Efficacy and Safety of Ipragliflozin As Add-on Therapy to Insulin in Japanese Patients with Type 2 Diabetes Mellitus (IOLITE): a 36-week, Open-label Extension of a 16-week, Randomized, Placebo-controlled, Double-blind Study

Overview

Journal Diabetol Int

Specialty Endocrinology

Date 2019 Feb 26

PMID 30800562

Citations 4

Authors

Hisamitsu Ishihara

Susumu Yamaguchi

Ikko Nakao

Seitaro Asahina

Taishi Sakatani

Affiliations

Soon will be listed here.

Abstract

Objective: To examine long-term efficacy/safety of ipragliflozin, a sodium-glucose cotransporter 2 inhibitor, added to ongoing insulin therapy in Japanese patients with type 2 diabetes.

Methods: We conducted a 36-week, open-label extension of ipragliflozin therapy following a 16-week, randomized, placebo-controlled, double-blind period (treatment periods II and I, respectively). Prior to the open-label period, patients taking insulin with/without a dipeptidyl peptidase-4 (DPP-4) inhibitor were randomized to receive placebo or 50 mg once-daily ipragliflozin. Oral antidiabetic drugs other than DPP-4 inhibitors were discontinued 4 weeks before screening. Following treatment period I, all patients received open-label ipragliflozin 50 mg, with the possibility of a dose increase to 100 mg at week 24 if HbA1c was ≥ 7.0% at week 20. Efficacy endpoints were changes in HbA1c, fasting plasma glucose (FPG), self-monitored blood glucose, bodyweight, and metabolic hormones. Drug-related treatment-emergent adverse events (TEAEs) were monitored for safety.

Results: Of 175 patients randomized to ipragliflozin, 168 entered treatment period II, 121 (69%) of whom completed this period. The mean ± standard deviation changes in HbA1c, FPG, and bodyweight from baseline (start of treatment period I) to the end of treatment were - 0.83 ± 0.72%, - 31.5 ± 41.2 mg/dL, and - 1.34 ± 1.80 kg, respectively. Between weeks 8 and 32, HbA1c was lower in patients taking a DPP-4 inhibitor than in those without. The most common drug-related TEAE was hypoglycemia; no drug-related TEAEs not already reported for ipragliflozin were observed.

Conclusions: Ipragliflozin was well tolerated, effective, and reduced bodyweight over a period of 52 weeks in patients treated with insulin with/without a DPP-4 inhibitor.

Clinicaltrialsgov Identifier: NCT02175784.

Citing Articles

Real-world risk of hypoglycemia-related hospitalization in Japanese patients with type 2 diabetes using SGLT2 inhibitors: a nationwide cohort study.

Horii T, Oikawa Y, Kunisada N, Shimada A, Atsuda K BMJ Open Diabetes Res Care. 2020; 8(2).

PMID: 33246930 PMC: 7703042. DOI: 10.1136/bmjdrc-2020-001856.

Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials.

Kashiwagi A, Shestakova M, Ito Y, Noguchi M, Wilpshaar W, Yoshida S Diabetes Ther. 2019; 10(6):2201-2217.

PMID: 31606880 PMC: 6848447. DOI: 10.1007/s13300-019-00699-8.

Open-Label Study to Assess the Efficacy of Ipragliflozin for Reducing Insulin Dose in Patients with Type 2 Diabetes Mellitus Receiving Insulin Therapy.

Ishihara H, Yamaguchi S, Sugitani T, Kosakai Y Clin Drug Investig. 2019; 39(12):1213-1221.

PMID: 31552641 PMC: 6842350. DOI: 10.1007/s40261-019-00851-z.

Combination Therapy with Empagliflozin and Insulin Results in Successful Glycemic Control: A Case Report of Uncontrolled Diabetes Caused by Autoimmune Pancreatitis and Subsequent Steroid Treatment.

Kishimoto M, Yamaoki K, Adachi M Case Rep Endocrinol. 2019; 2019:9415347.

PMID: 30895163 PMC: 6393920. DOI: 10.1155/2019/9415347.

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