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Efficacy, safety and albuminuria‐reducing effect of gemigliptin in K orean type 2 diabetes patients with moderate to severe renal impairment: A 12‐week, double‐blind randomized study (the GUARD S tudy)
Author(s) -
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 W.,
Na Ki R.,
Kang Sun W.,
Kim Nam H.,
Jang Young H.,
Shin Seong H.,
Cha Dae R.
Publication year - 2017
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12863
Subject(s) - fructosamine , albuminuria , microalbuminuria , renal function , creatinine , placebo , medicine , type 2 diabetes , urology , diabetes mellitus , endocrinology , alternative medicine , pathology
Aims This multicentre, randomized, double‐blind study investigated the efficacy and safety of gemigliptin in K orean 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 m 2 ). At W eek 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.