Efficacy, safety and albuminuria-reducing effect of gemigliptin in Korean type 2 diabetes patients with moderate to severe renal impairment

A 12-week, double-blind randomized study (the GUARD Study)

Sun A. Yoon, Byoung G. Han, Sung G. Kim, Sang Y. Han, Young I. Jo, Kyung H. Jeong, Kook H. Oh, Hyeong C. Park, Sun H. Park, Shin-Wook Kang, Ki R. Na, Sun W. Kang, Nam H. Kim, Young H. Jang, Seong H. Shin, Dae R. Cha

Research output: Contribution to journalArticle

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Abstract

Aims: This multicentre, randomized, double-blind study investigated the efficacy and safety of gemigliptin in Korean type 2 diabetes mellitus (T2DM) patients with moderate to severe renal impairment (RI). Methods: The study comprised a 12-week main part and a 40-week extension. We report here the results from the main part. In total, 132 patients were randomized to receive gemigliptin (n = 66) or placebo (n = 66). Changes in glycated haemoglobin (HbA1c; primary endpoint), other glycaemic control parameters (fasting plasma glucose, glycated albumin and fructosamine), lipid profiles, renal function parameters and safety profiles were evaluated. Results: Baseline characteristics were comparable between the groups (mean HbA1c, 8.4% [68 mmol/mol]; age, 62.0 years; duration of type 2 diabetes, 16.3 years; estimated glomerular filtration rate, 33.3 mL/min/1.73 m2). At Week 12, the adjusted mean change ± standard error in HbA1c with gemigliptin was −0.82% ± 0.14% (−8.9 ± 1.5 mmol/mol), whereas it was 0.38% ± 0.14% (4.2 ± 1.5 mmol/mol) with placebo (significant between-group difference, P <.001). Other glycaemic control parameters showed beneficial changes as well. Body weight change (gemigliptin, −0.3 kg; placebo, −0.2 kg) was not significant. In the gemigliptin group, the mean decrease in urinary albumin creatinine ratio (UACR) was significant, both in patients with microalbuminuria (−41.9 mg/g creatinine, P =.03) and macroalbuminuria (−528.9 mg/g creatinine, P <.001). Drug-related adverse events were similar with gemigliptin and placebo (15% and 12%, respectively). Conclusions: A 12-week treatment with gemigliptin improved glycaemic control and provided UACR reduction in T2DM patients with moderate to severe RI. Gemigliptin was well tolerated, with no additional risk of hypoglycaemia and change in body weight.

Original languageEnglish
Pages (from-to)590-598
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume19
Issue number4
DOIs
Publication statusPublished - 2017 Apr 1

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compound A 12
Albuminuria
Double-Blind Method
Type 2 Diabetes Mellitus
Kidney
Safety
Creatinine
Placebos
Body Weight Changes
Albumins
Fructosamine
LC15-0444
Glycosylated Hemoglobin A
Drug-Related Side Effects and Adverse Reactions
Glomerular Filtration Rate
Hypoglycemia
Fasting
Lipids
Glucose

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Yoon, Sun A. ; Han, Byoung G. ; Kim, Sung G. ; Han, Sang Y. ; Jo, Young I. ; Jeong, Kyung H. ; Oh, Kook H. ; Park, Hyeong C. ; Park, Sun H. ; Kang, Shin-Wook ; Na, Ki R. ; Kang, Sun W. ; Kim, Nam H. ; Jang, Young H. ; Shin, Seong H. ; Cha, Dae R. / Efficacy, safety and albuminuria-reducing effect of gemigliptin in Korean type 2 diabetes patients with moderate to severe renal impairment : A 12-week, double-blind randomized study (the GUARD Study). In: Diabetes, Obesity and Metabolism. 2017 ; Vol. 19, No. 4. pp. 590-598.
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abstract = "Aims: This multicentre, randomized, double-blind study investigated the efficacy and safety of gemigliptin in Korean type 2 diabetes mellitus (T2DM) patients with moderate to severe renal impairment (RI). Methods: The study comprised a 12-week main part and a 40-week extension. We report here the results from the main part. In total, 132 patients were randomized to receive gemigliptin (n = 66) or placebo (n = 66). Changes in glycated haemoglobin (HbA1c; primary endpoint), other glycaemic control parameters (fasting plasma glucose, glycated albumin and fructosamine), lipid profiles, renal function parameters and safety profiles were evaluated. Results: Baseline characteristics were comparable between the groups (mean HbA1c, 8.4{\%} [68 mmol/mol]; age, 62.0 years; duration of type 2 diabetes, 16.3 years; estimated glomerular filtration rate, 33.3 mL/min/1.73 m2). At Week 12, the adjusted mean change ± standard error in HbA1c with gemigliptin was −0.82{\%} ± 0.14{\%} (−8.9 ± 1.5 mmol/mol), whereas it was 0.38{\%} ± 0.14{\%} (4.2 ± 1.5 mmol/mol) with placebo (significant between-group difference, P <.001). Other glycaemic control parameters showed beneficial changes as well. Body weight change (gemigliptin, −0.3 kg; placebo, −0.2 kg) was not significant. In the gemigliptin group, the mean decrease in urinary albumin creatinine ratio (UACR) was significant, both in patients with microalbuminuria (−41.9 mg/g creatinine, P =.03) and macroalbuminuria (−528.9 mg/g creatinine, P <.001). Drug-related adverse events were similar with gemigliptin and placebo (15{\%} and 12{\%}, respectively). Conclusions: A 12-week treatment with gemigliptin improved glycaemic control and provided UACR reduction in T2DM patients with moderate to severe RI. Gemigliptin was well tolerated, with no additional risk of hypoglycaemia and change in body weight.",
author = "Yoon, {Sun A.} and Han, {Byoung G.} and Kim, {Sung G.} and Han, {Sang Y.} and Jo, {Young I.} and Jeong, {Kyung H.} and Oh, {Kook H.} and Park, {Hyeong C.} and Park, {Sun H.} and Shin-Wook Kang and Na, {Ki R.} and Kang, {Sun W.} and Kim, {Nam H.} and Jang, {Young H.} and Shin, {Seong H.} and Cha, {Dae R.}",
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Efficacy, safety and albuminuria-reducing effect of gemigliptin in Korean type 2 diabetes patients with moderate to severe renal impairment : A 12-week, double-blind randomized study (the GUARD Study). / Yoon, Sun A.; Han, Byoung G.; Kim, Sung G.; Han, Sang Y.; Jo, Young I.; Jeong, Kyung H.; Oh, Kook H.; Park, Hyeong C.; Park, Sun H.; Kang, Shin-Wook; Na, Ki R.; Kang, Sun W.; Kim, Nam H.; Jang, Young H.; Shin, Seong H.; Cha, Dae R.

