Efficacy and Safety of Miglitol: Switching Study from Voglibose in Japanese Patients with Type 2 Diabetes

Abstract

We investigated the efficacy and safety of miglitol, a new alpha-glucosidase inhibitor, by switching from voglibose in Japanese patients with type 2 diabetes. Subjects included those who had previously been administered with voglibose (n=90, 0.6mg/day). After voglibose was changed into miglitol (150mg/day), HbA1C level, body weight and abdominal symptoms were evaluated six months later. HbA1C level was significantly decreased from 7.8±1.2 to 7.3±1.0% (P<0.01). Body weight showed a small but significant decrease after 6 months (62.5±11.0 to 62.1±12.3kg, P<0.01). There was no significant difference between frequencies of side effects before and after switching from voglibose to miglitol. This study suggests the efficacy and safety of miglitol to improve glycemic control in Japanese patients with type 2 diabetes, who had previously been treated with voglibose. Several recent studies have suggested that the clinical significance of postprandial hyperglycemia in relation to the risk of microvascular and macrovascular complications (1). In 2007, International Diabetes Federation has announced the guideline which claimed that postprandial glucose should be less than 140mg/dl (2). Miglitol is a new alpha-glucosidase inhibitor ( -GI), which has recently been approved for clinical use in Japan. A distinctive feature of miglitol is that it is partially absorbed from the upper portion of the small intestine, thereby making it possible to administer in large doses. Although there have been several preliminary reports about the effects of miglitol on glycemic control (3), there has been no study which compares the clinical effects of miglitol and other  -GIs. In the present study, we investigated the efficacy and safety of miglitol by switching from voglibose, another  - GI, which has broadly been used in Japanese patients with type 2 diabetes. Subjects included a total of 90 Japanese patients with type 2 diabetes (54 men and 36 women, mean age 66.5±SD10.9 years), who had previously been administered with voglibose (0.6mg/day). In all subjects, voglibose was changed into miglitol (150mg/day). Serum HbA1C level, plasma postprandial C-peptide level (2 h after the meal), body weight and abdominal symptoms were evaluated before and 6 months after switching from voglibose to miglitol. The data was expressed as mean±SD. Statistical analysis was performed with Student's t test between the two groups. Differences were defined as significant at P < 0.05.