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Long-term treatment study of global standard dose metformin in Japanese patients with type 2 diabetes mellitus

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Abstract

In 169 Japanese patients with type 2 diabetes mellitus with blood glucose levels that were inadequately controlled with diet and exercise therapy alone, or with diet and exercise therapy plus a sulfonylurea (SU) drug, we evaluated the safety and efficacy of global standard dose metformin given up to a maximum daily dose of 2250 mg for 54 weeks. The changes in HbA1c from baseline to the final evaluation visit were −1.32 ± 0.76% for metformin monotherapy and −1.29 ± 0.81% for metformin plus SU, both significantly lower than baseline. The incidences of adverse events and adverse drug reactions were 91.1% (154/169 patients) and 67.5% (114/169 patients), respectively. The most common adverse events were gastrointestinal symptoms, and most of the gastrointestinal symptoms were considered by investigators to be related to metformin treatment. An increased blood lactic acid level was observed in three subjects (1.8%); however, no clinical symptoms were reported, and there was no increase in mean lactic acid concentration throughout the evaluation period. Symptoms of hypoglycemia were reported in 16 patients, all receiving metformin plus SU, but none received metformin monotherapy. There was a decrease in mean body weight. Global standard dose metformin may be useful for maintaining good blood glucose control over the long term in the treatment of type 2 diabetes mellitus in Japanese patients.

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Acknowledgements

We thank the study participants, the investigators and contributors from each of the study sites.

Author information

Authors and Affiliations

  1. Division of Diabetes, Endocrinology and Metabolism, Department of Diabetes, Endocrinology, Metabolism and Rheumatology, Tokyo Medical University, Tokyo, Japan

    Masato Odawara

  2. Sportology Center, Juntendo University Graduate School of Medicine, Supported by High Technology Research Center Grant from the Ministry of Education, Culture, Sports, Science and Technology of Japan, Tokyo, Japan

    Ryuzo Kawamori

  3. Jikei University School of Medicine, Tokyo, Japan

    Naoko Tajima

  4. The Institute for Adult Disease, Asahi Life Foundation, Tokyo, Japan

    Yasuhiko Iwamoto

  5. Division of Clinical Pharmacology and Therapeutics, Jikei University School of Medicine, Tokyo, Japan

    Shigeru Kageyama

  6. Drug Department Division, Sumitomo Dainippon Pharma Co., Ltd.,, Tokyo, Japan

    Yasuhide Yodo & Fumiko Ueki

  7. Japan Labour Health and Welfare Organization Chubu Rosai Hospital, Aichi, Japan

    Nigishi Hotta

Authors
  1. Masato Odawara
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  2. Ryuzo Kawamori
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  3. Naoko Tajima
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  4. Yasuhiko Iwamoto
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  5. Shigeru Kageyama
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  6. Yasuhide Yodo
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  7. Fumiko Ueki
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  8. Nigishi Hotta
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Corresponding author

Correspondence to Masato Odawara.

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Conflict of interest

These studies were funded by Sumitomo Dainippon Pharma Co., Ltd. MO, RK, NT and YI are members of a coordinating committee of this study. SK and NH are members of a safety data monitoring committee. All of these committee members have received honoraria from Sumitomo Dainippon Pharma. No other potential conflicts of interest relevant to this article were reported. YY and FU are employees of Sumitomo Dainippon Pharma and carried out statistical analysis and managed this study, respectively.

Human rights statement and informed consent

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent or substitute for it was obtained from all patients for being included in the study.

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Odawara, M., Kawamori, R., Tajima, N. et al. Long-term treatment study of global standard dose metformin in Japanese patients with type 2 diabetes mellitus. Diabetol Int 8, 286–295 (2017). https://doi.org/10.1007/s13340-017-0309-z

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  • DOI: https://doi.org/10.1007/s13340-017-0309-z

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