In: Diabetes, Obesity and Metabolism, Vol. 19, No. 4, 01.04.2017, p. 590-598.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy, safety and albuminuria-reducing effect of gemigliptin in Korean type 2 diabetes patients with moderate to severe renal impairment

T2 - A 12-week, double-blind randomized study (the GUARD Study)

AU - Yoon, Sun A.

AU - Han, Byoung G.

AU - Kim, Sung G.

AU - Han, Sang Y.

AU - Jo, Young I.

AU - Jeong, Kyung H.

AU - Oh, Kook H.

AU - Park, Hyeong C.

AU - Park, Sun H.

AU - Kang, Shin-Wook

AU - Na, Ki R.

AU - Kang, Sun W.

AU - Kim, Nam H.

AU - Jang, Young H.

AU - Shin, Seong H.

AU - Cha, Dae R.

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Aims: This multicentre, randomized, double-blind study investigated the efficacy and safety of gemigliptin in Korean type 2 diabetes mellitus (T2DM) patients with moderate to severe renal impairment (RI). Methods: The study comprised a 12-week main part and a 40-week extension. We report here the results from the main part. In total, 132 patients were randomized to receive gemigliptin (n = 66) or placebo (n = 66). Changes in glycated haemoglobin (HbA1c; primary endpoint), other glycaemic control parameters (fasting plasma glucose, glycated albumin and fructosamine), lipid profiles, renal function parameters and safety profiles were evaluated. Results: Baseline characteristics were comparable between the groups (mean HbA1c, 8.4% [68 mmol/mol]; age, 62.0 years; duration of type 2 diabetes, 16.3 years; estimated glomerular filtration rate, 33.3 mL/min/1.73 m2). At Week 12, the adjusted mean change ± standard error in HbA1c with gemigliptin was −0.82% ± 0.14% (−8.9 ± 1.5 mmol/mol), whereas it was 0.38% ± 0.14% (4.2 ± 1.5 mmol/mol) with placebo (significant between-group difference, P <.001). Other glycaemic control parameters showed beneficial changes as well. Body weight change (gemigliptin, −0.3 kg; placebo, −0.2 kg) was not significant. In the gemigliptin group, the mean decrease in urinary albumin creatinine ratio (UACR) was significant, both in patients with microalbuminuria (−41.9 mg/g creatinine, P =.03) and macroalbuminuria (−528.9 mg/g creatinine, P <.001). Drug-related adverse events were similar with gemigliptin and placebo (15% and 12%, respectively). Conclusions: A 12-week treatment with gemigliptin improved glycaemic control and provided UACR reduction in T2DM patients with moderate to severe RI. Gemigliptin was well tolerated, with no additional risk of hypoglycaemia and change in body weight.

AB - Aims: This multicentre, randomized, double-blind study investigated the efficacy and safety of gemigliptin in Korean type 2 diabetes mellitus (T2DM) patients with moderate to severe renal impairment (RI). Methods: The study comprised a 12-week main part and a 40-week extension. We report here the results from the main part. In total, 132 patients were randomized to receive gemigliptin (n = 66) or placebo (n = 66). Changes in glycated haemoglobin (HbA1c; primary endpoint), other glycaemic control parameters (fasting plasma glucose, glycated albumin and fructosamine), lipid profiles, renal function parameters and safety profiles were evaluated. Results: Baseline characteristics were comparable between the groups (mean HbA1c, 8.4% [68 mmol/mol]; age, 62.0 years; duration of type 2 diabetes, 16.3 years; estimated glomerular filtration rate, 33.3 mL/min/1.73 m2). At Week 12, the adjusted mean change ± standard error in HbA1c with gemigliptin was −0.82% ± 0.14% (−8.9 ± 1.5 mmol/mol), whereas it was 0.38% ± 0.14% (4.2 ± 1.5 mmol/mol) with placebo (significant between-group difference, P <.001). Other glycaemic control parameters showed beneficial changes as well. Body weight change (gemigliptin, −0.3 kg; placebo, −0.2 kg) was not significant. In the gemigliptin group, the mean decrease in urinary albumin creatinine ratio (UACR) was significant, both in patients with microalbuminuria (−41.9 mg/g creatinine, P =.03) and macroalbuminuria (−528.9 mg/g creatinine, P <.001). Drug-related adverse events were similar with gemigliptin and placebo (15% and 12%, respectively). Conclusions: A 12-week treatment with gemigliptin improved glycaemic control and provided UACR reduction in T2DM patients with moderate to severe RI. Gemigliptin was well tolerated, with no additional risk of hypoglycaemia and change in body weight.

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