Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice

Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Nakamura, Ichiro

doi:10.1080/14656566.2016.1217994

Cited by 23 publications

(44 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The safety and efficacy of ipragliflozin in type 2 diabetes patients has been shown through clinical trials and post‐marketing surveys. Several studies have shown that ipragliflozin lowers blood glucose levels in an insulin‐independent fashion, and hence is expected to be efficacious in type 1 diabetes, as well as type 2 diabetes.…”

Section: Introductionmentioning

confidence: 99%

Long‐term (52‐week) efficacy and safety of ipragliflozin add‐on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open‐label extension of a phase III study

Kaku

Isaka

Sakatani

et al. 2020

J of Diabetes Invest

View full text Add to dashboard Cite

Introduction: The aim of the present study was to assess the long-term (52-week) efficacy and safety of ipragliflozin in insulin-treated Japanese patients with type 1 diabetes mellitus and inadequate glycemic control. Materials and Methods: In this 28-week, open-label extension of a multicenter, randomized, placebo-controlled, 24-week phase III study, ipragliflozin recipients continued treatment (50 mg, once daily), and placebo recipients were switched to once-daily 50 mg ipragliflozin at the start of the extension period. The ipragliflozin dose could be increased to 100 mg if warranted. The primary end-point was change in glycated hemoglobin; secondary end-points were change in insulin dose and bodyweight. Safety outcomes were monitored as treatment-emergent adverse events. Results: A total of 53 (placebo switched to ipragliflozin) and 108 (ipragliflozin) patients completed the open-label extension (treatment period 2), with 24 and 44 patients, respectively, receiving dose increases. From baseline to end of treatment, the overall mean change (standard deviation [SD]) in glycated hemoglobin was -0.33% (0.72; -3.7 mmol/ mol [7.9]), with changes in basal, bolus and total insulin doses of -3.76 IU (SD 3.85 IU), -2.51 IU (SD 7.08 IU) and -6.27 IU (SD 8.16 IU), respectively. No serious drug-related treatment-emergent adverse events or deaths were reported. Treatment-emergent adverse events leading to study discontinuation occurred in zero and three (2.6%) patients in the placebo switched to ipragliflozin and ipragliflozin groups, respectively; all were considered drug-related. There were no cases of severe hypoglycemia or diabetic ketoacidosis, and no safety concerns related to dose increase. Conclusions: The efficacy and safety of 50 mg, once-daily ipragliflozin in insulin-treated type 1 diabetes mellitus patients were confirmed in this long-term, open-label extension study. No safety concerns were attributed to a dose increase to 100 mg.

show abstract

Section: Introductionmentioning

confidence: 99%

Long‐term (52‐week) efficacy and safety of ipragliflozin add‐on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open‐label extension of a phase III study

Kaku

Isaka

Sakatani

et al. 2020

J of Diabetes Invest

View full text Add to dashboard Cite

show abstract

“…The initial report describes in detail the way in which the minimum sample size was calculated and the rationale for the duration of the study. Of note, no sample size calculation was considered regarding the subgroup comparisons.…”

Section: Methodsmentioning

confidence: 99%

“…The study is currently ongoing; patients will be observed for a total of 3 years. The baseline characteristics of the patients have been reported previously; notably, the proportion of overweight or obese patients registered for the study is unexpectedly large compared with the general Japanese population. Here, we describe a subgroup analysis of the 3‐month interim results from STELLA‐LONG TERM, in which patients were stratified by BMI to investigate the impact of obesity on the efficacy and safety of ipragliflozin.…”

Section: Introductionmentioning

confidence: 93%

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus: A subgroup analysis of 3‐month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use study

Tobe

Maegawa

Tabuchi

et al. 2019

J of Diabetes Invest

Self Cite

View full text Add to dashboard Cite

Aims/Introduction Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use is an ongoing postmarketing study of ipragliflozin for long‐term use in Japanese patients with type 2 diabetes mellitus. A subgroup analysis of data from the study was carried out to investigate the impact of obesity on the efficacy and safety of ipragliflozin in this population. Materials and Methods Patients were divided into the following subgroups according to their body mass index (BMI): <22.0, 22.0 to <25.0, 25.0 to <30.0 and ≥30.0 kg/m2. Changes in bodyweight and glycemic parameters up to 3 months were evaluated, as well as adverse drug reactions (ADRs) that occurred during ipragliflozin treatment. Results In the efficacy analysis set (8,633 patients), glycemic control and bodyweight statistically significantly improved from baseline to 3 months in all BMI subgroups (all P < 0.05). No strong correlations were identified between changes in bodyweight and changes in hemoglobin A1c, waist circumference or BMI in any of the subgroups. The incidence of adverse drug reactions was 6.29, 8.44, 11.18 and 11.74% in the <22.0, 22.0 to <25.0, 25.0 to <30.0 and ≥30.0 kg/m2 groups, respectively (P = 0.001), in the safety analysis set (n = 11,053 patients). Conclusions In Japanese patients with type 2 diabetes mellitus, ipragliflozin improved glycemic control and reduced bodyweight, regardless of BMI. Adverse drug reactions were more common in patients with higher BMI than in those with lower BMI.

