Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function: Interim Report from Post-marketing Surveillance

Masakazu Haneda, Takashi Kadowaki, Hiroshi Itoh, Kazuyo Sasaki, Sonoe Hiraide, Manabu Ishii, Miyuki Matsukawa, Makoto Ueno

Research output: Contribution to journalArticle

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Abstract

Introduction: Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. Methods: For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1–G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. Results: A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98–6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was − 0.68 to − 0.85% and − 0.71 to − 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [− 2.29%, (p < 0.001) after 1 year; − 1.64%, (p = 0.064) after 2 years]. Conclusions: During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from normal to end-stage renal disease, including those on dialysis, and improved glycemic control. Trial Registration Number: Japic CTI-153047. Funding: Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co, Ltd.

Original languageEnglish
Pages (from-to)1083-1097
Number of pages15
JournalDiabetes Therapy
Volume9
Issue number3
DOIs
Publication statusPublished - Jun 1 2018

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Marketing
Type 2 Diabetes Mellitus
Kidney
Safety
Drug-Related Side Effects and Adverse Reactions
Dialysis
Glomerular Filtration Rate
3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
Dipeptidyl-Peptidase IV Inhibitors
Therapeutics
Least-Squares Analysis
Chronic Renal Insufficiency
Hypoglycemia
Chronic Kidney Failure
Incidence

Keywords

  • Dialysis
  • Dipeptidyl peptidase-4 inhibitor
  • Post-marketing surveillance
  • Renal impairment
  • Teneligliptin
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function : Interim Report from Post-marketing Surveillance. / Haneda, Masakazu; Kadowaki, Takashi; Itoh, Hiroshi; Sasaki, Kazuyo; Hiraide, Sonoe; Ishii, Manabu; Matsukawa, Miyuki; Ueno, Makoto.

In: Diabetes Therapy, Vol. 9, No. 3, 01.06.2018, p. 1083-1097.

Research output: Contribution to journalArticle

Haneda, Masakazu ; Kadowaki, Takashi ; Itoh, Hiroshi ; Sasaki, Kazuyo ; Hiraide, Sonoe ; Ishii, Manabu ; Matsukawa, Miyuki ; Ueno, Makoto. / Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function : Interim Report from Post-marketing Surveillance. In: Diabetes Therapy. 2018 ; Vol. 9, No. 3. pp. 1083-1097.
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abstract = "Introduction: Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. Methods: For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1–G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. Results: A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98–6.98{\%} of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was − 0.68 to − 0.85{\%} and − 0.71 to − 0.85{\%} across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [− 2.29{\%}, (p < 0.001) after 1 year; − 1.64{\%}, (p = 0.064) after 2 years]. Conclusions: During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from normal to end-stage renal disease, including those on dialysis, and improved glycemic control. Trial Registration Number: Japic CTI-153047. Funding: Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co, Ltd.",
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T1 - Safety and Efficacy of Teneligliptin in Patients with Type 2 Diabetes Mellitus and Impaired Renal Function

T2 - Interim Report from Post-marketing Surveillance

AU - Haneda, Masakazu

AU - Kadowaki, Takashi

AU - Itoh, Hiroshi

AU - Sasaki, Kazuyo

AU - Hiraide, Sonoe

AU - Ishii, Manabu

AU - Matsukawa, Miyuki

AU - Ueno, Makoto

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N2 - Introduction: Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. Methods: For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1–G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. Results: A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98–6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was − 0.68 to − 0.85% and − 0.71 to − 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [− 2.29%, (p < 0.001) after 1 year; − 1.64%, (p = 0.064) after 2 years]. Conclusions: During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from normal to end-stage renal disease, including those on dialysis, and improved glycemic control. Trial Registration Number: Japic CTI-153047. Funding: Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co, Ltd.

AB - Introduction: Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function. Methods: For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1–G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation. Results: A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98–6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was − 0.68 to − 0.85% and − 0.71 to − 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [− 2.29%, (p < 0.001) after 1 year; − 1.64%, (p = 0.064) after 2 years]. Conclusions: During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from normal to end-stage renal disease, including those on dialysis, and improved glycemic control. Trial Registration Number: Japic CTI-153047. Funding: Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co, Ltd.

KW - Dialysis

KW - Dipeptidyl peptidase-4 inhibitor

KW - Post-marketing surveillance

KW - Renal impairment

KW - Teneligliptin

KW - Type 2 diabetes mellitus

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