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Diabetes Obes Metab. 2019 Mar;21(3):631-639. doi: 10.1111/dom.13566. Epub 2018 Nov 22.

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

Author information

1
Department of Internal Medicine, Daejin Medical Center, Seongnam, Korea.
2
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.
3
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
4
Department of Internal Medicine, Inje University Ilsanpaik Hospital, Goyang, Korea.
5
Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.
6
Department of Internal Medicine, Ulsan University Hospital, Ulsan, Korea.
7
Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Korea.
8
Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.
9
Department of Internal Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.
10
Clinical Research Science, Handok Inc., Seoul, Korea.
11
Clinical Research Operation, Handok Inc., Seoul, Korea.
12
Division of Endocrinology and Metabolism, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul, Korea.

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.

KEYWORDS:

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

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