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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)

 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 W. Kang  ;  Ki R. Na  ;  Sun W. Kang  ;  Nam H. Kim  ;  Young H. Jang  ;  Seong H. Shin  ;  Dae R. Cha 
 DIABETES OBESITY & METABOLISM, Vol.19(4) : 590-598, 2017 
Journal Title
Issue Date
Aged ; Albuminuria/drug therapy* ; Albuminuria/etiology ; Albuminuria/urine ; Blood Glucose/drug effects ; Body Weight/drug effects ; Creatinine/urine ; Diabetes Mellitus, Type 2/complications* ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/urine ; Diabetic Nephropathies/complications* ; Diabetic Nephropathies/drug therapy ; Diabetic Nephropathies/urine ; Double-Blind Method ; Female ; Glycated Hemoglobin A/drug effects ; Humans ; Hypoglycemic Agents/administration & dosage* ; Male ; Middle Aged ; Piperidones/administration & dosage* ; Pyrimidines/administration & dosage* ; Republic of Korea ; Treatment Outcome
DPP-IV inhibitor ; diabetic nephropathy ; phase III study ; type 2 diabetes mellitus
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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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Hyeong Cheon(박형천) ORCID logo https://orcid.org/0000-0002-1550-0812
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