Efficacy and safety of stepwise introduction of insulin lispro mix 50 in Japanese patients with type 2 diabetes inadequately controlled by oral therapy

• Nakashima Eitaro

  Chubu Rosai Hospital, Nagoya 455-8530, Japan

• Kuribayashi Nobuichi

  Misaki Naika Clinic, Funabashi 274-0805, Japan

• Ishida Kazufumi

  Hiroshima General Hospital, Hatsukaichi 738-8503, Japan

• Taketsuna Masanori

  Eli Lilly Japan K.K., Kobe 651-0086, Japan

• Takeuchi Masakazu

  Eli Lilly Japan K.K., Kobe 651-0086, Japan

• Imaoka Takeshi

  Eli Lilly Japan K.K., Kobe 651-0086, Japan

抄録

The objective of this study was to evaluate the efficacy and safety of stepwise introduction of insulin lispro mix 50 (LM50) from once to 3 times daily in Japanese patients with type 2 diabetes mellitus inadequately controlled by oral therapy. This was a multicenter, open-label, non-randomized trial consisting of three 16-week periods (48 weeks total); all patients were given once-daily injections of LM50 in Period 1. The regimen was intensified to twice daily in Period 2, and 3 times daily in Period 3 if HbA_1c was ≥6.9% before the start of the period. A total of 135 patients were enrolled, and 116 patients completed the study. Main baseline characteristics of enrolled patients were a mean age of 60.3 years, mean diabetes duration of 11.4 years, mean BMI of 25.2 kg/m², and mean HbA_1c of 8.71%. The percentages of patients who achieved HbA_1c levels <6.9% and <7.4% at endpoint were 18.5% (25/135 patients) and 52.6% (71/135 patients), respectively. Mean HbA_1c decreased significantly from 8.70% to 7.44% (p<0.001). The incidence of hypoglycemic episodes over the treatment periods was 65.9% (89/135 patients); severe hypoglycemia occurred in 2.2% (3/135 patients). There were no other clinically significant safety issues related to the study drug. Stepwise introduction of LM50 from once to 3 times daily can be a safe, effective, and simple therapy for Japanese patients with type 2 diabetes mellitus inadequately controlled by oral therapy.

収録刊行物

• Endocrine Journal

  Endocrine Journal 60 (6), 763-772, 2013

  一般社団法人 日本内分泌学会

キーワード

• Type 2 diabetes mellitus
• HbA_1c
• Insulin lispro mix 50

詳細情報

• CRID: 1390001206298625920
• NII論文ID: 10031184545
• NII書誌ID: AA10901436
• DOI: 10.1507/endocrj.ej12-0411
• COI: 1:STN:280:DC%2BC3svjtFagsA%3D%3D
• ISSN: 13484540
• ISSN: 09188959
• PubMed: 23459461
• Web Site: https://www.jstage.jst.go.jp/article/endocrj/60/6/60_EJ12-0411/_pdf
• Web Site: https://search.jamas.or.jp/link/ui/2014196819
• 本文言語コード: en
• データソース種別:
  • JaLC
  • Crossref
  • PubMed
  • CiNii Articles
• 抄録ライセンスフラグ: 使用不可