Status:
COMPLETED
Safety and Tolerability of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients Treated With Metformin and Sulfonylurea
Lead Sponsor:
AstraZeneca
Conditions:
Type II Diabetes Mellitus
Eligibility:
All Genders
30-75 years
Phase:
PHASE1
Brief Summary
The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.
Eligibility Criteria
Inclusion
- Male or females of non-childbearing potential
- Patients treated with a combination of Metformin and SU (glyburide, glimepiride, glibenclamide, glipizide or gliclazide) in stable doses for at least 2 months prior to enrolment visit
- Patients should have FPG in the range of 6,0 to 14 mmol/L (108 to 250 mg/dL) at enrolment and on the morning of randomisation
Exclusion
- History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
- Impaired renal function in terms of GFR\<60 ml/min
- Use of insulin, glitazones, gemfibrozil, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent CYP450 inhibitors, e.g., ketoconazole within 14 days before randomisation
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00995787
Start Date
October 1 2009
End Date
February 1 2010
Last Update
February 26 2010
Active Locations (1)
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1
Research Site
San Diego, California, United States