Status:
COMPLETED
Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-65 years
Phase:
PHASE1
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00707954
Start Date
June 1 2008
End Date
February 1 2009
Last Update
January 8 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
P-One Clinic
Hachiōji, Tokyo-to, Japan