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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

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

No

none