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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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
JournalDiabetes, Obesity and Metabolism
DOIs
Publication statusAccepted/In press - 2018 Jan 1

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glimepiride
Metformin
Type 2 Diabetes Mellitus
Confidence Intervals
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemia
Sitagliptin Phosphate
3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
Fasting
Body Mass Index
Body Weight
Lipids
Safety
Glucose

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride : A randomized, double-blind, non-inferiority trial. / Kim, Yonghyun; Kang, Eun Seok; Jang, Hak Chul; Kim, Dong Jun; Oh, Taekeun; Kim, Eun Sook; Kim, Nan Hee; Choi, Kyung Mook; Kim, Sung Rae; You, Ji Young; Kim, Se Jin; Lee, Moon Kyu.

In: Diabetes, Obesity and Metabolism, 01.01.2018.

Research output: Contribution to journalArticle

Kim, Yonghyun ; Kang, Eun Seok ; Jang, Hak Chul ; Kim, Dong Jun ; Oh, Taekeun ; Kim, Eun Sook ; Kim, Nan Hee ; Choi, Kyung Mook ; Kim, Sung Rae ; You, Ji Young ; Kim, Se Jin ; Lee, Moon Kyu. / Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride : A randomized, double-blind, non-inferiority trial. In: Diabetes, Obesity and Metabolism. 2018.
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title = "Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride: A randomized, double-blind, non-inferiority trial",
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",
author = "Yonghyun Kim and Kang, {Eun Seok} and Jang, {Hak Chul} and Kim, {Dong Jun} and Taekeun Oh and Kim, {Eun Sook} and Kim, {Nan Hee} and Choi, {Kyung Mook} and Kim, {Sung Rae} and You, {Ji Young} and Kim, {Se Jin} and Lee, {Moon Kyu}",
year = "2018",
month = "1",
day = "1",
doi = "10.1111/dom.13566",
language = "English",
journal = "Diabetes, Obesity and Metabolism",
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T1 - Teneligliptin versus sitagliptin in Korean patients with type 2 diabetes inadequately controlled with metformin and glimepiride

T2 - A randomized, double-blind, non-inferiority trial

AU - Kim, Yonghyun

AU - Kang, Eun Seok

AU - Jang, Hak Chul

AU - Kim, Dong Jun

AU - Oh, Taekeun

AU - Kim, Eun Sook

AU - Kim, Nan Hee

AU - Choi, Kyung Mook

AU - Kim, Sung Rae

AU - You, Ji Young

AU - Kim, Se Jin

AU - Lee, Moon Kyu

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - DPP-4 inhibitor

KW - sitagliptin

KW - teneligliptin

KW - triple therapy

KW - type 2 diabetes

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