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The Efficacy of Acarbose in the Treatment of Patients with Non–Insulin-Dependent Diabetes Mellitus: A Multicenter, Controlled Clinical Trial

Jean-Louis Chiasson, MD; Robert G. Josse, MBBS; John A. Hunt, MBBS; Carol Palmason, ART; N. Wilson Rodger, MD; Stuart A. Ross, MBBS; Edmond A. Ryan, MD; Meng H. Tan, MD; and Thomas M. S. Wolever*, MD, PhD
[+] Article and Author Information

From the Hopital Hotel-Dieu de Montreal and the Universite de Montreal, Montreal, Canada; St. Michael's Hospital and the University of Toronto, Toronto, Canada; Lion's Gate Hospital and the University of British Columbia, North Vancouver, Canada; Miles Canada, Inc., Toronto, Canada; St. Joseph's Health Center and the University of Western Ontario, London, Canada; Foothills Hospital and the University of Calgary, Calgary, Canada; Walter C. Mackenzie Health Sciences Center and the University of Alberta, Edmonton, Canada; and Camp Hill Medical Center and Dalhousie University, Halifax, Canada. Requests for Reprints: Jean-Louis Chiasson, MD, Centre de Recherche/Hotel-Dieu de Montreal, 3850 Rue Saint-Urbain, Montreal, Quebec, Canada H2W 1T8. Acknowledgments: The authors thank Mrs. Susanne Bordeleau-Chenier for preparation of the manuscript. Grant Support: In part by a research grant from Miles Canada, Inc.


Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1994;121(12):928-935. doi:10.7326/0003-4819-121-12-199412150-00004
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Objective: To evaluate the long-term efficacy of acarbose, an α-glucosidase inhibitor, in improving glycemic control in patients with non–insulin-dependent diabetes mellitus.

Design: A 1-year, multicenter, randomized, double-blind, placebo-controlled study.

Setting: Seven university-affiliated, community-based, tertiary care diabetes clinics.

Patients: 354 patients with non–insulin-dependent diabetes mellitus were recruited; 77 were being treated with diet alone, 83 with diet and metformin, 103 with diet and sulfonylurea, and 91 with diet and insulin. Patients in each treatment group were randomly assigned to either acarbose or placebo for 1 year. Eighty-seven percent of patients receiving acarbose and 92% of those receiving placebo were included in the efficacy analysis (n = 316).

Measurements: At baseline and at 3-month intervals, levels of hemoglobin A1c (HbA1c), fasting and postprandial plasma glucose, fasting and postprandial serum C-peptide, and fasting serum lipids were measured.

Results: Compared with placebo, acarbose treatment caused a significant decrease in the mean postprandial plasma glucose peak (90 minutes) in all four groups (19.0 ±0.4 mmol/L to 15.5 ±0.4 mmol/L; P < 0.001). Analysis of the postprandial plasma glucose incremental area under the curve showed that the change from baseline to the end of the treatment period differed for placebo and acarbose recipients by 4.73 mmol x h/L in the diet alone group (P < 0.001), 2.06 mmol x h/L in the metformin group (P = 0.01), 2.65 mmol x h/L in the sulfonylurea group (P < 0.001), and 3.13 mmol x h/L in the insulin group (P = 0.001). Corresponding decreases in HbA1c levels occurred; these were 0.9% in the diet alone group (P = 0.005), 0.8% in the metformin group (P = 0.011), 0.9% in the sulfonylurea group (P = 0.002), and 0.4% in the insulin group (P = 0.077). Acarbose did not significantly affect mean serum C-peptide or mean serum lipid levels.

Conclusions: Acarbose improved long-term glycemic control in patients with non–insulin-dependent diabetes mellitus regardless of concomitant antidiabetic medication.

*For author affiliations, current author addresses, and a listing of collaborators, see end of text.

Figures

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Figure 1.
The effects of acarbose (black circles) and placebo (○) after 12 months of treatment on postprandial plasma glucose concentrations in response to a test meal in groups of patients treated with diet alone (A), metformin (B), sulfonylurea (C), and insulin (D).PPPP

Data are expressed as means with 95% CIs. *  < 0.01, †  < 0.019, ‡  < 0.026. values are for differences between changes from baseline (time, 0) to end point (time, 12 months) for acarbose compared with placebo.

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Figure 2.
The effects of acarbose (black circles) and placebo (○) on postprandial plasma glucose incremental area under the curve in response to a test meal throughout the 1-year study period in patients treated with diet alone (A), metformin (B), sulfonylurea (C), and insulin (D).PP

Data are expressed as means with 95% CIs. *  ≤ 0.01. value is for differences between changes from baseline (time, 0) to end point (time, 12 months) for acarbose compared with placebo.

Grahic Jump Location
Grahic Jump Location
Figure 3.
The effects of acarbose (black circles) and placebo (○) on hemoglobin A1c levels throughout the 1-year study period in groups of patients treated with diet alone (A), metformin (B), sulfonylurea (C), and insulin (D).PPPP

Data are expressed as means with 95% CIs. *  ≤ 0.010, †  = 0.077. values are for differences between changes from baseline (time 0) to end point (time 12 months) for acarbose and placebo. ‡  = 0.01 by covariance analysis.

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Figure 4.
The percentage of patients in four treatment groups who responded to acarbose or to placebo with decreases hemoglobin A1c levels by 15% from baseline or to less than 7% without any increase.PPPP

A. Study dropouts were carried over for analysis. B. All dropouts were considered failures. Data are expressed as percentage of patients with 95% CIs, and the number of patients who responded over the total number of patients are listed at bottom of the histograms. *  < 0.010, †  = 0.024, ‡  = 0.040. values are for differences between acarbose and placebo at the end of the study.

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