Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients

NCT ID: NCT00707954

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-02-28

Brief Summary

The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TA-7284

Group Type: EXPERIMENTAL

TA-7284

Intervention Type: DRUG

Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)

Placebo of TA-7284

Group Type: PLACEBO_COMPARATOR

Placebo of TA-7284

Intervention Type: DRUG

Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)

Interventions

TA-7284

Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)

Intervention Type: DRUG

Placebo of TA-7284

Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinically stable Type 2 Diabetes Mellitus
• Females without childbearing potential
• Body mass index (BMI) >= 18.5 kg/m2 and <= 39.9 kg/m2
• Hemoglobin A1c levels >= 6.5% and <= 10%
• Fasting blood glucose levels >= 140 mg/dL and <= 270 mg/dL
• Systolic blood pressure >= 95 mmHg and <= 160 mmHg, and diastolic blood pressure >= 50 mmHg and <= 100 mmHg, and pulse rate >= 50 bpm
• Patients who have not been administered anti-diabetic medication within 2 weeks Prior to dosing
• Medicines if necessary for Hypertension or Dyslipidemia should be administered with stable dosage at least 3 months
• Treatment with diet and exercise should be unchanged for more than 3 months

Exclusion Criteria

• Type 1 Diabetes Mellitus or Secondary Diabetic Mellitus
• History of diabetic complications which need treatment
• Treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
• Serum creatinine > upper limit of the normal range
• Patients with significant complications

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

P-One Clinic

Hachiōji, Tokyo-to, Japan

Countries

Japan

References

Iijima H, Kifuji T, Maruyama N, Inagaki N. Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Aug;32(8):768-82. doi: 10.1007/s12325-015-0234-0. Epub 2015 Aug 18.

Reference Type: DERIVED

PMID: 26280756 (View on PubMed)

Other Identifiers

TA-7284-02

Identifier Type: -

Identifier Source: org_study_id