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Diabetes Obes Metab. 2018 Feb;20(2):292-300. doi: 10.1111/dom.13059. Epub 2017 Sep 6.

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 information

1
Department of Internal Medicine, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.
2
Department of Internal Medicine, Catholic University Uijeongbu St. Mary's Hospital, Uijeongbu, Republic of Korea.
3
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
4
Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.
5
Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Republic of Korea.
6
Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Republic of Korea.
7
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
8
Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Republic of Korea.
9
Department of Internal Medicine, Kyungpook National University School of Medicine, Daegu, Republic of Korea.
10
Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
11
Department of Internal Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea.
12
Department of Nephrology, Busan Paik Hospital Inje University, Busan, Republic of Korea.
13
Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, Republic of Korea.
14
LG Life Sciences, Seoul, Republic of Korea.
15
Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.

Abstract

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 < .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.

KEYWORDS:

DPP-IV inhibitor; diabetic nephropathy; phase III study; type 2 diabetes mellitus

PMID:
28719008
DOI:
10.1111/dom.13059
[Indexed for MEDLINE]

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