show abstract

“…4 The regular dose of ipragliflozin is 50 mg/day and doses up to 100 mg/day are approved in cases of insufficient efficacy. [7][8][9][10] Furthermore, in a multicentre, randomized, placebo-controlled, double-blind study in insulin-treated patients with type 2 diabetes mellitus, ipragliflozin was shown to be well tolerated and effective. 5,6 The safety and efficacy of ipragliflozin in type 2 diabetes mellitus patients (including elderly patients) have been confirmed in preapproval clinical trials, as well as in large-scale postmarketing surveillance studies in the realworld clinical setting in Japan.…”

mentioning

confidence: 99%

“…5,6 The safety and efficacy of ipragliflozin in type 2 diabetes mellitus patients (including elderly patients) have been confirmed in preapproval clinical trials, as well as in large-scale postmarketing surveillance studies in the realworld clinical setting in Japan. [7][8][9][10] Furthermore, in a multicentre, randomized, placebo-controlled, double-blind study in insulin-treated patients with type 2 diabetes mellitus, ipragliflozin was shown to be well tolerated and effective. 11 Although there is a large amount of published data on the efficacy and safety of ipragliflozin for type 2 diabetes, to date, no data have been obtained on the use of ipragliflozin for the treatment of type 1 diabetes mellitus.…”

mentioning

confidence: 99%

Clinical pharmacology study of ipragliflozin in Japanese patients with type 1 diabetes mellitus: A phase 2, randomized, placebo‐controlled trial

Kaku

Isaka

Toyoshima

et al. 2019

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

Aim To evaluate the pharmacodynamics, pharmacokinetics, and safety of the novel oral sodium‐glucose co‐transporter‐2 inhibitor, ipragliflozin, in Japanese patients with type 1 diabetes mellitus. Materials and methods We conducted a multicentre, double‐blind, placebo‐controlled, parallel‐group study. Patients were randomized to receive 25, 50, or 100 mg/day ipragliflozin or placebo for 2 weeks. Key pharmacokinetic endpoints included area under the concentration‐time curve 24 hours postdose (AUC24h), maximum plasma concentration (Cmax), and renal clearance. Key pharmacodynamic endpoints included 24‐hour urinary glucose excretion, mean plasma glucose AUC0‐24h, and mean renal glucose clearance. Changes in total, basal, and bolus insulin dosages were recorded. Adverse events (AEs) were monitored for safety. Results Dose‐dependent increases were observed in AUC24h and Cmax on days 1 and 14 for 25‐, 50‐, and 100‐mg ipragliflozin. The mean plasma glucose AUC0‐24h was lower than that of placebo and the mean renal glucose clearance increased in a dose‐dependent manner from baseline, but remained unchanged in the placebo group. The mean (standard deviation) change from baseline in total daily insulin dose was greater in the ipragliflozin 25‐, 50‐, and 100‐mg groups (−14.77 ± 14.04%, −18.40 ± 12.49% and −19.25 ± 16.77%, respectively), than placebo (−4.51 ± 16.28%). Most AEs were mild in severity; no patients discontinued the study because of treatment‐emergent AEs. Conclusions The pharmacokinetic and pharmacodynamic properties of ipragliflozin in Japanese patients with type 1 diabetes mellitus were confirmed. Increases in urinary glucose excretion lead to dose‐dependent decreases in plasma glucose. Concomitant insulin dose decreased with ipragliflozin treatment. No clinically relevant safety concerns were identified.

show abstract

Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice

Cited by 23 publications

References 34 publications

Long‐term (52‐week) efficacy and safety of ipragliflozin add‐on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open‐label extension of a phase III study

Long‐term (52‐week) efficacy and safety of ipragliflozin add‐on therapy to insulin in Japanese patients with type 1 diabetes mellitus: An uncontrolled, open‐label extension of a phase III study

Impact of body mass index on the efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes mellitus: A subgroup analysis of 3‐month interim results from the Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use study

Clinical pharmacology study of ipragliflozin in Japanese patients with type 1 diabetes mellitus: A phase 2, randomized, placebo‐controlled trial

Contact Info

Product

Resources

About