Status:
COMPLETED
Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin
Eligibility Criteria
Inclusion
- Male or women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
- Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
- HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial \[DCCT\] standard)
Exclusion
- History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00817778
Start Date
January 1 2009
End Date
July 1 2009
Last Update
November 16 2012
Active Locations (1)
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1
Research Site
San Antonio, Texas, United States