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Randomized Controlled Trial
. 2011 Mar;48(1):71-7.
doi: 10.1007/s00592-010-0220-6. Epub 2010 Oct 21.

Evaluation of the efficacy and tolerability of miglitol in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylureas

Sheng-Hwu Hsieh  1 , Kuang-Chung Shih, Chien-Wen Chou, Chih-Hsun Chu
Affiliations
Randomized Controlled Trial

Evaluation of the efficacy and tolerability of miglitol in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylureas

Sheng-Hwu Hsieh et al. Acta Diabetol. 2011 Mar.

Abstract

The objective of this study is to examine the efficacy and tolerability of miglitol with respect to improving glycemic control in Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment. This was a randomized, double-blinded, placebo-controlled, multicenter study. A total of 105 patients were randomized to receive 24 weeks of treatment with miglitol (n = 52; titrated from 50 mg to 100 mg 3 times daily) or placebo (n = 53). Concomitant sulfonylurea treatment and diet remained unchanged. The primary endpoint was change in glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary endpoints were changes in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), and postprandial serum insulin (PSI). The miglitol treatment group showed significantly greater reductions in HbA1c and PPG levels compared with the placebo group. With respect to adverse events, abdominal discomfort, diarrhea, and hypoglycemia occurred with similar frequency in both groups. Results of this study indicate that miglitol significantly improves metabolic control in Chinese patients with type 2 diabetes mellitus. Miglitol is safe and well tolerated, with the exception of abdominal discomfort. Therefore, miglitol may be a useful adjuvant therapy for Chinese patients with type 2 diabetes mellitus inadequately controlled by diet and sulfonylurea treatment.

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Figures

Fig. 1
Fig. 1
Progress of patients throughout the 24-week trial period
Fig. 2
Fig. 2
Glycated hemoglobin levels for each study group in the intent-to-treat population (N = 100) during the 24-week trial period. **P < 0.01, ***P < 0.001
See this image and copyright information in PMC

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