3区 · 医学
ArticleOA
作者: Park, Sung Woo ; Park, Joong Yeol ; Kim, Sung Rae ; Son, Hyun Shik ; Choi, Sung Hee ; Song, Young Duk ; Park, Tae Sun ; Cha, Bong Soo ; Lee, Kwan Woo ; Min, Kyung Wan ; Yoon, Kun Ho ; Kim, Yong Seong ; Yu, Jae Myung ; Kim, Doo Man ; Baik, Sei Hyun ; Kim, In Joo ; Lee, Moon Kyu ; Jeong, In Kyung ; Lee, In Kyu ; Oh, Tae Jung ; Park, Jeong Hyung
BACKGROUNDCombination of metformin to reduce the fasting plasma glucose level and an α-glucosidase inhibitor to decrease the postprandial glucose level is expected to generate a complementary effect. We compared the efficacy and safety of a fixed-dose combination of voglibose plus metformin (vogmet) with metformin monotherapy in drug-naïve newly-diagnosed type 2 diabetes mellitus.METHODSA total of 187 eligible patients aged 20 to 70 years, with a glycosylated hemoglobin (HbA1c) level of 7.0% to 11.0%, were randomized into either vogmet or metformin treatments for 24 weeks. A change in the HbA1c level from baseline was measured at week 24.RESULTSThe reduction in the levels of HbA1c was -1.62%±0.07% in the vogmet group and -1.31%±0.07% in the metformin group (P=0.003), and significantly more vogmet-treated patients achieved the target HbA1c levels of <6.5% (P=0.002) or <7% (P=0.039). Glycemic variability was also significantly improved with vogmet treatment, estimated by M-values (P=0.004). Gastrointestinal adverse events and hypoglycemia (%) were numerically lower in the vogmet-treated group. Moreover, a significant weight loss was observed with vogmet treatment compared with metformin (-1.63 kg vs. -0.86 kg, P=0.039).CONCLUSIONVogmet is a safe antihyperglycemic agent that controls blood glucose level effectively, yields weight loss, and is superior to metformin in terms of various key glycemic parameters without increasing the risk of hypoglycemia.