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Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (Diabetes metab J 2019;43;276-86)

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D I A B E T E S & M E T A B O L I S M J O U R N A L

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Copyright © 2019 Korean Diabetes Association http://e-dmj.org

Efficacy and Safety of Voglibose Plus Metformin in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial (Diabetes metab J 2019;43;276-86)

Tae Jung Oh1, Sung Hee Choi1,2

1Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam,

2Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea

Corresponding author: Sung Hee Choi https://orcid.org/0000-0003-0740-8116 Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 13620, Korea

E-mail: [email protected]

We appreciate Dr. Seok and Dr. Sohn for their thoughtful com- ments on our recently published article, “Efficacy and safety of voglibose plus metformin in patients with type 2 diabetes mel- litus: a randomized controlled trial” [1]. They pointed out the potential role of fixed dose combination of voglibose and met- formin (vogmet) in patients with type 2 diabetes mellitus with higher initial hyperglycemia. Also, this medication would be more efficacious in Korean population consuming carbohy- drate-rich diet, considering the mode of action of alpha-gluco- sidase inhibitor that prohibits the rapid absorption of glucose.

We want to emphasize the data of gastrointestinal adverse events (AEs) and body weight reduction in our study, which was discussed by Dr. Seok and Dr. Sohn. First, we thought that lower dose of metformin might be the contributing factor of lower incidence of gastrointestinal AEs in vogmet (fixed dose combination) group compared with metformin group. How- ever, the mechanism of metformin-associated gastrointestinal AEs has still not been well studied, and it might be related with individual genetic factors [2]. In this study, although we do not know the exact mechanism, voglibose at least did not increase the gastrointestinal AEs when it was used with low dose met- formin. Second, a previous meta-analysis study [3] demon- strated body weight reduction effect of alpha-glucosidase in- hibitors compared with placebo (weighted mean difference, –1.0 kg; 95% confidence interval, –1.69 to –0.31 kg) in Asian as

well as Caucasian. Therefore, some studies showed weight- neutrality or weight-benefit, but this finding is not globally ac- ceptable. In fact, our study showed a much more significant body weight reduction in vogmet group than metformin group (–1.63 kg vs. –0.86 kg, P<0.05). Based on our study and others, it will be interesting to select appropriate patients who will benefit in terms of both reducing hyperglycemia and body weight.

We totally agree with their opinion that measuring glucose fluc- tuation using continuous glucose monitoring system (CGMS) will provide more valuable understanding for our study. An- other alpha-glucosidase inhibitor, miglitol has been tested whether it reduced glucose variability in patients with acute coronary syndrome [4]. This study showed that miglitol re- duced standard deviation and mean amplitude of glycemic ex- cursion compared with pretreatment. Further study is neces- sary to test whether vogmet reduces glucose variability in out- patient setting using CGMS, but we can assume that vogmet will have similar benefit as miglitol in glucose variability due to its composition and nature. We also think that it will be neces- sary to test body composition and other cardiovascular risk factors such as blood pressure, lipid profiles, and insulin resis- tance, to understand the possible cardiovascular benefits of vogmet in future.

Response

https://doi.org/10.4093/dmj.2019.0148 pISSN 2233-6079 · eISSN 2233-6087 Diabetes Metab J 2019;43:547-548

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Oh TJ, et al.

548 Diabetes Metab J 2019;43:547-548 http://e-dmj.org

CONFLICTS OF INTEREST

No potential conflict of interest relevant to this article was re- ported.

REFERENCES

1. Oh TJ, Yu JM, Min KW, Son HS, Lee MK, Yoon KH, Song YD, Park JY, Jeong IK, Cha BS, Kim YS, Baik SH, Kim IJ, Kim DM, Kim SR, Lee KW, Park JH, Lee IK, Park TS, Choi SH, Park SW.

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

Diabetes Metab J 2019;43:276-86.

2. McCreight LJ, Bailey CJ, Pearson ER. Metformin and the gas-

trointestinal tract. Diabetologia 2016;59:426-35.

3. Cai X, Han X, Luo Y, Ji L. Comparisons of the efficacy of alpha glucosidase inhibitors on type 2 diabetes patients between Asian and Caucasian. PLoS One 2013;8:e79421.

4. Shimabukuro M, Tanaka A, Sata M, Dai K, Shibata Y, Inoue Y, Ikenaga H, Kishimoto S, Ogasawara K, Takashima A, Niki T, Arasaki O, Oshiro K, Mori Y, Ishihara M, Node K; Collabora- tors on the Effect of Miglitol on Glucose Metabolism in Acute Coronary Syndrome (MACS) Study. α-Glucosidase inhibitor miglitol attenuates glucose fluctuation, heart rate variability and sympathetic activity in patients with type 2 diabetes and acute coronary syndrome: a multicenter randomized con- trolled (MACS) study. Cardiovasc Diabetol 2017;16:86.

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