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KMID : 1200020190430030276
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Diabetes & Metabolism Journal
2019 Volume.43 No. 3 p.276 ~ p.286
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Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial
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Oh Tae-Jung
Yu Jae-Myung
Min Kyung-Wan
Son Hyun-Shik
Lee Moon-Kyu
Yoon Kun-Ho
Song Young-Duk
Park Joong-Yeol
Jeong In-Kyung
Cha Bong-Soo
Kim Yong-Seong
Baik Sei-Hyun
Kim In-Joo
Kim Doo-Man
Kim Sung-Rae
Lee Kwan-Woo
Park Jeong-Hyung
Lee In-Kyu
Park Tae-Sun
Choi Sung-Hee
Park Sung-Woo
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Abstract
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Background: Combination 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-naive newly-diagnosed type 2 diabetes mellitus.
Methods: A 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.
Results: The 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).
Conclusion: Vogmet 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.
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KEYWORD
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Diabetes mellitus, type 2, Metformin, Voglibose
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