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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
Author(s) -
Han Sang Youb,
Yoon Sun Ae,
Han Byoung Geun,
Kim Sung Gyun,
Jo YoungIl,
Jeong Kyung Hwan,
Oh KookHwan,
Park Hyeong Cheon,
Park SunHee,
Kang ShinWook,
Na KiRyang,
Kang Sun Woo,
Kim NamHo,
Jang Younghwan,
Kim Bogyeong,
Shin Seonghye,
Cha Dae Ryong
Publication year - 2018
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.13059
Subject(s) - fructosamine , linagliptin , medicine , placebo , renal function , type 2 diabetes , diabetes mellitus , albuminuria , randomized controlled trial , clinical endpoint , urology , endocrinology , alternative medicine , pathology
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 m 2 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 < .001 and P = .003), respectively. No significant difference in the change in HbA1c level was found between the 2 groups ( P = .148). Trends in fasting plasma glucose, fructosamine and glycated albumin levels in the 2 groups were similar to trends in HbA1c levels. The eGFR of both groups was also significantly lower at week 52 than at baseline, and no significant difference in change in eGFR was found between the 2 groups. In contrast, both drugs had little effect on urinary albumin excretion, although both drugs significantly reduced the urinary type IV collagen level. The overall rates of adverse events were similar between the 2 groups. Conclusions Gemigliptin and linagliptin did not differ with respect to safety and efficacy in patients with T2DM and renal impairment. The 2 drugs had similar glucose‐lowering effects, and the changes in eGFR and albuminuria were also similar. Additionally, the risk of side effects, including hypoglycaemia, was similar between the 2 groups.