-01
- Volume
- 21
- Issue
- 12
- Pages
- 2050-2055
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- OpenAlex
- W4254177295
- Cited by
- 93
- References
- 0
- Citations by year
- 2025: 2 · 2024: 2 · 2022: 1 · 2021: 3 · 2020: 1 · 2019: 3 · 2018: 3 · 2017: 2 · 2016: 3 · 2015: 8 · 2014: 6 · 2013: 4 · 2012: 6
- FWCI
- 1.48
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- acarbose, type 2 diabetes, metformin, glycemic control, HbA1c, postprandial blood glucose, fasting blood glucose, serum insulin, gastrointestinal adverse effects, drug safety, alpha-glucosidase inhibitors, dietary therapy
- MeSH terms
- Adult, Blood Glucose, Diabetes Mellitus, Type 2, Double-Blind Method, Fasting, Female, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Insulin, Male, Metformin, Middle Aged, Placebos, Triglycerides, Trisaccharides, Postprandial Period, Acarbose
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