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Efficacy of combined use of miglitol in Type 2 diabetes patients receiving insulin therapy-placebo-controlled double-blind comparative study

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Abstract

Combination therapy with an α-glucosidase inhibitor and insulin is commonly performed for type 2 diabetes mellitus. We conducted a placebo-controlled double-blind comparative study to investigate the efficacy of combination therapy with miglitol and insulin. The patients with T2DM on insulin therapy were randomly assigned to either a miglitol treatment group (Group M) or a placebo group (Group P) and treated for 12 weeks. Meal tolerance tests were conducted at the observation period, week 0 and week 12 of the treatment period. Mean values of decrease in 1-h- and 2-h postprandial plasma glucose level were significantly larger in Group M than in Group P (60.3 ± 70.1 mg/dl vs. −5.1 ± 68.2 mg/dl (P < 0.001)), as was HbA1c as well (0.36 ± 0.66% vs. −0.03 ± 0.56% (P < 0.001)). Adverse events included abdominal distension and flatulence, which were significantly more frequent in Group M. The frequency of nocturnal hypoglycemia events tended to be reduced in Group M. Combined use of insulin and miglitol is useful for postprandial glucose regulation and improves glycemic control.

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Acknowledgments

The authors would like to thank the individuals of many medical institutions for their efforts in support of this study. This clinical trial received financial support from Sanwa Kagaku Kenkyusyo Co., LTD. Sanwa Kagaku Kenkyusyo Co., LTD had no influence on the analysis and interpretation of data.

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There are no conflicts of interest.

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Authors and Affiliations

  1. Department of General Internal Medicine, Jikei University School of Medicine Aoto Hospital, Aoto 6-41-2, Katsushika-ku, Tokyo, 125-8506, Japan

    Masami Nemoto

  2. Jikei University School of Medicine, Nishishinbashi 3-25-8, Minatoku-ku, Tokyo, 105-8461, Japan

    Naoko Tajima

  3. Department of Medicine, Metabolism, and Endocrinology, Center for Therapeutic Innovations in Diabetes, Center for Beta Cell Biology and Regeneration, and Sportology Center, Juntendo University Graduate School of Medicine, Hongo 3-1-3, Bunkyo-ku, Tokyo, 113-8431, Japan

    Ryuzo Kawamori

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  1. Masami Nemoto
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Correspondence to Masami Nemoto.

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Nemoto, M., Tajima, N. & Kawamori, R. Efficacy of combined use of miglitol in Type 2 diabetes patients receiving insulin therapy-placebo-controlled double-blind comparative study. Acta Diabetol 48, 15–20 (2011). https://doi.org/10.1007/s00592-010-0206-4

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  • DOI: https://doi.org/10.1007/s00592-010-0206-4

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