Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes: A 24-week randomized, controlled trial with open label extension

Sang Mo Hong, Cheol Young Park, Dong Min Hwang, Kyung Ah Han, Chang Beom Lee, Choon Hee Chung, Kun Ho Yoon, Ji Oh Mok, Kyong Soo Park, Sung Woo Park

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Aims: This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone. Methods: Adult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (≥1000 mg/d) were randomized 1:1 to add-on evogliptin 5 mg (N = 112) or sitagliptin 100 mg (N = 110) once daily for 24 weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was <0.35%. Results: Mean changes in HbA1c following addition of evogliptin or sitagliptin were −0.59% and −0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, −0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (−0.44% ± 0.65%, P <.0001). In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups. Hypoglycaemic events, mostly mild, were reported in 0.9% of patients treated with evogliptin and in 2.8% of patients treated with sitagliptin for 24 weeks. Conclusions: Evogliptin 5 mg added to metformin therapy effectively improved glycaemic control and was non-inferior to sitagliptin and well tolerated in patients with type 2 diabetes mellitus that was inadequately controlled by metformin alone.

Original languageEnglish
Pages (from-to)654-663
Number of pages10
JournalDiabetes, Obesity and Metabolism
Volume19
Issue number5
DOIs
Publication statusPublished - 2017 May

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Metformin
Type 2 Diabetes Mellitus
Randomized Controlled Trials
Safety
Confidence Intervals
Dipeptidyl-Peptidase IV Inhibitors
Therapeutics
Hypoglycemic Agents
4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one
Sitagliptin Phosphate
Incidence

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Hong, Sang Mo ; Park, Cheol Young ; Hwang, Dong Min ; Han, Kyung Ah ; Lee, Chang Beom ; Chung, Choon Hee ; Yoon, Kun Ho ; Mok, Ji Oh ; Park, Kyong Soo ; Park, Sung Woo. / Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes : A 24-week randomized, controlled trial with open label extension. In: Diabetes, Obesity and Metabolism. 2017 ; Vol. 19, No. 5. pp. 654-663.
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author = "Hong, {Sang Mo} and Park, {Cheol Young} and Hwang, {Dong Min} and Han, {Kyung Ah} and Lee, {Chang Beom} and Chung, {Choon Hee} and Yoon, {Kun Ho} and Mok, {Ji Oh} and Park, {Kyong Soo} and Park, {Sung Woo}",
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Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes : A 24-week randomized, controlled trial with open label extension. / Hong, Sang Mo; Park, Cheol Young; Hwang, Dong Min; Han, Kyung Ah; Lee, Chang Beom; Chung, Choon Hee; Yoon, Kun Ho; Mok, Ji Oh; Park, Kyong Soo; Park, Sung Woo.

In: Diabetes, Obesity and Metabolism, Vol. 19, No. 5, 05.2017, p. 654-663.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of adding evogliptin versus sitagliptin for metformin-treated patients with type 2 diabetes

T2 - A 24-week randomized, controlled trial with open label extension

AU - Hong, Sang Mo

AU - Park, Cheol Young

AU - Hwang, Dong Min

AU - Han, Kyung Ah

AU - Lee, Chang Beom

AU - Chung, Choon Hee

AU - Yoon, Kun Ho

AU - Mok, Ji Oh

AU - Park, Kyong Soo

AU - Park, Sung Woo

PY - 2017/5

Y1 - 2017/5

N2 - Aims: This trial consisted of a 24-week multicentre, randomized, double-blind, double-dummy, active-controlled study and a 52-week open label extension study to assess the efficacy and safety of evogliptin, a novel dipeptidyl peptidase-4 inhibitor, compared to sitagliptin in patients with type 2 diabetes who have inadequate glycaemic control with metformin alone. Methods: Adult patients with type 2 diabetes mellitus (N = 222) with HbA1c 6.5% to 11% who were receiving stable doses of metformin (≥1000 mg/d) were randomized 1:1 to add-on evogliptin 5 mg (N = 112) or sitagliptin 100 mg (N = 110) once daily for 24 weeks. The primary efficacy analysis consisted of a comparison of the change from baseline HbA1c at week 24. Non-inferiority was concluded if the upper limit of the 2-sided 95% confidence interval for the HbA1c difference between treatments was <0.35%. Results: Mean changes in HbA1c following addition of evogliptin or sitagliptin were −0.59% and −0.65%, respectively. The between-group difference was 0.06% (2-sided 95% confidence interval, −0.10 to 0.22), demonstrating non-inferiority. After the 52-week treatment, evogliptin caused a persistently decreased level of HbA1c (−0.44% ± 0.65%, P <.0001). In general, both treatments were well tolerated, with incidences and types of adverse events comparable between the two groups. Hypoglycaemic events, mostly mild, were reported in 0.9% of patients treated with evogliptin and in 2.8% of patients treated with sitagliptin for 24 weeks. Conclusions: Evogliptin 5 mg added to metformin therapy effectively improved glycaemic control and was non-inferior to sitagliptin and well tolerated in patients with type 2 diabetes mellitus that was inadequately controlled by metformin alone.

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