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Efficacy and safety of insulin degludec biosimilar B01411 versus originator insulin degludec in Chinese patients with type 2 diabetes inadequately controlled on oral antidiabetic drugs: a multicenter, randomized, open-label, phase 3 study.
Ji, Linong; Gao, Leili; Cheng, Zhifeng; Ma, Guoqing; Li, Shu; Wang, Haifang; Liu, Jie; Lu, Yibing; Liu, Meiying; Geng, Jianlin; Gao, Yunming; Ling, Hongwei; Sun, Wenli; Song, Chengwei; Sun, Jingfang.
Afiliación
  • Ji L; Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
  • Gao L; Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
  • Cheng Z; Fourth Affiliated Hospital, Harbin Medical University, Harbin, China.
  • Ma G; The Second Affiliated Hospital, Heilongjiang University of Traditional Chinese Medicine, Harbin, China.
  • Li S; Huizhou Central People's Hospital, Huizhou, China.
  • Wang H; Handan First Hospital, Handan, China.
  • Liu J; The First Affiliated Hospital, Henan University of Science and Technology, Luoyang, China.
  • Lu Y; The Second Affiliated Hospital, Nanjing Medical University, Nanjing, China.
  • Liu M; BaoGang Hospital of Inner Mongolia, Baotou, China.
  • Geng J; Harrison International Peace Hospital, Hengshui, China.
  • Gao Y; The Second People's Hospital of Lianyungang, Lianyungang, China.
  • Ling H; The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
  • Sun W; The Second People's Hospital of Yueyang City, Yueyang, China.
  • Song C; Jilin Province FAW General Hospital, Changchun, China.
  • Sun J; Hui Sheng Bio-pharmaceutical Co, Ltd, Beijing, China.
Curr Med Res Opin ; : 1-7, 2024 Sep 18.
Article en En | MEDLINE | ID: mdl-39235266
ABSTRACT

OBJECTIVE:

To compare the efficacy and safety of insulin degludec biosimilar B01411 (HS-IDeg) with originator insulin degludec-Tresiba (NN-IDeg) in Chinese patients with type 2 diabetes mellitus (T2DM) who were inadequately controlled on oral antidiabetic drugs (OADs) for at least 3 months.

METHODS:

This multicenter, randomized, open-label, parallel-group, active-controlled, phase 3 study enrolled 362 participants with T2DM. Participants were stratified according to whether the insulin secretagogue (sulfonylurea or glinide) had been used before the screening and then randomized 11 to receive once-daily subcutaneous injections of HS-IDeg (n = 180) or NN-IDeg (n = 182) for 18 weeks. The primary endpoint was the change from baseline in glycated hemoglobin (HbA1c) to week 18.

RESULTS:

At week 18, the least squares (LS) mean change in HbA1c from baseline was -1.34% (95% CI -1.47 to -1.21) and -1.25% (95% CI -1.38 to -1.12) with HS-IDeg and NN-IDeg, respectively. The LS mean difference (HS-IDeg minus NN-IDeg) in HbA1c at week 18 was -0.09% (95% CI -0.28 to 0.10), demonstrating non-inferiority of HS-IDeg to NN-IDeg. Participants achieving HbA1c <7.0% at week 18 were 34.5% and 29.5% with HS-IDeg and NN-IDeg, respectively. Mean decreases in fasting plasma glucose and standard deviation of blood glucose were similar between both groups. Safety and tolerability, including hypoglycemia, adverse events, and weight change were similar between both groups. No severe hypoglycemia and no death occurred in the study.

CONCLUSIONS:

HS-IDeg and NN-IDeg demonstrated similar efficacy and safety over 18 weeks of treatment in Chinese patients with T2DM who had inadequate responses to OADs for at least 3 months.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Curr Med Res Opin Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Curr Med Res Opin Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido