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

Sang Youb Han, Sun Ae Yoon, Byoung Geun Han, Sung Gyun Kim, Young Il Jo, Kyung Hwan Jeong, Kook Hwan Oh, Hyeong Cheon Park, Sun Hee Park, Shin Wook Kang, Ki Ryang Na, Sun Woo Kang, Nam Ho Kim, Younghwan Jang, Bogyeong Kim, Seonghye Shin, Dae-Ryong Cha

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)292-300
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume20
Issue number2
DOIs
Publication statusPublished - 2018 Feb 1

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Type 2 Diabetes Mellitus
Kidney
Safety
Glomerular Filtration Rate
Placebos
Pharmaceutical Preparations
Fructosamine
Glucose
Albuminuria
Collagen Type IV
Glycosylated Hemoglobin A
LC15-0444
Linagliptin
Hypoglycemia
Serum Albumin
Albumins
Fasting

Keywords

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

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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. / 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.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 2, 01.02.2018, p. 292-300.

Research output: Contribution to journalArticle

Han, SY, Yoon, SA, Han, BG, Kim, SG, Jo, YI, Jeong, KH, Oh, KH, Park, HC, Park, SH, Kang, SW, Na, KR, Kang, SW, Kim, NH, Jang, Y, Kim, B, Shin, S & Cha, D-R 2018, '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', Diabetes, Obesity and Metabolism, vol. 20, no. 2, pp. 292-300. https://doi.org/10.1111/dom.13059
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. / 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. In: Diabetes, Obesity and Metabolism. 2018 ; Vol. 20, No. 2. pp. 292-300.
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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.",
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T1 - Comparative efficacy and safety of gemigliptin versus linagliptin in type 2 diabetes patients with renal impairment

T2 - A 40-week extension of the GUARD randomized study

AU - Han, Sang Youb

AU - Yoon, Sun Ae

AU - Han, Byoung Geun

AU - Kim, Sung Gyun

AU - Jo, Young Il

AU - Jeong, Kyung Hwan

AU - Oh, Kook Hwan

AU - Park, Hyeong Cheon

AU - Park, Sun Hee

AU - Kang, Shin Wook

AU - Na, Ki Ryang

AU - Kang, Sun Woo

AU - Kim, Nam Ho

AU - Jang, Younghwan

AU - Kim, Bogyeong

AU - Shin, Seonghye

AU - Cha, Dae-Ryong

PY - 2018/2/1

Y1 - 2018/2/1

N2 - 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.

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 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.

KW - diabetic nephropathy

KW - DPP-IV inhibitor

KW - phase III study

KW - type 2 diabetes mellitus

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