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Efficacy and safety of generic exenatide injection in Chinese patients with type 2 diabetes: a multicenter, randomized, controlled, non-inferiority trial.

Jin YangWenhua XiaoLixin GuoQuanmin LiLiyong ZhongJinkui YangJing YangYongyi GaoQing TianTianpei Hong
Published in: Acta diabetologica (2020)
In patients with T2DM inadequately controlled on monotherapy or combination therapy of metformin and insulin secretagogues, add-on treatment with generic exenatide demonstrated non-inferiority to branded exenatide in terms of improvements in HbA1c after 16 weeks of treatment. Furthermore, the two drugs were also similar for other efficacy endpoints and safety profile. Trial registration Chinese Clinical Trial Registry: ChiCTR-IPR-15006558, Date registered May 27, 2015.
Keyphrases
  • combination therapy
  • clinical trial
  • phase iii
  • phase ii
  • open label
  • double blind
  • study protocol
  • type diabetes
  • placebo controlled
  • weight loss
  • drug induced