Status:
COMPLETED
To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.
Eligibility Criteria
Inclusion
- Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
- A body mass index (BMI) of 19 to 27 kg/m2.
- Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
Exclusion
- Renal dysfunction GFR \< 60 mL/min.
- Systolic pressure (SBP) \> 160 mmHg or diastolic pressure (DBP) \> 95 mmHg
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
- History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00916604
Start Date
May 1 2009
End Date
October 1 2009
Last Update
November 3 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Fukuoka, Japan
2
Research Site
Tokyo, Japan