Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study
Abstract Introduction To investigate the efficacy and safety of trelagliptin 25 mg in patients with type 2 diabetes mellitus with severe renal impairment or end‐stage renal disease. Materials and Methods This multicenter, randomized, phase 3 study comprised a 12‐week double‐blind phase followed by a...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2020-03-01
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| Series: | Journal of Diabetes Investigation |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/jdi.13126 |
| _version_ | 1819135120107372544 |
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| author | Kohei Kaku Kazuyuki Ishida Kohei Shimizu Meguru Achira Yuusuke Umeda |
| author_facet | Kohei Kaku Kazuyuki Ishida Kohei Shimizu Meguru Achira Yuusuke Umeda |
| author_sort | Kohei Kaku |
| collection | DOAJ |
| description | Abstract Introduction To investigate the efficacy and safety of trelagliptin 25 mg in patients with type 2 diabetes mellitus with severe renal impairment or end‐stage renal disease. Materials and Methods This multicenter, randomized, phase 3 study comprised a 12‐week double‐blind phase followed by a 40‐week open‐label phase. Patients had type 2 diabetes mellitus with severe renal impairment (creatinine clearance <30 mL/min) or end‐stage renal disease (undergoing hemodialysis), and were receiving diet and/or exercise therapy with/without one antidiabetic drug. Results Patients were randomized to trelagliptin (A/A, n = 55) or placebo (P/A, n = 52; double‐blind phase). Both groups received trelagliptin in the open‐label phase. The least square mean change (95% confidence interval [CI]) from baseline in hemoglobin A1c at the end of the double‐blind phase was −0.71% (95% CI −0.885, −0.542) and 0.01% (95% CI −0.170, 0.183) in the A/A and P/A groups, respectively (intergroup least square means difference −0.72%, 95% CI −0.966, −0.473; P < 0.0001). Mean hemoglobin A1c decreased after trelagliptin treatment in the P/A group to similar levels observed in the A/A group and remained comparable in both groups versus baseline up to week 52. In the double‐blind phase, the incidence of treatment‐emergent adverse events (TEAEs) was 72.7% and 61.5% in the A/A and P/A group, respectively; most TEAEs were mild‐to‐moderate, except in one patient (P/A group), who experienced two severe TEAEs. The incidence of serious TEAEs was 7.3% and 3.8% in the A/A and P/A group, respectively. Conclusions Once‐weekly trelagliptin 25 mg was efficacious, with no major safety concerns, and represents a meaningful treatment option in this patient population. |
| first_indexed | 2024-12-22T10:14:02Z |
| format | Article |
| id | doaj.art-938dabafc6de4fc0bd13629af2ba05e3 |
| institution | Directory Open Access Journal |
| issn | 2040-1116 2040-1124 |
| language | English |
| last_indexed | 2024-12-22T10:14:02Z |
| publishDate | 2020-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Investigation |
| spelling | doaj.art-938dabafc6de4fc0bd13629af2ba05e32022-12-21T18:29:47ZengWileyJournal of Diabetes Investigation2040-11162040-11242020-03-0111237338110.1111/jdi.13126Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 studyKohei Kaku0Kazuyuki Ishida1Kohei Shimizu2Meguru Achira3Yuusuke Umeda4Department of Medicine Kawasaki Medical School OkayamaJapanTakeda Development Center Japan Takeda Pharmaceutical Company Limited OsakaJapanTakeda Development Center Japan Takeda Pharmaceutical Company Limited OsakaJapanTakeda PRA Development Center KK Osaka JapanTakeda Development Center Japan Takeda Pharmaceutical Company Limited OsakaJapanAbstract Introduction To investigate the efficacy and safety of trelagliptin 25 mg in patients with type 2 diabetes mellitus with severe renal impairment or end‐stage renal disease. Materials and Methods This multicenter, randomized, phase 3 study comprised a 12‐week double‐blind phase followed by a 40‐week open‐label phase. Patients had type 2 diabetes mellitus with severe renal impairment (creatinine clearance <30 mL/min) or end‐stage renal disease (undergoing hemodialysis), and were receiving diet and/or exercise therapy with/without one antidiabetic drug. Results Patients were randomized to trelagliptin (A/A, n = 55) or placebo (P/A, n = 52; double‐blind phase). Both groups received trelagliptin in the open‐label phase. The least square mean change (95% confidence interval [CI]) from baseline in hemoglobin A1c at the end of the double‐blind phase was −0.71% (95% CI −0.885, −0.542) and 0.01% (95% CI −0.170, 0.183) in the A/A and P/A groups, respectively (intergroup least square means difference −0.72%, 95% CI −0.966, −0.473; P < 0.0001). Mean hemoglobin A1c decreased after trelagliptin treatment in the P/A group to similar levels observed in the A/A group and remained comparable in both groups versus baseline up to week 52. In the double‐blind phase, the incidence of treatment‐emergent adverse events (TEAEs) was 72.7% and 61.5% in the A/A and P/A group, respectively; most TEAEs were mild‐to‐moderate, except in one patient (P/A group), who experienced two severe TEAEs. The incidence of serious TEAEs was 7.3% and 3.8% in the A/A and P/A group, respectively. Conclusions Once‐weekly trelagliptin 25 mg was efficacious, with no major safety concerns, and represents a meaningful treatment option in this patient population.https://doi.org/10.1111/jdi.13126Chronic kidney failureTrelagliptinType 2 diabetes mellitus |
| spellingShingle | Kohei Kaku Kazuyuki Ishida Kohei Shimizu Meguru Achira Yuusuke Umeda Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study Journal of Diabetes Investigation Chronic kidney failure Trelagliptin Type 2 diabetes mellitus |
| title | Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study |
| title_full | Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study |
| title_fullStr | Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study |
| title_full_unstemmed | Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study |
| title_short | Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end‐stage renal disease: Results from a randomized, phase 3 study |
| title_sort | efficacy and safety of trelagliptin in japanese patients with type 2 diabetes with severe renal impairment or end stage renal disease results from a randomized phase 3 study |
| topic | Chronic kidney failure Trelagliptin Type 2 diabetes mellitus |
| url | https://doi.org/10.1111/jdi.13126 |
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