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 language | English |
|---|---|
| Pages (from-to) | 590-598 |
| Number of pages | 9 |
| Journal | Diabetes, Obesity and Metabolism |
| Volume | 19 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - 2017 Apr 1 |
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All Science Journal Classification (ASJC) codes
- Internal Medicine
- Endocrinology, Diabetes and Metabolism
- Endocrinology
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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 journal › Article
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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U2 - 10.1111/dom.12863
DO - 10.1111/dom.12863
M3 - Article
VL - 19
SP - 590
EP - 598
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 4
ER -