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Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Combination of metformin to reduce the fasting plasma glucose level and an ?-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. 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.

SUBMITTER: Oh TJ

PROVIDER: S-EPMC6581551 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

Oh Tae Jung TJ Yu Jae Myung JM Min Kyung Wan KW Son Hyun Shik HS Lee Moon Kyu MK Yoon Kun Ho KH Song Young Duk YD Park Joong Yeol JY Jeong In Kyung IK Cha Bong Soo BS Kim Yong Seong YS Baik Sei Hyun SH Kim In Joo IJ Kim Doo Man DM Kim Sung Rae SR Lee Kwan Woo KW Park Jeong Hyung JH Lee In Kyu IK Park Tae Sun TS Choi Sung Hee SH Park Sung Woo SW

Diabetes & metabolism journal 20181207 3

<h4>Background</h4>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-naïve newly-diagnosed type 2 diabetes mellitus.<h4>Methods</h4>A total of 187 eligible patients aged 20 to 70 years, with a glycosylated hemoglobin (HbA1c) ...[more]

PMID: 30604594

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Dataset Information

Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

Publications

Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial.

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