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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 2

Phase 1

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: TA-7284

Drug: Placebo of TA-7284

Study type

Interventional

Funder types

Industry

Identifiers

NCT00707954

TA-7284-02

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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