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A Phase 3 Randomized, Double-blind, Placebo-controlled /Long-term Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus

A Phase 3 Clinical Study of TS-071 in Paediatric Patients with Type 2 Diabetes Mellitus

48

Mean +/- SD (the same applies hereinafter) of age (year), 14.3 +/- 1.7 (minimum: 11, maximum: 17); weight (kg), 74.61 +/- 18.41; BMI, 28.74 +/- 5.37; duration of disease (year), 2.13 +/- 1.65; HbA1c (%), 8.87 +/- 1.15. The proportion of patients with concomitant metformin was 68.8%.

A total of 49 patients were randomized at treatment period I and one of these patients in TS-071 2.5 mg group was discontinued before the initiation of investigational drug administration due to protocol violation. 48 patients completed treatment period I and transitioned to treatment period II. 3 patients were discontinued in treatment period II due to adverse events (2 patients) and other reason (1 patient) and 45 patients completed the study.

The adverse events were observed in 41 of 48 patients (85.4%) and the serious adverse events were observed in 3 patients (6.3%).

As the primary endpoint, mean change (95% CI) of HbA1c (%) from baseline at the end of treatment period I in TS-071 2.5 mg group was -1.45 (-1.78 to -1.11). The upper limit of 95% CI fell below 0.00%, indicating the significant decrement in HbA1c.

The efficacy of TS-071 in pediatric type 2 diabetes was demonstrated and no new safety concern was observed.

Oct. 07, 2026

Sept. 05, 2026

https://doi.org/10.1159/hrp/adaag009

No

-

https://jrct.mhlw.go.jp/latest-detail/jRCT2031200244

Mita Seiji

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

shu_chiken@taisho.co.jp

Development Management Development Headquarters

Taisho Pharmaceutical Co., LTD.

3-24,1, Takada, Toshima-Ku, Tokyo

+81-3-3985-1118

shu_chiken@taisho.co.jp

Complete

Jan. 25, 2021

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Previous diagnosis of type 2 diabetes (outpatient)
2. Males and Females, ages 10 years of age, up to but not including 18 years of age at the time of obtaining informed consent
3. Treatment for type 2 diabetes is applicable to one of the following
a. Currently on stable diet and exercise for a minimum of 8 weeks prior to Visit 1 (Week - 4)
b. In addition to stable diet and exercise, currently on stable and within the approved dose of metformin for a minimum of 8 weeks prior to Visit 1 (Week - 4)
4. HbA1c >= 7.0% and <= 12.0% measured at Visit 1 (Week - 4)
5. For all HbA1c measured within 8 weeks prior to Visit 1 (Week - 4), the difference from HbA1c measured at Visit 1 (Week - 4) is within 1.0%
6. Fasting plasma glucose >= 126 mg/dL and < 250 mg/dL measured at Visit 1 (Week - 4)

1. Concurrent diabetes mellitus other than type 2 (type 1 diabetes mellitus, diabetes mellitus due to some specific mechanism/condition other than type 2, or gestational diabetes mellitus)
2. Presense of either: pancreatic island-related autoantibodies [glutamic acid decarboxylase (GAD) antibody, insulinoma-associated protein-2 (IA-2) antibody, zinc transporter 8 (ZnT-8) antibody, insulin autoantibody]
3. Any concurrent endocrine disease other than diabetes mellitus that may have an effect on plasma glucose (such as diseases associated with an abnormality in thyroid function)
4. Current use of the following medications within 8 weeks before Visit 1 (Week - 4)
- antidiabetic drugs except for metformin
- corticosteroids (excluding topical administration such as external use, nasal drops and eye drops)
5. Patients who developed diabetic ketoacidosis multiple times within 1 year before obtaining informed consent
6. Concurrent severe diabetic microangiopathy (e.g., preproliferative or proliferative diabetic retinopathy, or diabetic neuropathy whose symptoms cannot be adequately controlled in spite of continuous pharmacotherapy, or other complications)
7. Concurrent or history of Diabetic macrovascular disease (cerebrovascular accident, coronary artery disease, peripheral arterial disease)
8. A history of nephrectomy or renal transplantation
9. Any concurrent renal disease requiring aggressive treatment (administration of medications such as adrenocorticosteroids or immunosuppressive agents);
10. Estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2 (after rounding to the nearest integer) consecutively at Visit 1 (Week - 4)
11. A concurrent urinary tract infection or genital infection
12. Patients with an evident urination disorder due to neuropathic bladder, prostatic hypertrophy, or other urinary or bladder disorders
13. ALT or AST > 2 times the upper limit of normal measured at visit 1(Week -4)
14. Patients whose blood pressure was poorly controlled, with a systolic blood pressure (SBP) > 170 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Visit 1 (Week - 4)

Both

Type 2 diabetes mellitus

-Treatment period I: TS-071 2.5 mg or Placebo orally once daily
-Treatment period II: TS-071 2.5 mg orally once daily (the dose could be increased to 5 mg)

HbA1c

HbA1c, fasting blood glucose, body weight

+81-54-247-6251

Jan. 04, 2021

none