Comparative efficacy and safety of gemigliptin versus linagliptin in type 2 diabetes patients with renal impairment: A 40‐week extension of the GUARD randomized study

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2018-02, Vol.20 (2), p.292-300
• Main Authors: Han, Sang Youb, Yoon, Sun Ae, Han, Byoung Geun, Kim, Sung Gyun, Jo, Young‐Il, Jeong, Kyung Hwan, Oh, Kook‐Hwan, Park, Hyeong Cheon, Park, Sun‐Hee, Kang, Shin‐Wook, Na, Ki‐Ryang, Kang, Sun Woo, Kim, Nam‐Ho, Jang, Younghwan, Kim, Bogyeong, Shin, Seonghye, Cha, Dae Ryong
• Format: Article
• Language: English
• Subjects: Aged; Albumin; Collagen (type IV); Diabetes; Diabetes mellitus; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - blood; Diabetes Mellitus, Type 2 - complications; Diabetes Mellitus, Type 2 - drug therapy; Diabetic Nephropathies - complications; Diabetic Nephropathies - physiopathology; Diabetic nephropathy; Dipeptidyl-Peptidase IV Inhibitors - adverse effects; Dipeptidyl-Peptidase IV Inhibitors - therapeutic use; Double-Blind Method; DPP‐IV inhibitor; Drug Monitoring; Drug Therapy, Combination - adverse effects; Epidermal growth factor receptors; Excretion; Female; Follow-Up Studies; Glomerular filtration rate; Hemoglobin; Humans; Hyperglycemia - prevention & control; Hypoglycemia; Hypoglycemic Agents - therapeutic use; Insulin - therapeutic use; Kidney - drug effects; Kidney - physiopathology; Kidneys; Linagliptin - adverse effects; Linagliptin - therapeutic use; Male; Middle Aged; Patient Dropouts; phase III study; Piperidones - adverse effects; Piperidones - therapeutic use; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - physiopathology; Safety; Severity of Illness Index; Sulfonylurea Compounds - therapeutic use; Trends; type 2 diabetes mellitus
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.13059

Aims The long‐term safety and efficacy of gemigliptin was evaluated in the present extension study after a 12‐week study during a 40‐week follow‐up period. Methods The main study was a randomized, placebo‐controlled, double‐blinded, phase IIIb study in which 50 mg of gemigliptin (N = 66) or placebo (N = 66) was administered to patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal impairment over a 12‐week period. Patients with a glycated haemoglobin (HbA1c) level of 7% to 11% and an estimated glomerular filtration rate (eGFR) of 15 to 59 mL/min/1.73 m2 were enrolled in the main study. After 12 weeks, patients in the gemigliptin group continued to receive gemigliptin (N = 50), whereas patients in the placebo group were transitioned from placebo to linagliptin (N = 52). Each group received the indicated treatment over the subsequent 40‐week period. A total of 102 patients consented to participate in the extension study, and 79 patients ultimately completed the study. Results The HbA1c levels of both groups were significantly reduced at week 52 compared with baseline. Specifically, the adjusted mean change ± standard error in HbA1c level in the gemigliptin and placebo/linagliptin groups was 1.00% ± 0.21% and 0.65% ± 0.22% lower at week 52 than at baseline (P