Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study)

Chang Ho Ahn, Kyung Ah Han, Jae Myung Yu, Joo Young Nam, Kyu Jeung Ahn, Tae Keun Oh, Hyoung Woo Lee, Dae Ho Lee, Jaetaek Kim, Choon Hee Chung, Tae Sun Park, Byung Joon Kim, Seok Won Park, Hyeong Kyu Park, Kwang Jae Lee, Sang Wook Kim, Jeong Hyun Park, Kwan Pyo Ko, Chong Hwa Kim, Hyunjin LeeHak Chul Jang, Kyong Soo Park

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Aims: To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM). Materials and methods: We conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Results: The baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change −0.87%, 95% confidence interval [CI] −1.09% to −0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (−0.93 mmol/L, 95% CI −1.50 to −0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (−0.21 mmol/L, 95% CI −0.38 to −0.03 mmol/L for total cholesterol, −0.18 mmol/L, 95% CI −0.34 to −0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group. Conclusions: Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.

Original languageEnglish
Pages (from-to)635-643
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume19
Issue number5
DOIs
Publication statusPublished - 2017 May

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Dipeptidyl-Peptidase IV Inhibitors
Metformin
Type 2 Diabetes Mellitus
Placebos
glimepiride
Safety
Confidence Intervals
Therapeutics
Hypoglycemia
LDL Cholesterol
Cholesterol
LC15-0444
Incidence
Glycosylated Hemoglobin A
Fasting
Glucose

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Ahn, Chang Ho ; Han, Kyung Ah ; Yu, Jae Myung ; Nam, Joo Young ; Ahn, Kyu Jeung ; Oh, Tae Keun ; Lee, Hyoung Woo ; Lee, Dae Ho ; Kim, Jaetaek ; Chung, Choon Hee ; Park, Tae Sun ; Kim, Byung Joon ; Park, Seok Won ; Park, Hyeong Kyu ; Lee, Kwang Jae ; Kim, Sang Wook ; Park, Jeong Hyun ; Ko, Kwan Pyo ; Kim, Chong Hwa ; Lee, Hyunjin ; Jang, Hak Chul ; Park, Kyong Soo. / Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea : a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study). In: Diabetes, Obesity and Metabolism. 2017 ; Vol. 19, No. 5. pp. 635-643.
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title = "Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study)",
abstract = "Aims: To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM). Materials and methods: We conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Results: The baseline HbA1c was 8.2{\%} in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change −0.87{\%}, 95{\%} confidence interval [CI] −1.09{\%} to −0.64{\%}). Fasting plasma glucose level was also significantly reduced with gemigliptin (−0.93 mmol/L, 95{\%} CI −1.50 to −0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7{\%} (39.3{\%} vs 5.5{\%}; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (−0.21 mmol/L, 95{\%} CI −0.38 to −0.03 mmol/L for total cholesterol, −0.18 mmol/L, 95{\%} CI −0.34 to −0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4{\%} in the gemigliptin group and 2.7{\%} in the placebo group. Conclusions: Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.",
author = "Ahn, {Chang Ho} and Han, {Kyung Ah} and Yu, {Jae Myung} and Nam, {Joo Young} and Ahn, {Kyu Jeung} and Oh, {Tae Keun} and Lee, {Hyoung Woo} and Lee, {Dae Ho} and Jaetaek Kim and Chung, {Choon Hee} and Park, {Tae Sun} and Kim, {Byung Joon} and Park, {Seok Won} and Park, {Hyeong Kyu} and Lee, {Kwang Jae} and Kim, {Sang Wook} and Park, {Jeong Hyun} and Ko, {Kwan Pyo} and Kim, {Chong Hwa} and Hyunjin Lee and Jang, {Hak Chul} and Park, {Kyong Soo}",
year = "2017",
month = "5",
doi = "10.1111/dom.12866",
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Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea : a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study). / Ahn, Chang Ho; Han, Kyung Ah; Yu, Jae Myung; Nam, Joo Young; Ahn, Kyu Jeung; Oh, Tae Keun; Lee, Hyoung Woo; Lee, Dae Ho; Kim, Jaetaek; Chung, Choon Hee; Park, Tae Sun; Kim, Byung Joon; Park, Seok Won; Park, Hyeong Kyu; Lee, Kwang Jae; Kim, Sang Wook; Park, Jeong Hyun; Ko, Kwan Pyo; Kim, Chong Hwa; Lee, Hyunjin; Jang, Hak Chul; Park, Kyong Soo.

In: Diabetes, Obesity and Metabolism, Vol. 19, No. 5, 05.2017, p. 635-643.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea

T2 - a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study)

AU - Ahn, Chang Ho

AU - Han, Kyung Ah

AU - Yu, Jae Myung

AU - Nam, Joo Young

AU - Ahn, Kyu Jeung

AU - Oh, Tae Keun

AU - Lee, Hyoung Woo

AU - Lee, Dae Ho

AU - Kim, Jaetaek

AU - Chung, Choon Hee

AU - Park, Tae Sun

AU - Kim, Byung Joon

AU - Park, Seok Won

AU - Park, Hyeong Kyu

AU - Lee, Kwang Jae

AU - Kim, Sang Wook

AU - Park, Jeong Hyun

AU - Ko, Kwan Pyo

AU - Kim, Chong Hwa

AU - Lee, Hyunjin

AU - Jang, Hak Chul

AU - Park, Kyong Soo

PY - 2017/5

Y1 - 2017/5

N2 - Aims: To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM). Materials and methods: We conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Results: The baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change −0.87%, 95% confidence interval [CI] −1.09% to −0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (−0.93 mmol/L, 95% CI −1.50 to −0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (−0.21 mmol/L, 95% CI −0.38 to −0.03 mmol/L for total cholesterol, −0.18 mmol/L, 95% CI −0.34 to −0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group. Conclusions: Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.

AB - Aims: To assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM). Materials and methods: We conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24. Results: The baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change −0.87%, 95% confidence interval [CI] −1.09% to −0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (−0.93 mmol/L, 95% CI −1.50 to −0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (−0.21 mmol/L, 95% CI −0.38 to −0.03 mmol/L for total cholesterol, −0.18 mmol/L, 95% CI −0.34 to −0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group. Conclusions: Gemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.

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