title: 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).
abstract: 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).
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Department of Internal Medicine, Catholic University Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea.
authors.forename: Sun A
authors.initials: SA
authors.lastname: Yoon
authors.affiliation: Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
authors.forename: Byoung G
authors.initials: BG
authors.lastname: Han
authors.affiliation: Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
authors.forename: Sung G
authors.initials: SG
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Inje University, Ilsan Paik Hospital, Goyang, Republic of Korea
authors.forename: Sang Y
authors.initials: SY
authors.lastname: Han
authors.affiliation: Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea.
authors.forename: Young I
authors.initials: YI
authors.lastname: Jo
authors.affiliation: Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Republic of Korea.
authors.forename: Kyung H
authors.initials: KH
authors.lastname: Jeong
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Kook H
authors.initials: KH
authors.lastname: Oh
authors.affiliation: Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.
authors.forename: Hyeong C
authors.initials: HC
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
authors.forename: Sun H
authors.initials: SH
authors.lastname: Park
authors.forename: Shin W
authors.initials: SW
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea.
authors.forename: Ki R
authors.initials: KR
authors.lastname: Na
authors.affiliation: Department of Internal Medicine, Busan Paik Hospital, Busan, Republic of Korea.
authors.forename: Sun W
authors.initials: SW
authors.lastname: Kang
authors.affiliation: Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, Republic of Korea.
authors.forename: Nam H
authors.initials: NH
authors.lastname: Kim
authors.affiliation: LG Life Sciences, Seoul, Republic of Korea.
authors.forename: Young H
authors.initials: YH
authors.lastname: Jang
authors.affiliation: LG Life Sciences, Seoul, Republic of Korea.
authors.forename: Seong H
authors.initials: SH
authors.lastname: Shin
authors.affiliation: Korea University Ansan-Hospital, Ansan, Republic of Korea.
authors.forename: Dae R
authors.identifier: 0000-0003-0063-2844
authors.initials: DR
authors.lastname: Cha
mesh_terms: D000368:Aged; D000419:Albuminuria / Q000188:drug therapy* / Q000209:etiology / Q000652:urine; D001786:Blood Glucose / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003404:Creatinine / Q000652:urine; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000188:drug therapy / Q000652:urine; D003928:Diabetic Nephropathies / Q000150:complications* / Q000188:drug therapy / Q000652:urine; D004311:Double-Blind Method; D005260:Female; D006442:Glycated Hemoglobin / Q000187:drug effects; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010881:Piperidones / Q000008:administration & dosage*; D011743:Pyrimidines / Q000008:administration & dosage*; D056910:Republic of Korea; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D003404:Creatinine; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D010881:Piperidones; D011743:Pyrimidines; C534891:LC15-0444; C517652:hemoglobin A1c protein, human
keywords: DPP-IV inhibitor; diabetic nephropathy; phase III study; type 2 diabetes mellitus