Efficacy and safety of voglibose plus metformin in patients with type 2 diabetes mellitus

A randomized controlled trial

Tae Jung Oh, Jae Myung Yu, Kyung Wan Min, Hyun Shik Son, Moon Kyu Lee, Kun Ho Yoon, Young Duk Song, Joong Yeol Park, In Kyung Jeong, Bong Soo Cha, Yong Seong Kim, Sei-Hyun Baik, In Joo Kim, Doo Man Kim, Sung Rae Kim, Kwan Woo Lee, Jeong Hyung Park, In Kyu Lee, Tae Sun Park, Sung Hee Choi & 1 others Sung Woo Park

Research output: Contribution to journalArticle

Abstract

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-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.

Original languageEnglish
Pages (from-to)276-286
Number of pages11
JournalDiabetes and Metabolism Journal
Volume43
Issue number3
DOIs
Publication statusPublished - 2019 Jun 1

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Metformin
Type 2 Diabetes Mellitus
Randomized Controlled Trials
Safety
Hypoglycemia
voglibose
Weight Loss
Glucosidases
Glucose
Glycosylated Hemoglobin A
Hypoglycemic Agents
Blood Glucose
Fasting
Therapeutics

Keywords

  • Diabetes mellitus
  • Metformin
  • Type 2
  • Voglibose

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

Cite this

Efficacy and safety of voglibose plus metformin in patients with type 2 diabetes mellitus : A randomized controlled trial. / 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.

In: Diabetes and Metabolism Journal, Vol. 43, No. 3, 01.06.2019, p. 276-286.

Research output: Contribution to journalArticle

Oh, TJ, Yu, JM, Min, KW, Son, HS, Lee, MK, Yoon, KH, Song, YD, Park, JY, Jeong, IK, Cha, BS, Kim, YS, Baik, S-H, Kim, IJ, Kim, DM, Kim, SR, Lee, KW, Park, JH, Lee, IK, Park, TS, Choi, SH & Park, SW 2019, 'Efficacy and safety of voglibose plus metformin in patients with type 2 diabetes mellitus: A randomized controlled trial', Diabetes and Metabolism Journal, vol. 43, no. 3, pp. 276-286. https://doi.org/10.4093/dmj.2018.0051
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. / Efficacy and safety of voglibose plus metformin in patients with type 2 diabetes mellitus : A randomized controlled trial. In: Diabetes and Metabolism Journal. 2019 ; Vol. 43, No. 3. pp. 276-286.
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T1 - Efficacy and safety of voglibose plus metformin in patients with type 2 diabetes mellitus

T2 - A randomized controlled trial

AU - Oh, Tae Jung

AU - Yu, Jae Myung

AU - Min, Kyung Wan

AU - Son, Hyun Shik

AU - Lee, Moon Kyu

AU - Yoon, Kun Ho

AU - Song, Young Duk

AU - Park, Joong Yeol

AU - Jeong, In Kyung

AU - Cha, Bong Soo

AU - Kim, Yong Seong

AU - Baik, Sei-Hyun

AU - Kim, In Joo

AU - Kim, Doo Man

AU - Kim, Sung Rae

AU - Lee, Kwan Woo

AU - Park, Jeong Hyung

AU - Lee, In Kyu

AU - Park, Tae Sun

AU - Choi, Sung Hee

AU - Park, Sung Woo

PY - 2019/6/1

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N2 - 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-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.

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