Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride: A randomized, double-blind, non-inferiority trial

Yonghyun Kim, Eun Seok Kang, Hak Chul Jang, Dong Jun Kim, Taekeun Oh, Eun Sook Kim, Nan Hee Kim, Kyung Mook Choi, Sung Rae Kim, Ji Young You, Se Jin Kim, Moon Kyu Lee

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5 Citations (Scopus)

Abstract

Aim: To assess the efficacy and safety of add-on therapy with the dipeptidyl peptidase-4 inhibitor teneligliptin compared with sitagliptin in patients with type 2 diabetes (T2DM) inadequately controlled with metformin and glimepiride. Materials and Methods: This was a phase 3, randomized, double-blind, non-inferiority study of adult Korean subjects with T2DM (n = 201), with HbA1c ranging from 7.0% to 11.0%, on stable doses of metformin plus glimepiride. Subjects were randomized in a 1:1 fashion to receive either oral teneligliptin 20 mg or sitagliptin 100 mg for 24 weeks. The primary endpoint was change from baseline in HbA1c. Results: At baseline, mean age was 60.56 ± 9.41 years, body mass index was 25.23 ± 2.85 kg/m2 and HbA1c was 8.11% ± 0.79%. At 24 weeks, both groups achieved significant reductions from baseline in HbA1c (teneligliptin, −1.03% ± 0.10% [P < 0.0001]; sitagliptin, −1.02% ± 0.10% [P < 0.0001]). The inter-group difference was −0.01% (95% confidence interval [CI]: −0.28, 0.26; P = 0.9497); the upper limit of the 95% CI was within the preset limit for non-inferiority (0.4%). There were no significant differences between groups in the proportion of patients achieving HbA1c targets, or changes from baseline in fasting plasma glucose, body weight or lipid levels at 24 weeks. Rates of adverse events (teneligliptin, n = 63 [61.76%]; sitagliptin, n = 61 [62.24%]; P = 0.9442) and hypoglycaemia (teneligliptin, n = 32 [31.37%]; sitagliptin, n = 28 [28.57%]; P = 0.6656) were similar. Conclusion: Teneligliptin was non-inferior to sitagliptin in the context of triple therapy for T2DM and is an important option in this setting.

Original languageEnglish
Pages (from-to)631-639
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume21
Issue number3
DOIs
Publication statusPublished - 2019 Mar

Keywords

  • DPP-4 inhibitor
  • sitagliptin
  • teneligliptin
  • triple therapy
  • type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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