Clinical Trial of Metformin Monotherapy in Children and Adolescents with Type 2 Diabetes Mellitus in Japan

• Matsuura Nobuo

  Department of Early Childhood Education, Seitoku University

• Takeuchi Masahiro

  Division of Biostatistics, School of Pharmaceutical Science, Kitasato University and Research Center for Clinical Pharmacology, Academic Clinical Trial Unit, The Kitasato Insutitute

• Amemiya Shin

  Department of Pediatrics, Saitama Medical University

• Sugihara Shigetaka

  Department of Pediatrics, Tokyo Women's Medical University Medical Center East

• Yokota Yukihumi

  Department of Pediatrics, Kitasato University School of Medicine

• Tanaka Toshiaki

  Department of Clinical Laboratory, National Center for Child Health and Development

• Nakamura Hidehumi

  Division of Clinical Administration, Department of National Center for Child Health and Development on behalf of the Pediatric Clinical Trial of Metformin Study Group

• Sasaki Nozomu

  Department of Pediatrics, Saitama Medical University

• Ohki Yukashi

  日本医科大学小児科

• Urakami Tatsuhiko

  日本大学駿河台病院小児科

• Miyamoto Shigeki

  千葉県こども病院内分泌科

• Kikuchi Nobuyuki

  横浜市立大学付属市民総合医療センター

• Kobayashi Koji

  山梨大学医学部小児科

• Horikawa Reiko

  国立成育医療センター内分泌代謝科

• Kikuchi Toru

  新潟大学医学部小児科

Bibliographic Information

Other Title

• 小児2型糖尿病に対するメトホルミン単独療法
• ショウニ 2ガタ トウニョウビョウ ニ タイスル メトホルミン タンドク リョウホウ

Abstract

A clinical trial by a Study Group supported by ministry of Health, Labour and Welfare Research Grants for Clinical Research on Pediatric Disease investigated whether a 750 mg/d and double that dose of metformin could be used to treat Japanese children with T2DM by means of an open, non-randomized single arm study. The primary efficacy outcome measure was a significant improvement in HbA₁c level between wk 0 and wk 24. The subjects were 50 patients between 10 and 19 y/o who had not been given any anti-diabetic medication for at least for 28 days before the study (naïve group) or whose diabetes had been treated with metformin alone at dose of 750 mg/day for at least 28 days before study (already-on group). At entry their HbA₁c had to be≥5.8% (reference upper limit<5.8%) and their SDS-BMI had to be>0 for their age and sex. Secondary efficacy outcome measures, including fasting plasma glucose (FPG), and adverse events, including lactic acidosis, were observed. Metformin 750 mg/d was given to both groups for the first 12 wk. For the second 12 wk, the metformin dosed was increased to 1,500 mg/d if the HbA₁c was ≥6.5% at wk 12, but remained at 750 mg/d, if the HbA₁c value was <6.4% at wk 12. Ultinately, 47 patients (24 in group A and 23 in group B) were enrolled, and 38 patients completed the clinical study. The mean HbA₁c level of the 38 patients was 7.4±1.3 at 0 wk and 6.9±1.2% at wk 24, and the improvement between wk 0 and wk 24 was significant (p=0.01). The FPG value also decrease significantly (p=0.017), from 165.3±79.6 to 135.3±37.7 mg/dl. No serious adverse events were observed. This fourth clinical trial in the world of metformin for pediatric use demonstrated once again that metformin is effective and safe in children and adolescents with T2DM.

Journal

• Journal of the Japan Diabetes Society

  Journal of the Japan Diabetes Society 51 (5), 427-434, 2008

  THE JAPAN DIABETES SOCIETY

Keywords

• メトホルミン
• 小児2型糖尿病
• 臨床試験
• 公的研究費
• 安全性・有効性

Details

• CRID: 1390001204903486464
• NII Article ID: 130004511093
• NII Article ID: 10021275262
• NII Book ID: AN00166576
• DOI: 10.11213/tonyobyo.51.427
• ISSN: 1881588X
• ISSN: 0021437X
• NDL BIB ID: 9546143
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I9546143
• Web Site: https://search.jamas.or.jp/link/ui/2008253932
• Text Lang: ja
• Data Source:
  • JaLC
  • NDL
  • CiNii Articles
  • KAKEN
• Abstract License Flag: Disallowed