トルリシティ（デュラグルチド）の臨床試験で、甲状腺腫瘍は認められたのか？

解説

国内第2相及び第3相臨床試験では、デュラグルチド投与群に甲状腺腫瘍又は甲状腺新生物は認められませんでした^1-5。

外国第2相及び第3相臨床試験では、甲状腺腫瘍又は甲状腺新生物（因果関係を問わない）が全てのデュラグルチド投与群で7 例、0.2%の被験者に認められました。しかしながら、デュラグルチドと癌の発生・促進の関係を評価するのに十分な期間の投与を受けた被験者は少ないため、複数の製薬会社で構成する甲状腺髄様癌登録［medullary thyroid cancer（MTC）registry］に参加し、これらの評価を継続しています⁶。

［参考資料］

1. Terauchi Y et al. Monotherapy with the once weekly GLP-1 receptor agonist dulaglutide for 12 weeks in Japanese patients with type 2 diabetes: dose-dependent effects on glycaemic control in a randomised, double-blind, placebo-controlled study. ENDOCRINE JOURNAL 2014; 61(10):949-959 https://www.jstage.jst.go.jp/article/endocrj/61/10/61_EJ14-0147/_article

2. Miyagawa J et al. Once-weekly glucagon-like peptide-1 receptor agonist dulaglutide is non-inferior to once-daily liraglutide and superior to placebo in Japanese patients with type 2 diabetes: a 26-week randomized phase III study. Diabetes, Obesity and Metabolism 2015; 17(10):974-983 https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.12534

3. Odawara M et al. Once‐weekly glucagon‐like peptide‐1 receptor agonist dulaglutide significantly decreases glycated haemoglobin compared with once‐daily liraglutide in J apanese patients with type 2 diabetes: 52 weeks of treatment in a randomized phase III study. Diabetes, Obesity and Metabolism 2016; 18(3):249-257 https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.12602

4. Emoto M et al. A 1-year safety study of dulaglutide in Japanese patients with type 2 diabetes on a single oral hypoglycemic agent: an open-label, nonrandomized, phase 3 trial. Endocrine Journal 2015; 62(12):1101-1114 https://www.jstage.jst.go.jp/article/endocrj/62/12/62_EJ15-0401/_article

5. Araki E et al. Efficacy and safety of once-weekly dulaglutide in combination with sulphonylurea and/or biguanide compared with once-daily insulin glargine in Japanese patients with type 2 diabetes: a randomized, open-label, phase III, non-inferiority study. Diabetes, Obesity and Metabolism 2015; 17(10):994-1002 https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.12540

6. トルリシティ 申請資料概要 https://www.pmda.go.jp/drugs/2015/P20150706001/index.html