Long-term safety and efficacy of fasiglifam (TAK-875), a G-protein-coupled receptor 40 agonist, as monotherapy and combination therapy in Japanese patients with type 2 diabetes: a 52-week open-label phase III study

2016 ◽  
Vol 18 (9) ◽  
pp. 925-929 ◽  
Author(s):  
K. Kaku ◽  
K. Enya ◽  
R. Nakaya ◽  
T. Ohira ◽  
R. Matsuno
Keyword(s):  
Type 2 Diabetes ◽  
Japanese Patients ◽  
Phase Iii ◽  
Open Label ◽  
Safety And Efficacy ◽  
Open Label Phase ◽  
Phase Iii Study ◽  
G Protein Coupled

scholarly journals Efficacy and safety of esaxerenone (CS-3150) in Japanese patients with type 2 diabetes and macroalbuminuria: a multicenter, single-arm, open-label phase III study

2021 ◽  
Author(s):  
Sadayoshi Ito ◽  
Naoki Kashihara ◽  
Kenichi Shikata ◽  
Masaomi Nangaku ◽  
Takashi Wada ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Renin Angiotensin System ◽  
Japanese Patients ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Open Label Phase ◽  
Phase Iii Study

Abstract Background Esaxerenone has potential renoprotective effects and reduces the urinary albumin-to-creatinine ratio (UACR) in patients with diabetic kidney disease and overt nephropathy. We investigated the efficacy and safety of esaxerenone in Japanese patients with type 2 diabetes (T2D) and macroalbuminuria (UACR ≥ 300 mg/g creatinine). Methods We conducted a multicenter, single-arm, open-label phase III study in 56 patients with T2D and UACR ≥ 300 mg/g creatinine with estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 and treated with a renin–angiotensin system inhibitor. Patients received esaxerenone for 28 weeks at 1.25 mg/day initially with titration to 2.5 mg/day based on serum potassium (K+) monitoring. Efficacy was evaluated as the change in UACR from baseline to week 28. Safety endpoints included adverse events (AEs), incidence of serum K+ increase, and change in eGFR from baseline. Results UACR decreased by 54.6% (95% CI 46.9%, 61.3%) on average from baseline (544.1 mg/g creatinine) to the end of treatment (246.8 mg/g creatinine); 51.8% of patients showed improvement to early nephropathy. AE incidence was 69.6%. Three patients (5.4%) had serum K+ levels ≥ 6.0 mEq/L or ≥ 5.5 mEq/L on two consecutive occasions. Hyperkalemia in two patients was transient and resolved during the treatment period. One patient discontinued following two consecutive serum K+ values ≥ 5.5 mEq/L. The maximum change from baseline in eGFR was − 8.3 mL/min/1.73 m2 at week 24. Conclusions Esaxerenone reduced UACR in Japanese patients with T2D and UACR ≥ 300 mg/g creatinine; more than half experienced a transition from UACR ≥ 300 mg/g creatinine to UACR < 300 mg/g creatinine. Clinical trial registration JapicCTI-173696

scholarly journals Long-term safety and efficacy of exenatide twice daily in Japanese patients with suboptimally controlled type 2 diabetes

2011 ◽  
Vol 2 (6) ◽  
pp. 448-456 ◽  
Author(s):  
Nobuya Inagaki ◽  
Kohjiro Ueki ◽  
Ayuko Yamamura ◽  
Hitoshi Saito ◽  
Takeshi Imaoka
Keyword(s):  
Type 2 Diabetes ◽  
Japanese Patients ◽  
Safety And Efficacy
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