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Clinical Pharmacology Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus

Clinical Pharmacology Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus

19

No obvious differences in demographic characteristics were observed among the administration groups at baseline. The median of age was 15.0 years and body weight was 72.50 kg. The median of duration of type 2 diabetes mellitus was 2.10 years and age of definite diagnosis was 12.70 years. 14 out of 19 participants had a complication and 16 out of 19 participants were treated with metformin.

A total of 27 participants were enrolled into the study.Of these participants, 8 participants discontinued the study berore the assignment of investigational drug due to the inclusion criteria, 19 participants were assigned to the group of TS-071 1.25 mg (n=6), 2.5 mg (n=6), 5 mg (n=7).All assigned participants were administrated investigational drug and completed the study. None of the participants discontinued after the administration.

No adverse events (AEs) was reported in the TS-071 1.25 mg group, but AEs were reported by 2 out of 6 participants in the TS-071 2.5 mg group and 4 out of 7 participants in the TS-071 5 mg group. No adverse drug reaction (ARD) was reported in the TS-071 1.25 mg and 2.5 mg group, but ADR was reported by 1 out of 7 participants in the TS-071 5 mg group. No deaths and other serious adverse events were reported in the study. Classified by event, the most frequently reported AEs was headache that were reported by 2 participants in the TS-071 5 mg group. Besides, each nausea and nasopharyngitis was reported by 1 participant in the TS-071 2.5 mg group and each acetonaemia and miliaria was reported by 1 participant in the TS-071 5 mg group. Among those events, acetonaemia occurred in the TS-071 5 mg group was considered to be ADR. The intensity of all events was mild and resolved or recovered by no treatment or appropriate treatment.

Pharmacokinetic Results: Following the single administration of TS-071, plasma concentration of unchanged form and each metabolites was dose-proportionally elevated. Pharmacodynamics Results: Following the single administration of TS-071, urinary glucose excretion was observed in all group and no statistically dose response was observed in urinary glucose excretion and its amount of change. Safety Results: Please refer to "Adverse Events" section.

absence

Following each single-dose of 1.25 mg, 2.5 mg and 5 mg administration in paediatric patients with type 2 diabetes mellitus, the pharmacokinetics of plasma concentration of unchanged form and each metabolites were dose proportionality, urinary glucose excretion was observed. Also tolerability was confirmed because there was no critical AEs, deaths or other serious adverse events.

Oct. 09, 2026

No

Taisho Pharmaceutical Co., Ltd.

clinical-trials@taisho.co.jp

Taisho Pharmaceutical Co., Ltd.

clinical-trials@taisho.co.jp

completed

Aug. 06, 2018

Interventional

Open-label

treatment purpose

N/A

- Type 2 diabetes mellitus
- HbA1c 6.5% to 10.5%

etc.

- Diabetes mellitus other than type 2
- Fasting plasma glucose exceeding 250 mg/dL at the screening test
- Concurrent urinary tract infection or genital infection, or a history of repeated occurrences of such infection

etc.

Both

Type 2 diabetes mellitus

investigational material(s)
Generic name etc : TS-071
INN of investigational material : Luseogliflozin hydrate
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material : Oral

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral

safety
pharmacokinetics
pharmacodynamics
Pharmacokinetics, pharmacodynamics, and safety

other
-

-

Oct. 16, 2018