PMID- 28719008 OWN - NLM STAT- MEDLINE DCOM- 20181227 LR - 20181227 IS - 1463-1326 (Electronic) IS - 1462-8902 (Linking) VI - 20 IP - 2 DP - 2018 Feb TI - 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. PG - 292-300 LID - 10.1111/dom.13059 [doi] AB - 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. CI - (c) 2017 John Wiley & Sons Ltd. FAU - Han, Sang Youb AU - Han SY AD - Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea. FAU - Yoon, Sun Ae AU - Yoon SA AD - Department of Internal Medicine, Catholic University Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea. FAU - Han, Byoung Geun AU - Han BG AD - Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. FAU - Kim, Sung Gyun AU - Kim SG AD - Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea. FAU - Jo, Young-Il AU - Jo YI AD - Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea. FAU - Jeong, Kyung Hwan AU - Jeong KH AD - Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Republic of Korea. FAU - Oh, Kook-Hwan AU - Oh KH AD - Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. FAU - Park, Hyeong Cheon AU - Park HC AD - Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea. FAU - Park, Sun-Hee AU - Park SH AD - Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea. FAU - Kang, Shin-Wook AU - Kang SW AD - Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea. FAU - Na, Ki-Ryang AU - Na KR AD - Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea. FAU - Kang, Sun Woo AU - Kang SW AD - Department of Nephrology, Busan Paik Hospital Inje University, Busan, Republic of Korea. FAU - Kim, Nam-Ho AU - Kim NH AD - Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, Republic of Korea. FAU - Jang, Younghwan AU - Jang Y AD - LG Life Sciences, Seoul, Republic of Korea. FAU - Kim, Bogyeong AU - Kim B AD - LG Life Sciences, Seoul, Republic of Korea. FAU - Shin, Seonghye AU - Shin S AD - LG Life Sciences, Seoul, Republic of Korea. FAU - Cha, Dae Ryong AU - Cha DR AUID- ORCID: 0000-0003-0063-2844 AD - Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea. LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20170906 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Dipeptidyl-Peptidase IV Inhibitors) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (LC15-0444) RN - 0 (Piperidones) RN - 0 (Pyrimidines) RN - 0 (Sulfonylurea Compounds) RN - 3X29ZEJ4R2 (Linagliptin) SB - IM MH - Aged MH - Diabetes Mellitus, Type 2/blood/complications/*drug therapy MH - Diabetic Nephropathies/complications/*physiopathology MH - Dipeptidyl-Peptidase IV Inhibitors/adverse effects/*therapeutic use MH - Double-Blind Method MH - Drug Monitoring MH - Drug Therapy, Combination/adverse effects MH - Female MH - Follow-Up Studies MH - Humans MH - Hyperglycemia/prevention & control MH - Hypoglycemic Agents/therapeutic use MH - Insulin/therapeutic use MH - Kidney/*drug effects/physiopathology MH - Linagliptin/adverse effects/*therapeutic use MH - Male MH - Middle Aged MH - Patient Dropouts MH - Piperidones/adverse effects/*therapeutic use MH - Pyrimidines/adverse effects/*therapeutic use MH - Renal Insufficiency, Chronic/complications/*physiopathology MH - Severity of Illness Index MH - Sulfonylurea Compounds/therapeutic use OTO - NOTNLM OT - DPP-IV inhibitor OT - diabetic nephropathy OT - phase III study OT - type 2 diabetes mellitus EDAT- 2017/07/19 06:00 MHDA- 2018/12/28 06:00 CRDT- 2017/07/19 06:00 PHST- 2017/03/22 00:00 [received] PHST- 2017/07/12 00:00 [revised] PHST- 2017/07/13 00:00 [accepted] PHST- 2017/07/19 06:00 [pubmed] PHST- 2018/12/28 06:00 [medline] PHST- 2017/07/19 06:00 [entrez] AID - 10.1111/dom.13059 [doi] PST - ppublish SO - Diabetes Obes Metab. 2018 Feb;20(2):292-300. doi: 10.1111/dom.13059. Epub 2017 Sep 6.